[Title 21 CFR 522]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)]
[Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS]
[Part 522 - IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
6
1996-04-01
1996-04-01
false
IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
522
PART 522
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
Sec.
522.23 Acepromazine maleate injection.
522.44 Sterile sodium acetazolamide.
522.46 Alfaprostol.
522.56 Amikacin sulfate injection.
522.62 Aminopentamide hydrogen sulfate injection.
522.82 Aminopropazine fumarate sterile solution injection.
522.88 Sterile amoxicillin trihydrate for suspension.
522.90 Ampicillin implantation and injectible dosage forms.
522.90a Ampicillin trihydrate sterile suspension.
522.90b Ampicillin trihydrate for sterile suspension.
522.90c Ampicillin sodium for aqueous injection.
522.144 Arsenamide sodium aqueous injection.
522.150 Azaperone injection.
522.161 Betamethasone acetate and betamethasone disodium phosphate
aqueous suspension.
522.163 Betamethasone dipropionate and betamethasone sodium phosphate
aqueous suspension.
522.204 Boldenone undecylenate injection.
522.234 Butamisole hydrochloride.
522.246 Butorphanol tartrate injection.
522.281 Calcium disodium edetate injection.
522.311 Carfentanil citrate injection.
522.313 Ceftiofur sterile powder for injection.
522.380 Chloral hydrate, pentobarbital, and magnesium sulfate sterile
aqueous solution.
522.390 Chloramphenicol injection.
522.460 Cloprostenol sodium.
522.480 Repository corticotropin injection.
522.518 Cupric glycinate injection.
522.536 Detomidine hydrochloride injection.
522.540 Dexamethasone injection.
522.542 Dexamethasone-21-isonicotinate suspension.
522.563 Diatrizoate meglumine and diatrizoate sodium injection.
522.575 Diazepam injection.
522.650 Dihydrostreptomycin sulfate injection.
522.690 Dinoprost tromethamine sterile solution.
522.723 Diprenorphine hydrochloride injection.
522.740 Disophenol sodium injection.
522.775 Doxapram hydrochloride injection.
522.784 Doxylamine succinate injection.
522.800 Droperidol and fentanyl citrate injection.
522.812 Enrofloxacin solution.
522.820 Erythromycin injection.
522.840 Estradiol.
522.842 Estradiol benzoate and testosterone propionate in combination.
522.850 Estradiol valerate and norgestomet in combination.
522.863 Ethylisobutrazine hydrochloride injection.
522.883 Etorphine hydrochloride injection.
522.900 Euthanasia solution.
522.914 Fenprostalene solution.
522.940 Colloidal ferric oxide injection.
522.960 Flumethasone implantation or injectable dosage forms.
522.960a Flumethasone suspension.
522.960b Flumethasone acetate injection.
522.960c Flumethasone solution.
522.970 Flunixin meglumine solution.
522.995 Fluprostenol sodium injection.
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522.1002 Follicle stimulating hormone.
522.1010 Furosemide injection.
522.1020 Gelatin solution.
522.1044 Gentamicin sulfate injection.
522.1055 Gleptoferron injection.
522.1066 Glycopyrrolate injection.
522.1077 Gonadorelin injectable.
522.1078 Gonadorelin diacetate tetrahydrate injection.
522.1079 Serum gonadotropin and chorionic gonadotropin.
522.1081 Chorionic gonadotropin for injection; chorionic gonadotropin
suspension.
522.1085 Guaifenesin sterile powder.
522.1086 Guaifenesin injection.
522.1145 Hyaluronate sodium injection.
522.1150 Hydrochlorothiazide injection.
522.1155 Imidocarb dipropionate sterile powder.
522.1182 Iron dextran complex injection.
522.1183 Iron hydrogenated dextran injection.
522.1192 Ivermectin injection.
522.1193 Ivermectin and clorsulon injection.
522.1204 Kanamycin sulfate injection.
522.1222 Ketamine hydrochloride injectable dosage forms.
522.1222a Ketamine hydrochloride injection.
522.1222b Ketamine hydrochloride with promazine hydrochloride and
aminopentamide hydrogen sulfate injection.
522.1225 Ketoprofen solution.
522.1228 [Reserved]
522.1244 Levamisole phosphate injection.
522.1258 Lidocaine injection with epinephrine.
522.1260 Lincomycin injection.
522.1290 Luprostiol sterile solution.
522.1350 Melatonin implant.
522.1362 Melarsomine dihydrochloride for injection.
522.1372 Mepivacaine hydrochloride injection.
522.1380 Methocarbamol injection.
522.1410 Sterile methylprednisolone acetate suspension.
522.1452 Nalorphine hydrochloride injection.
522.1462 Naloxone hydrochloride injection.
522.1468 Naproxen for injection.
522.1484 Neomycin sulfate sterile solution.
522.1503 Neostigmine methylsulfate injection.
522.1610 Oleate sodium solution.
522.1620 Orgotein for injection.
522.1642 Oxymorphone hydrochloride injection.
522.1660 Oxytetracycline injection.
522.1662 Oxytetracycline hydrochloride implantation or injectable
dosage forms.
522.1662a Oxytetracycline hydrochloride injection.
522.1662b Oxytetracycline hydrochloride with lidocaine injection.
522.1680 Oxytocin injection.
522.1696 Penicillin G procaine implantation and injectable dosage
forms.
522.1696a Penicillin G benzathine and penicillin G procaine sterile
suspension.
522.1696b Penicillin G procaine aqueous suspension.
522.1696c Penicillin G procaine in oil.
522.1698 Pentazocine lactate injection.
522.1704 Sodium pentobarbital injection.
522.1720 Phenylbutazone injection.
522.1820 Pituitary luteinizing hormone for injection.
522.1850 Polysulfated glycosaminoglycan.
522.1862 Sterile pralidoxime chloride.
522.1870 Praziquantel injectable solution.
522.1881 Sterile prednisolone acetate aqueous suspension.
522.1883 Prednisolone sodium phosphate injection, sterile.
522.1884 Prednisolone sodium succinate injection.
522.1885 Prednisolone tertiary butylacetate suspension.
522.1890 Sterile prednisone suspension.
522.1920 Prochlorperazine, isopropamide for injection.
522.1940 Progesterone and estradiol benzoate in combination.
522.1962 Promazine hydrochloride injection.
522.2002 Propiopromazine hydrochloride injection.
522.2012 Prostalene solution.
522.2022 Protokylol hydrochloride injection.
522.2063 Pyrilamine maleate injection.
522.2095 Sarafloxacin solution for injection.
522.2100 Selenium, vitamin E injection.
522.2112 Sterile sometribove zinc suspension.
522.2120 Spectinomycin injection.
522.2150 Stanozolol sterile suspension.
522.2200 Sulfachlorpyridazine.
522.2220 Sulfadimethoxine injection.
522.2240 Sulfaethoxypyridazine.
522.2260 Sulfamethazine injectable solution.
522.2340 Sulfomyxin.
522.2404 Thialbarbitone sodium for injection.
522.2424 Sodium thiamylal for injection.
522.2444 Sodium thiopental implantation or injectable dosage forms.
522.2444a Sodium thiopental for injection.
522.2444b Sodium thiopental, sodium pentobarbital for injection.
522.2470 Tiletamine hydrochloride and zolazepam hydrochloride for
injection.
522.2471 Tilmicosin phosphate injection.
522.2476 Trenbolone acetate.
522.2477 Trenbolone acetate and estradiol.
522.2478 Trenbolone acetate and estradiol benzoate.
522.2480 Triamcinolone injection.
522.2483 Sterile triamcinolone acetonide suspension.
522.2582 Triflupromazine hydrochloride injection.
522.2610 Trimethoprim and sulfadiazine sterile suspension.
522.2615 Tripelennamine hydrochloride injection.
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522.2640 Tylosin injectable dosage forms.
522.2640a Tylosin injection.
522.2640b Tylosin tartrate for injection.
522.2662 Xylazine hydrochloride injection.
522.2670 Yohimbine injectable.
522.2680 Zeranol.
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b).
Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
Sec. 522.23 Acepromazine maleate injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 10 milligrams of acepromazine maleate.
(b) Conditions of use. See No. 000856 in Sec. 510.600(c) of this
chapter for use in dogs, cats, and horses as follows:
(1) Indications for use. It is used in dogs, cats, and horses as a
tranquilizer.
(2) Amount. Dogs: 0.25 to 0.5 milligram per pound of body weight;
Cats: 0.5 to 1.0 milligram per pound of body weight; Horses: 2.0 to 4.0
milligrams per 100 pounds of body weight.
(c) Conditions of use. See No. 054273 in Sec. 510.600(c) of this
chapter for use in dogs as follows:.
(1) Indications for use. It is used in dogs as an aid in
tranquilization and as a preanesthetic agent.
(2) Amount. Dogs: 0.25 to 0.5 milligram per pound of body weight.
(3) Limitations. The drug is administered intravenously,
intramuscularly or subcutaneously with the dosage individualized
depending upon the degree of tranquilization required. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[46 FR 43831, Sept. 1, 1981, as amended at 53 FR 40727, Oct. 18, 1988]
Sec. 522.44 Sterile sodium acetazolamide.
(a) Specifications. Sterile sodium acetazolamide contains
acetazolamide sodium complying with United States Pharmacopeia as a
sterile powder with directions for reconstituting the product with
sterile distilled water to furnish a product having a concentration of
100 milligrams acetazolamide activity per milliliter.
(b) Sponsor. See No. 010042 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used as an aid in the treatment of
dogs with mild congestive heart failure and for rapid reduction of
intraocular pressure.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(2) It is administered intramuscularly or intraperitoneally to dogs
at a level of 5 to 15 milligrams per pound of body weight daily
preferably administered in two or more divided doses.\1\
(3) For use only by or on the order of a licensed veterinarian.\1\
Sec. 522.46 Alfaprostol.
(a) Specifications. Each milliliter of sterile solution contains 1
milligram of alfaprostol.
(b) Sponsor. No. 055882 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. It is used in horses as follows:
(1) Amount. For average mature mares, 6.0 micrograms per kilogram of
body weight.
(2) Indications for use. To cause luteolysis in mares with active
corpora lutea.
(3) Limitations. For intramuscular or subcutaneous use as a single
injection. Not for horses intended for food. Alfaprostol is readily
absorbed through the skin and can cause abortion and/or bronchial
spasms. Women of childbearing age, asthmatics, and persons with
bronchial and other respiratory problems should exercise extreme caution
when handling this product. Federal law restricts this drug to use by or
on the order of a licensed veterinarian.
[48 FR 43300, Sept. 23, 1983, as amended at 53 FR 40057, Oct. 13, 1988]
Sec. 522.56 Amikacin sulfate injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 50 milligrams of amikacin (as the sulfate).
(b) Sponsor. See 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. 5 milligrams per pound of body
weight twice daily.
(2) Indications for use. The drug is used in dogs for treatment of
[[Page 244]]
genitourinary tract infections (cystitis) caused by susceptible strains
of Escherichia coli and Proteus spp. and skin and soft tissue infections
caused by susceptible strains of Pseudomonas spp. and E. coli.
(3) Limitations. The drug is administered intramuscularly or
subcutaneously. Treat dogs with skin and soft tissue infections for a
minimum of 7 days and those with genitourinary infections for 7 to 21
days or until culture is negative and asymptomatic. If no response is
observed after 3 days of treatment, therapy should be discontinued and
the case reevaluated. Maximum duration of therapy should not exceed 30
days. Systemic aminoglycoside therapy is contraindicated in dogs with
seriously impaired renal function. Not for use in breeding dogs as
reproductive studies have not been conducted. Use with extreme caution
in dogs in which hearing acuity is required for functioning. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[52 FR 11816, Apr. 13, 1987; 52 FR 15412, Apr. 28, 1987, as amended at
53 FR 27851, July 25, 1988]
Sec. 522.62 Aminopentamide hydrogen sulfate injection.
(a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide hydrogen
sulfate.
(b) Specifications. It is sterile and each milliliter of aqueous
solution contains 0.5 milligram of the drug.
(c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) It is intended for use in dogs and cats
only for the treatment of vomiting and/or diarrhea, nausea, acute
abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.
Note: Not for use in animals with glaucoma because of the occurrence
of mydriasis.
(2) Dosage is administered by subcutaneous or intramuscular
injection every 8 to 12 hours, as follows:
------------------------------------------------------------------------
Dosage in
Weight of animal in pounds milligrams
------------------------------------------------------------------------
Up to 10.................................................... 0.1
11 to 20.................................................... 0.2
21 to 50.................................................... 0.3
51 to 100................................................... 0.4
Over 100.................................................... 0.5
------------------------------------------------------------------------
Dosage may be gradually increased up to a maximum of five times the
suggested dosage. Following parenteral use dosage may be continued by
oral administration of tablets.
(3) For use only by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988
Sec. 522.82 Aminopropazine fumarate sterile solution injection.
(a) Specifications. Each milliliter of aminopropazine fumarate
sterile aqueous solution, veterinary, contains aminopropazine fumarate
equivalent to 25 milligrams of aminopropazine base.
(b) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used for reducing excessive
smooth muscle contractions, such as occur in urethral spasms associated
with urolithiasis in cats and dogs and in colic spasms in horses.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(2) It is administered intramuscularly or intravenously to dogs and
cats at a level of 1 to 2 milligrams per pound of body weight. It is
administered intramuscularly or intravenously to horses at a level of
0.25 milligrams per pound of body weight. Dosage can be repeated every
12 hours, as indicated.\1\
(3) Not for use in animals intended for food purposes.\1\
(4) For use only by or on the order of a licensed veterinarian.\1\
[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61
FR 8873, Mar. 6, 1996]
Sec. 522.88 Sterile amoxicillin trihydrate for suspension.
(a) (1) Specifications. Each vial contains 3 grams of amoxicillin as
the trihydrate. The powder is reconstituted with sterile water for
injection USP to
[[Page 245]]
a concentration of 100 or 250 milligrams per milliliter for use as in
paragraph (d) of this section.
(2) Each vial contains 25 grams of amoxicillin as the trihydrate.
The powder is reconstituted with sterile water for injection USP to a
concentration of 250 milligrams per milliliter for use as in paragraph
(e).
(b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
(c) Related tolerance. See Sec. 556.38 of this chapter.
(d) Conditions of use in dogs and cats--(1) Amount. 5 milligrams per
pound of body weight daily.
(2) Indications for use--(i) Dogs. Treatment of infections caused by
susceptible strains of organisms as follows: Respiratory infections
(tonsillitis, tracheobronchitis) due to Staphylococcus aureus,
Streptococcus spp., Escherichia coli, and Proteus mirabilis;
genitourinary infections (cystitis) due to S. aureus, Streptococcus
spp., E. coli, and P. mirabilis; gastrointestinal infections (bacterial
gastroenteritis) due to S. aureus, Streptococcus spp., E. coli, and P.
mirabilis; bacterial dermatitis due to S. aureus, Streptococcus spp.,
and P. mirabilis; soft tissue infections (abscesses, lacerations, and
wounds), due to S. aureus, Streptococcus spp., E. coli, and P.
mirabilis.
(ii) Cats. Treatment of infections caused by susceptible strains of
organisms as follows: Upper respiratory infections due to S. aureus,
Staphylococcus spp., Streptococcus spp., Hemophilus spp., E. coli,
Pasteurella spp., and P. mirabilis; genitourinary infections (cystitis)
due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and
Corynebacterium spp.; gastrointestinal infections due to E. coli,
Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft
tissue infections (abscesses, lacerations, and wounds) due to S. aureus,
Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella
multocida.
(3) Limitations. For use in dogs and cats only. Administer once
daily for up to 5 days by intramuscular or subcutaneous injection.
Continue treatment for 48 hours after the animal has become afebrile or
asymptomatic. If no improvement is seen within 5 days, review the
diagnosis and change therapy. As with all antibiotics, appropriate in
vitro culturing susceptibility testing of samples taken before treatment
should be conducted. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(e) Condition of use. Cattle--(1) Amount. 3 to 5 milligrams per
pound of body weight once a day according to the animal being treated,
the severity of infection, and the animal's response.
(2) Indications for use.--Treatment of diseases due to amoxicillin-
susceptible organisms as follows: Respiratory tract infections (shipping
fever, pneumonia) due to P. multocida, P. hemolytica, Hemophilus spp.,
Staphylococcus spp., and Streptococcus spp. and acute necrotic
pododermatitis (foot rot) due to Fusobacterium necrophorum.
(3) Limitations. Administer once daily for up to 5 days by
intramuscular or subcutaneous injection. Continue treatment for 48 to 72
hours after the animal has become afebrile or asymptomatic. Do not
continue treatment beyond 5 days. Treated animals must not be
slaughtered for food during treatment and for 25 days after the last
treatment. As with all antibiotics, appropriate in vitro culturing and
susceptibility testing of samples taken before treatment should be
conducted. Milk from treated cows must not be used for human consumption
during treatment or for 96 hours (8 milkings) after last treatment.
Maximum volume per injection should not exceed 30 milliliters. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
[57 FR 37330, Aug. 18, 1992; 60 FR 55659, Nov. 2, 1995]
Sec. 522.90 Ampicillin implantation and injectible dosage forms.
Sec. 522.90a Ampicillin trihydrate sterile suspension.
(a) Specifications. Each milliliter contains ampicillin trihydrate
equivalent to 200 milligrams of ampicillin.
(1) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(2) Related tolerances. See Sec. 556.40 of this chapter.
(3) Conditions of use--(i) Calves.
(A) Amount. For enteritis: 3 milligrams per pound of body weight,
[[Page 246]]
intramuscularly, once or twice daily, for up to 3 days. For pneumonia: 3
milligrams per pound of body weight, intramuscularly, twice daily, for
up to 3 days.
(B) Indications for use. Treatment of bacterial enteritis caused by
Escherichia coli and bacterial pneumonia caused by Pasteurella spp.
susceptible to ampicillin.
(C) Limitations. Not for use in other animals raised for food
production. Treated animals must not be slaughtered for food use during
treatment or for 9 days after the last treatment. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(ii) Dogs. (A) Amount. 3 to 6 milligrams per pound of body weight
intramuscularly, once or twice daily.
(B) Indications for use. Treatment of respiratory tract infections
due to E. coli, Pseudomonas spp., Proteus spp., Staphylococcus spp., and
Streptococcus spp.; tonsillitis due to E. coli, Pseudomonas spp.,
Streptococcus spp., and Staphylococcus spp.; generalized infections
(septicemia) associated with abscesses, lacerations, and wounds due to
Staphylococcus spp. and Streptococcus spp.
(C) Limitations. Continue treatment at least 48 hours after the
animal's temperature has returned to normal and other signs of infection
have subsided. Usual treatment is 3 to 5 days. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(iii) Cats. (A) Amount. 5 to 10 milligrams per pound of body weight
intramuscularily or subcutaneously, once or twice daily.
(B) Indications for use. Treatment of generalized infections
(septicemia) associated with abscesses, lacerations, and wounds due to
Staphylococcus spp., Streptococcus spp., and Pasteurella spp.
(C) Limitations. Continue treatment at least 48 hours after the
animal's temperature has returned to normal and other signs of infection
have subsided. Usual treatment is 3 to 5 days. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(iv) Swine. (A) Amount. 3 milligrams per pound of body weight,
intramuscularily, once or twice daily, for up to 3 days.
(B) Indications for use. Treatment of bacterial enteritis
(colibacillosis) caused by E. coli and bacterial pneumonia caused by
Pasteurella spp. susceptible to ampicillin.
(C) Limitations. Treated animals must not be slaughtered for food
use during treatment or for 15 days after the last treatment. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(b) Specifications. Each milliliter contains ampicillin trihydrate
equivalent to 150 milligrams of ampicillin.
(1) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(2) Related tolerances. See Sec. 556.40 of this chapter.
(3) Conditions of use. Dogs--(i) Amount. 3 to 5 milligrams of
ampicillin per pound of body weight, once a day for up to 4 days.
(ii) Indications for use. Treatment of bacterial infections of the
upper respiratory tract (tonsillitis) due to Streptococcus spp.,
Staphylococcus spp., E. coli, Proteus spp., and Pasteurella spp., and
soft tissue infections (abscesses, lacerations, and wounds) due to
Staphylococcus spp., Streptococcus spp., and E. coli, when caused by
susceptible organisms.
(iii) Limitations. Administer intramuscularly. If continued
treatment is indicated, oral dosage is recommended. As with all
antibiotics, appropriate in vitro culturing and susceptibility tests of
samples taken before treatment are recommended. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
[57 FR 37330, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]
Sec. 522.90b Ampicillin trihydrate for sterile suspension.
(a) Specifications. When reconstituted, each milliliter contains
ampicillin trihydrate equivalent to 50, 100, or 250 milligrams of
ampicillin.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.40 of this chapter.
(d) Conditions of use. (1) Dogs--(i) Amount. 3 milligrams per pound
of body weight twice daily.
[[Page 247]]
(ii) Indications for use. Treatment against strains of organisms
susceptible to ampicillin and associated with respiratory tract
infections, urinary tract infections, gastrointestinal infections, skin
infections, soft tissue infections, and postsurgical infections.
(iii) Limitations. Administer by subcutaneous or intramuscular
injection. Treatment should be continued for 48 to 72 hours after the
animal has become afebrile or asymptomatic. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(2) Cats--(i) Amount. 3 milligrams per pound of body weight twice
daily.
(ii) Indications for use. Treatment against strains of organisms
susceptible to ampicillin and associated with respiratory tract
infections, urinary tract infections, gastrointestinal infections, skin
infections, soft tissue infections, and postsurgical infections.
(iii) Limitations. Administer by subcutaneous or intramuscular
injection. Treatment should be continued for 48 to 72 hours after the
animal has become afebrile or asymptomatic. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(3) Cattle--(i) Amount. 2 to 5 milligrams per pound of body weight
once daily by intramuscular injection.
(ii) Indications for use. Treatment of respiratory tract infections
caused by organisms susceptible to ampicillin, bacterial pneumonia
(shipping fever, calf pneumonia, and bovine pneumonia) caused by
Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus
spp., Pasteurella multocida, and Escherichia coli.
(iii) Limitations. Do not treat cattle for more than 7 days. Milk
from treated cows must not be used for food during treatment and for 48
hours (4 milkings) after the last treatment. Cattle must not be
slaughtered for food during treatment and for 144 hours (6 days) after
the last treatment. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
[57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304,
Apr. 8, 1993]
Sec. 522.90c Ampicillin sodium for aqueous injection.
(a) Specifications. When reconstituted, each milliliter contains
ampicillin sodium equivalent to 300 milligrams of ampicillin.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. Horses--(1) Amount: 3 milligrams per pound of
body weight twice daily.
(2) Indications for use. Treatment of respiratory tract infections
(pneumonia and strangles) due to Staphylococcus spp., Escherichia coli,
and Proteus mirabilis, and skin and soft tissue infections (abscesses
and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and
P. mirabilis, when caused by susceptible organisms.
(3) Limitations. Administer either intravenously or intramuscularly.
Treatment should be continued 48 hours after all symptoms have subsided.
If no response is seen in 4 to 5 days, reevaluate diagnosis. Not for use
in horses or other animals which are raised for food production. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
[57 FR 37331, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]
Sec. 522.144 Arsenamide sodium aqueous injection.
(a) Chemical name. [[(p-Carbamoylphenyl) arsylene]dithio diacetic
acid, sodium salt.
(b) Specifications. The drug is a sterile aqueous solution and each
milliliter contains 10.0 milligrams of arsenamide sodium.
(c) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) For the treatment and prevention of
canine heartworm disease caused by Dirofilaria immitis.
(2) It is administered intravenously at 0.1 milliliter per pound of
body weight (1.0 milliliter for every 10 pounds) twice a day for 2 days.
For dogs in poor condition, particularly those with evidence of reduced
liver function, a more conservative dosage schedule of 0.1 milliliter
per pound of body weight daily for 15 days is recommended.
(3) Restricted to use only by or on the order of a licensed
veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 43 FR 27785, June 27, 1978;
45 FR 56798, Aug. 26, 1980; 55 FR 26683, June 29, 1990]
[[Page 248]]
Sec. 522.150 Azaperone injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 40 milligrams of azaperone.
(b) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Indications for use. Control of
aggressiveness when mixing or regrouping weanling or feeder pigs
weighing up to 80 pounds.
(2) Dosage. 2.2 milligrams per kilogram (1 milligram per pound).
(3) Limitations. Inject by deep intramuscular injection. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[48 FR 48229, Oct. 18, 1983]
Sec. 522.161 Betamethasone acetate and betamethasone disodium phosphate aqueous suspension.
(a) Chemical names. Betamethasone acetate: 9--Fluoro-16-
-methylprednisolone - 21 - acetate (C24H31F O6).
Betamethasone disodium phosphate: 9--Fluoro-16--
methylprednisolone-21-disodium phosphate (C22H28F
Na2O8P).
(b) Specifications. The drug is a sterile aqueous suspension and
each cubic centimeter contains: 12 milligrams of betamethasone acetate
(equivalent to 10.8 milligrams of betamethasone), 3.9 milligrams of
betamethasone disodium phosphate (equivalent to 3 milligrams of
betamethasone), 2 milligrams of dibasic sodium phosphate, 5 milligrams
of sodium chloride, 0.1 milligram of disodium EDTA, 0.5 milligram of
polysorbate 80, 9 milligrams of benzyl alcohol, 5 milligrams of sodium
carboxymethylcellulose, 1.8 milligrams of methylparaben, 0.2 milligram
of propylparaben, hydrochloric acid and/or sodium hydroxide to adjust
pH, and water for injection q.s.
(c) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. It is used or intended for use by intra-
articular injection of horses for the treatment of various inflammatory
joint conditions; for example, acute and traumatic lameness involving
the carpel and fetlock joints. Administer from 2.5 to 5 cubic
centimeters per dose. Dose may be repeated when necessary depending upon
the duration of relief obtained. Not for use in horses intended for
food. For use only by or on the order of a licensed veterinarian.
[40 FR13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987]
Sec. 522.163 Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension.
(a) Specifications. Betamethasone dipropionate and betamethasone
sodium phosphate aqueous suspension is a sterile aqueous suspension.
Each milliliter of the suspension contains the equivalent of 5
milligrams of betamethasone as betamethasone dipropionate and 2
milligrams of betamethasone as betamethasone sodium phosphate.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs. (i) It is used as an aid in the
control of pruritus associated with dermatoses.
(ii) It is administered by intramuscular injection at a dosage of
0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the
severity of the condition. Frequency of dosage depends on recurrence of
pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms
recur, not to exceed a total of 4 injections.
(2) Horses. (i) It is used as an aid in the control of inflammation
associated with various arthropathies.
(ii) It is administered aseptically by intraarticular injection at a
dosage of 2.5 to 5 milliliters per joint, depending on the severity of
the condition and the joint size. Dosage may be repeated upon recurrence
of clinical signs. Injection into the joint cavity should be preceded by
withdrawal of synovial fluid.
(iii) Not for use in horses intended for food.
(3) Clinical and experimental data. It has been demonstrated that
corticosteroids administered orally or parenterally to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
[[Page 249]]
(4) Restrictions. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 27316, July 2, 1976; 52
FR 7832, Mar. 13, 1987]
Sec. 522.204 Boldenone undecylenate injection.
(a) Specifications. Each milliliter contains 25 or 50 milligrams of
boldenone undecylenate in a sesame oil base.
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is intended for use as an aid in
treating debilitated horses following disease or overwork and
overexertion when an improvement in weight, hair coat, or general
physical condition is desired. The drug is given only as adjunctive
therapy to other specific and supportive therapy for diseases, surgical
cases, and traumatic injuries. Optimal results can be expected only when
good management and feeding practices are followed.
(2) It is administered intramuscularly at a dosage level of 0.5
milligram per pound of body weight. Treatment may be repeated at 3-week
intervals.
(3) For use in horses only. Do not administer to horses intended for
use as food. The effectiveness of the drug in stallions and pregnant
mares has not been established, nor has the drug been shown not to be
teratogenic in pregnant mares; therefore, this drug should not be used
in stallions and pregnant mares.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985]
Sec. 522.234 Butamisole hydrochloride.
(a) Specifications. The drug contains 11 milligrams of butamisole
per milliliter in a solution consisting of 70 percent propylene glycol,
4 percent benzyl alcohol and distilled water.
(b) Sponsor. See Nos. 000859 and 043781 in Sec. 510.600(c) of this
chapter.
(c) Conditions of use. (1) The drug is administered by subcutaneous
injection to dogs for the treatment of infections with whipworms
(Trichuris vulpis), and the hookworm (Ancylostoma caninum).
(2) The drug is administered subcutaneously at the rate of 0.1
milliliter per pound of body weight. In problem cases, retreatment for
whipworms may be necessary in approximately 3 months. For hookworms, a
second injection should be given 21 days after the initial treatment.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[43 FR 15625, Apr. 14, 1978. Redesignated at 43 FR 60883, Dec. 29, 1978,
and amended at 45 FR 29789, May 6, 1980; 51 FR 19329, May 29, 1986]
Sec. 522.246 Butorphanol tartrate injection.
(a) Specifications. Each milliliter of aqueous solution contains
either 0.5, 2 or 10 milligrams of butorphanol (as butorphanol tartrate).
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 0.025 milligram of
butorphanol base activity per pound of body weight (equivalent to 0.5
milliliter per 10 pounds), using 0.5 milligram per milliliter solution.
(ii) Indications for use. For the relief of chronic nonproductive
cough associated with tracheo-bronchitis, tracheitis, tonsillitis,
laryngitis, and pharyngitis associated with inflammatory conditions of
the upper respiratory tract.
(iii) Limitations. For subcutaneous injection in dogs only. Repeat
at intervals of 6 to 12 hours as required. If necessary, increase dose
to maximum of 0.05 milligram per pound of body weight. Treatment should
not normally be required for longer than 7 days. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(2) Horses--(i) Amount. 0.05 milligram of butorphanol base activity
per pound of body weight (0.1 milligram/kilogram) using 10 milligrams
per milliliter solution.
(ii) Indications for use. For the relief of pain associated with
colic and postpartum pain in adult horses and yearlings.
(iii) Limitations. For intravenous use in horses only. Dose may be
repeated
[[Page 250]]
within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use
in horses intended for food. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
(3) Cats--(i) Amount. 0.2 milligram of butorphanol base activity per
pound of body weight (0.4 milligram/kilogram), using 2 milligrams per
milliliter solution.
(ii) Indications for use. For the relief of pain in cats caused by
major or minor trauma, or pain associated with surgical procedures.
(iii) Limitations. For subcutaneous injection in cats only. Dose may
be repeated up to 4 times per day. Do not treat for more than 2 days.
Safety for use in pregnant female cats, breeding male cats or kittens
less than 4 months of age has not been determined. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
[45 FR 29276, May 2, 1980, as amended at 50 FR 24508, June 11, 1985; 53
FR 27851, July 25, 1988; 59 FR 41665, Aug. 15, 1994]
Sec. 522.281 Calcium disodium edetate injection.
(a) Specifications. Calcium disodium edetate injection contains 6.6-
percent calcium disodium edetate in purified water.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used as an aid in the treatment of
acute lead poisoning in horses.1
---------------------------------------------------------------------------
1 These conditions of use are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter.
---------------------------------------------------------------------------
(2) It is administered by slow intravenous injection at the rate of
1 milliliter per 2 pounds of body weight daily. It is best administered
in divided doses 2 to 3 times daily and continued for 3 to 5 days. If
additional treatment is indicated, a 2-day rest period is recommended
which may be followed by another 3- to 5-day period of therapy.1
(3) Do not use in horses intended for food purposes.1
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.1
[40 FR 13858, Mar. 27, 1975, as amended at 42 FR 65151, Dec. 30, 1977]
Sec. 522.311 Carfentanil citrate injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 3 milligrams of carfentanil citrate.
(b) Sponsor. See No. 053923 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. 5 to 20 micrograms per kilogram
(.005 to .020 milligram per kilogram) of body weight.
(2) Indications for use. For immobilizing free ranging and confined
members of the family Cervidae (deer, elk, and moose).
(3) Limitations. Inject into large muscle of neck, shoulder, back,
or hindquarter. Avoid intrathoracic, intra-abdominal, or subcutaneous
injection. To reverse effect, use 7 milligrams of diprenorphine for each
milligram of carefentanil citrate, given intravenously or one-half
intravenously and one-half intramuscularly or subcutaneously. Do not use
in domestic animals intended for food. Do not use 30 days before or
during hunting season. Do not use in animals that display clinical signs
of severe cardiovascular or respiratory disease. Available data are
inadequate to recommend use in pregnant animals. Avoid use during
breeding season. Federal law restricts this drug to use by or on the
order of a licensed veterinarian. The licensed veterinarian shall be a
veterinarian engaged in zoo and exotic animal practice, wildlife
management programs, or research.
[53 FR 40057, Oct. 13, 1988]
Sec. 522.313 Ceftiofur sterile powder for injection.
(a) Specifications. Ceftiofur sodium sterile powder for injection is
reconstituted to form an aqueous solution containing the equivalent of
50 milligrams ceftiofur per milliliter.
(b) Sponsor. See 000009 in Sec. 510.600 of this chapter.
(c) Related tolerances. See Sec. 556.113 of this chapter.
(d) Conditions of use--(1) Cattle--(i) Amount. 0.5 to 1.0 milligram
of ceftiofur per pound of body weight intramuscularly.
(ii) Indications for use. Treatment of bovine respiratory disease
(shipping fever, pneumonia) associated with
[[Page 251]]
Pasteurella hemolytica, P. multocida, and Haemophilus somnus in beef and
dairy cattle. Also, for the treatment of acute bovine interdigitial
necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium
necrophorum and Bacteroides melaninogenicus.
(iii) Limitations. Treatment should be repeated once every 24 hours
for 3 days. Treat for an additional 2 days if animals do not show a
satisfactory response. Do not use in animals previously found to be
hypersensitive to the drug. Use of doses in excess of those indicated
may result in illegal residues in tissues. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(2) Swine--(i) Amount. 3 to 5 milligrams per kilogram (1.36 to 2.27
milligrams per pound) of body weight.
(ii) Indications for use. For treatment and control of swine
bacterial respiratory disease (swine bacterial pneumonia) associated
with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella
multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.
(iii) Limitations. For intramuscular use only. Treatment should be
repeated at 24 hour intervals for a total of 3 consecutive days. Do not
use in animals previously found to be hypersensitive to the drug. Use of
dosages in excess of those indicated or route of administration other
than that recommended may result in illegal residues in tissues. Safety
of ceftiofur has not been determined in breeding swine. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(3) Day-old chickens--(i) Amount. 0.08 to 0.20 milligram per chick.
(ii) Indications for use. For control of colibacillosis associated
with E. coli sensitive to ceftiofur.
(iii) Limitations. For subcutaneous use in the neck of day-old
chicks only. As a single dose only. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
(4) Horses--(i) Amount. 2.2 to 4.4 milligrams per kilogram (1.0 to
2.0 milligrams per pound) of body weight.
(ii) Indications for use. For treatment of respiratory infections in
horses associated with Streptococcus zooepidemicus.
(iii) Limitations. For intramuscular use only. Treatment should be
repeated every 24 hours, continued for 48 hours after clinical signs
have disappeared, and should not exceed 10 days. A maximum of 10
milliliters should be administered per injection site. Not for use in
horses intended for food. Do not use in animals previously found to be
hypersensitive to the drug. Federal law restricts this drug to use by or
on the order of a licensed veterinarian.
(5) Dogs--(i) Amount. 1.0 milligrams per pound (2.2 milligrams per
kilogram) of body weight.
(ii) Indications for use. Treatment of canine urinary tract
infections associated with Escherichia coli and Proteus mirabilis.
(iii) Limitations. For subcutaneous use only. Treatment should be
repeated at 24-hour intervals, continued for 48 hours after clinical
signs have disappeared, for 5 to 14 days. Do not use in animals found to
be hypersensitive to the drug. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
[53 5369, Feb. 24, 1988, as amended at 55 FR 13768, Apr. 12, 1990; 56 FR
12119, Mar. 22, 1991; 57 FR 41862, Sept. 14, 1992; 59 FR 41666, Aug. 15,
1994; 59 FR 54518, Nov. 1, 1994; 60 FR 51719, Oct. 3, 1995]
Sec. 522.380 Chloral hydrate, pentobarbital, and magnesium sulfate sterile aqueous solution.
(a) [Reserved]
(b)(1) Specifications. Chloral hydrate, pentobarbital, and magnesium
sulfate sterile aqueous solution contains 42.5 milligrams of chloral
hydrate, 8.86 milligrams of pentobarbital, and 21.2 milligrams of
magnesium sulfate in each milliliter of sterile aqueous solution
containing water, 33.8 percent propylene glycol, and 14.25 percent ethyl
alcohol.
(2) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) It is used for general anesthesia and as
a sedative-relaxant in cattle and horses.
(ii) For intravenous use only. The drug is administered at a dosage
level of 20 to 50 milliliters per 100 pounds of body weight for general
anesthesia until the desired effect is produced. Cattle usually require
a lower dosage
[[Page 252]]
on the basis of body weight. When used as a sedative-relaxant, it is
administered at a level of one-fourth to one-half of the anesthetic
dosage level.
(iii) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 45 FR 16482, Mar. 14, 1980]
Sec. 522.390 Chloramphenicol injection.
(a) Specifications. Each milliliter contains 100 milligrams of
chloramphenicol.
(b) Sponsor. See Nos. 000069 and 050604 in Sec. 510.600(c) of this
chapter.
(c) Conditions of use. Dogs--(1) Amount. 5 to 15 milligrams per
pound of body weight, intramuscularly or intravenously, every 6 hours.
In severe infections, use 4 to 6 hour treatment intervals the first day.
If no response is obtained in 3 to 5 days, discontinue use and
reevaluate diagnosis.
(2) Indications for use. Treatment of infections of the respiratory
tract, the urinary tract, and enteritis and tonsillitis caused by
organisms susceptible to chloramphenicol.
(3) Limitations. Not for use in animals raised for food production.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[57 FR 37331, Aug. 18, 1992]
Sec. 522.460 Cloprostenol sodium.
(a)(1) Specifications. Each milliliter of the aqueous solution
contains 263 micrograms of cloprostenol sodium (equivalent to 250
micrograms of cloprostenol) in a sodium citrate, anhydrous citric acid
and sodium chloride buffer containing 0.1 percent w/v chlorocresol B.P.
as a bactericide.
(2) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. For intramuscular use in beef and dairy
cattle to induce luteolysis.
(i) Amount. 2 milliliters (equivalent to 500 micrograms of
cloprostenol).
(ii) Indications. (a) For scheduling estrus and ovulation to control
the time at which cycling cows or heifers can be bred.
(1) Single cloprostenol injection. Treat only animals with a mature
corpus luteum. Estrus should occur in 2 to 5 days, and cattle should be
inseminated at the usual time relative to the detection of estrus. If
estrus is not observed, treated animals may be inseminated either once
at 72 hours post injection or twice at 72 and 96 hours post injection.
(2) Double cloprostenol injection. Give cattle a second injection 11
days after the first injection. Estrus should occur 2 to 5 days after
the second injection, and cattle should be inseminated at the usual time
relative to the detection of estrus. If estrus is not observed, treated
animals may be inseminated either once at about 72 hours post injection
or twice at 72 and 96 hours following the second injection.
(b) Single cloprostenol injection for terminating unwanted
pregnancies from mismatings from 1 week after mating until 5 months
after conception, or for treating unobserved (nondetected) estrus,
mummified fetus, and luteal cysts.
(c) Single cloprostenol injection for the treatment of pyometra.
(iii) Do not administer to pregnant animals where the calf is not to
be aborted.
(iv) Women of childbearing age, asthmatics, and persons with
bronchial and other respiratory problems should exercise extreme caution
when handling this product. Cloprostenol is readily absorbed through the
skin and may cause abortion and/or bronchiospasms. Accidental spillage
on the skin should be washed off immediately with soap and water.
(v) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(b)(1) Specifications. Each milliliter of sterile aqueous solution
contains 131.5 micrograms of cloprostenol sodium (equivalent to 125
micrograms of cloprostenol).
(2) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(3) Special considerations. Labeling shall bear the statements
prescribed in paragraphs (a)(3) (iii) and (iv) of this section.
(4) Conditions of use--(i) Amount. 3 milliliters (equivalent to 375
micrograms of cloprostenol) intramuscularly per animal as a single dose.
[[Page 253]]
(ii) Indications for use. To induce abortion in pregnant feedlot
heifers from 1 week after mating until 4\1/2\ months of gestation.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
[47 FR 4678, Feb. 2, 1982, as amended at 48 FR 15619, Apr. 12, 1983; 49
FR 5100, Feb. 10, 1984; 49 FR 29957, July 25, 1984]
Sec. 522.480 Repository corticotropin injection.
(a)(1) Specifications. The drug conforms to repository corticotropin
injection U.S.P. It contains 40 or 80 U.S.C. (I.U.) units per cubic
centimeter.
(2) Sponsor. See No. 037990 in Sec. 510.600(c) of this chapter.
(3) Special considerations. The drug should be refrigerated. With
prolonged use supplement daily diet with potassium chloride at one gram
for small animals and from 5 to 10 grams for large animals.
(4) Conditions of use. (i) It is used as an intramuscular or
subcutaneous injection in cattle and small animals for stimulation of
the adrenal cortex where there is a general deficiency of corticotropin
(ACTH). It is also a therapeutic agent for primary bovine ketosis.
(ii) It is administered to cattle initially at 200 to 600 units
followed by a dose daily or every other day of 200 to 300 units and to
small animals at one unit per pound of body weight to be repeated as
indicated.
(iii) For use only by or on the order of a licensed veterinarian.
(b)(1) Specifications. The drug conforms to respository
corticotropin injection U.S.P. It contains 40 or 80 U.S.P. units per
milliliter.
(2) Sponsor. See No. 000864 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) For intramuscular injection in dogs as a
diagnostic aid to test for adrenal dysfunction. For intramuscular or
subcutaneous injection in dogs and cats for stimulation of the adrenal
cortex where there is a general deficiency of ACTH.
(ii) For diagnostic use: Administer at one unit per pound of body
weight intramuscularly. For therapeutic use: Administer at one unit per
pound of body weight intramuscularly or subcutaneously, initially, to be
repeated as indicated.
(iii) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(c) National Academy of Sciences/National Reserach Council (NAS/NRC)
status. The therapeutic indication for use has been reviewed by NAS/NRC
and found to be effective. Applications for this use need not include
effectiveness data as specified in Sec. 514.111 of this chapter, but may
require bioequivalency and safety information.
[40 FR 13858, Mar. 27, 1985, as amended at 50 FR 40966, Oct. 8, 1985; 53
FR 45760, Nov. 14, 1988]
Sec. 522.518 Cupric glycinate injection.
(a) Specifications. Each milliliter (mL) of sterile aqueous
suspension contains 200 milligrams of cupric glycinate (equivalent to 60
milligrams of copper).
(b) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. 200 milligrams (1 mL) for calves
300 pounds and under; 400 milligrams (2 mL) for calves over 300 pounds
and adult cattle.
(2) Indications for use. For beef calves and beef cattle for the
prevention of copper deficiency, or when labeled for veterinary
prescription use, for the prevention and/or treatment of copper
deficiency alone or in association with molybdenum toxicity.
(3) Limitations. For subcutaneous use only; repeat dose in 3 months
in young calves, in 6 months in cattle; discontinue use 30 days before
treated animals are slaughtered for food use; Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
[46 FR 20159, Apr. 3, 1981, as amended at 52 FR 7832, Mar. 13, 1987]
Sec. 522.536 Detomidine hydrochloride injection.
(a) Specification. Each milliliter of sterile aqueous solution
contains 10 milligrams of detomidine hydrochloride.
(b) Sponsor. See 052483 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. For sedation, analgesia, or
sedation and analgesia: 20 or 40 micrograms per kilogram (0.2 or 0.4
milliliter per 100
[[Page 254]]
kilogram or 220 pounds) by body weight, depending on depth and duration
required.
(2) Indication for use. As a sedative and analgesic to facilitate
minor surgical and diagnostic procedures in mature horses and yearlings.
(3) Limitations. For sedation administer intraveneously (IV) or
intramuscularly (IM); for analgesia by IV; for both sedation and
analgesia by IV. Do not use in horses with pre-existing atrioventricular
or sinoauricular block, with severe coronary insufficiency,
cerebrovascular disease, respiratory disease, or chronic renal failure.
Do not use in breeding animals. Not for use in horses intended for food.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[54 FR 50365, Dec. 6, 1989; 54 FR 51551, Dec. 15, 1989]
Sec. 522.540 Dexamethasone injection.
(a)(1) Specifications. The drug is a sterile aqueous solution. Each
milliliter contains 2 mg of dexamethasone.
(2) Sponsor. See No. 000061 and 057319 in Sec. 510.600(c) of this
chapter.
(3) Conditions of use. (i) The drug is indicated for the treatment
of primary bovine ketosis and as an anti-inflammatory agent in dogs,
cats, cattle, and horses.\1\
(ii) The drug is administered intravenously or intramuscularly and
dosage may be repeated if necessary, as follows:1
(a) Canine--0.25 to 1 mg.
(b) Feline--0.125 to 0.5 mg.
(c) Equine--2.5 to 5 mg.
(d) Bovine--5 to 20 mg depending on the severity of the condition.
(iii) Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
(iv) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(b)(1) Specifications. The drug is a sterile aqueous solution. Each
milliliter contains either 2.0 milligrams of dexamethasone or 4.0
milligrams of dexamethasone sodium phosphate (equivalent to 3.0
milligrams dexamethasone).
(2) Sponsor. See number in Sec. 510.600(c) of this chapter as
follows:
(i) No. 000864 for use of 2.0 milligrams dexamethasone or 4.0
milligrams dexamethasone sodium phosphate injections.
(ii) No. 000402 for use of 2.0 milligrams dexamethasone or 4.0
milligrams dexamethasone sodium phosphate injections.
(3) Conditions of use. (i) The drug is used in dogs for the
treatment of inflammatory conditions, as supportive therapy in canine
posterior paresis, as supportive therapy before or after surgery to
enhance recovery of poor surgical risks, and as supportive therapy in
nonspecific dermatosis. \1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC-reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(ii) The drug is administered intravenously at 0.25 to 1 milligram
initially. The dose may be repeated for 3 to 5 days or until a response
is noted. If continued treatment is required, oral therapy may be
substituted. When therapy is withdrawn after prolonged use, the daily
dose should be reduced gradually over several days.1
(iii) Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
(iv) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(c)(1) Specifications. The drug is a sterile aqueous solution. Each
milliliter contains 2.0 milligrams of dexamethasone or 4.0 milligrams of
dexamethasone sodium phosphate (equivalent to 3.0 milligrams of
dexamethasone).
(2) Sponsor. See Nos. 000402 and 000864 in Sec. 510.600(c) of this
chapter.
[[Page 255]]
(3) Conditions of use. (i) The drug is used as a rapid adrenal
glucocorticoid and/or anti-inflammatory agent in horses.1
(ii) The drug is administered intravenously at a dosage of 2.5 to
5.0 milligrams. If permanent corticosteroid effect is required, oral
therapy may be substituted. When therapy is withdrawn after prolonged
use, the daily dose should be reduced gradually over several days.1
(iii) Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
(iv) Not for use in horses intended for food.
(v) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(d)(1) Specifications. The drug is a sterile aqueous solution. Each
milliliter contains 2.0 milligrams of dexamethasone or 4.0 milligrams of
dexamethasone sodium phosphate (equivalent to 3.0 milligrams of
dexamethasone).
(2) Sponsors. See the following numbers in Sec. 510.600(c) of this
chapter:
(i) Nos. 000069 and 050604 for intravenous or intramuscular use of
2.0 milligrams dexamethasone injection.
(ii) No. 000069 for intravenous use of 2.0 milligrams dexamethasone
injection.
(3) Conditions of use. (i) The drug is used as an anti-inflammatory
agent in dogs, cats, and horses.
(ii) It is administered intravenously or intramuscularly as follows:
dogs--0.25 to 1 milligram; cats--0.125 to 0.5 milligram; horses--2.5 to
5 milligrams.
(iii) Clinical and experimental data have demonstrated that
corticosteroids administered orally or by injection to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
(iv) Not for use in horses intended for food.
(v) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(e)(1) Specifications. The drug is a sterile aqueous solution. Each
milliliter contains 4.0 milligrams of dexamethasone sodium phosphate
(equivalent to 3 milligrams of dexamethasone).
(2) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is given for glucocorticoid and
anti-inflammatory effect in dogs and horses.
(ii) Administer intravenously as follows: Dogs--0.25 to 1 milligram
initially; may be repeated for 3 to 5 days or until response is noted.
Horses--2.5 to 5 milligrams. If permanent glucocorticoid effect is
required, oral therapy may be substituted. When therapy is to be
withdrawn after prolonged use, the daily dose should be reduced
gradually over several days.
(iii) Clinical and experimental data have demonstrated that
corticosteroids administered orally or by injection may induce the first
stage of parturition when administered during the last trimester of
pregnancy and may precipitate premature parturition followed by
dystocia, fetal death, retained placenta, and metritis.
(iv) Do not use in viral infections. Anti-inflammatory action of
corticosteroids may mask signs of infections. Except when used for
emergency therapy, the product is contraindicated in animals with
tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers.
(v) Not for use in horses intended for food.
(vi) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[41 FR 28265, July 9, 1976]
Editorial Note: For Federal Register citations affecting
Sec. 522.540, see the List of CFR Sections Affected in the Finding Aids
section of this volume.
Sec. 522.542 Dexamethasone-21-isonicotinate suspension.
(a) Specifications. Each milliliter of sterile suspension contains 1
milligram of dexamethasone-21-isonicotinate.
(b) Sponsor. No. 000010 in Sec. 510.600(c) of this chapter.
[[Page 256]]
(c) Conditions of use. (1) The drug is used in the treatment of
various inflammatory conditions associated with the musculoskeletal
system in dogs, cats, and horses.
(2) It is recommended for intramuscular administration as follows:
Dogs--0.25 to 1 milligram; cats--0.125 to 0.5 milligram; horses--5 to 20
milligrams. Dosage may be repeated.
(3) Clinical and experimental data have demonstrated that
corticosteriods administered orally or parenterally to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
following by dystocia, fetal death, retained placenta, and metritis.
(4) Not for use in horses intended for food.
(5) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[42 FR 37543, July 22, 1977, as amended at 47 FR 14703, Apr. 6, 1982]
Sec. 522.563 Diatrizoate meglumine and diatrizoate sodium injection.
(a) Specifications. Diatrizoate meglumine and diatrizoate sodium
injection contains 34.3 percent diatrizoate meglumine and 35 percent
diatrizoate sodium, or 66 percent diatrizoate meglumine and 10 percent
diatrizoate sodium, in sterile aqueous solution.
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is indicated for use in dogs and cats
for visualization in excretion urography, including renal angiography,
uretography, cystography, and urethrography; aortography;
angiocardiography, peripheral arteriography, and venography; selective
coronary arteriography; cerebral angiography; lymphography;
arthrography; discography; and sialography. It is also useful as an aid
in delineating peritoneal hernias and fistulous tracts.
(2) For excretion urography administer 0.5 to 1.0 milliliter per
pound of body weight to a maximum of 30 milliliters intravenously. For
cystography remove urine, administer 5 to 25 milliliters directly into
the bladder via catheter. For urethrography administer 1.0 to 5
milliliters via catheter into the urethra to provide desired contrasts
delineation. For angiocardiography (including aortography) rapidly
inject 5 to 10 milliliters directly into the heart via catheter or
intraventricular puncture. For cerebral angiography rapid injection of 3
to 10 milliliters via carotid artery. For peripheral arteriography and/
or venography and selective coronary arteriography rapidly inject 3 to
10 milliliters intravascularly into the vascular bed to be delineated.
For lymphography slowly inject 1.0 to 10 milliliters directly into the
lymph vessel to be delineated. For arthrography slowly inject 1.0 to 5
milliliters directly into the joint to be delineated. For discography
slowly inject 0.5 to 1.0 milliliter directly into the disc to be
delineated. For sialography slowly inject 0.5 to 1.0 milliliter into the
duct to be delineated. For delineation of fistulous tracts slowly inject
quantity necessary to fill the tract. For delineation of peritoneal
hernias inject 0.5 to 1.0 milliliter per pound of body weight directly
into the peritoneal cavity.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985]
Sec. 522.575 Diazepam injection.
(a) Specification. Each milliliter of sterile solution contains 5
milligrams of diazepam.
(b) Sponsor. See 000004 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. Dogs--(1) Indications for use. As a
preanesthetic agent to reduce the amount of barbiturate required for
short duration anesthesia.
(2) Dosage. Intravenously, 0.2 milligram per kilogram of body
weight 3-5 minutes before anesthesia is to be induced using a short
acting barbiturate.
(3) Limitations. Not for use in dogs with known sensitivity to
benzodiazepines. Safety in animals intended for breeding and pregnant
animals has not been established. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
[58 FR 500, Jan. 6, 1993]
[[Page 257]]
Sec. 522.650 Dihydrostreptomycin sulfate injection.
(a) Specifications. Each milliliter contains dihydrostreptomycin
sulfate equivalent to 500 milligrams of dihydrostreptomycin.
(b) Sponsor. See Nos. 000069 and 055529 in Sec. 510.600(c) of this
chapter.
(c) National Academy of Sciences/National Research Council (NAS/NRC)
status. The conditions of use were NAS/NRC reviewed and found effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter but may require bioequivalency
and safety information.
(d) Conditions of use--(1) Amount. 5 milligrams per pound of body
weight every 12 hours.
(2) Indications for use. Treatment of leptospirosis in dogs and
horses due to Leptospira canicola, L. icterohemorrhagiae, and L. pomona;
in cattle due to L. pomona; and in swine due to L. pomona; and L.
grippotyphosa.
(3) Limitations. Administer by deep intramuscular injection only.
Treatment should be continued for 3 to 5 days or until the urine is free
of leptospira for at least 72 hours as measured by darkfield microscopic
examination. Treatment with subtherapeutic dosages, excessive duration
of therapy, or inappropriate use of this antibiotic may lead to the
emergence of streptomycin or dihydrostreptomycin resistant organisms.
Discontinue use 30 days before slaughter for food. Not for use in
animals producing milk because use of the drug will contaminate the
milk. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]
Sec. 522.690 Dinoprost tromethamine sterile solution.
(a) Specifications. Each milliliter of sterile solution contains the
equivalent of 5 milligrams of dinoprost.
(b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Women of child-bearing age, asthmatics,
and persons with bronchial and other respiratory problems should
exercise extreme caution when handling this product. Dinoprost
tromethamine is readily absorbed through the skin and can cause abortion
and bronchiospasms. Accidental spillage on the skin should be washed off
immediately with soap and water. Use of this product in excess of the
approved dose may result in drug residues. Do not administer to pregnant
cattle unless abortion is desired. Do not administer intravenously; this
may potentiate adverse reactions.
(d) Conditions of use--(1) Mares--(i) Amount. Equivalent of 1
milligram of dinoprost per 100 pounds of body weight.
(ii) Indications. For its luteolytic effect to control timing of
estrus in estrus cycling mares and in clinically anestrous mares that
have a corpus luteum.
(iii) Limitations. For use once as a single intramuscular injection.
Not for use in horses intended for food. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(2) Cattle--(i) Amount. 5 milliliters (equivalent to 25 milligrams
of dinoprost).
(ii)(a) Indications. For its luteolytic effect to control timing of
estrus and ovulation in estrous cycling cattle that have a corpus
luteum.
(b) Limitations. For use in beef cattle and nonlactating dairy
heifers, as follows: Inject a dose of 5 milliliters intramuscularly
either once or twice at a 10- to 12-day interval. With a single
injection, cattle should be bred at the usual time relative to estrus.
With the two injections, cattle can be bred after the second injection
either at the usual time relative to detected estrus or at about 80
hours after the second injection. Estrus is expected to occur 1 to 5
days after injection if a corpus luteum was present. Cattle that do not
become pregnant to breeding at estrus on days 1 to 5 after injection
will be expected to return to estrus in about 18 to 24 days. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(iii)(a) Indications. For treatment of pyometra (chronic
endometritis).
(b) Limitations. For intramuscular use as a single injection.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[[Page 258]]
(3) Nonlactating cattle--(i) Amount. Five milliliters
intramuscularly as a single injection.
(ii) Indications. For its abortifacient effect in nonlactating
cattle.
(iii) Limitations. For intramuscular use only, during first 100 days
of gestation. Cattle that abort will abort within 35 days after
injection. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
(4) Lactating dairy cattle--(i) Amount. Five milliliters
intramuscularly as a single injection.
(ii) Indications. For treatment of unobserved (silent) estrus in
lactating dairy cattle that have a corpus luteum.
(iii) Limitations. Breed cattle as they are detected in estrus. If
estrus has not been observed by 80 hours after injection, breed at 80
hours. If cattle return to estrus breed at the usual time relative to
estrus. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(5) Swine--(i) Amount. 2 milliliters (equivalent to 10 milligrams of
dinoprost).
(ii) Indications. For parturition induction in swine when injected
within 3 days of normal predicted farrowing.
(iii) Limitations. For use in swine as follows: Inject a dose of 2
milliliters intramuscularly within 3 days of predicted farrowing. The
response to treatment varies by individual animals with a mean interval
from administration to parturition of approximately 30 hours. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
[41 FR 4818, Feb. 2, 1976, as amended at 46 FR 13214, Feb. 20, 1981; 46
FR 39127, July 31, 1981; 48 FR 6331, Feb. 11, 1983; 48 FR 46023, Oct.
11, 1983; 49 FR 4373, Feb. 6, 1984]
Sec. 522.723 Diprenorphine hydrochloride injection.
(a) Chemical name. N-(Cyclopropyl-methyl)-6,7,8,14-tetrahydro-7-
alpha-(1-hydroxy - 1 - methylethyl) - 6,14 - endoethanonororipavine
hydrochloride.
(b) Specifications. Each milliliter of diprenorphine hydrochloride
injection, veterinary, contains 2 mg of diprenorphine hydrochloride in
sterile aqueous solution.
(c) Sponsors. See No. 010042 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) The drug is used for reversing the
effects of etorphine hydrochloride injection, veterinary, the use of
which is provided for in Sec. 522.883, in wild and exotic animals.
(2) It is administered intramuscularly or intravenously at a
suitable dosage level depending upon the species.
(3) For use in wild or exotic animals only. Do not use in domestic
food-producing animals. Do not use 30 days before, or during, the
hunting season in free-ranging wild animals that might be used for food.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian. Distribution is restricted to veterinarians
engaged in zoo and exotic animal practice, wildlife management programs
and researchers.
[40 FR 13858, Mar. 27, 1975, as amended at 48 FR 16241, Apr. 15, 1983;
60 FR 39847, Aug. 4, 1995]
Sec. 522.740 Disophenol sodium injection.
(a) Chemical name. Sodium 2,6-diiodo-4-nitrophenoxide.
(b) Specifications. The drug is sterile and contains the equivalent
of 0.9 or 4.5 percent disophenol in polyethylene glycol 400 and
distilled water.
(c) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) The drug is used for the treatment of
both dogs infested with hookworms (including Ancylostoma caninum, A.
braziliense and Uncinaria stenocephala) and cats infested with the
hookworm A. tubaeforme.
(2) It is administered subcutaneously at a dosage level equivalent
to 4.5 milligrams of disophenol per pound of body weight. A second
treatment may be indicated 21 days after the initial treatment.
(3) Do not repeat treatment in less than 21 days.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(5) Use for the treatment of dogs infested with hookworms (including
Ancylostoma canium, A. braziliense and Uncinaria stenocephala) is NAS/
NRC reviewed and deemed effective. Applications for these uses need not
include ef
[[Page 259]]
fectiveness data as specified by Sec. 514.111 of this chapter, but may
require bioequivalency and safety information.
[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 43400, Oct. 1, 1976; 42
FR 41855, Aug. 19, 1977; 45 FR 43402, June 27, 1980; 47 FR 14150, Apr.
2, 1982]
Sec. 522.775 Doxapram hydrochloride injection.
(a) Specifications. The drug is a sterile aqueous solution
containing 20 milligrams doxapram hydrochloride per milliliter.
(b) Sponsor. See No. 000031 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) Administer to dogs, cats, and horses to
stimulate respiration during and after general anesthesia; to speed
awakening and return of reflexes after anesthesia. Administer to neonate
dogs and cats to initiate respiration following dystocia or caesarean
section; to stimulate respiration following dystocia or caesarean
section.
(2) For intravenous use in dogs and cats at a dose of 2\1/2\ to 5
milligrams of doxapram hydrochloride per pound of body weight in
barbiturate anesthesia, 0.5 mg per lb. in gas anesthesia; for
intravenous use in horses at 0.25 mg per lb. of body weight in
barbiturate anesthesia, 0.2 mg per lb. in inhalation anesthesia, 0.25 mg
per lb. with chloral hydrate with or without magnesium sulfate; for
subcutaneous, sublingual, or umbilical vein administration in neonate
puppies at a dose rate of 1 to 5 mg; for subcutaneous or sublingual use
in neonate kittens at 1 to 2 mg. Dosage may be repeated in 15 to 20
minutes if necessary.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 17838, Apr. 23, 1975]
Sec. 522.784 Doxylamine succinate injection.
(a) Specifications. Each milliliter of the drug contains 11.36 mg of
doxylamine succinate.
(b) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used in conditions in which
antihistaminic therapy may be expected to alleviate some signs of
disease in horses, dogs, and cats.1
---------------------------------------------------------------------------
1 These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter.
---------------------------------------------------------------------------
(2) It is administered to horses at a dosage level of 25 mg per
hundred pounds of body weight. It is administered to dogs and cats at a
dosage level of 0.5 to 1 mg per pound of body weight. Doses may be
repeated at 8 to 12 hours, if necessary, to produce desired effect.
Intravenous route is not recommended for dogs and cats and should be
injected slowly in horses. Intramuscular and subcutaneous administration
should be by divided injection sites.1
(3) Not for use in horses intended for food.1
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.1
[40 FR 13858, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977;
46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996]
Sec. 522.800 Droperidol and fentanyl citrate injection.
(a) Specifications. Droperidol and fentanyl citrate injection is a
sterile solution containing 20 milligrams of droperidol and 0.4
milligram of fentanyl citrate per cubic centimeter.
(b) Sponsor. See No. 000045 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used in dogs as an analgesic and
tranquilizer and for general anesthesia.
(2) It is administered as follows:
(i) For analgesia and tranquilization administer according to
response desired, as follows:
(a) Intramuscularly at the rate of 1 cubic centimeter per 15 to 20
pounds of body weight in conjunction with atropine sulfate administered
at the rate of 0.02 milligram per pound of body weight, or
(b) Intravenously at the rate of 1 cubic centimeter per 25 to 60
pounds of body weight in conjunction with atropine sulfate administered
at the rate of 0.02 milligram per pound of body weight.
(ii) For general anesthesia administer according to response
desired, as follows:
[[Page 260]]
(a) Intramuscularly at the rate of 1 cubic centimeter per 40 pounds
of body weight in conjunction with atropine sulfate administered at the
rate of 0.02 milligram per pound of body weight and followed in 10
minutes by an intravenous administration of sodium pentobarbital at the
rate of 3 milligrams per pound of body weight, or
(b) Intravenously at the rate of 1 cubic centimeter per 25 to 60
pounds of body weight in conjunction with atropine sulfate administered
at the rate of 0.02 milligram per pound of body weight and followed
within 15 seconds by an intravenous administration of sodium
pentobarbital at the rate of 3 milligrams per pound of body weight.
(3) For use only by or on the order of a licensed veterinarian.
Sec. 522.812 Enrofloxacin solution.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 22.7 milligrams of enrofloxacin.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. 2.5 milligrams per kilogram (1.13
milligrams per pound) of body weight as an initial dose only.
(2) Indications for use. Dogs for treatment of the following
bacterial infections: dermal infections (wounds and abscesses) caused by
susceptible strains of Escherichia coli, Klebsiella pneumoniae, Proteus
mirabilis, and Staphylococcus aureus; respiratory infections (pneumonia,
tonsillitis, rhinitis) caused by susceptible strains of Escherichia coli
and Staphylococcus aureus; and urinary cystitis caused by susceptible
strains of Escherichia coli, Proteus mirabilis, and Staphylococcus
aureus.
(3) Limitations. As a single, intramuscular, initial dose followed
by use of tablets twice daily for 2 to 3 days beyond cessation of
clinical signs to a maximum of 10 days. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
[55 FR 26683, June 29, 1990]
Sec. 522.820 Erythromycin injection.
(a) Sponsor. See 050604 in Sec. 510.600(c) of this chapter.
(b) NAS/NRC status. The conditions of use have been reviewed by NAS/
NRC and found effective.
(c) Dogs and cats--(1) Specifications. Each milliliter of
polyethylene glycol vehicle contains 100 milligrams of erythromycin base
with 2 percent butyl aminobenzoate.
(2) Conditions of use--(i) Amount. 3 to 5 milligrams per pound of
body weight, intramuscularly, two to three times daily, for up to 5
days.
(ii) Indications for use--(A) Dogs. For the treatment of bacterial
pneumonia, upper respiratory infections (tonsillitis, bronchitis,
tracheitis, pharyngitis, pleurisy), endometritis and metritis, and
bacterial wound infections caused by Staphylococcus spp., Streptococcus
spp., and Corynebacterium spp., sensitive to erythromycin.
(B) Cats. For the treatment of bacterial pneumonia, upper
respiratory infections (rhinitis, bronchitis), secondary infections
associated with panleukopenia, and bacterial wound infections caused by
Staphylococcus spp. and Streptococcus spp., susceptible to erythromycin.
(iii) Limitations. Administer by deep intramuscular injection into
the heavy muscles of the neck and limbs. Do not administer intravenously
or intraperitoneally. Avoid subscutaneous use. Do not administer from
moist or wet syringe. As with all antibiotics, appropriate in vitro
culturing and susceptibility testing of samples taken before treatment
should be conducted. Do not administer in conjunction with penicillin.
As with all antibiotics, excessive continuous use may result in an
overgrowth of nonsusceptible organisms. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(d) Cattle.--(1) Specifications. Each milliliter of nonaqueous,
buffered, alcohol base sterile solution contains 200 milligrams of
erythromycin base.
(2) Related tolerances. See Sec. 556.230 of this chapter.
(3) Conditions of use--(i) Amount. 4 milligrams of erythromycin base
per pound of body weight once daily for up to 5 days.
(ii) Indications for use. For the treatment of bovine respiratory
disease (shipping fever complex and bacterial
[[Page 261]]
pneumonia) associated with Pasteurella multocida susceptible to
erythromycin.
(iii) Limitations. For intramuscular use only. Do not use in female
dairy cattle over 20 months of age. Do not slaughter treated animals
within 6 days of last treatment. To avoid excess trim, do not slaughter
within 21 days of last injection.
[58 FR 43795, Aug. 18, 1993]
Sec. 522.840 Estradiol.
(a) Specifications. Each silicone rubber implant contains 25.7 or
43.9 milligrams of estradiol.
(b) Sponsor. See 000986 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. It is used for implantation in steers and
heifers as follows:
(1) Amount. Insert one 25.7-milligram implant every 200 days; insert
one 43.9-milligram implant every 400 days.
(2) Indications for use. For increased rate of weight gain in
suckling and pastured growing steers; for improved feed efficiency and
increased rate of weight gain in confined steers and heifers.
(3) Limitations. For subcutaneous ear implantation in steers and
heifers only. A second implant may be used if desired. No additional
effectiveness may be expected from reimplanting in less than 200 days
for the 25.7-milligram implant or 400 days for the 43.9 milligram
implant. Increased sexual activity (bulling, riding, and excitability)
has been reported in implanted animals.
[51 FR 22276, June 19, 1986, as amended at 57 FR 41861, Sept. 14, 1992]
Sec. 522.842 Estradiol benzoate and testosterone propionate in combination.
(a) Chemical names. (1) Estradiol benzoate: 1,3,5(10)-Estratriene-
3,17 beta-diol 3-benzoate.
(2) Testosterone propionate: 17beta-Hydroxyandrost-4-en-3-one
propionate.
(b) Sponsor. See Nos. 000856 and 021641 in Sec. 510.600(c) of this
chapter.
(c) Related tolerances. See Secs. 556.240 and 556.710 of this
chapter.
(d) Conditions of use. It is used for implantation in heifers as
follows:
(1) Amount. 20 milligrams of estradiol benzoate and 200 milligrams
of testosterone propionate per dose.
(2) Indications for use. Growth promotion and improved feed
efficiency.
(3) Limitations. For heifers weighing 400 pounds or more; for
subcutaneous ear implantation, one dose per animal; not for use in dairy
or beef replacement heifers.
(e) NAS/NRC status. These conditions are NAS/NRC reviewed and deemed
effective. Applications for these uses need not include effectiveness
data as specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety data.
[40 FR 13858, Mar. 27, 1975, as amended at 49 FR 29778, July 24, 1984;
61 FR 5506, Feb. 13, 1996]
Sec. 522.850 Estradiol valerate and norgestomet in combination.
(a) Specifications. The product is a two-component drug consisting
of the following:
(1) An implant containing 6.0 milligrams of norgestomet.
(2) An injectable solution (sesame oil) containing 3.0 milligrams of
norgestomet and 5.0 milligrams of estradiol valerate per 2 milliliters.
(b) Sponsor. See 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. One implant and 2 milliliters of
injection at time of implantation.
(2) Indications for use. For synchronization of estrus/ovulation in
cycling beef cattle and non-lactating dairy heifers.
(3) Limitations. Insert implant subcutaneously in the ear only; then
immediately inject solution intramuscularly only. Counting the day of
implantation as day 1, remove the implant on day 10. Collect all
implants as they are removed and burn them. While animals are restrained
for artificial insemination, avoid other treatments such as
vaccinations, dipping, pour-on grub and louse prevention, spraying, etc.
When inseminating without estrus detection, the entire treated group
should be started at 48 hours after the last implant has been removed
and should be completed within 6 hours. Where estrus detection is
preferred, insemination should be approximately 12 hours after first
detection of estrus. Those that do not conceive can be re-bred when they
return
[[Page 262]]
to estrus approximately 17 to 25 days after implant removal. Do not use
in cows producing milk for human consumption.
[47 FR 55477, Dec. 10, 1982, as amended at 48 FR 49656, Oct. 27, 1983;
51 FR 33592, Sept. 22, 1986; 54 FR 1165, Jan. 12, 1989]
Sec. 522.863 Ethylisobutrazine hydrochloride injection.
(a) Specifications. The drug is a sterile aqueous solution. Each
milliliter contains 50 milligrams of ethylisobutrazine hydrochloride.
(b) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used in dogs as a tranquilizer.\1\
(2) It is administered intramuscularly at a dosage level of 2 to 5
milligrams of ethylisobutrazine hydrochloride per pound of body weight
for profound tranquilization. It is administered intravenously at a
dosage level of 1 to 2 milligrams of ethylisobutrazine hydrochloride per
pound of body weight to effect.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(3) It is not to be used in conjunction with organophosphates and/or
procaine hydrochloride because phenothiazines may potentiate the
toxicity of organophosphates and the activity of procaine
hydrochloride.\1\
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.\1\
[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61
FR 8873, Mar. 6, 1996]
Sec. 522.883 Etorphine hydrochloride injection.
(a) Chemical name. 6,7,8,14 - tetrahydro - alpha - methyl - alpha -
propyl - 6,14 - endo-ethenooripavine-alpha-methanol hydrochloride.
(b) Specifications. Each milliliter of etorphine hydrochloride
injection, veterinary, contains 1 mg of etorphine hydrochloride in
sterile aqueous solution.
(c) Sponsors. See No. 053923 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) The drug is used for the immobilization
of wild and exotic animals.
(2) It is administered intramuscularly by hand syringe or syringe
dart at a suitable dosage level depending upon the species.
(3) Do not use the drug unless diprenorphine hydrochloride
injection, veterinary, as provided for in Sec. 522.723, is available for
use in reversing the effects of etorphine hydrochloride injection,
veterinary.
(4) For use in wild or exotic animals only. Do not use in domestic
food-producing animals. Do not use 30 days before, or during, the
hunting season in free-ranging wild animals that might be used for food.
(5) Federal law restricts this drug to use by or on the order of a
licensed veterinarian. Distribution is restricted to veterinarians
engaged in zoo and exotic animal practice, wildlife management programs,
and researchers.
[40 FR 13858, Mar. 27, 1975, as amended at 48 FR 16241, Apr. 15, 1983;
61 FR 260, Jan. 4, 1996]
Sec. 522.900 Euthanasia solution.
(a) [Reserved]
(b)(1) Specifications. Each milliliter of nonsterile solution
contains 390 milligrams of pentobarbital sodium and 50 milligrams of
phenytoin sodium.
(2) Sponsor. Nos. 000061 and 059079 in Sec. 510.600(c) of this
chapter.
(3) Conditions of use--(i) Indications for use. For the humane,
painless, and rapid euthanasia of dogs.
(ii) Amount. One milliliter (390 milligrams of pentobarbital sodium
and 50 milligrams of phenytoin sodium) for each 10 pounds of body
weight.
(iii) Limitations. For intravenous injection or intracardiac
injection when intravenous use is impractical. Do not use for
therapeutic purposes. Do not use in animals intended for food. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(c)(1) Specifications. Each milliliter of nonsterile, aqueous
solution contains 400 milligrams of secobarbital sodium and 25
milligrams of dibucaine hydrochloride.
(2) Sponsor. See 000033 in Sec. 510.600(c) of this chapter.
[[Page 263]]
(3) Conditions of use--(i) Indications for use. To induce rapid,
humane, painless euthanasia of dogs.
(ii) Amount. For dogs, 1 milliliter for each 10 pounds of body
weight.
(iii) Limitations. For intravenous injection. Do not use for
therapeutic purposes. Do not use in animals intended for food. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
[46 FR 23232, Apr. 24, 1981, as amended at 47 FR 15327, Apr. 9, 1982; 48
FR 16241, Apr. 15, 1983; 52 FR 7832, Mar. 13, 1987; 56 FR 9623, Mar. 7,
1991; 59 FR 14367, Mar. 28, 1994]
Sec. 522.914 Fenprostalene solution.
(a) Specifications--(1) Cattle. Each milliliter of sterile solution
contains 0.5 milligram of fenprostalene.
(2) Swine. Each milliliter of sterile solution contains 0.25
milligram of fenprostalene.
(b) Sponsor. See 000856 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.277 of this chapter.
(d) Special considerations. Labeling shall bear the following
statements: Women of childbearing age, asthmatics, and persons with
bronchial and other respiratory problems should exercise extreme caution
when handling this product. It is readily absorbed through the skin and
may cause abortion and/or bronchiospasms. Accidental spillage on the
skin should be washed off immediately with soap and water.
(e) Conditions of use--(1) Cattle--(i) Amount. 1 milligram (2
milliliters) subcutaneously per animal.
(ii) Indications for use. For feedlot heifers to induce abortion
when pregnant 150 days or less. For beef or nonlactating dairy cattle
for estrus synchronization.
(iii) Limitations. Subcutaneous use in cattle only. Feedlot heifers
to induce abortion, single dose. Beef or nonlactating dairy cattle for
estrus synchronization, a single dose or two doses 11 to 13 days apart.
Do not use in pregnant animals unless abortion is desired. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Swine--(i) Amount. 0.25 milligram (1 milliliter) subcutaneously
once per animal.
(ii) Indications for use. For sows and gilts pregnant at least 112
days for the induction of parturition.
(iii) Limitations. Subcutaneous use in swine only. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[48 FR 7164, Feb. 18, 1983, as amended at 49 FR 26715, June 29, 1984; 54
FR 400, Jan. 6, 1989; 61 FR 5506, Feb. 13, 1996]
Sec. 522.940 Colloidal ferric oxide injection.
(a) Specifications. Each milliliter of the drug contains colloidal
ferric oxide equivalent to 100 milligrams of iron stabilized with a low-
viscosity dextrin and contains 0.5 percent phenol as a preservative.
(b) NAS/NRC status. Use of this drug has been NAS/NRC reviewed and
found effective. Applications for these uses need not include
effectiveness data as specified by Sec. 514.111 of this chapter, but may
require bioequivalency and safety information.
(c)(1) Sponsor. See Nos. 010042 and 017800 in Sec. 510.600(c) of
this chapter.
(2) Conditions of use. It is used in baby pigs as follows:
(i) For the prevention of anemia due to iron deficiency, administer
an initial intramuscular injection of 1 milliliter of the drug to each
animal at any time between 2 to 5 days of age. Dosage may be repeated at
2 weeks of age.
(ii) For the treatment of anemia due to iron deficiency, administer
an intramuscular injection of from 1 to 2 milliliters of the drug to
each animal at any time between 5 to 28 days of age.
[40 FR 13858, Mar. 27, 1975, as amended at 49 FR 38938, Oct. 2, 1984; 50
FR 23298, June 3, 1985; 50 FR 25216, June 18, 1985; 51 FR 14989, Apr.
22, 1986; 51 FR 18314, May 19, 1986]
Sec. 522.960 Flumethasone implantation or injectable dosage forms.
Sec. 522.960a Flumethasone suspension.
(a) Chemical name. 6,9-Difluoro-11,17,21
- trihydroxy - 16 - methylpregna - 1,4 - diene - 3,20 - dione.
(b) Specifications. Flumethasone suspension is sterile and each
milliliter of the drug contains: 2 milligrams of
[[Page 264]]
flumethasone, 20 milligrams of propylene glycol, 9 milligrams of benzyl
alcohol (as preservative), 8 milligrams of sodium chloride, 0.02
milligram of polysorbate-80, 0.1 milligram of citric acid, and water for
injection q.s.
(c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) It is recommended in the various disease
states involving synovial structures (joints) of horses where excessive
synovial fluid of inflammatory origin is present and where permanent
structural changes do not exist. Such conditions include arthritis,
carpitis, and osselets.
(2) The drug is administered intraarticularly at a dosage level of 6
to 10 milligrams per injection. The dosage level is dependent upon the
size of the involved synovial structure and the degree of severity of
the condition under treatment. The dosage is limited to a single
injection per week in any one synovial structure.
(3) Clinical and experimental data have demonstrated that
corticosteroids administered orally and parenterally to animals during
the last trimester of pregnancy may induce the first stage of
parturition and may precipitate premature parturition followed by
dystocia, fetal death, retained placenta, and metritis. The drug is not
to be used in horses intended for slaughter for food purposes.
(4) For use only by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975. Redesignated at 44 FR 16011, Mar. 16, 1979,
as amended by 61 FR 5506, Feb. 13, 1996]
Sec. 522.960b Flumethasone acetate injection.
(a) Chemical name. 6-alpha,9-alpha-difluoro - 16 - alpha -
methylprednisolone 21-acetate.
(b) Specifications. Flumethasone injection is sterile and contains
per cubic centimeter: 2 milligrams of flumethasone acetate; 20
milligrams of propylene glycol; 9 milligrams of benzyl alcohol (as
preservative); 8 milligrams of sodium chloride; 1 milligram of
polysorbate 80; 0.1 milligram of citric acid; water for injection q.s.
(c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) It is recommended in certain acute and
chronic canine dermatoses of varying etiology to help control the
pruritus, irritation, and inflammation associated with these conditions.
(2) The drug is administered intramuscularly at the following
recommended daily dosage:
------------------------------------------------------------------------
Dosage in
Weight of animal in pounds milligrams
------------------------------------------------------------------------
Up to 10.................................................... 1.0
10 to 25.................................................... 2.0
25 and over................................................. 4.0
------------------------------------------------------------------------
Dosage should be adjusted according to the weight of the animal, the
severity of the symptoms, and the response noted. Dosage by injection
should not exceed 3 days of therapy. With chronic conditions
intramuscular therapy may be followed by oral administration of
flumethasone tablets at a daily dose of from 0.0625 to 0.25 milligram
per animal.
(3) For use only by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975. Redesignated at 44 FR 16011, Mar. 16, 1979,
as amended at 61 FR 5507, Feb. 13, 1996]
Sec. 522.960c Flumethasone solution.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 0.5 milligram flumethasone.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. It is used as follows:
(1) Horses--(i) Amount. 1.25 to 2.5 milligrams daily, intravenously,
intramuscularly, or intra-articularly.
(ii) Indications for use. It is used for the treatment of
musculoskeletal conditions due to inflammation, where permanent
structural changes do not exist, e.g., bursitis, carpitis, osselets, and
myositis; and allergic states, e.g., hives, urticaria, and insect bites.
(iii) Limitations--(a) Clinical and experimental data have
demonstrated that corticosteroids administered orally or parenterally to
animals may induce the first stage of parturition when administered
during the last trimester of pregnancy and may precipitate premature
parturition followed by
[[Page 265]]
dystocia, fetal death, retained placenta, and metritis.
(b) When a long-term therapy is used, the dose should be
individually adjusted to the minimum maintenance dose. A protein-rich
diet is useful in dogs and cats on long-term therapy to counteract
nitrogen loss if it should occur. A small amount of potassium chloride
daily in the diet will counteract excessive potassium loss if this is
present.
(c) It has been demonstrated that corticosteroids, especially at
high dose levels, may result in delayed wound and fracture healing.
(d) Flumethasone may be administered to animals with bacterial
diseases provided appropriate antibacterial therapy is administered
simultaneously.
(e) The drug is not to be used in horses intended for slaughter for
food purposes.
(f) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(2) Dogs--(i) Amount. 0.0625 to 0.25 milligram daily, intravenously,
intramuscularly, or subcutaneously; 0.125 to 1.0 milligram daily,
intralesionally, depending on the size and location of the lesion; 0.166
to 1.0 milligram daily, intra-articularly, depending on the severity of
the condition and the size of the involved joint.
(ii) Indications for use. It is used for the treatment of
musculoskeletal conditions due to inflamation of muscles or joints and
accessory structures where permanent structural changes do not exist,
e.g., arthritis, osteoarthritis, disc syndrome, and myositis (in septic
arthritis, appropriate antibacterial therapy should be concurrently
administered); certain acute and chronic dermatoses of varying etiology
to help control associated pruritus, irritation, and inflammation;
otitis externa in conjunction with topical medication; allergic states,
e.g., hives, urticaria, and insect bites; and shock and shock-like
states by intravenous administration.
(iii) Limitations. See paragraph (c)(1)(iii) of this section.
(3) Cats--(i) Amount. 0.03125 to 0.125 milligram daily
intravenously, intramuscularly, or subcutaneously.
(ii) Indications for use. It is used for the treatment of certain
acute and chronic dermatoses of varying etiology to help control
associated pruritus, irritation, and inflammation.
(iii) Limitations. See paragraph (c)(1)(iii) of this section.
[44 FR 16011, Mar. 16, 1978, as amended at 61 FR 5507, Feb. 13, 1996]
Sec. 522.970 Flunixin meglumine solution.
(a) Specifications. The drug contains 50 milligrams of flunixin per
milliliter of aqueous solution.
(b) Sponsors. See Nos. 000061, 000856, and 059130 in Sec. 510.600(c)
of this chapter.
(c) Conditions of use--(1) Amount. 0.5 milligram of flunixin per
pound of body weight (1 milliliter per 100 pounds) per day.
(2) Indications for use. Horses: For alleviation of inflammation and
pain associated with musculoskeletal disorders, and alleviation of pain
associated with colic.
(3) Limitations. For musculoskeletal disorders, administer
intravenously or intramuscularly for up to 5 days. For colic, administer
a single dose intravenously--the single dose may be repeated if signs of
colic recur. Caution: The effect of this drug on pregnancy has not been
determined. Not for use in horses intended for food. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[42 FR 39103, Aug. 2, 1977, as amended at 52 FR 7832, Mar. 13, 1987; 60
FR 54942, Oct. 27, 1995]
Sec. 522.995 Fluprostenol sodium injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains fluprostenol sodium equivalent to 50 micrograms of
fluprostenol.
(b) Sponsor. See 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. 0.55 microgram fluprostenol per
kilogram of body weight.
(2) Indications for use. The drug is used in mares for its
luteolytic effect to control the timing of estrus in estrous cycling and
in clinically anestrous mares that have a corpus luteum.
(3) Limitations. Administer by intramuscular injection only.
Warning:
[[Page 266]]
Not for use in horses intended for food. For veterinary use only.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian. Women of childbearing age, asthmatics, and persons with
bronchial and other respiratory problems should exercise extreme caution
when handling this product. In the early stages, women may be unaware of
their pregnancies. Fluprostenol is readily absorbed through the skin and
can cause abortion and/or bronchiospasms. Direct contact with the skin
should therefore be avoided. Accidental spillage on the skin should be
washed off immediately with soap and water.
[44 FR 52191, Sept. 7, 1979, as amended at 47 FR 22092, May 21, 1982]
Sec. 522.1002 Follicle stimulating hormone.
(a)(1) Specifications. Each package contains 2 vials. One vial
contains dry, powdered, porcine pituitary gland equivalent to 75 units
(NIH-FSH-S1) of follicle stimulating hormone. The other vial contains 10
milliliters of aqueous diluent.
(2) Sponsor. See 059521 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) Dosage. 12.5 units of follicle
stimulating hormone twice a day for 3 days (a total of 75 units). To
effect regression of the corpus luteum, prostaglandin should be given
with the 5th dose.
(ii) Indications for use. For induction of superovulation in cows
for procedures requiring the production of multiple ova at a single
estrus.
(iii) Limitations. For intramuscular use in cows that are not
pregnant and have a normal corpus luteum. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(b)(1) Specifications. The drug is a lyophilized pituitary extract
material. Each 10-milliliter vial contains an amount equivalent to 50
milligrams of standard porcine follicle stimulating hormone and is
reconstituted for use by addition of 10 milliliters of 0.9 percent
aqueous sodium chloride solution.
(2) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) Dosage. Cattle and horses, 10-50
milligrams; sheep and swine, 5-25 milligrams; dogs, 5-15 milligrams.
(ii) Indications for use. The drug is used as a supplemental source
of follicle stimulating hormone where there is a general deficiency in
cattle, horses, sheep, swine, and dogs.
(iii) Limitations. Administer intramuscularly, subcutaneously, or
intravenously. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
[58 FR 47377, Sept. 9, 1993]
Sec. 522.1010 Furosemide injection.
(a) Specifications. Each milliliter of sterile solution contains 50
milligrams of furosemide as the diethanolamine salt.
(b) Sponsor. See No. 012799 in Sec. 510.600(c) of this chapter for
use in dogs and cats as in paragraph (c)(1) of this section, horses as
in paragraph (c)(2)(i) of this section, and cattle as in paragraph
(c)(3) of this section. See Nos. 000864 and 054273 in Sec. 510.600(c)
for use in horses as in paragraph (c)(2)(ii) of this section. See No.
054273 in Sec. 510.600(c) of this chapter for use in dogs as in
paragraph (c)(1) of this section.
(c) Conditions of use--(1) Dogs and cats. (i) It is used for the
treatment of edema (pulmonary congestion, ascites) associated with
cardiac insufficiency and acute noninflammatory tissue edema.
(ii) The drug is administered intramuscularly or intravenously at a
dosage of 12.5 to 25 milligrams per 10 pounds of body weight; once or
twice daily after a 6- to 8-hour interval. The lower dosage is suggested
for cats. The dosage should be adjusted to the individual animal's
response. In refractory or severe edematous cases, the dosage may be
doubled or increased by increments of 1 milligram per pound of body
weight to establish the effective dose. The established effective dose
should be administered once or twice daily on an intermittent daily
schedule. Diuretic therapy should be discontinued after reduction of
edema, or when necessary, maintained after determining a programmed
dosage schedule to prevent recurrence.
(2) Horses. (i) It is used for the treatment of edema (pulmonary
congestion,
[[Page 267]]
ascites) associated with cardiac insufficiency and acute noninflammatory
tissue edema.
(a) Administer intramuscularly or intravenously at 250 to 500
milligrams per animal once or twice daily at 6- to 8-hours intervals
until desired results are achieved.
(b) Do not use in horses intended for food.
(ii) It is used for treatment of acute noninflammatory tissue edema.
(a) Administer intramuscularly or intravenously at 0.5 milligram per
pound of body weight (1.0 milligram per kilogram); once or twice daily
at 6- to 8-hour intervals.
(b) The dosage should be adjusted to the individual's response. In
refractory or severe edematous cases, the dosage may be doubled or
increased by increments of 1 milligram per pound of body weight to
establish the effective dose. The established effective dose should be
administered once or twice daily on an intermittent daily schedule,
i.e., every other day or 2 to 4 consecutive days weekly. Concurrent
therapy for treatment of systemic conditions causing edema (pulmonary
congestion, ascites, cardiac insufficiency) should be instituted.
(3) Cattle. (i) It is used for the treatment of physiological
parturient edema of the mammary gland and associated structures.
(ii) The drug is administered intramuscularly or intravenously at a
dosage of 500 milligrams per animal once daily or 250 milligrams per
animal twice daily at 12-hour intervals, treatment not to exceed 48
hours postparturition.
(iii) Milk taken during treatment and for 48 hours (four milkings)
after the last treatment must not be used for food.
(iv) Cattle must not be slaughtered for food within 48 hours
following last treatment.
(4) The drug if given in excessive amounts may result in dehydration
and electrolyte imbalance.
(5) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 60051, Dec. 31, 1975, as amended at 41 FR 10426, Mar. 11, 1976;
48 FR 36572, Aug. 12, 1983; 49 FR 26715, June 29, 1984; 53 FR 40727,
Oct. 18, 1988]
Sec. 522.1020 Gelatin solution.
(a) Specifications. It is sterile and each 100 cubic centimeters
contains 8 grams of gelatin in an 0.85 percent sodium chloride solution.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used to restore circulatory volume
and maintain blood pressure in animals being treated for shock.
(2) The exact dosage to be administered must be determined after
evaluating the animal's condition and will vary according to the size of
the animal and the degree of shock. A suggested dosage range for small
animals such as dogs is 4 to 8 cubic centimeters per pound body weight.
The suggested dosage range for large animals such as sheep, calves,
cows, or horses is 2 to 4 cubic centimeters per pound of body weight. It
is administered intravenously at a rate of 10 cubic centimeters per
minute in small animals and 20 to 30 cubic centimeters per minute in
large animals. The solution is administered aseptically and must be
between 50 deg. to 70 deg. F. when injected.
(3) A few animals will exhibit signs of allergic reaction. This
solution can cause transient reversible nephrosis. This product is not
intended to replace whole blood in cases of anemia and should not be
used in the presence of renal dysfunction. Unused portions remaining in
bottles should be discarded.
(4) For use only by or on the order of a licensed veterinarian.
Sec. 522.1044 Gentamicin sulfate injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains gentamicin sulfate equivalent to either 5, 50, or 100
milligrams of gentamicin.
(b) Sponsors. (1) See No. 000061 in Sec. 510.600(c) of this chapter
for use of 5
[[Page 268]]
milligrams-per-milliliter solution in swine as in paragraph (d)(4) of
this section, for use of 50 milligrams-per-solution in dogs, cats, and
chickens as in paragraph (d)(1) and (d)(3) of this section, for use of
100 milligrams-per-milliliter solution in chickens as in paragraph
(d)(3) of this section.
(2) See No. 000138 for use of 5 milligram-per-milliliter solution in
turkeys as in paragraph (d)(2) of this section.
(3) See No. 054273 for use of 50 milligram-per-milliliter solution
in dogs as in paragraph (d)(5) of this section.
(4) See No. 050604 for use of 100 milligrams-per-milliliter solution
in chickens as in paragraph (d)(3) of this section.
(c) Related tolerances. See Sec. 556.300 of this chapter.
(d) Conditions of use--(1) Dogs and cats--(i) Amount. Two milligrams
of gentamicin per pound of body weight, twice daily on the first day,
once daily thereafter, using a 50 milligram-per-milliliter solution.
(ii) Indications for use--(a) Dogs. For the treatment of infections
of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis,
pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis,
wounds, lacerations, peritonitis).
(b) Cats. For the treatment of infections of urinary tract
(cystitis, nephritis), respiratory tract (pneumonitis, pneumonia, upper
respiratory tract infections), skin and soft tissue (wounds,
lacerations, peritonitis), and as supportive therapy for secondary
bacterial infections associated with panleucopenia.
(iii) Limitations. Administer intramuscularly or subcutaneously. If
response is not noted after 7 days, the antibiotic sensitivity of the
infecting organism should be retested. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(2) Turkeys--(i) Amount. One milligram of gentamicin per poult,
using a 5 milligram-per-milliliter solution.
(ii) Indications for use. As an aid in the prevention of early
mortality due to Arizona paracolon infections susceptible to gentamicin.
(iii) Limitations. For 1- to 3-day old turkey poults. Administer
subcutaneously in the neck. Injected poults must not be slaughtered for
food for at least 9 weeks after treatment.
(3) Chickens--(i) Amount. 0.2 milligram of gentamicin per 0.2
milliliter dose, using a 50 milligram-per-milliliter solution diluted
with sterile physiological saline to 1.0 milligram per milliliter.
(ii) Indications for use. In day-old chickens, for prevention of
early mortality caused by Escherichia coli. Salmonella typhimurium, and
Pseudomonas aeruginosa that are susceptible to gentamicin.
(iii) Limitations. For use in day-old chickens only. Administer
aseptically, injecting the diluted product subcutaneously in the neck.
Do not slaughter treated animals for food for at least 5 weeks after
treatment.
(4) Swine--(i) Amount. 5 milligrams of gentamicin as a single
intramuscular dose using 5 milligram-per-milliliter solution.
(ii) Indications for use. In piglets up to 3 days old for treatment
of porcine colibacillosis caused by strains of E. coli sensitive to
gentamicin.
(iii) Limitations. For single intramuscular dose in pigs up to 3
days of age only. Do not slaughter treated animals for food for at least
40 days following treatment.
(5) Dogs--(i) Amount. 2 milligrams of gentamicin per pound of body
weight, twice daily on the first day, then once daily.
(ii) Indications for use. For use in the treatment of urinary tract
infections (cystitis) caused by Proteus mirabilis, Escherichia coli, and
Staphylococcus aureus.
(iii) Limitations. Administer intramuscularly or subcutaneously. If
no improvement is seen after 3 days, treatment should be discontinued
and the diagnosis reevaluated. Treatment not to exceed 7 days. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
[43 FR 1942, Jan. 13, 1978, as amended at 48 FR 791, Jan. 7, 1983; 51 FR
15606, Apr. 25, 1986; 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18,
1988; 60 FR 29985, June 7, 1995]
Sec. 522.1055 Gleptoferron injection.
(a) Specifications. Each milliliter contains the equivalent of 200
milligrams
[[Page 269]]
of elemental iron as gleptoferron (complex of ferric hydroxide and
dextran glucoheptonic acid), and 0.5 percent phenol as a preservative.
(b) Sponsor. See 012525 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. It is used in baby pigs as follows:
(1) For prevention of iron deficiency anemia, administer 200
milligrams of elemental iron intramuscularly on or before 3 days of age.
(2) For treatment of iron deficiency anemia, administer 200
milligrams of elemental iron intramuscularly.
[45 FR 61288, Sept. 16, 1980]
Sec. 522.1066 Glycopyrrolate injection.
(a) Specifications. Each milliliter of aqueous solution contains 0.2
milligram of glycopyrrolate.
(b) Sponsor. See No. 000031 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is indicated as a preanesthetic agent
in dogs and cats.
(2) It is administered intravenously, intramuscularly, or
subcutaneously in dogs and intramuscularly in cats at a dosage level of
5 micrograms per pound of body weight (0.25 milliliter per 10 pounds of
body weight).
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[48 FR 21567, May 13, 1983]
Sec. 522.1077 Gonadorelin injectable.
(a) Specifications. Each milliliter sterile aqueous solution
contains 50 micrograms of gonadorelin (as hydrochloride).
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cattle--(1) Amount. 100 micrograms per cow
intramuscularly.
(2) Indications for use. For the treatment of cystic ovaries
(ovarian follicular cysts) in cattle to reduce the time to first estrus.
(3) Limitations. For intramuscular use only. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
[54 FR 50235, Dec. 5, 1989]
Sec. 522.1078 Gonadorelin diacetate tetrahydrate injection
(a) Specifications. The drug contains 50 micrograms of gonadorelin
diacetate tetrahydrate in each milliliter of sterile solution.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. It is used in dairy cows as follows:
(1) Amount. 100 micrograms per cow.
(2) Indications for use. The drug is used for the treatment of
ovarian cysts.
(3) Limitations. Administer as a single intramuscular or intravenous
injection. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
[43 FR 9804, Mar. 10, 1978, as amended at 45 FR 56798, Aug. 26, 1980]
Sec. 522.1079 Serum gonadotropin and chorionic gonadotropin.
(a) Specifications. Each dose consists of 400 international units
(I.U.) serum gonadotropin and 200 I.U. chorionic gonadotropin as a
freeze-dried powder to be reconstituted with 5 milliliters of sterile
aqueous diluent.
(b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in swine. (1) Amount. 400 I.U. serum
gonadotropin with 200 I.U. chorionic gonadotropin per 5 milliliters dose
per animal.
(2) Indications for use. (i) Gilts. For induction of fertile estrus
(heat) in healthy prepuberal (noncycling) gilts.
(ii) Sows. For induction of estrus in healthy weaned sows
experiencing delayed return to estrus.
(3) Limitations. For subcutaneous use only.
(i) Gilts. For use only in gilts over 5 1/2 months of age and
weighing at least 85 kilograms (187 pounds).
(ii) Sows. Delayed return to estrus is most prevalent after the
first litter. The effectiveness has not been established after later
litters. Delayed return to estrus often occurs during periods of adverse
environmental conditions, and sows mated under such conditions may
farrow smaller than normal litters.
[55 FR 1405, Jan. 16, 1990, as amended at 58 FR 52222, Oct. 7, 1993]
[[Page 270]]
Sec. 522.1081 Chorionic gonadotropin for injection; chorionic gonadotropin suspension.
(a)(1) Specifications. Chorionic gonadotropin for injection is
supplied in vials containing 5,000, 10,000 or 20,000 U.S.P. units of
lyophilized powder for reconstitution with the accompanying sterile
diluent to a 10 milliliter solution.
(2) Sponsor. See sponsor numbers in Sec. 510.600(c) of this chapter,
as follows:
(i) Nos. 000402 and 053501 for use of 10,000 U.S.P. units
intramuscularly, 2,500 to 5,000 U.S.P. units intravenously, and 500 to
2,500 U.S.P. units intrafollicularly.
(ii) Nos. 000469 and 058639 for use of 10,000 U.S.P. units
intramuscularly and 500 to 2,500 U.S.P. units intrafollicularly.
(iii) No. 057926 for use of 10,000 U.S.P. units intramuscularly.
(3) Conditions of use--(i) Amount. (a) 10,000 U.S.P. units as a
single, deep intramuscular injection.1
---------------------------------------------------------------------------
1 These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified as Sec. 514.111 of this chapter.
---------------------------------------------------------------------------
(b) 500 to 2,500 U.S.P. units for intrafollicular injection.1
(c) 2,500 to 5,000 U.S.P. units intravenously.
(ii) Indications for use. For parenteral use in cows for treatment
of nymphomania (frequent or constant heat) due to cystic ovaries.1
(iii) Limitations. Dosage may be repeated in 14 days if the animal's
behavior or rectal examination of the ovaries indicates the necessity
for retreatment. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.1
(b)(1) Specifications. Chorionic gonadotropin suspension, veterinary
contains in each milliliter, 750 I.U. of chorionic gonadotropin
suspended in white wax and sesame oil.
(2) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. 2 milliliters (1,500 I.U.)
subcutaneously, at the time of insemination, in the neck or shoulder
region.
(ii) Indications for use. The drug is used as an aid in increasing
pregnancy rate of estrus-synchronized and normalcycling heifers.
(iii) Limitations. The drug is not to be used to induce multiple
ovualtions. Doses higher than recommended may reduce pregnancy rate.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[42 FR 58167, Nov. 8, 1977, as amended at 45 FR 81038, Dec. 9, 1980; 50
FR 41489, Oct. 11, 1985; 50 FR 45603, Nov. 1, 1985; 52 FR 25212, July 6,
1987; 56 FR 67175, Dec. 30, 1991; 56 FR 14642, Apr. 11, 1991]
Sec. 522.1085 Guaifenesin sterile powder.
(a) Specifications. It is a sterile powder containing guaifenesin.
(b) Sponsor. See No. 000031 and 037990 in Sec. 510.600(c) of this
chapter.
(c) Conditions of use. (1) It is indicated for intravenous use as a
muscle relaxant in horses.
(2) A solution is prepared by dissolving the drug in sterile water
for injection to make a solution containing 50 milligrams of guaifenesin
per milliliter of solution. It is administered by rapid intravenous
infusion at a fixed dosage of 1 milliliter of prepared solution per
pound of body weight.
(3) Not to be used in horses intended for food.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[49 FR 48039, Dec. 10, 1984, as amended at 60 FR 27223, May 23, 1995]
Sec. 522.1086 Guaifenesin injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 50 milligrams of guaifenesin and 50 milligrams of dextrose.
(b) Sponsor. See No. 037990 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used intravenously in horses
as a skeletal muscle relaxant.
(2) Administer rapidly at a dosage of 1 milliliter per pound of body
weight.
(3) No to be used in horses intended for food.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[60 FR 27223, May 23, 1995]
[[Page 271]]
Sec. 522.1145 Hyaluronate sodium injection.
(a)(1) Specifications. Each milliliter of sterile aqueous solution
contains 10 milligrams of hyaluronate sodium.
(2) Sponsors. See 000016 and 060865 in Sec. 510.600(c) of this
chapter.
(3) Conditions of use--(i) Amount. Small and medium-size joints
(carpal, fetlock)--20 milligrams; larger joint (hock)--40 milligrams.
(ii) Indications for use. Treatment of joint dysfunction in horses
due to noninfectious synovitis associated with equine osteoarthritis.
(iii) Limitations. For intra-articular injection in horses only.
Treatment may be repeated at weekly intervals for a total of three
treatments. Not for use in horses intended for food. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(b)(1) Specifications. Each milliliter of sterile aqueous solution
contains 5 milligrams of hyaluronate sodium.
(2) Sponsor. See 053501 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. Small and medium-size joints
(carpal, fetlock)--10 milligrams; larger joint (hock)--20 milligrams.
(ii) Indications for use. Treatment of joint dysfunction in horses
due to noninfectious synovitis associated with equine osteoarthritis.
(iii) Limitations. For intraarticular injection in horses only.
Treatment may be repeated at weekly intervals for a total of four
treatments. Not for use in horses intended for food. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(c)(1) Specifications. Each milliliter of sterile aqueous solution
contains 10 milligrams of hyaluronate sodium.
(2) Sponsor. See 000856 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. Small and medium-size joints
(carpal, fetlock)--20 milligrams.
(ii) Indications for use. Treatment of carpal or fetlock joint
dysfunction in horses due to acute or chronic noninfectious synovitis
associated with equine osteoarthritis.
(iii) Limitations. For intraarticular injection in horses only.
Treatment may be repeated after 1 or more weeks but not to exceed 2
injections per week for a total of 4 weeks. Not for use in horses
intended for food. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(d)(1) Specifications. Each milliliter of sterile aqueous solution
contains 10 milligrams of hyaluronate sodium.
(2) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. 50 milligrams in carpal and
fetlock joints.
(ii) Indications for use. For treatment of equine carpal and
fetlock joint dysfunction caused by traumatic and/or degenerative joint
disease of mild to moderate severity.
(iii) Limitations. For intraarticular injection in horses only. Not
for use in horses intended for food. Not intended for use in breeding
animals. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(e)(1) Specifications. Each milliliter of sterile aqueous solution
contains 10 milligrams of hyaluronate sodium.
(2) Sponsor. See 000859 in Sec. 510.600(c)(2) of this chapter.
(3) Conditions of use--(i) Amount. Intraarticular: 20 milligrams in
the carpus or fetlock. Intravenous: 40 milligrams slowly into the
jugular vein.
(ii) Indications for use. Treatment of carpal or fetlock joint
dysfunction in horses due to noninfectious synovitis associated with
equine osteoarthritis.
(iii) Limitations. For intraarticular or intravenous use in horses
only. Treatment may be repeated at weekly intervals for a total of three
treatments. Not for use in horses intended for food. The safety of use
of this drug in breeding animals has not been determined. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[49 FR 45124, Nov. 15, 1984, as amended at 51 FR 11438, Apr. 3, 1986; 51
FR 25032, July 10, 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, June
15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR 2837, Jan. 24, 1992; 59 FR
33198, June 28, 1994]
Sec. 522.1150 Hydrochlorothiazide injection.
(a) Specifications. Each milliliter contains 25 milligrams of
hydrochlorothiazide.
(b) Sponsor. See No. 000006 in Sec. 510.600(c) of this chapter.
[[Page 272]]
(c) Conditions of use--(1) Amount. 5 to 10 milliliters (125 to 250
milligrams) intravenously or intramuscularly once or twice a day. After
onset of diuresis, treatment may be continued with an orally
administered maintenance dose.
(2) Indications for use. For use in cattle as an aid in the
treatment of postparturient udder edema.1
---------------------------------------------------------------------------
1 These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(3) Limitations. Animals should be regularly and carefully observed
for early signs of fluid and electrolyte imbalance. Take appropriate
countermeasures if this should occur. Milk taken from dairy animals
during treatment and for 72 hours (6 milkings) after the latest
treatment must not be used for food. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.1
[43 FR 59058, Dec. 19, 1978]
Sec. 522.1155 Imidocarb dipropionate sterile powder.
(a) Specifications. Imidocarb dipropionate powder is reconstituted
with sterile water. Each milliliter of solution contains 100 milligrams
of imidocarb base.
(b) Sponsor. No. 011716 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. The drug is used in horses and zebras as
follows:
(1) Amount. For Babesia caballi infections, use intramuscularly 2
milligrams of imidocarb base per kilogram of body weight, repeating
dosage once after 24 hours. For Babesia equi infections, use 4
milligrams of imidocarb base per kilogram of body weight, repeating
dosage four times at 72-hour intervals.
(2) Indications for use. For the treatment of babesiosis
(piroplasmosis) caused by Babesia caballi and Babesia equi.
(3) Limitations. Administer intramuscularly in the neck region. Do
not inject intravenously. Do not use for other equidae or for animals of
other species. Do not use in horses less than 1 year old. Do not use for
animals in near-term pregnancies. Imidocarb dipropionate is a
cholinesterase inhibitor. Do not use this product simultaneously with or
a few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides, or chemicals. Do not use in horses
intended for food. Federal law restricts this drug to use by or on the
order of a licensed veterinarian. Imidocarb dipropionate is sold only
under permit issued by the Director of the National Program Planning
Staff, Veterinary Services, APHIS, USDA, to licensed or full-time State,
Federal, or military veterinarians.
[43 FR 40455, Sept. 12, 1978, as amended at 46 FR 48642, Oct. 2, 1981;
61 FR 8873, Mar. 6, 1996]
Sec. 522.1182 Iron dextran complex injection.
(a)(1) Specifications. Each milliliter of sterile solution contains
ferric hydroxide dextran complex equivalent to 100 milligrams of
elemental iron. It contains 0.5 percent phenol as a preservative.
(2) [Reserved]
(3)(i) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(ii) Conditions of use. It is used in baby pigs as follows:
(a) For the prevention of anemia due to iron deficiency, administer
an initial intramuscular injection of 100 milligrams of elemental iron
to each animal at 2 to 4 days of age. Dosage may be repeated in 14 to 21
days.
(b) For the treatment of anemia due to iron deficiency, administer
and intramuscular injection of 200 milligrams of elemental iron.
(4)(i) Sponsor. See Nos. 000061 and 012525 in Sec. 510.600(c) of
this chapter.
(ii) Conditions of use. It is used in baby pigs as follows:
(a) For the prevention of iron deficiency anemia, administer
intramuscularly an amount of drug containing 100 to 150 milligrams of
elemental iron to animals from 1 to 3 days of age.
(b) For the treatment of iron deficiency anemia, administer
intramuscularly an amount of drug containing 100 to 200 milligrams of
elemental iron per animal. Dosage may be repeated in 10 days to 2 weeks.
[[Page 273]]
(b)(1) Specifications. Each milliliter of sterile solution contains
ferric hydroxide in complex with dextran equivalent to 200 milligrams of
elemental iron. It contains 0.5 percent phenol as a preservative.
(2)(i) Sponsor. See No. 054273 in Sec. 510.600(c) of this chapter.
(ii) Conditions of use. It is used in baby pigs as follows:
(a) For prevention of baby pig anemia due to iron deficiency,
intramuscularly inject 200 milligrams of elemental iron (1 milliliter)
at 1 to 3 days of age.
(b) For treatment of baby pig anemia due to iron deficiency,
intramuscularly inject 200 milligrams of elemental iron at the first
sign of anemia.
[49 FR 38938, Oct. 2, 1984, as amended 52 FR 7832, Mar. 13, 1987; 53 FR
40727, Oct. 18, 1988; 54 FR 41442, Oct. 10, 1989]
Sec. 522.1183 Iron hydrogenated dextran injection.
(a) Specifications. Each milliliter contains 100 milligrams of
elemental iron stabilized with a low molecular weight hydrogenated
dextran and 0.5 percent phenol as a preservative.
(b) NAS/NRC status. Use of this drug has been NAS/NRC reviewed and
found effective. Applications for these uses need not include
effectiveness data as specified by Sec. 514.111 of this chapter, but may
require bioequivalency and safety information.
(c)(1) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
(2) Conditions of use. It is used in baby pigs as follows:
(i) For the prevention of anemia due to iron deficiency, administer
an initial intramuscular injection of 100 milligrams of elemental iron
to each animal at 2 to 5 days of age. Dosage may be repeated at 2 weeks
of age.
(ii) For the treatment of anemia due to iron deficiency, administer
an intramuscular injection of 100 milligrams of elemental iron to each
animal when indicated between 5 and 28 days of age.
(d)(1) Sponsor. See No. 000003 in Sec. 510.600(c) of this chapter.
(2) Conditions of use. It is used in baby pigs as follows:
(i) For the prevention of anemia due to iron deficiency, administer
by intramuscular or subcutaneous injection of 100 milligrams of
elemental iron to each animal at 2 to 4 days of age.
(ii) For the treatment of anemia due to iron deficiency, administer
by intramuscular or subcutaneous injection of 100 milligrams of
elemental iron in baby pigs up to 4 weeks of age.
(e)(1) Sponsors. See Nos. 017287, 050604, and 054273 in
Sec. 510.600(c) of this chapter.
(2) Conditions of use. It is used in baby pigs as follows:
(i) For the prevention of iron deficiency anemia, administer
intramuscularly 100 milligrams at 2 to 4 days of age.
(ii) For the treatment of iron deficiency anemia, administer
intramuscularly 100 milligrams. Treatment may be repeated in 10 days.
[42 FR 53955, Oct. 4, 1977, as amended at 46 FR 39128, July 31, 1981; 50
FR 23298, June 3, 1985; 52 FR 18691, May 19, 1987; 52 FR 36023, Sept.
25, 1987; 53 FR 40728 and 40729, Oct. 18, 1988; 55 FR 8462, Mar. 8,
1990; 55 FR 33670, Aug. 17, 1990]
Sec. 522.1192 Ivermectin injection.
(a) Specifications--(1) Horses. Each milliliter of sterile aqueous
solution contains 20 milligrams of ivermectin (2 percent).
(2) Cattle, reindeer, and swine. Each milliliter of sterile aqueous
solution contains 10 milligrams of ivermectin (1 percent).
(3) Piglets 70 pounds or less and ranch-raised foxes. Each
milliliter of sterile aqueous solution contains 2.7 milligrams of
ivermectin (0.27 percent).
(b) Sponsor. See No. 000006 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.344 of this chapter.
(d) Conditions of use--(1) Horses--(i) Amount. 20 milligrams per 100
kilograms (220 pounds) of body weight.
(ii) Indications for use. It is used in horses for the treatment and
control of large strongyles (adult) (Strongylus vulgaris, Strongylus
edentatus, Triodontophorus spp.), small strongyles (adult and fourth
stage larvae) (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus
spp.), pinworms (adult and fourth-stage larvae) (Oxyuris equi), large
roundworms (adult) (Parascaris equorum), hairworms (adult)
(Trichostrongylus axei), large mouth stomach worms (adult) (Habronema
[[Page 274]]
muscae), neck threadworms (microfilariae) (Onchocerca spp.), and stomach
bots (Gastrophilus spp.).
(iii) Limitations. For intramuscular use only. Do not use
intravenously. Not for use in horses intended for food. Effects of this
drug on pregnant mares have not been determined. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(2) Cattle--(i) Amount. 10 milligrams per 50 kilograms (110 pounds)
body weight (200 micrograms per kilogram).
(ii) Indications for use. It is used in cattle for the treatment and
control of gastrointestinal nematodes (adults and fourth-stage larvae)
(Haemonchus placei, Ostertagia ostertagi (including inhibited larvae),
O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora,
C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus
helvetianus (adults only), N. spathiger (adults only), Bunostomum
phlebotomum); lungworms (adults and fourth-stage larvae) (Dictyocaulus
viviparus); grubs (first, second, and third instars) (Hypoderma bovis,
H. lineatum); lice (Linognathus vituli, Haematopinus eurysternus,
Solenopotes capillatus); mites (Psoroptes ovis (syn. P. communis var.
bovis), Sarcoptes scabiei var. bovis).
(iii) Limitations. For subcutaneous use only. Not for intramuscular
use. Do not treat cattle within 35 days of slaughter. Because a
withdrawal time in milk has not been established, do not use in female
dairy cattle of breeding age. Do not use in other animal species because
severe adverse reactions, including fatalities in dogs, may result.
Consult your veterinarian for assistance in the diagnosis, treatment,
and control of parasitism.
(3) Reindeer--(i) Amount. 10 milligrams per 50 kilograms (110
pounds) body weight.
(ii) Indications for use. It is used in reindeer for treatment and
control of warbles (Oedemagena tarandi).
(iii) Limitations. For subcutaneous use only. Not for intramuscular
use. Do not treat reindeer within 56 days of slaughter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(4) Swine--
(i) Amount. 300 micrograms per kilogram (2.2 pounds).
(ii) Indications for use. It is used in swine for treatment and
control of gastrointestinal roundworms (adults and fourth-stage larvae)
(large roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus;
nodular worm, Oesophagostomum spp.; threadworm, Strongyloides ransomi
(adults only)); somatic roundworm larvae (threadworm, Strongyloides
ransomi (somatic larvae)); lungworms (Metastrongylus spp. (adults
only)); lice (Haematopinus suis); and mites (Sarcoptes scabiei var.
suis).
(iii) Limitations. For subcutaneous injection in the neck of swine
only. Do not treat swine within 18 days of slaughter. Do not use in
other animal species as severe adverse reactions, including fatalities
in dogs, may result. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism.
(5) Ranch-raised foxes. (i) Amount. 200 micrograms per kilogram body
weight. Repeat in 3 weeks.
(ii) Indications for use. For treatment and control of ear mites
(Otodectes cynotis).
(iii) Limitations. For subcutaneous use only. Consult your
veterinarian for assistance in the diagnosis, treatment, and control of
parasitism.
[49 FR 5344, Feb. 13, 1984, as amended at 50 FR 30268, July 25, 1985; 51
FR 25686, July 16, 1986; 51 FR 27021, July 29, 1986; 51 FR 29463, Aug.
18, 1986; 53 FR 11064, Apr. 5, 1988; 56 FR 14020, Apr. 5, 1991; 60 FR
45041, Aug. 30, 1995]
Sec. 522.1193 Ivermectin and clorsulon injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 10 milligrams (1 percent) of ivermectin and 100 milligrams (10
percent) of clorsulon.
(b) Sponsor. See 000006 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Secs. 556.163 and 556.344 of this
chapter.
(d) Conditions of use--(1) Amount. 1 milliliter (10 milligrams of
ivermectin and 100 milligrams of clorsulon) per 50 kilograms (110
pounds).
(2) Indications for use. It is used in cattle for the treatment and
control of gastrointestinal nematodes (adults and fourth-stage larvae)
(Haemonchus
[[Page 275]]
placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata,
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C.
punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus
helvetianus (adults only), N. spathiger (adults only), Bunostomum
phlebotomum; lungworms (adults and fourth-stage larvae) (Dictyocaulus
viviparus); liver flukes (adults only) (Fasciola hepatica); grubs
(parasitic stages) (Hypoderma bovis, H. lineatum); lice (Linognathus
vituli, Haematopinus eurysternus, Solenopotes capillatus); mites
(Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var.
bovis).
(3) Limitations. For subcutaneous use only. Not for intravenous or
intramuscular use. Do not treat cattle within 49 days of slaughter.
Because a withdrawal time in milk has not been established, do not use
in female dairy cattle of breeding age. Do not use in other animal
species because severe adverse reactions, including fatalities in dogs,
may result. Consult your veterinarian for assistance in the diagnosis,
treatment, and control of parasitism.
[55 FR 38984, Sept. 24, 1990]
Sec. 522.1204 Kanamycin sulfate injection.
(a) Specifications. Kanamycin sulfate injection veterinary conforms
to the standards of identify, strength, quality, and purity prescribed
by Sec. 444.230(a) of this chapter, except that each milliliter contains
either 50 or 200 milligrams of kanamycin.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used in the treatment of bacterial
infections due to kanamycin sensitive organisms in dogs and cats.
(2) It is administered subcutaneously or intramuscularly at 5
milligrams per pound of body weight per day in equally divided doses at
12-hour intervals.
(3) Its label shall bear an appropriate expiration date.
(4) Restricted to use by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988]
Sec. 522.1222 Ketamine hydrochloride injectable dosage forms.
Sec. 522.1222a Ketamine hydrochloride injection.
(a) [Reserved]
(b) Specifications. The drug is a sterile aqueous solution and each
mililiter contains: Ketamine hydrochloride equivalent to 100 milligrams
ketamine base activity and 1:10,000 benzethonium chloride.
(c) Sponsors. See Nos. 000856, 045984, 054273, and 057319 in
Sec. 510.600(c) of this chapter.
(d) [Reserved]
(e) Conditions of use. (1) In cats: (i) It is used for restraint or
as the sole anesthetic agent in diagnostic or minor, brief surgical
procedures that do not require skeletal muscle relaxation.
(ii) It is administered intramuscularly at a recommended dose that
ranges from 5 to 15 milligrams per pound of body weight depending on the
effect desired.
(2) In subhuman primates: (i) It is used for restraint.
(ii) It is administered intramuscularly at a recommended dose that
ranges from 3 to 15 milligrams per kilogram of body weight depending
upon the species, general condition, and age of the subject.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 59342, Dec. 23, 1975, as amended at 53 FR 27851, July 25, 1988;
59 FR 41976, Aug. 16, 1994; 59 FR 49291, Sept. 27, 1994; 60 FR 49339,
Sept. 25, 1995]
Sec. 522.1222b Ketamine hydrochloride with promazine hydrochloride and aminopentamide hydrogen sulfate injection.
(a) Chemical name. Ketamine hydrochloride, (plus-minus),-2-(o-
chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride, with
promazine hydrochloride, 10-[3-(dimethylamino) propyl] phenothiazine
monohydrochloride, and aminopentamide hydrogen sulfate.
(b) Specifications. The drug is a sterile aqueous solution and each
milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams
ketamine base activity, 7.5 milligrams of
[[Page 276]]
promazine hydrochloride, and 0.0625 milligram of aminopentamide hydrogen
sulfate, with 1:10,000 benzethonium chloride.
(c) Sponsor. See Code No. 000856 in Sec. 510.600(c) of this chapter.
(d) Special considerations. Store in a cool place. Protect from
light. Do not use if precipitate appears.
(e) Conditions of use. (1) It is used in cats as the sole anesthetic
agent for ovariohysterectomy and general surgery.
(2) It is administered intramuscularly at a recommended dose from 15
to 20 milligrams ketamine base per pound of body weight, depending on
the effect desired.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 59342, Dec. 23, 1975, as amended at 42 FR 3838, Jan. 21, 1977; 53
FR 27851, July 25, 1988]
Sec. 522.1225 Ketoprofen solution.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 100 milligrams of ketoprofen.
(b) Sponsor. See 000856 in 21 CFR 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. 1.0 milligram per pound
of body weight once daily for up to 5 days.
(2) Indications for use. For alleviation of inflammation and pain
associated with musculoskeletal disorders in horses.
(3) Limitations. For intravenous use only. Do not use in breeding
animals. Effects on fertility, pregnancy, or fetal health have not been
determined. Not for use in horses intended for food. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[55 FR 40653, Oct. 4, 1990]
Sec. 522.1228 [Reserved]
Sec. 522.1244 Levamisole phosphate injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains levamisole phosphate equivalent to 136.5 or 182 milligrams of
levamisole hydrochloride (13.65 or 18.2 percent).
(b) Sponsor. See No. 011716 in Sec. 510.600 of this chapter for use
of 13.65 percent injection, and see No. 043781 for use of 13.65 and 18.2
percent injection.
(c) Conditions of use--(1) Amount. 2 milliliters per 100 pounds of
body weight, subcutaneously in the neck.
(2) Indications for use. (i) The 13.65 percent injection is used as
an anthelmintic in cattle for treatment of the following parasites:
stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal
worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum,
Oesophagostomum, Chabertia), and lungworms (Dictyocaulus).
(ii) The 18.2 percent injection is used as an anthelmintic in cattle
for treatment of the following parasites: stomach worms (Haemonchus,
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus,
Cooperia, Nematodirus, Bunostomum, Oesophagostomum) and lungworms
(Dictyocaulus).
(3) Limitations. Do not administer more than 10 milliliters per
site. Cattle that are severely parasitized or maintained under
conditions of constant helminth exposure may require re-treatment within
2 to 4 weeks after first treatment. Consult your veterinarian for
assistance in the diagnosis, treatment, and control of parasitism.
Consult your veterinarian before using in severely debilitated animals
or animals under severe stress. Do not administer to cattle within 7
days of slaughter. Do not administer to dairy animals of breeding age.
[43 FR 20489, May 12, 1978, as amended at 43 FR 29289, July 7, 1978; 43
FR 60895, Dec. 29, 1978; 47 FR 10807, Mar. 12, 1982]
Sec. 522.1258 Lidocaine injection with epinephrine.
(a) Specifications. Each milliliter of the drug contains 20
milligrams (2 percent) of lidocaine hydrochloride, 0.01 milligram of
epinephrine, with sodium chloride, and with methylparaben as a
preservative, in water for injection.
(b) Sponsor. See No. 000402 in Sec. 510.600(c) of this chapter.
(c) Conditions of use\1\--(1) Amount. The drug is administered by
injection as a 2
[[Page 277]]
percent solution or diluted with bacteriostatic water for injection to a
0.5 percent solution for local anesthesia of large and small animals, as
follows:
---------------------------------------------------------------------------
1 These conditions are National Academy of Science/National
Research Council reviewed and deemed effective for this drug.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter but may require bioequivalency
and safety information.
---------------------------------------------------------------------------
(i) Cats: Administer approximately 2 milliliters of 2 percent
solution with epinephrine by caudal injection.
(ii) Cattle: Administer 5 milliliters of 2 percent solution with
epinephrine by epidural injection (standing animal). Administer 10 to 20
milliliters of 2 percent solution with epinephrine by cornural nerve
block injection. For teat operations and infiltration, inject 0.5
percent solution with epinephrine to effect.
(iii) Dogs: Administer 2 to 10 milliliters of 2 percent solution
with epinephrine by caudal injection. Do not give intravascularly. For
infiltration, administer 0.5 percent solution with epinephrine to
effect.
(iv) Horses: Administer 5 to 10 milliliters of 2 percent solution
with epinephrine by volar nerve block. Administer 10 to 15 milliliters
of 2 percent solution with epinephrine by epidural injection. For
standing animal, apply slowly and observe individual sensitivity. For
infiltration, administer 0.5 percent solution with epinephrine to
effect.
(2) Limitations. (i) The drug is contraindicated in the presence of
sepsis in the region of proposed injection, shock and heart block,
neurologic disease, spinal deformities, septicema, and hypertension.
(ii) Do not give intravascularly.
(iii) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[43 FR 46300, Oct. 6, 1978; 43 FR 59059, Dec. 19, 1978, as amended at 52
FR 25212, July 6, 1987]
Sec. 522.1260 Lincomycin injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains lincomycin hydrochloride equivalent to 25, 50, 100, or 300
milligrams of lincomycin.
(b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
(c) Special considerations. When common labeling for use of the drug
in dogs, cats, and swine is included with the drug, all such uses are
subject to the labeling requirements of Sec. 201.105 of this chapter.
(d) Related tolerances. See Sec. 556.360 of this chapter.
(e) Conditions of use. It is used for animals as follows:
(1) Dogs and cats--(i) Amount. 5 to 10 milligrams per pound of body
weight per day.
(ii) Indications for use. Infections caused by Gram-positive
organisms, particularly streptococci and staphylococci.
(iii) Limitations. Administer intramuscularly 10 milligrams per
pound of body weight once a day or 5 milligrams per pound of body weight
twice daily or intravenously 5 to 10 milligrams per pound of body weight
one or two times daily by slow injection. May be diluted with 5 percent
glucose in water or normal saline and given as an infusion; as
lincomycin hydrochloride monohydrate; for use by or on the order of a
licensed veterinarian.
(2) Swine--(i) Amount. 5 milligrams per pound of body weight per
day.
(ii) Indications for use. Treatment of infectious arthritis and
mycoplasma pneumonia.
(iii) Limitations. Administer intramuscularly as a single daily dose
for 3 to 7 days; as lincomycin hydrochloride monohydrate: do not treat
within 48 hours of slaughter.
[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 31351, Aug. 2, 1985]
Sec. 522.1290 Luprostiol sterile solution.
(a) Specifications. Each milliliter of sterile solution contains 7.5
milligrams of luprostiol.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Labeling shall bear the following
statements: Warning: Women of childbearing age, asthmatics, and persons
with bronchial and other respiratory problems should exercise extreme
caution when handling this product. In the early stages, women may be
unaware of their pregnancies. Luprostiol is readily absorbed through the
skin and can cause abortion and/or bronchiospasms. Direct
[[Page 278]]
contact with the skin should therefore be avoided. Accidental spillage
on the skin should be washed off immediately with soap and water.
(d) Conditions of use--(1) Amount. 7.5 milligrams per mare.
(2) Indications for use. The drug is used in mares for estrus
control and termination of pregnancy.
(3) Limitations. Administer by intramuscular injection only. Not for
use in horses intended for food. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
[55 FR 1185, Jan. 12, 1990, as amended at 56 FR 50653, Oct. 8, 1991; 60
FR 55659, Nov. 2, 1995]
Sec. 522.1350 Melatonin implant.
(a) Specifications. The drug is a silicone rubber elastomer implant
containing 2.7 milligrams of melatonin.
(b) Sponsor. See No. 053923 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. One implant per mink.
(2) Indications for use. For use in healthy male and female kit and
adult female mink (Mustela vison) to accelerate the fur priming cycle.
(3) Limitations. For subcutaneous implantation in mink only. Do not
implant potential breeding stock. Do not use in food-producing animals.
[59 FR 37422, July 22, 1994]
Sec. 522.1362 Melarsomine dihydrochloride for injection.
(a) Specifications. The drug consists of a vial of lyophilized
powder containing 50 milligrams of melarsomine dihydrochloride which is
reconstituted with the provided 2 milliliters of sterile water for
injection.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. For asymptomatic to moderate
(class 1 to class 2) heartworm disease: 2.5 milligrams per kilogram of
body weight (1.1 milligram per pound) twice, 24 hours apart. The series
can be repeated in 4 months depending on the response to the first
treatment and the condition, age, and use of the dog. For severe (class
3) heartworm disease: Single injection of 2.5 milligrams per kilogram
followed, approximately 1 month later, by 2.5 milligrams per kilogram
administered twice, 24 hours apart.
(2) Indications. Treatment of stabilized, class 1, 2, and 3
heartworm disease (asymptomatic to mild, moderate, and severe,
respectively) caused by immature (4 month-old, stage L5) to mature
adult infections of Dirofilaria immitis in dogs.
(3) Limitations. Administer only by deep intramuscular injection in
the lumbar muscles (L3-L5). Use a 23 gauge 1 inch needle for
dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2
inch needle for dogs greater than 10 kilograms (22 pounds). Use
alternate sides with each administration. The drug is contraindicated in
dogs with class 4 (very severe) heartworm disease (Caval Sydrome). Not
for use in breeding animals and lactating or pregnant bitches. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
[60 FR 49340, Sept. 25, 1995]
Sec. 522.1372 Mepivacaine hydrochloride injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 20 milligrams of mepivacaine hydrochloride.
(b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is intended for use in horses as a
local anesthetic for infiltration, nerve block, intra-articular and
epidural anesthesia and topical and/or infiltration anesthesia of the
laryngeal mucosa prior to ventriculectomy.
(2) It is administered as follows: for nerve block, 3 to 15
milliliters; for epidural anesthesia, 5 to 20 milliliters; for intra-
articular anesthesia, 10 to 15 milliliters; for infiltration, as
required; for anesthesia of the laryngeal mucosa prior to
ventriculectomy, by topical spray, 25 to 40 milliliters, by
infiltration, 20 to 50 milliliters.
(3) Not for use in horses intended for food.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[42 FR 5349, Jan. 28, 1977, as amended at 42 FR 36995, July 19, 1977; 55
FR 23076, June 6, 1990]
[[Page 279]]
Sec. 522.1380 Methocarbamol injection.
(a) Specifications. The product is a sterile, pyrogen-free solution,
each milliliter containing 100 milligrams of methocarbamol, 0.5
milliliter of polyethylene glycol 300, and water for injection q.s. Its
pH is 3.5 to 6.0.
(b) Sponsor. See 000031 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount--(i) Dogs and cats. 20 milligrams
per pound of body weight for moderate conditions, 25 to 100 milligrams
per pound of body weight for severe conditions (tetanus and strychnine
poisoning), total cumulative dose not to exceed 150 milligrams per pound
of body weight.
(ii) Horses. 2 to 10 milligrams per pound of body weight for
moderate conditions, 10 to 25 milligrams per pound of body weight for
severe conditions (tetanus), additional amounts may be needed to relieve
residual effects and to prevent recurrence of symptoms.
(2) Indications for use. As an adjunct for treating acute
inflammatory and traumatic conditions of the skeletal muscles and to
reduce muscular spasms.
(3) Limitations. For intravenous use only. For dogs, administer
rapidly half the estimated dose, pause until the animal starts to relax,
then continue administration to effect. For horses, administer rapidly
to effect. Not for horses intended for food use. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
[45 FR 79758, Dec. 2, 1980, as amended at 46 FR 18964, Mar. 27, 1981]
Sec. 522.1410 Sterile methylprednisolone acetate suspension.
(a) Specifications. Each milliliter of aqueous suspension contains
20 or 40 milligrams of methylprednisolone acetate.1
---------------------------------------------------------------------------
1 These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(b) Sponsors. See Nos. 000009 and 054273 in Sec. 510.600(c) of this
chapter.
(c) Special considerations. (1) Clinical and experimental data have
demonstrated that corticosteroids administered orally or parenterally to
animals may induce the first stage of parturition when administered
during the last trimester of pregnancy and may precipitate premature
parturition followed by dystocia, fetal death, retained placenta, and
metritis.
(2) Systemic therapy with methylprednisolone acetate, as with other
corticoids, is contraindicated in animals with arrested tuberculosis,
peptic ulcer, and Cushing's syndrome. The presence of active
tuberculosis, diabetes mellitus, osteoporosis, renal insufficiency,
predisposition to thrombophlebitis, hypertension, or congestive heart
failure necessitates carefully controlled use of corticosteroids.
Intrasynovial, intratendinous, or other injections of corticosteroids
for local effect are contraindicated in the presence of acute infectious
conditions. Exacerbation of pain, further loss of joint motion, with
fever and malaise following injection may indicate that the condition
has become septic. Appropriate antibacterial therapy should be
instituted immediately.
(d) Conditions of use--(1) Amount--(i) Intramuscular. Dosage may be
repeated when necessary, as follows: dogs--2 to 40 milligrams (up to 120
milligrams in extremely large breeds or dogs with severe involvement);
cats--10 to 20 milligrams; horses--200 milligrams. \1\
(ii) Intrasynovial. Dosage may be repeated when necessary, as
follows: horses--40 to 240 milligrams; dogs--up to 20 milligrams.1
(2) Indications for use. Treatment of inflammation and related
disorders in dogs, cats, and horses; 1 treatment of allergic and
dermatologic disorders in dogs and cats; and as supportive therapy to
antibacterial treatment of severe infections in dogs and cats.
(3) Limitations. Not for use in horses intended for food. Not for
human use. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
[43 FR 59058, Dec. 19, 1978, as amended at 51 FR 741, Jan. 8, 1986; 53
FR 40728, Oct. 18, 1988]
[[Page 280]]
Sec. 522.1452 Nalorphine hydrochloride injection.
(a) Specifications. Each milliliter of aqueous solution contains 5
milligrams of nalorphine hydrochloride.
(b) Sponsor. See No. 000006 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. One milligram per 5 pounds;
intravenously, intramuscularly, or subcutaneously.
(2) Indications for use. Respiratory and circulatory depression in
dogs resulting from overdosage of, or unusual sensitivity to, morphine
and certain other narcotics. Not for depression due to any other cause.
(3) Limitations. Successive doses of the drug gradually lose their
analeptic effect and eventually induce respiratory depression equal to
that of opiates. Therefore, do not exceed therapeutic dosage. Do not mix
drug with meperidine solutions because the buffer will cause
precipitation. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
[44 FR 6707, Feb. 2, 1979, as amended at 47 FR 36418, Aug. 20, 1982]
Sec. 522.1462 Naloxone hydrochloride injection.
(a) Specifications. Naloxone hydrochloride injection is an aqueous
sterile solution containing 0.4 milligram of naloxone hydrochloride per
milliliter.
(b) Sponsor. See No. 000056 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used as a narcotic antagonist in
dogs.
(2) It is administered by intravenous, intramuscular, or
subcutaneous injection at an initial dose of 0.04 milligram per kilogram
of body weight. When given intravenously, the dosage may be repeated at
2- to 3-minute intervals as necessary. Onset of action by intramuscular
or subcutaneous injection is slightly longer than it is by intravenous
injection, and repeated dosages must be administered accordingly.
(3) For use only by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 47 FR 20757, May 14, 1982; 54
FR 32632, Aug. 9, 1989]
Sec. 522.1468 Naproxen for injection.
(a) Specifications. The drug is a lyophilized powder which is
reconstituted with sterile water for injection to form a 10 percent
sterile aqueous solution (100 milligrams per milliliter).
(b) Sponsor. See 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses. (1) Dosage. Five milligrams per
kilogram of body weight intravenously followed by maintenance oral
therapy of 10 milligrams per kilogram of body weight twice daily for up
to 14 consecutive days.
(2) Indications for use. For the relief of inflammation and
associated pain and lameness exhibited with arthritis, as well as
myositis and other soft tissue diseases of the musculoskeletal system of
the horse.
(3) Limitations. Not for use in horses intended for food. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
[46 FR 26763, May 15, 1981. Redesignated and amended at 51 FR 24525,
July 7, 1986; 61 FR 5507, Feb. 13, 1996]
Sec. 522.1484 Neomycin sulfate sterile solution.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 50 milligrams of neomycin sulfate (equivalent to 35 milligrams
of neomycin base). The neomycin sulfate used in manufacturing the drug
conforms to the standards of identity, strength, quality, and purity
prescribed by Sec. 444.42a(a)(1) of this chapter.1
---------------------------------------------------------------------------
1 These claims are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter.
---------------------------------------------------------------------------
(b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. 5 milligrams per pound of body
weight daily divided into portions administered every 6 to 8 hours for 3
to 5 days.1
(2) Indications for use. Administer to dogs and cats for the
treatment of acute and chronic bacterial infections due to organisms
susceptible to neomycin.1
(3) Limitations. For intramuscular or intravenous use only. Neomycin
is not for use parenterally in food-producing
[[Page 281]]
animals because of prolonged residues in edible tissues. Labeling shall
bear an appropriate expiration date. For use by or on the order of a
licensed veterinarian.1
[43 FR 48996, Oct. 20, 1978]
Sec. 522.1503 Neostigmine methylsulfate injection.
(a) Specifications. Neostigmine methylsulfate injection contains two
milligrams of neostigmine methylsulfate in each milliliter of sterile
aqueous solution.
(b) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is intended for use for treating
rumen atony; initiating peristalsis which causes evacuation of the
bowel; emptying the urinary bladder; and stimulating skeletal muscle
contractions. It is a curare antagonist.
(2) It is administered to cattle and horses at a dosage level of 1
milligram per 100 pounds of body weight subcutaneously. It is
administered to sheep at a dosage level of 1 to 1\1/2\ milligrams per
100 pounds body weight subcutaneously. It is administered to swine at a
dosage level of 2 to 3 milligrams per 100 pounds body weight
intramuscularly. These doses may be repeated as indicated.
(3) The drug is contraindicated in mechanical, intestinal or urinary
obstruction, late pregnancy, and in animals treated with other
cholinesterase inhibitors.
(4) Not for use in animals producing milk, since this use will
result in contamination of the milk.
(5) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
Sec. 522.1610 Oleate sodium solution.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 50 milligrams of sodium oleate.
(b) Sponsor. See No. 037990 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) It is used in horses to stimulate
infiltration of cellular blood components that subsequently
differentiate into fibrous and/or fibrocartilagenous tissue.
(2) The drug is administered by parenteral injection dependent upon
the area of response desired. An injection of 1 milliliter will produce
a response of approximately 15 square centimeters. Do not inject more
than 2 milliliters per injection site. Regardless of the number of
injection sites, the total volume used should not exceed 10 milliliters.
(3) Not for use in horses intended for food.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[41 FR 27034, July 1, 1976, as amended at 50 FR 40966, Oct. 8, 1985]
Sec. 522.1620 Orgotein for injection.
(a) Specifications. Orgotein for injection is packaged in a vial
containing 5 milligrams of orgotein and 10 milligrams of sucrose as
lyophilized sterile nonpyrogenic powder with directions for dissolving
the contents of the vial in 2 milliliters of diluent which is sodium
chloride injection, U.S.P.
(b) Sponsor. See No. 024991 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Horses. (i) It is used in the treatment
of soft tissue inflammation associated with the musculoskeletal system.
(ii) It is administered by deep intramuscular injection at a dosage
level of 5 milligrams every other day for 2 weeks and twice weekly for 2
to 3 more weeks. Severe cases, both acute and chronic, may benefit more
from daily therapy initially. Dosage may be continued beyond 5 weeks if
satisfactory improvement has not been achieved.
(iii) Not for use in horses intended for food.
(2) Dogs. (i) It is used for the relief of inflammation associated
with ankylosing spondylitis, spondylosis, and disc disease. When severe
nerve damage is present, response will occur much more slowly, if at
all.
(ii) It is administered by subcutaneous injection at a dosage level
of 5 milligrams every day for 6 days, and thereafter, every other day
for 8 days. In less severe conditions, shorter courses of therapy may be
indicated.
[[Page 282]]
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 32583, Aug. 4, 1976]
Sec. 522.1642 Oxymorphone hydrochloride injection.
(a) Specifications. The drug contains 1 or 1.5 milligrams of
oxymorphone hydrochloride per milliliter of aqueous solution containing
0.8 percent sodium chloride.
(b) Sponsor. See No. 000056 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is a narcotic analgesic,
preanesthetic, anesthetic, and substitute anesthetic adjuvant for
intramuscular, subcutaneous or intravenous administration to cats and
dogs as follows:
------------------------------------------------------------------------
Dosage
Animal Body weight (pounds) (milligram)
------------------------------------------------------------------------
Dogs........................ 2 to 5....................... 0.75
5 to 15...................... 0.75-1.5
15 to 30..................... 1.5-2.5
30 to 60..................... 2.5-4.0
Over 60...................... 4.0
Cats........................ Small........................ 0.4-0.75
Large........................ 0.75-1.5
------------------------------------------------------------------------
(2) Do not mix with a barbiturate in the same syringe to preclude
precipitation.
(3) It tends to depress respiration. Naloxone hydrochloride and
other narcotic antagonists are used to counter over-dosing.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
Sec. 522.1660 Oxytetracycline injection.
(a) Specifications. Each milliliter of sterile solution contains 200
milligrams of oxytetracycline base.
(b) Sponsor. See 000010, 000069, 059130, and 061623 in
Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1)--Beef cattle and nonlactating dairy
cattle--(i) Amount. 3 to 5 milligrams of oxytetracycline per pound of
body weight per day; 5 milligrams per pound of body weight per day for
treatment of anaplasmosis, severe foot-rot, and advanced cases of other
indicated diseases; 9 milligrams per pound of body weight as a single
dosage where retreatment for anaplasmosis is impractical; 9 milligrams
per pound of body weight as single dosage where retreatment of calves
and yearlings for bacterial pneumonia is impractical; 9 milligrams per
pound of body weight as a single dosage for treatment of infectious
bovine keratoconjunctivitis.
(ii) Indications for use. Treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and shipping
fever complex associated with Pasteurella spp. and Hemophilis spp.,
foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial
enteritis (scours) caused by Escherichia coli, wooden tongue caused by
Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona,
wound infections and acute metritis caused by staphylococcus spp. and
Streptococcus spp., and infectious bovine keratoconjunctivitis (pinkeye)
caused by Moraxella bovis. If labeled for use by or on the order of a
licensed veterinarian, it may also be used for treatment of anaplasmosis
caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
(iii) Limitations. Administer intramuscularly or intravenously at 3
to 5 milligrams level; intramuscularly only at 9 milligrams level.
Treatment of all diseases should be instituted early and continued for
24 to 48 hours beyond remission of disease symptoms, but not to exceed a
total of 4 consecutive days. Consult your veterinarian if no improvement
is noted within 48 hours. Do not inject more than 10 milliliters per
site in adult cattle, reducing the volume according to age and body size
to 1 to 2 milliliters in small calves. Exceeding the highest recommended
dose, administering at recommended levels for more than 4 consecutive
days, and/or exceeding 10 milliliters intramuscularly per injection site
may result in antibiotic residues beyond the withdrawal time.
Discontinue treatment at least 28 days prior to slaughter. Not for use
in lactating dairy cattle.
(2) Swine--(i) Amount. 3 to 5 milligrams of oxytetracycline per
pound of body weight per day; 9 milligrams per pound of body weight as a
single dosage where re-treatment for pneumonia is impractical. Sows:
Administer once 3 milligrams of oxytetracycline per
[[Page 283]]
pound of body weight, approximately 8 hours before farrowing or
immediately after completion of farrowing.
(ii) Indications for use. Treatment of bacterial enteritis (scours,
colibacillosis) caused by Escherichia coli, pneumonia caused by
Pasteurella multicida, and leptospirosis caused by Leptospira pomona.
Sows: as an aid in control of infectious enteritis (baby pig scours,
colibacillosis) in suckling pigs caused by Escherichia coli.
(iii) Limitations. Administer intramuscularly. Do not inject more
than 5 milliliters per site in adult swine. Discontinue treatment at
least 42 days prior to slaughter when provided by 000010 and 28 days
prior to slaughter when provided by 000069 or 059130, 061623.
[45 FR 16479, Mar. 14, 1980, as amended at 46 FR 20160, Apr. 3, 1981; 46
FR 27913, May 22, 1981; 52 FR 19502, May 26, 1987; 60 FR 14218, Mar. 16,
1995; 60 FR 29755, June 6, 1995]
Sec. 522.1662 Oxytetracycline hydrochloride implantation or injectable
dosage forms.
Sec. 522.1662a Oxytetracycline hydrochloride injection.
(a)(1) Specifications. The drug contains 50 milligrams of
oxytetracycline hydrochloride in each milliliter of sterile solution.
(2) Sponsor. See No. 054273 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is intended for use in beef
cattle, beef calves, nonlactating dairy cattle, and dairy calves for
treatment of disease conditions caused by one or more of the following
oxytetracycline sensitive pathogens listed as follows: pneumonia and
shipping fever complex (Pasteurella spp.; Hemophilis spp.; Klebsiella
spp.), bacterial enteritis (scours) (E. coli), foot-rot (Spherophorus
necrophorus), diphtheria (Spherophorus necrophorus), wooden tongue
(Actinobacillus lignieresi), leptospirosis (Leptospira pomona), and
wound infections; acute metritis; traumatic injury (caused by a variety
of bacterial organisms (such as streptococcal and staphylococcal
organisms).)
(ii) It is administered by intramuscular injection of 3 to 5
milligrams of oxytetracycline hydrochloride per pound of body weight per
day. Leptospirosis, severe foot-rot and severe forms of the indicated
diseases should be treated with 5 milligrams per pound of body weight
per day. Treatment should be continued for 24 to 48 hours following
remission of disease symptoms; however, not to exceed a total of 4
consecutive days. Only 2 milliliters of the drug should be injected per
site in case of calves weighing 100 pounds or less and not more than 10
milliliters should be injected per site in adult cattle.
(iii) Discontinue treatment with the drug at least 20 days prior to
slaughter of the animal. When administered to animals within 30 days of
slaughter, muscle discoloration may necessitate trimming of injection
site and surrounding tissues.
(iv) For use only in beef cattle, beef calves, nonlactating dairy
cattle, and dairy calves.
(b)(1) Specifications. Each milliliter of sterile solution contains
50 or 100 milligrams of oxytetracycline (as oxytetracycline
hydrochloride).
(2) Sponsor. See 000010 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Beef cattle and nonlactating dairy
cattle--(a) Amount. Three to 5 milligrams of oxytetracycline per pound
of body weight per day; 5 milligrams per pound of body weight per day
for the treatment of anaplasmosis, severe foot-rot, and severe cases of
other indicated diseases.
(b) Indications for use. Treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and shipping
fever complex associated with Pasteurella spp., Hemophilus spp., and
Klebsiella spp., foot-rot and diphtheria caused by Spherophorus
necrophorus, bacterial enteritis (scours) caused by Escherichia coli,
wooden tongue caused by Actinobacillus lignieresi, leptospirosis caused
by Leptospira pomona, and wound infections and acute metritis caused by
Staphylococcus spp. and Streptococcus spp. If labeled for use by or on
the order of a licensed veterinarian, it may be used for the treatment
of anaplasmosis caused by Anaplasma marginale.
(c) Limitations. For 50-milligram-per-milliliter solution,
administer intramuscularly or intravenously; for
[[Page 284]]
100-milligram-per-milliliter solution, administer intramuscularly only.
Treatment of all diseases should be instituted early and continue for 24
to 48 hours beyond remission of disease symptoms, but not to exceed a
total of 4 consecutive days. Consult your veterinarian if no improvement
is noted within 48 hours. Do not inject more than 10 milliliters per
site in adult cattle, reducing the volume according to age and body size
to 0.5 to 2 milliliters in small calves. Exceeding the highest
recommended dose of 5 milligrams per pound of body weight, administering
at recommended levels for more than 4 consecutive days, and/or exceeding
10 milliliters intramuscularly per injection site may result in
antibiotic residues beyond the withdrawal time. Discontinue treatment at
least 18 days prior to slaughter. Not for use in lactating dairy cattle.
(ii) Swine--(a) Amount. Three to 5 milligrams of oxytetracycline per
pound of body weight per day. Sows: 3 milligrams of oxytetracycline per
pound of body weight, approximately 8 hours before farrowing or
immediately after completion of farrowing.
(b) Indications for use. For treatment of bacterial enteritis
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused by
Pasteurella multocida, and leptospirosis caused by Leptospira pomona.
Sows: as an aid in control of infectious enteritis (baby pig scours,
colibacillosis) in suckling pigs caused by Escherichia coli.
(c) Limitations. Administer intramuscularly. Do not inject more than
5 milliliters per site. Do not use for more than 4 consecutive days.
Discontinue treatment at least 26 days before slaughter.
(c)(1) Specifications. The drug contains 50 or 100 milligrams of
oxytetracycline hydrochloride in each milliliter of sterile solution.
(2) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is intended for use in the
treatment of disease due to oxytetracycline-susceptible organisms in
beef cattle and non-lactating dairy cattle. It is indicated in the
treatment of pneumonia and shipping fever complex associated with
Pasteurella spp., Hemophilus spp., Klebsiella spp., foot-rot and
diphtheria caused by Spherophorus necrophorus, bacterial enteritis
(scours) caused by Escherichia coli, wooden tongue caused by
Actinobacillus lignieresi, acute metritis, and wound infections caused
by staphylococcal and streptococcal organisms.
(ii) It is administered to cattle at a dosage level of 3 to 5
milligrams per pound of body weight per day. It may be administered
intramuscularly or intravenously from a 50 milligram per milliliter
solution. It is administered intravenously from a 100 milligram per
milliliter solution. Severe foot-rot and the severe forms of the
indicated diseases should be treated with 5 milligrams per pound of body
weight. Treatment should be continued 24 to 48 hours following remission
of disease symptoms, however, not to exceed a total of 4 consecutive
days. If no improvement is noted within 24 hours, consult a
veterinarian. When injecting the drug intramuscularly, do not inject
more than 10 milliliters per site in adult cattle. Reduce the amount
injected at each site according to the size of the animal. For very
small calves do not use more than 2 milliliters per injection site.
(iii) Not for use in lactating dairy cattle. Discontinue treatment
at least 19 days prior to slaughter. When administered intramuscularly
within 30 days of slaughter, muscle discoloration may necessitate
trimming of the injection site and surrounding tissues.
(d)(1) Specifications. The drug contains 50 milligrams of
oxytetracycline hydrochloride in each milliliter of sterile solution.
(2) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) In beef cattle and nonlactating dairy
cattle as follows:
(a) It is used for the treatment of pneumonia and shipping fever
complex associated with Pasteurella spp. and Hemophilus spp.; foot-rot
and diphtheria caused by Spherophorus necrophorus; bacterial enteritis
(scours) caused by Escherichia coli; wooden tongue caused by
Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona;
wound infections and acute metritis caused by
[[Page 285]]
staphylococcal and streptococcal organisms.
(b) Administer by intravenous or intramuscular injection at 3 to 5
milligrams of oxytetracycline per pound of body weight per day. In the
treatment of severe foot-rot and severe forms of the indicated diseases,
a dosage level of 5 milligrams per pound of body weight per day is
recommended.
(c) If the labeling of the drug bears the statement ``Federal law
restricts this drug to use by or on the order of a licensed
veterinarian,'' it may include additional directions for use in beef
cattle and nonlactating dairy cattle for the treatment of anaplasmosis
caused by Anaplasma marginale, and anthrax caused by Bacillus anthracis
in which case the drug is given at 3 to 5 milligrams of oxytetracycline
per pound of body weight per day for anthrax, and at 5 milligrams per
pound of body weight per day for anaplasmosis.
(ii) In swine as follows:
(a) It is used for the treatment of bacterial enteritis (scours,
colibacillosis) caused by Escherichia coli; pneumonia caused by
Pasteurella multocida; and leptospirosis caused by Leptospira pomona.
Administered to sows as an aid in the control of infectious enteritis
(baby pig scours, colibacillosis) in suckling pigs caused by Escherichia
coli.
(b) Administer by intramuscular injection at 3 to 5 milligrams of
oxytetracycline per pound of body weight per day to swine. Administered
to sows at 3 milligrams of oxytetracycline per pound of body weight
approximately 8 hours before farrowing or immediately after farrowing.
(iii) In poultry (broilers, turkeys, and breeding chickens) as
follows:
(a) It is used for the treatment of air sacculitis (air-sac disease,
chronic respiratory disease) caused by Mycoplasma gallisepticum and
Escherichia coli; fowl cholera caused by Pasteurella multocida;
infectious sinusitis caused by Mycoplasma gallisepticum; and infectious
synovitis caused by Mycoplasma synoviae.
(b) Administered subcutaneously to chickens 1 day to 2 weeks of age
at 6.25 milligrams of oxytetracycline per bird per day diluted with 1
part of the drug to 3 parts of sterile water; to chickens 2 to 4 weeks
of age using the same diluted product at 12.5 milligrams of
oxytetracycline per bird; to chickens 4 to 8 weeks of age without
dilution at 25 milligrams of oxytetracycline per bird; to chickens 8
weeks of age (broilers and light pullets) at 50 milligrams of
oxytetracycline per bird; to adult chickens at 100 milligrams of
oxytetracycline per bird.
(c) Administered subcutaneously to turkeys 1 day to 2 weeks of age
and 2 to 4 weeks of age at the same dosage as chickens; to turkeys 4 to
6 weeks of age at 50 milligrams of oxytetracycline as the undiluted
product per bird; to turkeys 6 to 9 weeks of age at 100 milligrams of
oxytetracycline per bird; to turkeys 9 to 12 weeks of age at 150
milligrams of oxytetracycline per bird; to turkeys 12 weeks of age and
older at 200 milligrams of oxytetracycline per bird. In light turkey
breeds, no more than 25 milligrams per pound of body weight is
administered. For the treatment of infectious sinusitis in turkeys, \1/
4\ to \1/2\ milliliter of the drug is injected directly into each
swollen sinus depending upon the age of the bird and the severity of the
condition. At the time that the sinuses are treated, the drug should
also be administered subcutaneously to the birds according to the dosage
schedule given in paragraph (d)(3)(iii)(c) of this section. If refilling
of the sinuses occurs, the treatment may be repeated in 5 to 7 days.
(iv) Treatment of all diseases should be instituted early. Treatment
should continue for 24 to 48 hours beyond the remission of disease
symptoms, but not exceed a total of 4 consecutive days. If no
improvement is noted within 24 to 48 hours, diagnosis and therapy should
be reevaluated.
(v) When injecting intramuscularly in adult livestock, do not inject
more than 10 milliliters at any one site. The volume administered per
injection site should be reduced according to age and body size so that
1 or 2 milliliters are injected in smaller animals such as small calves
and young pigs. Intravenous administration is recommended in cattle when
daily dosage exceeds 50 milliliters.
(vi) Treatment must be discontinued at least 5 days prior to
slaughter for chickens and turkeys and at least 22 days prior to
slaughter for cattle and
[[Page 286]]
swine. When administered intramuscularly to animals within 30 days of
slaughter, muscle discoloration may necessitate trimming of the
injection site(s) and surrounding tissues during the dressing procedure.
(vii) Not for use in lactating dairy animals. Do not administer to
laying hens unless the eggs are used for hatching only.
(e)(1) Specifications. Each milliliter of sterile solution contains
100 milligrams of oxytetracycline hydrochloride.
(2) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Beef cattle and nonlactating dairy
cattle--(a) Amount. 3 to 5 milligrams of oxytetracycline per pound of
body weight per day; 5 milligrams per pound of body weight per day for
treatment of anaplasmosis, severe foot-rot, and severe cases of other
indicated diseases.
(b) Indications for use. Treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and shipping
fever complex associated with Pasteurella spp. and Hemophilus spp.,
foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial
enteritis (scours) caused by Escherichia coli, wooden tongue caused by
Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona,
and wound infections and acute metritis caused by Staphylococcus spp.
and Streptococcus spp. If labeled for use by or on the order of a
licensed veterinarian, it may be used for the treatment of anaplasmosis
caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
(c) Limitations. Administer intramuscularly. Treatment of all
diseases should be instituted early and continue for 24 to 48 hours
beyond remission of disease symptoms, but not to exceed a total of 4
consecutive days. Consult your veterinarian if no improvement is noted
within 48 hours. Do not inject more than 10 milliliters per site in
adult cattle, reducing the volume according to age and body size to 1 to
2 milliliters in small calves. Exceeding the highest recommended dose of
5 milligrams per pound of body weight, administering at recommended
levels for more than 4 consecutive days, and/or exceeding 10 milliliters
intramuscularly per injection site may result in antibiotic residues
beyond the withdrawal time. Discontinue treatment at least 15 days prior
to slaughter. Not for use in lactating dairy cattle.
(ii) Swine--(a) Amount. 3 to 5 milligrams of oxytetracycline per
pound of body weight per day. Sows: 3 milligrams of oxytetracycline per
pound of body weight, administered once, approximately 8 hours before
farrowing or immediately after completion of farrowing.
(b) Indications for use. For treatment of bacterial enteritis
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused by
Pasteurella multocida, and leptospirosis caused by Leptospira pomona.
Sows: as an aid in control of infections enteritis (baby pig scours,
colibacillosis) in suckling pigs caused by Escherichia coli.
(c) Limitations. Administer intramuscularly. Do not inject more than
5 milliliters per site in adult swine, reducing the volume according to
age and body size to 1 to 2 milliliters in young pigs. Discontinue
treatment at least 22 days prior to slaughter.
(f) [Reserved]
(g)(1) Specifications. Each milliliter of sterile solution contains
100 milligrams of oxytetracycline as oxytetracycline hydrochloride.
(2) Sponsor. See No. 054273 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. The drug is used for the treatment of
diseases due to oxytetracycline-susceptible organisms as follows:
(i) Beef cattle, beef calves, nonlactating dairy cattle, and dairy
calves--(a) Amount. 3 to 5 milligrams of oxytetracycline per pound of
body weight per day.
(b) Indications for use. For the treatment of pneumonia and shipping
fever complex associated with Pasteurella spp., Hemophilus spp., or
Klebsiella spp.
(c) Limitations. Administer by intramuscular or intravenous
injection. In severe forms of the indicated diseases, administer 5
milligrams of oxytetracycline per pound of body weight per day. Continue
treatment 24 to 48 hours following remission of disease symptoms, not to
exceed a total of 4 consecutive days. If no improvement is
[[Page 287]]
noted within 48 hours, consult a veterinarian. Do not inject more than
10 milliliters per injection site intramuscularly in adult cattle; no
more than 1 milliliter per site in calves weighing 100 pounds or less.
Discontinue treatment at least 20 days prior to slaughter.
(ii) Swine--(a) Amount. 3 to 5 milligrams of oxytetracycline per
pound of body weight per day. Sows: Administer once 3 milligrams of
oxytetracycline per pound of body weight, approximately 8 hours before
farrowing or immediately after completion of farrowing.
(b) Indications for use. For treatment of bacterial enteritis
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused by
Pasteurella multocida, and leptospirosis caused by Leptospira pomona.
Sows: As an aid in control of infectious enteritis (baby pig scours,
colibacillosis) in suckling pigs caused by Escherichia coli.
(c) Limitations. Administer intramuscularly. If no improvement is
noted within 24 hours, consult a veterinarian. Do not inject more than 5
milliliters per site. Discontinue treatment at least 20 days prior to
slaughter.
(h)(1) Specifications. Each milliliter of sterile solution contains
50 or 100 milligrams of oxytetracycline hydrochloride.
(2) Sponsors. See 054273 in Sec. 510.600(c) of this chapter for use
of 50 and 100 milligrams/milliliter solution, and see No. 057319 in
Sec. 510.600(c) for use of 100 milligrams/milliliter solution.
(3) Conditions of use--(i) Amount. The drug is used in beef cattle,
beef calves, nonlactating dairy cattle, and dairy calves as follows: 3
to 5 milligrams of oxytetracycline hydrochloride per pound of body
weight per day; 5 milligrams per pound of body weight per day for
treatment of severe forms of the indicated diseases.
(ii) Indications for use. The drug is used for treatment of
bacterial pneumonia and shipping fever complex associated with
Pasteurella spp.; foot-rot and calf diphtheria caused by Spherophorus
necrophorus; bacterial enterities (scours) caused by Escherichia coli;
wooden tongue caused by Actinobacillus lignieresi; wound infections,
acute metrities, and traumatic injury caused by staphylococcal and
streptococcal organisms.
(iii) Limitations. Administer 50-milligram-per-milliliter solution
intramuscularly; administer 100-milligram-per-milliliter solution
intravenously. Continue treatment 24 to 48 hours following remission of
disease symptoms, not to exceed a total of 4 consecutive days. If no
improvement is noted within 24 to 48 hours, consult a veterinarian for
diagnosis and therapy. When injecting the drug intramuscularly, do no
inject more than 10 milliliters per site in adult cattle. Reduce the
volume administered per injection site according to age and body size.
In calves weighing 100 pounds or less, do no inject more than 2
milliliters intramuscularly per site. Discontinue treatment at least 22
days before slaughter. Not for use in lactating dairy animals.
(i)(1) Specifications. Each milliliter of sterile solution contains
50 milligrams of oxytetracycline hydrochloride.
(2) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. The drug is used in beef cattle,
beef calves, nonlactating dairy cattle, and dairy calves as follows:
Administer 3 to 5 milligrams of the oxytetracycline hydrochloride
intramuscularly per pound of body weight per day.
(ii) Indications for use. The drug is used for treatment of
bacterial pneumonia and shipping fever complex associated with
Pasteurella spp.; foot-rot and diptheria caused by Spherophorus
necrophorus; bacterial enteritis (scours) caused by Escherichia coli;
wooden tongue caused by Actinobacillus lignieresi; wound infections and
acute metritis caused by staphylococcal and streptococcal organisms
susceptible to oxytetracycline.
(iii) Limitations. In severe forms of the indicated diseases,
administer the equivalent of 5 milligrams of oxytetracycline
hydrochloride per pound of body weight per day. Continue treatment 24 to
48 hours following remission of disease symptoms, not to exceed a total
of 4 consecutive days. If no improvement is noted within 24 to 48 hours,
consult a veterinarian for diagnosis and therapy. In adult livestock, do
not inject more than 10 milliliters
[[Page 288]]
at any one site. Reduce the volume administered per injection site
according to age and body size. In calves weighing 100 pounds or less
inject only 2 milliliters per site. Discontinue treatment at least 18
days before slaughter. Not for use in lactating dairy cattle.
(j) [Reserved]
(k)(1) Specifications. Each milliliter of sterile solution contains
either 50 or 100 milligrams of oxytetracycline hydrochloride.
(2) Sponsor. See No. 000864 in Sec. 510.600(c) of this chapter.
(3) Conditions of use in beef cattle and nonlactating dairy cattle.
(i) Amount. 3 to 5 milligrams per pound of body weight daily, 5
milligrams per pound for anaplasmosis, severe foot rot, and severe forms
of other diseases.
(ii) Indications for use. Treatment of diseases due to
oxytetracycline-susceptible organisms as follows: pneumonia and shipping
fever complex associated with Pasteurella spp. and Hemophilus spp.; foot
rot and diphtheria caused by Fusobacterium necrophorum; bacterial
enteritis (scours) caused by Escherichia coli; wooden tongue caused by
Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona;
acute metritis and wound infections caused by staphylococcal and
streptococcal organisms; if labeled for use by or on the order of a
licensed veterinarian, it may be used for treatment of anaplasmosis
caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
(iii) Limitations. Administer by intravenous injection. Treatment
should be continued 24 to 48 hours following remission of disease
symptoms, but not to exceed a total of 4 consecutive days. If no
improvement occurs within 24 to 48 hours, reevaluate diagnosis and
therapy. Discontinue use at least 19 days prior to slaughter. Not for
use in lactating dairy cattle.
[40 FR 13858, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting
Sec. 522.1662a, see the List of CFR Sections Affected in the Finding
Aids section of this volume.
Sec. 522.1662b Oxytetracycline hydrochloride with lidocaine injection.
(a) Specifications. The drug contains 50 or 100 milligrams of
oxytetracycline hydrochloride and 2 percent lidocaine in each milliliter
of sterile aqueous solution.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is indicated for use in the
treatment of diseases of dogs caused by pathogens sensitive to
oxytetracycline hydrochloride including treatment for the following
conditions in dogs caused by susceptible microorganisms: Bacterial
infections of the urinary tract caused by Hemolytic staphylococcus,
Streptococcus spp., Bacterial pulmonary infections caused by Brucella
bronchiseptica, Streptococcus pyogenes, Staphylococcus aureus, secondary
bacterial infections caused by Micrococcus pyogenes var. albus, Brucella
bronchiseptica, Streptococcus spp.
(2) The drug is administered intramuscularly at a recommended daily
dosage to dogs at 5 milligrams per pound of body weight administered in
divided doses at 6 to 12 hour intervals. Therapy should be continued for
at least 24 hours after all symptoms have subsided.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 48 FR 30615, July 5, 1983]
Sec. 522.1680 Oxytocin injection.
(a) Specifications. Each milliliter of oxytocin injection contains
20 U.S.P. units of oxytocin.
(b) Sponsors. See Nos. 000402, 000856, 000857, 000864, 050604,
054273, 058639, and 059130 in Sec. 510.600(c) of this chapter.
(c) Conditions of use\1\--(1) Amount--(i) Obstetrical. Administer
drug intravenously, intramuscularly, or subcutaneously under aseptic
conditions as indicated. The following dosages are recommended and may
be repeated as conditions require:
---------------------------------------------------------------------------
1 These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require bio-
equivalency and safety information.
------------------------------------------------------------------------
ml U.S.P. units
------------------------------------------------------------------------
Cats............................ 0.25 to 0.5....... 5 to 10.
[[Page 289]]
Dogs............................ 0.25 to 1.5....... 5 to 30.
Ewes, Sows...................... 1.5 to 2.5........ 30 to 50.
Cows, Horses.................... 5.0............... 100.
------------------------------------------------------------------------
(ii) Milk letdown. Intravenous administration is desirable. The
following dosage is recommended and may be repeated as conditions
require:
------------------------------------------------------------------------
ml U.S.P. units
------------------------------------------------------------------------
Cows............................ 0.5 to 1.0........ 10 to 20.
Sows............................ 0.25 to 1.0....... 5 to 20.
------------------------------------------------------------------------
(2) Indications for use. Oxytocin may be used as a uterine
contractor to precipitate and accelerate normal parturition and
postpartum evacuation of uterine debris. In surgery it may be used
postoperatively following cesarean section to facilitate involution and
resistance to the large inflow of blood. It will contract smooth muscle
cells of the mammary gland for milk letdown if the udder is in proper
physiological state.
(3) Limitations. Do not use in dystocia due to abnormal presentation
of fetus until correction is accomplished. For prepartum usage, full
relaxation of the cervix should be accomplished either naturally or by
administration of estrogen prior to oxytocin therapy. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, 1980, as amended at 52
FR 18691, May 19, 1987; 52 FR 25212, July 6, 1987; 52 FR 36023, Sept.
25, 1987; 53 FR 32610, Aug. 26, 1988; 53 FR 40728, Oct. 18, 1988; 54 FR
41442, Oct. 10, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 14642, Apr. 11,
1991, 56 FR 16002, Apr. 19, 1991; 59 FR 31139, June 17, 1994]
Sec. 522.1696 Penicillin G procaine implantation and injectable dosage
forms.
Sec. 522.1696a Penicillin G benzathine and penicillin G procaine sterile suspension.
(a) Specifications. Each milliliter of aqueous suspension contains
penicillin G benzathine and penicillin G procaine, each equivalent to
150,000 units of penicillin G.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
the conditions of use in paragraph (d) of this section as follows:
(1) See Nos. 000008, 049185, 000856, 000864, and 010515 for use as
in paragraph (d)(1) of this section.
(2) See Nos. 049185 and 000856 for use as in paragraph (d)(2) of
this section.
(3) See Nos. 000069, 000864, and 010515 for use as in paragraph
(d)(3) of this section.
(c) Related tolerances. See Sec. 556.510 of this chapter.
(d) Conditions of use--(1) Horses, dogs, and beef cattle. Treatment
of bacterial infections susceptible to penicillin G. Repeat dosage in 48
hours. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(i) Horses. 2 milliliters per 150 pounds of body weight
intramuscularly. Do not use in horses intended for food purposes.
(ii) Dogs. 1 milliliter per 10 to 25 pounds of body weight
intramuscularly or subcutaneously.
(iii) Beef cattle. 2 milliliters per 150 pounds of body weight
intramuscularly or subcutaneously. Treatment should be limited to two
doses. Not to be used in beef cattle within 30 days of slaughter.
(iv) National Academy of Sciences/National Research Council (NAS/
NRC) status. The conditions of use were NAS/NRC reviewed and found
effective. Applications for these uses need not include effectiveness
data as specified by Sec. 514.111 of this chapter but may require
bioequivalency and safety information.
(2) Beef cattle. Treatment of bacterial pneumonia (Streptococcus
spp., Corynebacterium pyogenes, Staphylococcus aureus); upper
respiratory infections such as rhinitis or pharyngitis (C. pyogenes);
blackleg (Clostridium chauvoei); and prophylaxis of bovine shipping
fever in 300 to 500 pound beef calves.
(i) Amount. 2 milliliters per 150 pounds of body weight
subcutaneously. Repeat dosage in 48 hours. Limit treatment to two doses.
Not for use within 30 days of slaughter.
(ii) NAS/NRC status. The conditions of use were NAS/NRC reviewed and
found effective. Applications for these uses need not include
effectiveness data as specified by Sec. 514.111 of this chapter but
[[Page 290]]
may require bioequivalency and safety information.
(3) Beef cattle. Treatment of bacterial pneumonia (shipping fever)
(Streptococcus spp., C. pyogenes, S. aureus); upper respiratory
infections such as rhinitis or pharyngitis (C. pyogenes); and blackleg
(C. chauvoei).
(i) 2 milliliters per 150 pounds of body weight subcutaneously.
Repeat dosage in 48 hours. Limit treatment to two doses. Not for use
within 30 days of slaughter.
(ii) [Reserved]
[57 FR 37332, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at
58 FR 65285, Dec. 14, 1993; 59 FR 38119, July 27, 1994]
Sec. 522.1696b Penicillin G procaine aqueous suspension.
(a) Specifications. Each milliliter contains penicillin G procaine
equivalent to 300,000 units of penicillin G.
(b) Related tolerances. See Sec. 556.510 of this chapter.
(c) National Academy of Sciences/National Research Council (NAS/NRC)
status. The conditions of use were NAS/NRC reviewed and found effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
(d) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section, see No. 000864 for use as in
paragraph (d)(3) of this section.
(1) Dogs--(i) Amount. 10,000 units per pound of body weight daily at
24-hour intervals.
(ii) Indications for use. Treatment of infections caused by
penicillin-sensitive organisms.
(iii) Limitations. For intramuscular use only. Continue treatment at
least 48 hours after symptoms disappear. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(2) Cats--(i) Amount. 10,000 units per pound of body weight daily at
24-hour intervals.
(ii) Indications for use. Treatment of infections caused by
penicillin-sensitive organisms.
(iii) Limitations. For intramuscular use only. Continue treatment at
least 48 hours after symptoms disappear. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(3) Cattle, sheep, swine, and horses--(i) Amount. 3,000 units per
pound of body weight (1 milliliter per 100 pounds body weight) daily.
(ii) Indications for use. Treatment of cattle and sheep for
bacterial pneumonia (shipping fever) caused by Pasteurella multocida;
swine for erysipelas caused by Erysipelothrix insidiosa; and horses for
strangles caused by Streptococcus equi.
(iii) Limitations. Administer by deep intramuscular injection.
Continue treatment at least 48 hours after symptoms disappear but do not
exceed 7 days of treatment in nonlactating dairy and beef cattle, sheep,
and swine, or 5 days in lactating cattle. Milk that has been taken
during treatment and for 48 hours (four milkings) after the last
treatment must not be used for food. Discontinue treatment for the
following number of days before slaughter: Nonruminating cattle
(calves)--7; all other cattle--4; sheep--8; and swine--6. Not for use in
horses intended for food.
(e) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
(1) Cattle, sheep, swine, and horses--(i) Amount. 3,000 units per
pound of body weight (1 milliliter per 100 pounds body weight) daily.
(ii) Indications for use. Treatment of cattle and sheep for
bacterial pneumonia (shipping fever) caused by Pasteurella multocida;
swine for erysipelas caused by Erysipelothrix insidiosa; and horses for
strangles caused by Streptococcus equi.
(iii) Limitations. For intramuscular use only. Continue treatment at
least 1 day after symptoms disappear (usually 2 or 3 days). Treatment
should not exceed 4 consecutive days. Do not exceed 10 milliliters per
injection site. Milk that has been taken during treatment and for 72
hours (six milkings) after the latest treatment must not be used for
food. Discontinue treatment for the following number of days before
slaughter: Cattle--10, sheep--9, and swine--7. Not for use in horses
intended for food.
(2) [Reserved]
[[Page 291]]
(f) Sponsor. See Nos. 000069 and 010515 in Sec. 510.600(c) of this
chapter. See paragraph (d) of this section for conditions of use, except
that milk taken during treatment and for 48 hours (four milkings) after
the latest treatment shall not be used for food.
[57 FR 37332, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at
58 FR 11964, Mar. 2, 1993]
Sec. 522.1696c Penicillin G procaine in oil.
(a) Specifications. Each milliliter contains penicillin G procaine
equivalent to 300,000 units of penicillin G.
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(c) National Academy of Sciences/National Research Council (NAS/NRC)
status. The conditions of use were NAS/NRC reviewed and found effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
(d) Conditions of use. (1) Amount. Dogs and cats--10,000 units per
pound of body weight once daily. Horses--3,000 units per pound of body
weight once daily.
(2) Indications for use. Treatment of infections of dogs, cats, and
horses caused by penicillin-susceptible organisms such as Streptococci,
Staphylococci, and Corynebacteria.
(3) Limitations. Not for use in food-producing animals. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[57 FR 37333, Aug. 18, 1992]
Sec. 522.1698 Pentazocine lactate injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains pentazocine lactate equivalent to 30 milligrams of pentazocine
base.
(b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Horses--(i) Amount. 0.15 milligram of
pentazocine base per pound of body weight per day.
(ii) Indications for use. For symptomatic relief of pain due to
colic.
(iii) Limitations. Administer intravenously or intramuscularly.
Intravenous injections are given slowly in the jugular vein. In cases of
severe pain, a second dose is recommended intramuscularly 10 to 15
minutes after the initial dose at the same level. Not for use in horses
intended for food. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(2) Dogs--(i) Amount. 0.75 to 1.50 milligrams of pentazocine base
per pound of body weight.
(ii) Indications for use. For amelioration of pain accompanying
postoperative recovery, fracture, trauma, and spinal disorders.
(iii) Limitations. Administer intramuscularly only. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[42 FR 31450, June 21, 1977, as amended at 42 FR 36995, July 19, 1977;
47 FR 5409, Feb. 5, 1982; 55 FR 23076, June 6, 1990]
Sec. 522.1704 Sodium pentobarbital injection.
(a)(1) Specifications. Sodium pentobarbital injection is sterile and
contains in each milliliter 64.8 milligrams of sodium pentobarbital.
(2) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is indicated for use as a
general anesthetic in dogs and cats. Although it may be used as a
general surgical anesthetic for horses, it is usually given at a lower
dose to cause sedation and hypnosis and may be supplemented with a local
anesthetic. It may also be used in dogs for the symptomatic treatment of
strychnine poisoning.
(ii) The drug is administered intravenously ``to effect''. For
general surgical anesthesia, the usual dose is 11 to 13 milligrams per
pound of body weight. For sedation, the usual dose is approximately 2
milligrams per pound of body weight. For relieving convulsive seizures
in dogs, when caused by strychnine, the injection should be administered
intravenously ``to effect''. The drug may be given intraperitoneally if
desired. However, the results of such injections are less uniform. When
given intraperitoneally, it is administered at the same dosage level as
for intravenous administration. The dose must be reduced for animals
showing under-nourishment, toxemia, shock and similar conditions.
[[Page 292]]
(iii) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(b)(1) Specifications. Sodium pentobarbital injection is sterile and
contains in each milliliter 65 milligrams of sodium pentobarbital.
(2) Sponsor. See 000402 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is indicated for use as a
general anesthetic in dogs and cats.
(ii) The drug is administered intravenously ``to effect.'' For
general anesthesia, the usual dose is 13 milligrams per pound of body
weight.
(iii) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 45 FR 83483, Dec. 19, 1980;
52 FR 25212, July 6, 1987]
Sec. 522.1720 Phenylbutazone injection.
(a) Specifications. The drug contains 100 or 200 milligrams of
phenylbutazone in each milliliter of sterile aqueous solution.
(b) Sponsors. (1) Approval for use of the 200 milligrams per
milliliter drug in dogs and horses: See sponsor Nos. 000031, 011716, and
015579 in Sec. 510.600(c) of this chapter.
(2) Approval for use of the 200 milligrams per milliliter drug in
horses: See sponsor Nos. 000010, 000402, 000864, and 059130 in
Sec. 510.600(c) of this chapter.
(3) Approval for use of the 100 milligrams per milliliter drug in
dogs and horses: See sponsor No. 000856 in Sec. 510.600(c) of this
chapter.
(4) Approval for use of the 200 milligrams per milliliter drug in
dogs: See sponsor No. 000864 in Sec. 510.600(c) of this chapter.
(c) Conditions of use for dogs. (1) It is used for the relief of
inflammatory conditions associated with the musculoskeletal system.
(2) It is administered intravenously at a dosage level of 10
milligrams per pound of body weight daily in 3 divided doses, not to
exceed 800 milligrams daily regardless of weight. Limit intravenous
administration to 2 successive days. Oral medication may follow.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(d) Conditions of use for horses. (1) It is used for the relief of
inflammatory conditions associated with the musculoskeletal system.
(2) It is administered intravenously at a dosage level of 1 to 2
grams per 1,000 pounds of body weight daily in 3 divided doses, not to
exceed 4 grams daily. Limit intravenous administration to not more than
5 successive days.
(3) Not for use in animals intended for food.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting
Sec. 522.1720, see the List of CFR Sections Affected in the Finding Aids
section of this volume.
Sec. 522.1820 Pituitary luteinizing hormone for injection.
(a) Specifications. The drug is a lyophilized pituitary extract.
Each 6-milliliter vial contains an amount equivalent to 25 milligrams of
standard pituitary luteinizing hormone and is reconstituted for use by
addition of 5 milliliters of 0.9 percent aqueous sodium chloride
solution.
(b) Sponsor. No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is an aid in the treatment of
breeding disorders related to pituitary hypofunction in cattle, horses,
swine, sheep, and dogs.
(2) Preferably given by intravenous injection, it may be
administered subcutaneously; dosage is as follows: Cattle and horses, 25
mg; swine, 5 mg; sheep, 2.5 mg, and dogs, 1.0 mg. Treatment may be
repeated in 1 to 4 weeks, or as indicated.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987]
Sec. 522.1850 Polysulfated glycosaminoglycan.
(a) Specifications. Each 1-milliliter ampule of sterile aqueous
solution contains 250 milligrams of polysulfated glycosaminoglycan; each
5-milliliter ampule or vial contains 500 milligrams.
[[Page 293]]
(b) Sponsor. See No. 010797 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--horses. (1) Indications for use. Polysulfated
glycosaminoglycan is for the treatment of noninfectious degenerative
and/or traumatic joint dysfunction and associated lameness of the carpal
joint in horses.
(2) Amount (i) Intra-articular use: 250 milligrams once a week for 5
weeks. The joint area must be shaved, cleaned, and sterilized as in a
surgical procedure prior to injection. If the joint reacts with
excessive inflammation, after intra-articular treatment, cease therapy.
(ii) Intramuscular use: 500 milligrams every 4 days for 28 days.
Injection site must be thoroughly cleansed prior to injection.
(3) Limitations. Not for use in horses intended for food. Safe use
in breeding animals has not been established. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
[54 FR 53053, Dec. 27, 1989]
Sec. 522.1862 Sterile pralidoxime chloride.
(a) Chemical name. 2-Formyl-1-methylpyridinium chloride oxime.
(b) Specifications. Sterile pralidoxime chloride is packaged in
vials. Each vial contains 1 gram of sterile pralidoxime chloride powder
and includes directions for mixing this gram with 20 cubic centimeters
of sterile water for injection prior to use.
(c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) It is used in horses, dogs, and cats as
an antidote in the treatment of poisoning due to those pesticides and
chemicals of the organophosphate class which have anticholinesterase
activity in horses, dogs, and cats.
(2) It is administered as soon as possible after exposure to the
poison. Before administration of the sterile pralidoxime chloride,
atropine is administered intravenously at a dosage rate of 0.05
milligram per pound of body weight, followed by administration of an
additional 0.15 milligram of atropine per pound of body weight
administered intramuscularly. Then the appropriate dosage of sterile
pralidoxime chloride is administered slowly intravenously. The dosage
rate for sterile pralidoxime chloride when administered to horses is 2
grams per horse. When administered to dogs and cats, it is 25 milligrams
per pound of body weight. For small dogs and cats, sterile pralidoxime
chloride may be administered either intraperitoneally or
intramuscularly. A mild degree of atropinization should be maintained
for at least 48 hours. Following severe poisoning, a second dose of
sterile pralidoxime chloride may be given after 1 hour if muscle
weakness has not been relieved.
(3) For use only by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 49 FR 32061, Aug. 10, 1984]
Sec. 522.1870 Praziquantel injectable solution.
(a) Specification. Each milliliter contains 56.8 milligrams of
praziquantel.
(b) Sponsor. See 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. For dogs 5 pounds and
under, 0.3 milliliter (17.0 milligrams); for 6 to 10 pounds, 0.5
milliliter (28.4 milligrams); for 11 to 25 pounds, 1.0 milliliter (56.8
milligrams); if over 25 Pounds, 0.2 milliliter (11.4 milligrams) per 5
pounds body weight to a maximum of 3 milliliters (170.4 milligrams).
(ii) Indications for use. For removal of canine cestodes Dipylidium
caninum, Taenia pisiformis, and Echinococcus granulosus, and removal and
control of canine cestode Echinococcus multilocularis.
(iii) Limitations. For subcutaneous or intramuscular use; not
intended for use in puppies less than 4 weeks of age; Federal law
restricts the drug to use by or on the order of a licensed veterinarian.
(2) Cats--(i) Amount. For cats under 5 pounds, 0.2 milliliter (11.4
milligrams); 5 to 10 pounds, 0.4 milliliter (22.7 milligrams); 11 pounds
and over, 0.6 milliliter (34.1 milligrams) maximum.
(ii) Indications for use. For removal of feline cestodes Dipylidium
caninum and Taenia taeniaeformis.
(iii) Limitations. For subcutaneous or intramuscular injection only.
Not intended for use in kittens less than 6
[[Page 294]]
weeks of age. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
[46 FR 10464, Feb. 3, 1981, as amended at 47 FR 6617, Feb. 16, 1982; 58
FR 42853, Aug. 12, 1993]
Sec. 522.1881 Sterile prednisolone acetate aqueous suspension.
(a) Specifications. Each milliliter of sterile aqueous suspension
contains 25 milligrams of prednisolone acetate.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and
found effective. Applications for these uses need not include
effectiveness data as specified in Sec. 514.111 of this chapter but may
require bioequivalency and safety information.
(d) Conditions of use. (1) The drug is indicated in the treatment of
dogs, cats, and horses for conditions requiring an anti-inflammatory
agent. The drug is indicated for the treatment of acute musculoskeletal
inflammations such as bursitis, carpitis, and spondylitis. The drug is
indicated as supportive therapy in nonspecific dermatosis such as summer
eczema and atopy. The drug may be used as supportive therapy pre- and
post-operatively and for various stress conditions when corticosteroids
are required while the animal is being treated for a specific condition.
(2) The drug is administered to horses intra-articularly at a dosage
level of 50 to 100 milligrams. The dose may be repeated when necessary.
If no response is noted after 3 or 4 days, the possibility must be
considered that the condition is unresponsive to prednisolone therapy.
The drug is administered to dogs and cats intramuscularly at a dosage
level of 10 to 50 milligrams. The dosage may be repeated when necessary.
If the condition is of a chronic nature, an oral corticosteroid may be
given as a maintenance dosage. The drug may be given intra-articularly
to dogs and cats at a dosage level of 5 to 25 milligrams. The dose may
be repeated when necessary after 7 days for two or three doses.
(3) The labeling shall comply with the requirements of Sec. 510.410
of this chapter for corticosteroids.
(4) Not for use in horses intended for food.
(5) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[52 FR 23032, June 17, 1987]
Sec. 522.1883 Prednisolone sodium phosphate injection, sterile.
(a)(1) Specifications. Each milliliter contains 20 milligrams of
prednisolone sodium phosphate (equivalent to 14.88 milligrams of
prednisolone) in sterile aqueous solution.
(2) Sponsor. See No. 000864 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) It is used in treatment of dogs when a
rapid adrenal glucocorticoid and/or anti-inflammatory effect is
necessary.1
(ii) It is administered intravenously in a dosage of 2\1/2\ to 5
milligrams of prednisolone sodium phosphate per pound of body weight,
initially for shock and shock-like states, followed by equal
maintenance doses at 1-, 3-, 6-, or 10-hour intervals as determined
by the condition of the animal. If permanent use is required, oral
therapy (tablets) may be substituted. If therapy is to be withdrawn
after prolonged use, reduce daily dose gradually over a number of days.
(iii) Do not use in viral infections. Except in emergency therapy,
do not use with tuberculosis, chronic nephritis, Cushing's disease, or
peptic ulcers. With infections, use appropriate antibacterial therapy
with, and for at least 3 days after, discontinuance of use and
disappearance of all signs of infection.1
(iv) Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
(v) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.1
(b) [Reserved]
[43 FR 29769, July 11, 1978, as amended at 49 FR 23834, June 8, 1984]
[[Page 295]]
Sec. 522.1884 Prednisolone sodium succinate injection.
(a) Chemical name. 11 beta, 17, 21-Trihydroxypregna-1, 4-diene-3,
20-dione 21-succinate sodium salt.
(b) Specifications. Each milliliter of prednisolone sodium succinate
injection contains: Prednisolone sodium succinate equivalent in activity
to 10, 20, or 50 milligrams of prednisolone.
(c) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter for
products containing 10, 20, and 50 milligrams equivalent prednisolone
activity per milliliter for use in horses, dogs, and cats as provided in
paragraphs (d)(1), (2) (i), (ii), and (iii) of this section. See No.
000402 in Sec. 510.600(c) of this chapter for a product containing 10
milligrams equivalent prednisolone activity per milliliter for use in
horses as provided in paragraph (d)(2)(iv) of this section.
(d) Conditions of use. (1) The drug is intended for the treatment of
horses, dogs, and cats.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and found effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(2)(i) The dosage for horses is 50 to 100 milligrams as an initial
dose given intravenously over a period of one-half to 1 minute, or
intramuscularly, and may be repeated in inflammatory, allergic, or other
stress conditions at intervals of 12, 24, or 48 hours, depending upon
the size of the animal, the severity of the condition and the response
to treatment. \1\
(ii) In dogs, the drug is administered intravenously at a range of
2.5 to 5 milligrams per pound of body weight as an initial dose followed
by maintenance doses at 1, 3, 6, or 10 hour intervals, as determined by
the condition of the animal, for treatment of shock.
(iii) In dogs and cats, the drug may be given intramuscularly for
treatment of inflammatory, allergic and less severe stress conditions,
where immediate effect is not required, at 1 to 5 milligrams ranging
upward to 30 to 50 milligrams in large breeds of dogs. Dosage may be
repeated in 12 to 24 hours and continued for 3 to 5 days if necessary.
If permanent corticosteroid effect is required oral therapy with
prednisolone tablets may be substituted.
(iv) In horses, 50 to 100 milligrams as an initial dose given
intravenously over a period of \1/2\ to 1 minute. May be repeated in
inflammatory, allergic, or other stress conditions at intervals of 12,
24, or 48 hours, depending upon the size of the animal, the severity of
the condition and the response to treatment. Not for use in horses
intended for food. Clinical and experimental data have demonstrated that
corticosteroids adminstered orally or parenterally to animals may induce
the first stage of parturition when administered late in pregnancy and
may precipitate premature parturition followed by dystocia, fetal death,
retained placenta, and metritis.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian. \1\
[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 13215, Feb. 20, 1981;
46 FR 33513, June 30, 1981; 52 FR 25212, July 6, 1987]
Sec. 522.1885 Prednisolone tertiary butylacetate suspension.
(a) Specifications. Prednisolone tertiary butylacetate (Pregna-1,4-
diene-3, 20-dione-11B, 17 21-triol 21-(3,3, dimethyl butyrate)
suspension contains 20 milligrams of prednisolone tertiary butylacetate
per milliliter. It is sterile.
(b) Sponsor. See No. 000006 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used as an anti-inflammatory agent
in horses, dogs, and cats.\1\
(2) It is administered to horses intramuscularly at a dosage level
of 100 to 300 milligrams and intrasynovially at a dosage level of 50 to
100 milligrams. It is administered intramuscularly to dogs and cats at a
dosage level of 1 milligram per 5 pounds of body weight and
intrasynovially at a dosage level of 10 to 20 milligrams. Intramuscular
retreatment of horses in 24 to 48 hours may be necessary, depending on
the general condition of the animal and the severity and duration of the
disease.\1\
(3) Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may
induce the first stage of parturition when administered late in
[[Page 296]]
pregnancy and may precipitate premature parturition followed by
dystocia, fetal death, retained placenta, and metritis.\1\
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.\1\
Sec. 522.1890 Sterile prednisone suspension.
(a) [Reserved]
(b)(1) Specifications. Each milliliter of sterile aqueous suspension
contains 10 to 40 milligrams of prednisone.
(2) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. Administer intramuscularly as
follows:
(a) Horses. 100 to 400 milligrams, repeating if necessary. If no
response is observed after 3 to 4 days of therapy, reevaluate
diagnosis.\1\
(b) Dogs and cats. 0.25 to 1.0 milligram per pound of body weight
for 3 to 5 days or until a response is noted. Treatment may be continued
with an orally administered dose.\1\
(ii) Indications for use. It is used for conditions requiring an
anti-inflammatory agent.\1\
(iii) Limitations.\1\ Do not use in viral infections. Except in
emergency therapy, do not use in animals with tuberculosis, chronic
nephritis, or Cushings's disease. With infections, use appropriate
antibacterial therapy with and for at least 3 days after discontinuance
of use and disappearance of all signs of infection. Clinical and
experimental data have demonstrated that corticosteroids administered
orally or parenterally to animals may induce the first stage of
parturition when administered during the last trimester of pregnancy and
may precipitate premature parturition followed by dystocia, fetal death,
retained placenta, and metritis. Not for use in horses intended for
food. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
[45 FR 13446, Feb. 29, 1980, as amended at 50 FR 6160, Feb. 14, 1985; 52
FR 7832, Mar. 13, 1987]
Sec. 522.1920 Prochlorperazine, isopropamide for injection.
(a) Specifications. Prochlorperazine, isopropamide for injection,
veterinary, contains in each milliliter, 6 milligrams of
prochlorperazine edisylate (equivalent to 4 milligrams
prochlorperazine), and 0.38 milligrams of isopropamide iodide
(equivalent to 0.28 milligrams of isopropamide) in buffered aqueous
solution.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used in dogs and cats in
which gastrointestinal disturbances are associated with emotional
stress.
(2) Dosage is administered by subcutaneous injection twice daily as
follows:
------------------------------------------------------------------------
Dosage in
Weight of animal in pounds Milliliters
------------------------------------------------------------------------
Up to 4.................................................... 0.25
5 to 14.................................................... 0.5-1
15 to 30................................................... 2-3
30 to 45................................................... 3-4
45 to 60................................................... 4-5
Over 60.................................................... 6
------------------------------------------------------------------------
Following the last injection, administer prochlorperazine and
isopropamide sustained release capsules as indicated.
(3) For use only by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60
FR 55659, Nov. 2, 1995]
Sec. 522.1940 Progesterone and estradiol benzoate in combination.
(a) [Reserved]
(b) Sponsor. See 000856 for use as provided in paragraphs (d)(1) and
(d)(2) of this section; see 021641 for use as provided in paragraphs
(d)(1) and (d)(2)(i) through (d)(2)(iii)(A) of this section.
(c) Related tolerances. See Secs. 556.240 and 556.540 of this
chapter.
(d) Conditions of use. It is used for implantation in animals as
follows:
(1) Suckling beef calves--(i) Amount. 100 milligrams of progesterone
and 10 milligrams of estradiol benzoate per dose.
[[Page 297]]
(ii) Indications for use. Increased rate of weight gain.
(iii) Limitations. For use in suckling beef calves (at least 45 days
of age) up to 400 pounds of body weight. For subcutaneous ear
implantation, one dose per animal. For 000033: Do not use in bull calves
intended for reproduction. For 021641: Do not use in calves intended for
reproduction.
(2) Steers--(i) Amount. 200 milligrams of progesterone and 20
milligrams of estradiol benzoate per dose.
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency.
(iii) Limitations. (A) For animals weighing 400 pounds or more; for
subcutaneous ear implantation, one dose per animal.
(B) For additional improvement in rate of weight gain in steers fed
in confinement for slaughter, reimplant at approximately day 70.
(iv) NAS/NRC status. The conditions of use specified in paragraphs
(d)(2)(i) through (d)(2)(iii)(A) are NAS/NRC reviewed and found
effective.
[40 FR 13858, Mar. 27, 1975, as amended at 48 FR 48659, Oct. 20, 1983;
49 FR 13873, Apr. 9, 1984; 51 FR 21746, June 16, 1986; 52 FR 45312, Nov.
27, 1987; 53 FR 7406, Feb. 21, 1989; 55 FR 13769, Apr. 12, 1990; 59 FR
49808, Sept. 30, 1994; 61 FR 5507, Feb. 13, 1996]
Sec. 522.1962 Promazine hydrochloride injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 50 milligrams of promazine hydrochloride.
(b) Sponsor. In Sec. 510.600(c) of this chapter, see No. 000008 for
conditions of use as in paragraph (c)(1)(i) of this section; see No.
000856 for conditions of use as in paragraph (c)(1)(ii) of this section;
see No. 000864 for conditions of use as in paragraph (c)(1)(iii) of this
section.
(c) Conditions of use. (1)(i) To horses either intramuscularly or
intravenously at a dosage of 0.2 to 0.5 milligram per pound of body
weight, and to dogs and cats 1 to 3 milligrams per pound of body weight,
every 4 to 6 hours as a tranquilizer or preanesthetic.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and found effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(ii) To horses either intramuscularly or intravenously at a dosage
of 0.2 to 0.5 milligram per pound of body weight, and to dogs and cats
at 1 to 2 milligrams per pound of body weight, every 4 to 6 hours as a
tranquilizer, preanesthetic, for minor operative procedures in
conjunction with local anesthesia, as adjunctive therapy for tetanus,
and as an antiemetic in dogs and cats prior to worming, or to prevent
motion sickness in dogs.\1\
(iii) To horses intravenously at a dosage of 0.2 to 0.5 milligram
per pound of body weight, as a tranquilizer and preanesthetic, as
required.\1\
(2) Not for use in conjunction with organophosphates because their
toxicity may be potentiated, nor with procaine hydrochloride as its
activity may be increased.\1\
(3) Not for use in horses intended for food.\1\
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.\1\
[46 FR 18962, Mar. 27, 1981]
Sec. 522.2002 Propiopromazine hydrochloride injection.
(a) Chemical name. 1-Propanone, 1-[10-[3-(dimethylamino) propyl]
phenothiazine-2-yl]-, monohydrochloride.
(b) Specifications. Propiopromazine hydrochloride injection contains
5 or 10 milligrams of the drug in each milliliter of sterile aqueous
solution.
(c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) It is administered either intravenously
or intramuscularly to dogs and cats for tranquilization at a dosage
level of 0.05-0.5 milligram per pound of body weight and is also
administered intravenously to dogs and cats as a preanesthetic at a
dosage level of 0.25 milligram per pound of body weight.
(2) It is not to be used in conjunction with organophosphates and/or
procaine hydrochloride since phenothiazines may potentiate the toxicity
of organophosphates and the activity of procaine hydrochloride.
[[Page 298]]
(3) For use only by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 60570, Dec. 11, 1981;
61 FR 5507, Feb. 13, 1996]
Sec. 522.2012 Prostalene solution.
(a) Specifications. Each milliliter of sterile solution contains 1
milligram of prostalene.
(b) Sponsor. No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--Horses. (1) It is used in mares for the
control of estrus.
(2) It is administered at a dose of 5 micrograms per kilogram of
body weight as a single subcutaneous injection.
(3) Not for use in horses intended for food.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[41 FR 26854, June 30, 1976; as amended at 61 FR 5507, Feb. 13, 1996]
Sec. 522.2022 Protokylol hydrochloride injection.
(a) Specifications. Protokylol hydrochloride injection contains 0.5
milligram of protokylol hydrochloride per cubic centimeter of sterile
aqueous solution.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used in dogs and cats for relief of
bronchial spasm.\1\
(2) It is administered subcutaneously or intramuscularly at a dosage
level of 0.125 to 0.5 milligram to dogs and at a level of 0.125 to 0.25
milligram to cats.\1\
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and found effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
Sec. 522.2063 Pyrilamine maleate injection.
(a) Specifications. The drug is a sterile aqueous solution with each
milliliter containing 20 milligrams of pyrilamine maleate.
(b) Sponsors. See No. 000061 in Sec. 510.600(c) of this chapter for
uses in paragraph (c)(2)(i) of this section; see No. 000864 in
Sec. 510.600(c) of this chapter for uses in paragraph (c)(2)(ii) of this
section.
(c) Conditions of use. (1) It is intended for treating horses in
conditions in which antihistaminic therapy may be expected to lead to
alleviation of some signs of disease.\1\
(2)(i) It is administered intramuscularly, subcutaneously, or
intravenously. Local injection at the site of insect bites may be
indicated in severe cases. Intravenous injections must be given slowly
to avoid symptoms of overdosage. Dosage may be repeated every 6 to 12
hours whenever necessary. Horses, 40 to 60 milligrams per 100 pounds
body weight; foals, 20 milligrams per 100 pounds body weight.\1\
(ii) It is administered intravenously. Intravenous injections must
be given slowly to avoid symptoms of overdosage. Dosage may be repeated
every 6 to 12 hours if necessary. Horses, 40 to 60 milligrams per 100
pounds body weight; foals, 20 milligrams per 100 pounds body weight.\1\
(3) Do not use in horses intended for food purposes.1
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.\1\
[40 FR 13858, Mar. 27, 1975; 41 FR 9150, Mar. 3, 1976, as amended at 42
FR 13549, Mar. 11, 1977; 42 FR 61256, Dec. 2, 1977; 51 FR 41477, Nov.
17, 1986; 52 FR 7832, Mar. 13, 1987; 54 FR 1164, Jan. 12, 1989]
Sec. 522.2095 Sarafloxacin solution for injection.
(a) Specifications. Each milliliter contains sarafloxacin
hydrochloride equivalent to 50 milligrams of sarafloxacin in a 20
percent propylene glycol solution.
(b) Sponsor. See No. 000074 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.594 of this chapter.
(d) Conditions of use. Day-old broiler chickens:
(1) Amount. 0.1 milligram sarafloxacin per 0.2 milliliter dose.
(2) Indications for use. For control of early mortality in day-old
broiler
[[Page 299]]
chickens associated with Escherichia coli organisms susceptable to
sarafloxacin.
(3) Limitations. A single subcutaneous 0.2 milliliter - injection in
the neck. Dilute 1 milliliter of SaraFlox
Sec. 522.2100 Selenium, vitamin E injection.
(a)(1) Specifications. The drug is an emulsion containing in each
milliliter, 5.48 milligrams sodium selenite (equivalent to 2.5
milligrams selenium), 50 milligrams of vitamin E (68 I.U.) (as d-alpha
tocopheryl acetate), 250 milligrams polyoxyethylated vegetable oil, and
2.0 percent benzyl alcohol, and water for injection.
(2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is intended for use for the
prevention and treatment of selenium-tocopherol deficiency syndrome in
horses.
(ii) The drug is administered by intravenous or deep intramuscular
injection in divided doses in 2 or more sites in the gluteal or cervical
muscles at a dosage level of 1 milliliter per 100 pounds of body weight
and may be repeated at 5 to 10 day intervals.
(iii) Do not use in horses intended for food.
(iv) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(b)(1) Specifications. The drug contains in each milliliter 2.19
milligrams of sodium selenite (equivalent to 1 milligram of selenium),
50 milligrams of vitamin E (68 I.U.) (as d-alpha tocopheryl acetate),
100 milligrams of polyoxyethylated vegetable oil, 1:10,000 thimerosal,
and water for injection.
(2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is intended for use as an aid in
alleviating and controlling inflammation, pain and lameness associated
with certain arthropathies in dogs.
(ii) The drug is administered subcutaneously or intramuscularly in
divided doses in 2 or more sites at a dosage level of 1 milliliter per
20 pounds of body weight with a minimum dosage of \1/4\ milliliter and a
maximum dosage of 5 milliliters. The dosage is repeated at 3 day
intervals until a satisfactory therapeutic response is observed. A
maintenance regimen is then initiated which consists of 1 milliliter per
40 pounds of body weight with a minimum dosage of \1/4\ milliliter which
is repeated every 3 days or 7 days, or longer, as required to maintain
continued improvement or an asymptomatic condition; or the drug may be
used in capsule form for oral maintenance therapy.
(iii) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(c)(1) Specifications. Each milliliter contains 2.19 milligrams of
selenite sodium (equivalent to 1 milligram selenium), 50 milligrams
vitamin E (68 U.S.P. units), 250 milligrams polysorbate 80, 2 percent
benzyl alcohol, water for injection q. s.
(2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Dosage. Calves: 2.5 to 3.75 milliliters
per 100 pounds of body weight. Lambs 2 weeks of age or older: 1
milliliter per 40 pounds, minimum 1 milliliter. Ewes: 2.5 milliliters
per 100 pounds. Sows: 1 milliliter per 40 pounds. Weanling pigs: 1
milliliter per 40 pounds, minimum 1 milliliter.
(ii) Indications for use. Calves, lambs, and ewes: prevention and
treatment of white muscle disease (selenium-tocopherol deficiency
syndrome). Sows and weanling pigs: an aid in the prevention
[[Page 300]]
and treatment of selenium-tocopherol deficiency.
(iii) Limitations. For subcutaneous or intramuscular use. Not for
use in newborn pigs. Do not use in pregnant ewes. Calves: Discontinue
use 30 days before treated calves are slaughtered for human consumption.
Lambs, ewes, sows, or pigs: Discontinue use 14 days before treated
lambs, ewes, sows, or pigs are slaughtered for human consumption.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(d)(1) Specifications. Each milliliter contains 10.95 milligrams
selenite sodium (equivalent to 5 milligrams selenium), 50 milligrams
vitamin E (68 U.S.P. units), 250 milligrams polysorbate 80, 2 percent
benzyl alcohol, water for injection q. s.
(2) Sponsor. See Nos. 000061 and 000856 in Sec. 510.600(c) of this
chapter.
(3) Conditions of use--(i) Dosage. Breeding beef cows: 1 milliliter
per 200 pounds of body weight during the middle third of gestation, and
30 days before calving. Weanling calves: 1 milliliter per 200 pounds of
body weight.
(ii) Indications for use. Weanling calves and breeding beef cows:
For the prevention and treatment of selenium-tocopherol deficiency
syndrome.
(iii) Limitations. For subcutaneous or intramuscular use.
Discontinue use 30 days before treated cattle are slaughtered for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(e)(1) Specifications. Each milliliter contains 0.55 milligram
selenite sodium (equivalent to 0.25 milligram selenium), 50 milligrams
(68 U.S.P. units) vitamin E, 250 milligrams polysorbate 80, 2 percent
benzyl alcohol, water for injection q. s.
(2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Dosage. Newborn lambs: 1 milliliter.
Lambs 2 weeks of age or older: 4 milliliters. Baby pigs: 1 milliliter
(or treat the sow during the last week of pregnancy).
(ii) Indications for use. Lambs: for prevention and treatment of
white muscle disease (selenium-tocopherol deficiency syndrome). Baby
pigs: an aid in the prevention and treatment of selenium-tocopherol
deficiency.
(iii) Limitations. For subcutaneous or intramuscular use only.
Discontinue use 14 days before treated animals are slaughtered for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 57
FR 21209, May 19, 1992; 58 FR 57556, Oct. 26, 1993; 60 FR 57833, Nov.
22, 1995]
Sec. 522.2112 Sterile sometribove zinc suspension.
(a) Specifications. The drug product consists of a single-dose
syringe containing 500 milligrams of sometribove zinc in a sterile,
prolonged-release suspension.
(b) Sponsor. See No. 059945 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Use may result in reduced pregnancy
rates and, in first calf heifers, an increase in days open. Use of the
product has also been associated with increases in cystic ovaries and
disorders of the uterus during the treatment period. Also, the incidence
of retained placenta may be higher following subsequent calving. Treated
cows are at an increased risk for clinical mastitis and subclinical
mastitis. In some herds, use has been associated with increases in
somatic cell counts in milk. Care should be taken to differentiate
increased body temperature due to use of this product from an increased
body temperature that may occur due to illness. Use may result in an
increase in digestive disorders such as indigestion, bloat, and
diarrhea. There may be an increase in the number of cows experiencing
periods of ``off-feed'' (reduced feed intake) during treatment. Cows
treated with this product may have increased numbers of enlarged hocks
and lesions of the knee (carpal region), and second lactation or older
cows may have more disorders of the foot region. Use has been associated
with reductions in hemoglobin and hematocrit values during treatment.
Human warning: Avoid prolonged or repeated contact with eyes and skin.
(d) Conditions of use--(1) Amount. 500 milligrams of sometribove
zinc every 14 days beginning during the ninth
[[Page 301]]
week after calving and continuing until the end of lactation.
(2) Indications for use. For use in healthy lactating dairy cows to
increase the production of marketable milk.
(3) Limitations. For use in lactating dairy cows only. Administer
subcutaneously. Safety to replacement bulls born to treated dairy cows
has not been established. To minimize injection site blemishes on
carcass at time of slaughter, avoid injections within 2 weeks of
expected slaughter. No milk discard or preslaughter withdrawal period is
required.
[58 FR 59947, Nov. 12, 1993]
Sec. 522.2120 Spectinomycin injection.
(a) Specifications. The spectinomycin dihydrochloride pentahydrate
used in manufacturing the drug is the antibiotic substance produced by
the growth of Streptomyces flavopersicus (var. Abbott) or the same
antibiotic substance produced by any other means. Each milliliter of the
drug contains the following amount of spectinomycin activity from
spectinomycin dihydrochloride pentahydrate:
(1) 5 milligrams when used as provided in paragraph (d)(1) of this
section.
(2) [Reserved]
(3) 100 milligrams when used as provided in paragraphs (d) (2), (3),
and (4) of this section.
(b) Sponsor. See No. 000856 and No. 050604 in Sec. 510.600(c) of
this chapter.
(c) Special considerations. The quantity of spectinomycin referred
to in this section refers to the equivalent weight of base activity for
the drug.
(d) Conditions of use. It is administered as spectinomycin
dihydrochloride pentahydrate as follows:
(1) Subcutaneously in the treatment of 1-to-3-day-old turkey poults
at the rate of 1 to 2 milligrams per poult as an aid in the prevention
of mortality associated with Arizona group infection.
(2) Subcutaneously in the treatment of 1-to-3-day old:
(i) Turkey poults at the rate of 5 milligrams per poult as an aid in
the control of chronic respiratory disease (CRD) associated with E.
coli.
(ii) Baby chicks at the rate of 2.5 to 5 milligrams per chick as an
aid in the control of mortality and to lessen severity of infections
caused by M. synoviae, S. typhimurium, S. infantis, and E. coli.
(3) Intramuscularly in the treatment of dogs:
(i) At a dosage level of 2.5 milligrams to 5.0 milligrams per pound
of body weight twice daily. Treatment may be continued for 4 days. For
treatment of infections caused by gram-negative and gram-positive
organisms susceptible to spectinomycin.
(ii) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(4) Administer single injection of 0.1 milliliter (10 milligrams)
subcutaneously in nape of neck of 1- to 3-day-old turkey poults as an
aid in control of airsacculitis associated with M. mileagridis sensitive
to spectinomycin.
[40 FR 13858, Mar. 27, 1975, as amended at 43 FR 9273, Mar. 7, 1978; 46
FR 18964, Mar. 27, 1981; 47 FR 14149, Apr. 2, 1982; 61 FR 5507, Feb. 13,
1996]
Sec. 522.2150 Stanozolol sterile suspension.
(a) Specifications. Each milliliter of sterile suspension contains
50 milligrams of stanozolol.
(b) Sponsor. No. 000009 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) Used as an anabolic steroid treatment in
dogs, cats, and horses.
(2) Administered to dogs and cats by deep intramuscular injection in
the thigh at weekly intervals, for several weeks. For cats and small
breeds of dogs, 25 milligrams. For larger dogs, 50 milligrams.
(3) Administered to horses by deep intramuscular injection in the
gluteal region at weekly intervals, for not more than 4 weeks; 25
milligrams per 100 pounds of body weight.
(4) Not for use in horses intended for food.
(5) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 46101, Oct. 6, 1975, as amended at 42 FR 36995, July 19, 1977; 55
FR 23076, June 6, 1990]
[[Page 302]]
Sec. 522.2200 Sulfachlorpyridazine.
(a) Chemical name. N 1 -(6-Chloro-3-pyridazinyl) sulfanilamide.
(b) Specifications. Melting point range 190 deg. C to 191 deg. C.
(c) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(d) Related tolerances. See Sec. 556.630 of this chapter.
(e) Conditions of use. It is used for injection into calves as
follows:
(1) Amount. 30 to 45 milligrams per pound of body weight per day.
(2) Indications for use. Treatment of diarrhea caused or complicated
by E. coli (colibacillosis).
(3) Limitations. Administer as the sodium salt of
sulfachlorpyridazine intravenously in aqueous solution for 1 to 5 days
in divided doses twice daily; treated calves must not be slaughtered for
food during treatment or for 5 days after the last treatment.
[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985]
Sec. 522.2220 Sulfadimethoxine injection.
(a)(1) Specifications. Sulfadimethoxine injection containing 400
milligrams per milliliter.
(2) Sponsor. (i) See No. 000069 in Sec. 510.600(c) of this chapter
for conditions of use as in paragraphs (a)(3)(i) through (a)(3)(iii) of
this section.
(ii) See No. 057561 for conditions of use as in paragraph (a)(3) of
this section.
(3) Conditions of use. (i) It is used or intended for use in dogs
and cats as follows:
(a) For the treatment of respiratory, genitourinary tract, enteric,
and soft tissue infections when caused by Streptococci, Staphylococci,
Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms
sensitive to sulfadimethoxine, and in the treatment of canine bacterial
enteritis associated with coccidiosis and canine Salmonellosis.
(b) It is administered by intravenous or subcutaneous injection at
an initial dose of 55 milligrams per kilogram of body weight followed by
27.5 milligrams per kilogram of body weight every 24 hours.
(c) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(ii) It is used or intended for use in horses as follows:
(a) For the treatment of respiratory disease caused by Streptococcus
equi (strangles).
(b) It is administered by intravenous injection at an initial dose
of 55 milligrams per kilogram of body weight followed by 27.5 milligrams
per kilogram of body weight every 24 hours until the patient is
asymptomatic for 48 hours.
(c) Not for use in horses intended for food.
(d) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(iii) It is used or intended for use in cattle as follows:
(a) For the treatment of shipping fever complex, bacterial
pneumonia, calf diphtheria, and foot-rot.
(b) It is administered by intravenous injection at an initial dose
of 25 milligrams per pound of body weight followed by 12.5 milligrams
per pound of body weight every 24 hours until the animal is asymptomatic
for 48 hours.
(c) Milk taken from animals during treatment and for 60 hours (5
milkings) after the latest treatment must not be used for food. Do not
administer within 5 days of slaughter.
(d) Tissue damage may result from perivascular infiltration.
(b) [Reserved]
(c)(1) Specifications. Sulfadimethoxine containing 100 milligrams
per milliliter.
(2) Sponsor. See No. 054273 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) It is used or intended for use in the
treatment of sulfadimethoxine-susceptible bacterial infections in dogs.
(ii) It is administered by subcutaneous, intramuscular, or
intravenous injection at an initial dose of 25 milligrams per pound of
body weight followed by 12.5 milligrams per pound of body weight every
24 hours thereafter. Continue treatment until the animal is free from
symptoms for 48 hours.
(iii) For use by or on the order of a licensed veterinarian.
[[Page 303]]
(d) Related tolerances. See Sec. 556.640 of this chapter.
[40 FR 13858, Mar. 27, 1975, as amended at 40 FR 34112, Aug. 14, 1975;
40 FR 42007, Sept. 10, 1975; 50 FR 254, Jan. 3, 1985; 53 FR 40728, Oct.
18, 1988; 54 FR 30205, July 19, 1989; 58 FR 38972, July 21, 1993; 59 FR
56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996]
Sec. 522.2240 Sulfaethoxypyridazine.
(a) Chemical name. N 1 -(6-Ethoxy-3-pyridazinyl) sulfanilamide.
(b) Specifications. Melting point range of 180 deg. C to 186 deg. C.
(c) Sponsor. See No. 010042 in Sec. 510.600(c) of this chapter.
(d) Related tolerances. See Sec. 556.650 of this chapter.
(e) Conditions of use. It is used for injection into cattle as
follows:
(1) Amount. 2.5 grams per 100 pounds of body weight per day.
(2) Indications for use. Treatment of respiratory infection
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive
therapy in septicemia accompanying mastitis and metritis.
(3) Limitations. Administer intravenously for not more than 4 days;
or first treatment may be followed by 3 days of treatment with
sulfaethoxypyridazine in drinking water, feed, or tablet in accordance
with Sec. 558.579(e) or Secs. 520.2240a(e) and 520.2240b(e) of this
chapter; as sodium sulfaethoxypyridazine; do not treat within 16 days of
slaughter; as sole source of sulfonamide; milk that has been taken from
animals during treatment and for 72 hours (6 milkings) after the latest
treatment must not be used for food; for use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 11011, Mar. 15, 1976]
Sec. 522.2260 Sulfamethazine injectable solution.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 250 milligrams of sulfamethazine sodium.
(b) Sponsor. See No. 010042 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.670 of this chapter.
(d) NAS/NRC status. The conditions of use are NAS/NRC reviewed and
found effective. Applications for these uses need not include
effectiveness data as specified by Sec. 514.111 of this chapter, but may
require bioequivalency and safety information.
(e) Conditions of use--(1) Amount. 20 milliliters for each 50 pounds
of body weight (100 milligrams per pound) initially, 20 milliliters per
100 pounds of body weight (50 milligrams per pound) daily thereafter for
cattle.
(2) Indications for use. For cattle for treatment of bacterial
pneumonia and bovine respiratory disease complex (shipping fever
complex) (Pasteurella spp.), colibacillosis (bacterial scours)
(Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium
necrophorum), calf diphtheria (Fusobacterium necrophorum), acute
mastitis and acute metritis (Streptococcus spp.) when caused by one or
more pathogenic organisms sensitive to sulfamethazine.
(3) Limitations. For intravenous use only. Not for use in lactating
dairy animals. Withdraw medication from cattle 10 days prior to
slaughter for food. If symptoms persist for 2 or 3 days, consult a
veterinarian. Adequate water intake is important for animals treated
with sulfonamides. Treatment should continue 24 to 48 hours beyond the
remission of disease symptoms, but not to exceed a total of 5
consecutive days.
[46 FR 62055, Dec. 22, 1981]
Sec. 522.2340 Sulfomyxin.
(a) Specifications. Sulfomyxin for injection is sterile. It is
derived from the antibiotic substance produced by the growth of Bacillus
polymyxa or is the same substance produced by any other means.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Special considerations. The quantities of antibiotic in
paragraph (e) of this section refer to the activity of the appropriate
standard.
(d) Related tolerances. See Sec. 556.700 of this chapter.
(e) Conditions of use. (1) It is used or intended for use in
chickens and turkeys as an aid in the treatment of disease caused or
complicated by E. coli, such as colibacillosis and complicated chronic
respiratory disease.
(2) It is administered by subcutaneous injection as follows:
[[Page 304]]
------------------------------------------------------------------------
Antibiotic activity
-----------------------
Age of birds in days Chickens Turkeys
(units) (units)
------------------------------------------------------------------------
1 to 14......................................... 12,500 12,500
15 to 28........................................ 25,000 25,000
29 to 63........................................ 50,000 50,000
Over 63......................................... 50,000 100,000
------------------------------------------------------------------------
(3) A second injection may be given 3 days later if symptoms
persist.
(4) Not for use in laying hens; do not treat chickens within 5 days
of slaughter; do not treat turkeys within 7 days of slaughter.
Sec. 522.2404 Thialbarbitone sodium for injection.
(a) Specifications. Thialbarbitone sodium for injection when
reconstituted with sterile distilled water provides 94 milligrams of
thialbarbitone sodium per milliliter of solution.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is administered as a general
anesthetic in surgical procedures on dogs, cats, swine, sheep, cattle,
and horses. The drug is used for procedures of relatively short
duration. However, the period of anesthesia can be lengthened by slower
initial injection and supplemental administration during surgery.
(2) It is administered intravenously. The drug is injected slowly to
dogs, cats, cattle, sheep, and swine. For horses, it is recommended that
a pre-anesthetic sedation be administered to the horse 30 minutes before
the drug is administered. The drug is then injected rapidly and
completely. The drug is used at the following dosage levels:
------------------------------------------------------------------------
Dosage in
Species Weight of animal in milligrams
pounds per pound
------------------------------------------------------------------------
Dog................................. Over 50............... 14.1
Do.............................. 30-50................. 18.8
Do.............................. 10-30................. 23.5
Do.............................. Under 10.............. 28.2
Cat................................. ...................... 31.3-37.6
Horse............................... ...................... 6.3-7.8
Cattle and swine.................... ...................... 6.7-9.4
Calves and sheep.................... ...................... 9.4-11.8
------------------------------------------------------------------------
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
Sec. 522.2424 Sodium thiamylal for injection.
(a) Specifications. The drug is a sterile dry powder. It is
reconstituted aseptically with sterile distilled water, water for
injection, or sodium chloride injection, to a desired concentration of
0.5 to 4 percent sodium thiamylal.
(b) Sponsors. See code Nos. 000010, 000856, and 054273 in
Sec. 510.500(c) of this chapter.
(c) Conditions of use. (1) It is used as an ultra-short-acting
anesthetic in dogs, cats, swine, horses, and cattle.
(2) When diluted aseptically to the desired concentration and
administered intravenously to effect, the average single dose is:
(i) Dogs and cats: 8 milligrams per pound of body weight (when used
with a preanesthetic, generally one-half the normal dose).
(ii) Swine: 40 milligrams per 5 pounds of body weight.
(iii) Horses: Light anesthesia, 1 gram per 500 pounds to 1,100
pounds of body weight; deep anethesia, 1 gram per 300 pounds of body
weight (40 milligrams per 12 pounds of body weight).
(iv) Cattle: Short duration, 20 milligrams per 5 pounds of body
weight; longer duration, 40 milligrams per 7 pounds of body weight.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(4) NAS/NRC status: The conditions of use specified in this
paragraph are NAS/NRC reviewed and found effective. Applications for
these uses need not include effectiveness data as specified in
Sec. 514.111 of this chapter, but may require bioequivalency and safety
information.
[40 FR 25812, June 19, 1975, as amended at 49 FR 8434, Mar. 7, 1984; 53
FR 23390, June 22, 1988; 53 FR 40728, Oct. 18, 1988]
Sec. 522.2444 Sodium thiopental implantation or injectable dosage
forms.
Sec. 522.2444a Sodium thiopental for injection.
(a) Specifications. The drug contains sodium thiopental sterile
powder for dilution with sterile water for injection.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
[[Page 305]]
(c) Conditions of use. (1) It is used as an anesthetic for
intravenous administration to dogs and cats during short to moderately
long surgical and other procedures. It is also used to induce anesthesia
in dogs and cats which then have surgical anesthesia maintained by use
of a volatile anesthetic.
(2) It is administered as follows:
(i) For brief anesthesia (6 to 10 minutes) a dosage of 6 to 9
milligrams per pound of body weight is suggested.
(ii) To obtain anesthesia of 15 to 25 minutes duration the suggested
dosage is 10 to 12 milligrams per pound of body weight.
(iii) Use of a preanesthetic tranquilizer or morphine will decrease
the dosage of sodium thiopental required, provide for smoother induction
and smoother recovery, and sometimes prolong the recovery period. If
morphine is used as a preanesthetic agent the dose of the barbiturate
can be reduced as much as 40 to 50 percent. When a tranquilizer is
administered the barbiturate dosage can be reduced 10 to 25 percent.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
Sec. 522.2444b Sodium thiopental, sodium pentobarbital for injection.
(a) Specifications. Each gram of the drug contains 750 milligrams of
sodium thiopental and 250 milligrams of sodium pentobarbital sterile
powder for dilution with sterile water for injection.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used as an anesthetic for
intravenous administration to dogs and cats during short to moderately
long surgical procedures.
(2) It is administered as follows:
(i) For total anesthesia, it is given at approximately 10 to 12
milligrams per pound of body weight over a period of 3.5 to 5 minutes.
(ii) When preanesthetic medication is used, it is important to wait
at least an hour before administering thiopental and sodium
pentobarbital for injection, and the dosage necessary for anesthesia is
reduced. Usually \1/2\ to \2/3\ the normal amount is adequate.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 47 FR 14149, Apr. 2, 1982]
Sec. 522.2470 Tiletamine hydrochloride and zolazepam hydrochloride for injection.
(a) Specifications. Tiletamine hydrochloride and zolazepam
hydrochloride for injection when reconstituted with sterile distilled
water provides tiletamine hydrochloride and zolazepam hydrochloride
equivalent to 50 milligrams of tiletamine base and 50 milligrams of
zolazepam base per milliliter of solution.
(b) Sponsor. See No. 000031 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Indications for use. It is used for
restraint or for anesthesia combined with muscle relaxation in cats and
in dogs for restraint and minor procedures of short duration (30
minutes) requiring mild to moderate analgesia.
(2) Amount. Expressed as milligrams of the drug combination:
(i) In healthy dogs: An initial intramuscular dosage of 3 to 4.5
milligrams per pound of body weight for diagnostic purposes; 4.5 to 6
milligrams per pound of body weight for minor procedures of short
duration such as repair of lacerations and wounds, castrations, and
other procedures requiring mild to moderate analgesia. Supplemental
doses when required should be less than the initial dose and the total
dose given should not exceed 12 milligrams per pound of body weight. The
maximum total safe dose is 13.6 milligrams per pound of body weight.
(ii) In healthy cats: An initial intramuscular dosage of 4.4 to 5.4
milligrams per pound of body weight is recommended for such procedures
as dentistry, treatment of abscesses, foreign body removal, and related
types of surgery; 4.8 to 5.7 milligrams per pound of body weight for
minor procedures requiring mild to moderate analgesia, such as repair of
lacerations, castrations, and other procedures of short duration.
Initial dosages of 6.5 to 7.2 milligrams per pound of body weight are
recommended for ovariohysterectomy and onychectomy. When supplemental
[[Page 306]]
doses are required, such individual supplemental doses should be given
in increments that are less than the initial dose and the total dose
given (initial dose plus supplemental doses) should not exceed the
maximum allowable safe dose of 32.7 milligrams per pound of body weight.
(3) Limitations. Discard unused reconstituted solution after 48
hours. Not for use in dogs and cats with pancreatic disease, or with
severe cardiac or pulmonary dysfunction. Not for use in pregnant
animals. Not for use in cats suffering with renal insufficiency. The
dosage should be reduced in geriatric dogs and cats. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[47 FR 15328, Apr. 9, 1982, as amended at 51 FR 24142, July 2, 1986]
Sec. 522.2471 Tilmicosin phosphate injection.
(a) Specifications. Each milliliter contains 300 milligrams of
tilmicosin base as tilmicosin phosphate.
(b) Sponsor. See 000986 in Sec. 510.600(c). of this chapter.
(c) Related tolerances. See Sec. 556.735 of this chapter.
(d) Conditions of use--(1) Cattle--(i) Amount. 10 milligrams per
kilogram body weight.
(ii) Indications for use. For the treatment of bovine respiratory
disease associated with Pasteurella haemolytica.
(iii) Limitations. For use only in cattle as a single subcutaneous
injection. Not for human use. Use of this antibiotic in humans may prove
fatal. Do not use in automatically powered syringes. Do not inject more
than 15 milliliters per injection site. If no improvement is noted
within 48 hours, the diagnosis should be reevaluated. Do not use
intravenously in cattle. Intervenous injection in cattle will be fatal.
Do not use in other animal species. Injection of this antibiotic has
been found to be fatal in swine and nonhuman primates, and it may be
fatal in horses. Safety of use in pregnant and breeding animals has not
been established. Do not use in female dairy cattle 20 months of age or
older. Use of this antibiotic in this class of cattle may cause milk
residues. Do not use in veal calves, calves under 1 month of age, or
calves being fed an all-milk diet. Use in these classes of calves may
cause violative tissue residues to remain beyond withdrawal time. Do not
slaughter within 28 days of last treatment. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[57 FR 12712, Apr. 13, 1992]
Sec. 522.2476 Trenbolone acetate.
(a) Specifications. Each pellet for implanting contains 20
milligrams of trenbolone acetate.
(b) Sponsor. See 012579 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.739 of this chapter.
(d) Conditions of use--(1) Heifers 200 milligrams trenbolone acetate
(10 pellets of 20 milligrams each) for increased rate of weight gain and
improved feed efficiency in growing-finishing feedlot heifers, use last
63 days prior to slaughter.
(2) Steers. 140 milligrams trenbolone acetate (7 pellets of 20
milligrams each) for improved feed efficiency in growing-finishing
feedlot steers, use 126 days prior to slaughter, should be reimplanted
once after 63 days.
(3) Limitations. Not for use in animals intended for subsequent
breeding or in dairy animals. Implant in ear only.
[52 FR 24995, July 2, 1987]
Sec. 522.2477 Trenbolone acetate and estradiol.
(a) Sponsor. See No. 012579 in Sec. 510.600(c) of this chapter.
(b) Related tolerances. See Secs. 556.240 and 556.739 of this
chapter.
(c) Conditions of use--(1) Feedlot steers--(i) Amount. 120
milligrams of trenbolone acetate and 24 milligrams of estradiol (6
pellets, each pellet containing 20 milligrams of trenbolone acetate and
4 milligrams of estradiol) per animal.
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency in feedlot steers.
(iii) Limitations. Implant subcutaneously in ear only. Do not use in
animals intended for subsequent breeding or in dairy animals.
[[Page 307]]
(2) Heifers--(i) Amount. 140 milligrams of trenbolone acetate and 14
milligrams of estradiol (7 pellets, each pellet containing 20 milligrams
of trenbolone acetate and 2 milligrams of estradiol) per animal.
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency in heifers fed in confinement for slaughter.
(iii) Limitations. Implant subcutaneously in ear only. Do not use in
animals intended for subsequent breeding or in dairy animals.
[60 FR 4376, Jan. 23, 1995]
Sec. 522.2478 Trenbolone acetate and estradiol benzoate.
(a) Sponsor. See 000033 in Sec. 510.600(c) of this chapter.
(b) Related tolerance. See Secs. 556.240 and 556.739 of this
chapter.
(c) Conditions of use--(1) Steers--(i) Amount. 200 milligrams of
trenbolone acetate and 28 milligrams of estradiol benzoate (one implant
consisting of 8 pellets, each pellet containing 25 milligrams of
trenbolone acetate and 3.5 milligrams of estradiol benzoate) per animal.
(ii) Indications for use. For improved feed efficiency in steers fed
in confinement for slaughter.
(iii) Limitations. Implant subcutaneously in ear only.
(2) [Reserved]
[61 FR 14482, Apr. 2, 1996]
Effective Date Note: At 61 FR 14482, Apr. 2, 1996, Sec. 522.2478 was
added, effective Apr. 2, 1996.
Sec. 522.2480 Triamcinolone injection.
(a) Chemical name. 9-Fluro-11,16, 17,21 -
tetrahydroxypregna - 1,4-diene-3,20-dione.
(b) Specifications. Each cubic centimeter of triamcinolone injection
contains: 2.5 milligrams of triamcinolone and 10 milligrams of procaine
hydrochloride with 0.1 percent of sodium bisulfite and 84.4 percent of
polyethylene glycol 400.
(c) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) The drug is indicated for use in dogs and
cats for its anti-inflammatory activity.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and found effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(2)(i) In dogs, the drug may be given by intramuscular or
subcutaneous injection at 0.625 milligram for each 10 pounds of body
weight, and, if only one or two injections are anticipated, the dosage
may be doubled. It may also be given to dogs by intra-articular
administration at from 0.625 milligram to 1.25 milligrams per dose.
Repeat dosage as indicated.\1\
(ii) In cats, the drug may be given by intramuscular or subcutaneous
injection at 0.625 milligram for each 10 pounds of body weight. It may
also be given by intra-articular administration at from 0.31 milligram
to 0.625 milligram per dose. Repeat dosage as indicated.\1\
(iii) Since requirements vary with the individual animal,
recommended dosage is approximate and must be adjusted to the response
of the individual animal. Generally, initial dosages are at a higher
range. When response is satisfactory, gradually reduce dosage until a
minimum dose is obtained. This is particularly important for long-term
medication. If additional treatment or a long-term treatment is
necessary, triamcinolone tablets may be used as a maintenance dosage.\1\
(3) For use by or on the order of a licensed veterinarian.\1\
[40 FR 13858, Mar. 27, 1975, as amended at 47 FR 14150, Apr. 2, 1982]
Sec. 522.2483 Sterile triamcinolone acetonide suspension.
(a) Specifications. Each milliliter of suspension contains 2 or 6
milligrams triamcinolone acetonide.
(b) Sponsor. See 053501 and 054273 in Sec. 510.600(c) of this
chapter.
(c) Conditions of use--(1) Amount--(i) Dogs and cats--(a)
Intramuscular or subcutaneous. Single injection of 0.05 to 0.1 milligram
(mg.) per pound of body weight in inflammatory, arthritic, or allergic
disorders. Single injection of
[[Page 308]]
0.1 mg. per pound of body weight in dermatologic disorders. If symptoms
recur, the dose may be repeated, or oral corticosteroid therapy may be
instituted.1
(b) Intralesional. 1.2 to 1.8 mg., divided in several injections,
spaced around the lesion at 0.5 to 2.5 centimeters apart depending on
the size. At any one site the dose injected should not exceed 0.6 mg.
and should be well into the cutis to prevent rupture of the epidermis.
When treating animals with multiple lesions, do not exceed a total dose
of 6 mg.
(c) Intra-articular and intrasynovial. Single injection of 1 to 3
mg. dose, dependent on size of joint and severity of symptoms. After 3
or 4 days, repeat dosage if indicated. If initial results are inadequate
or too transient, dosage may be increased, not to exceed 3 mg.
(ii) Horses--(a) Intramuscular or subcutaneous. Single injection of
0.01 to 0.02 mg. per pound of body weight. Usual dose, 12 to 20 mg.
(b) Intra-articular and intrasynovial. Single injection of 6 to 18
mg. dose, dependent on size of joint and severity of symptoms. After 3
or 4 days, repeat dosage if indicated. If initial results are inadequate
or too transient, dosage may be increased, not to exceed 18 mg.
(2) Indications for use. Treatment of inflamation and related
disorders in dogs, cats, and horses; 1 and management and treatment
of acute arthritis and allergic and dermatologic disorders in dogs and
cats.
---------------------------------------------------------------------------
1 These conditions are NAS/NRC reviewed and are deemed
effective. Applications for these uses need not include the
effectiveness data specified by Sec. 514.111 of this chapter, but may
require bioequivalency and safety information.
---------------------------------------------------------------------------
(3) Limitations. (i) Do not use in viral infections. With bacterial
infections, appropriate antibacterial therapy should be used.
(ii) Do not use in animals with tuberculosis, chronic nephritis, or
cushingoid syndrome, except for emergency therapy.
(iii) Not for use in horses intended for food.
(iv) Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
(v) Do not use in the treatment of laminitis.
(vi) Intra-articular injection in equine leg injuries may produce
osseous metaplasia.
(vii) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[43 FR 4976, Feb. 7, 1978, as amended at 50 FR 41490, Oct. 11, 1985; 52
FR 1903, Jan. 16, 1987; 53 FR 40728, Oct. 18, 1988]
Sec. 522.2582 Triflupromazine hydrochloride injection.
(a) Specifications. Triflupromazine hydrochloride injection contains
20 milligrams of triflupromazine hydrochloride in each milliliter of
sterile aqueous solution.
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used in dogs, cats, and
horses to relieve anxiety and to help control psychomotor overactivity
as well as to increase the tolerance of animals to pain and pruritus.
The drug is indicated in various office and clinical procedures which
require the aid of a tranquilizer, antiemetic, or preanesthetic.\1\
(2) The drug is administered to dogs either intravenously at a
dosage level of 0.5 to 1 milligram per pound of body weight daily, or
intramuscularly at a dosage level of 1 to 2 milligrams per pound of body
weight daily. It is administered to cats intramuscularly at a dosage
level of 2 to 4 milligrams per pound of body weight daily. It is
administered to horses intravenously or intramuscularly at a dosage
level of 10 to 15 milligrams per 100 pounds of body weight daily to a
maximum dose of 100 milligrams. \1\
---------------------------------------------------------------------------
1 These conditions are NAS/NRC reviewed and are deemed
effective. Applications for these uses need not include the
effectiveness data specified by Sec. 514.111 of this chapter, but may
require bioequivalency and safety information.
---------------------------------------------------------------------------
(3) Not for use in horses intended for food.\1\
(4) Do not use in conjunction with organophosphates and/or procaine
hydrochloride, because phenothiazines
[[Page 309]]
may potentitate the toxicity of organophosphates and the activity of
procaine hydrochloride.\1\
(5) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.\1\
[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985]
Sec. 522.2610 Trimethoprim and sulfadiazine sterile suspension.
(a)(1) Specifications. Each milliliter of sterile aqueous suspension
contains 240 milligrams (40 milligrams of trimethoprim and 200
milligrams of sulfadiazine).
(2) Sponsor. See 000856 and 011716 in Sec. 510.600(c) of this
chapter.
(3) Conditions of use--(i) Dosage. One milliliter (40 milligrams of
trimethoprim and 200 milligrams of sulfadiazine) per 20 pounds (9
kilograms) of body weight per day.
(ii) Indications. For dogs for treatment of acute urinary tract
infections, acute bacterial complications of distemper, acute
respiratory tract infections, acute alimentary tract infections, and
acute septicemia due to Streptococcus zooepidemicus.
(iii) Limitations. For subcutaneous use in dogs only; administer
once every 24 hours, or for severe infections, after an initial dose,
administer half the normal daily dose every 12 hours; continue therapy 2
to 3 days after clinical signs of infection have subsided; if no
improvement is seen in 3 to 5 days, reevaluate diagnosis; injection may
be used alone or in conjunction with oral dosing; not recommended for
use for more than 14 days; a complete blood count should be done for
prolonged use; Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(b)(1) Specifications. Each milliliter of sterile aqueous suspension
contains 480 milligrams (80 milligrams of trimethoprim and 400
milligrams of sulfadiazine (as the sodium salt)).
(2) Sponsor. See 000856 and 017220 in Sec. 510.600(c) of this
chapter.
(3) Conditions of use--(i) Dosage. Two milliliters (160 milligrams
of trimethoprim and 800 milligrams of sulfadiazine) per 100 pounds (45
kilograms) of body weight per day.
(ii) Indications. For horses where systemic anti-bacterial action
against sensitive organisms is required during treatment of acute
strangles, respiratory tract infections, acute urogenital infections,
and wound infections and abscesses.
(iii) Limitations. For intravenous use; administer as single, daily
dose for 5 to 7 days; daily dose may also be halved and given morning
and evening; continue acute infection therapy 2 to 3 days after clinical
signs have subsided; if no improvement of acute infections is seen in 3
to 5 days, reevaluate diagnosis; a complete blood count should be done
periodically for prolonged use; not for use in horses intended for food;
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[48 FR 241, Jan. 4, 1983, as amended at 48 FR 23180, May 24, 1983; 48 FR
42809, Sept. 20, 1983; 61 FR 5507, Feb. 13, 1996; 61 FR 8873, Mar. 6,
1996]
Sec. 522.2615 Tripelennamine hydrochloride injection.
(a) Specifications. Each milliliter of aqueous solution contains 20
milligrams of tripelennamine hydrochloride.
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount--(i) Dogs, cats, and horses. For
intramuscular use only at a dose of 0.5 milligram per pound of body
weight.
(ii) Cattle. Administer intravenously or intramuscularly at a dose
of 0.5 milligram per pound of body weight.
(2) Indications for use. For use in treating conditions in which
antihistaminic therapy may be expected to lead to alleviation of some
signs of disease.
(3) Limitations. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(d) NAS/NRC status. These conditions are NAS/NRC reviewed and deemed
effective. Applications for these uses need not include effectiveness
data as specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety data.
[51 FR 44450, Dec. 10, 1986]
[[Page 310]]
Sec. 522.2640 Tylosin injectable dosage forms.
Sec. 522.2640a Tylosin injection.
(a) Specifications. Each milliliter of sterile solution of 50
percent propylene glycol with 4 percent benzyl alcohol contains 50 to
200 milligrams of tylosin activity (as tylosin base). Tylosin conforms
to the appropriate antibiotic standard. Tylosin contains at least 95
percent tylosin as a combination of tylosin A, tylosin B, tylosin C, and
tylosin D of which at least 80 percent is tylosin A as determined by a
method entitled ``Determination of Factor Content in Tylosin by High
Performance Liquid Chromatography,'' which is incorporated by reference.
Copies are available from the Dockets Management Branch (HFA-305), Food
and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD
20857, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20001.
(b) Sponsors. (1) See No. 000986 in Sec. 510.600(c) of this chapter
for use in paragraphs (e)(1), (2), and (3) of this section.
(2) See No. 054273 in Sec. 510.600(c) of this chapter for use as in
paragraphs (e)(1) and (2) of this section.
(c) NAS/NRC status. These conditions of use are NAS/NRC reviewed and
found effective. NADA's for these uses need not include effectiveness
data as specified by Sec. 514.111 of this chapter but may require
bioequivalency and safety information.
(d) Related tolerances. See Sec. 556.740 of this chapter.
(e) Conditions of use--(1) Beef cattle and nonlactating dairy
cattle--(i) Amount. 8 milligrams per pound of body weight once daily.
(ii) Indications for use. Treatment of bovine respiratory complex
(shipping fever, pneumonia) usually associated with Pasteurella
multocida and Corynebacterium pyogenes; foot rot (necrotic
pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum
and metritis caused by Corynebacterium pyogenes.
(iii) Limitations. Administer intramuscularly for not more than 5
consecutive days. Continue treatment 24 hours after symptoms disappear.
Do not inject more than 10 milliliters per site. Do not use in lactating
dairy cattle. Use a 50-milligram-per-milliliter solution for calves
weighing less than 200 pounds. Do not administer within 21 days of
slaughter.
(2) Swine--(i) Amount. 4 milligrams per pound of body weight twice
daily.
(ii) Indications for use. Treatment of swine arthritis caused by
Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.;
swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery
associated with Treponema hyodysenteriae when followed by appropriate
medication in the drinking water and/or feed.
(iii) Limitations. Administer intramuscularly for not more than 3
consecutive days. Continue treatment 24 hours after symptoms disappear.
Do not inject more than 5 milliliters per site. Do not administer within
14 days of slaughter. If tylosin medicated drinking water is used as
followup treatment for swine dysentery, the animal should thereafter
receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks
to assure depletion of tissue residues.
(3) Dogs and cats--(i) Amount. 3 to 5 milligrams per pound of body
weight at 12- to 24-hour intervals.
(ii) Indications for use--(a) Dogs. Treatment of upper respiratory
infections such as bronchitis, tracheobronchitis, tracheitis,
laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp.,
hemolytic Streptococci spp., and Pasteurella multocida.
(b) Cats. Treatment of upper respiratory infections when caused by
Staphylococci spp. and hemolytic Streptococci spp. and for feline
pneumonitis when caused by tylosin susceptible organisms.
(iii) Limitations. For intramuscular use only. If there is no
response to therapy in 5 days, diagnosis and treatment should be
reassessed. Use a 50-milligram-per-milliliter solution only. Dogs and
cats receiving a dose of less than 50 milligrams (1 milliliter) should
be dosed with a tuberculin syringe. Federal law restricts this drug to
use
[[Page 311]]
by or on the order of a licensed veterinarian.
[46 FR 48643, Oct. 2, 1981, as amended at 47 FR 9398, Mar. 5, 1982; 50
FR 49841, Dec. 5, 1985; 50 FR 50292, Dec. 10, 1985; 53 FR 40728, Oct.
18, 1988; 59 FR 14365, Mar. 28, 1994]
Sec. 522.2640b Tylosin tartrate for injection.
(a) Specifications. The drug is a sterile powder containing a
mixture of tylosin tartrate and sodium citrate which is reconstituted to
provide 25 milligrams of tylosin activity per milliliter. Tylosin as the
tartrate salt, conforms to the appropriate antibiotic standard. Tylosin
contains at least 95 percent tylosin as a combination of tylosin A,
tylosin B, tylosin C, and tylosin D of which at least 80 percent is
tylosin A as determined by a method entitled ``Determination of Factor
Content in Tylosin by High Performance Liquid Chromatography,'' which is
incorporated by reference. Copies are available from the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, or available for inspection at
the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20001.
(b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.740 of this chapter.
(d) Conditions of use--(1) Chickens--(i) Amount. 25 milligrams per 2
pounds of body weight.
(ii) Indications for use. As an aid in the control and treatment of
chronic respiratory disease caused by Mycoplasma gallisepticum sensitive
to tylosin.
(iii) Limitations. Not for use in laying chickens producing eggs for
human consumption; inject under the loose skin of the neck behind the
head; if no improvement is noted within 5 days, diagnosis should be
reevaluated; do not treat within 3 days of slaughter.
(2) Turkeys--(i) Amount. 6.25 to 12.5 milligrams per sinus.
(ii) Indications for use. As an aid in the control and treatment of
infectious sinusitis caused by Mycoplasma gallisepticum sensitive to
tylosin.
(iii) Limitations. Do not use in laying turkeys producing eggs for
human consumption; inject 6.25 milligrams to 12.5 milligrams per sinus
depending on severity of condition; treatment may be repeated in 10 days
if the swelling persists; do not treat within 5 days of slaughter; may
be used in conjunction with tylosin in drinking water as indicated in
Sec. 520.2640(e)(2) of this chapter.
[46 FR 48643, Oct. 2, 1981, as amended at 50 FR 49841, Dec. 5, 1985; 50
FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, 1994]
Sec. 522.2662 Xylazine hydrochloride injection.
(a) Specifications. Xylazine hydrochloride injection is a sterile
aqueous solution containing xylazine hydrochloride equivalent to 100
milligrams of xylazine in each milliliter of solution when intended for
use in horses, wild deer, and elk, and 20 milligrams of xylazine per
milliliter of solution when intended for use in dogs and cats.
(b) Sponsor. See No. 000856 and 061651 in Sec. 510.600(c) of this
chapter for use as horses, wild deer, and elk. See No. 000859 in
Sec. 510.600(c) of this chapter for use in horses, wild deer, elk, dogs,
and cats. See 061690 in Sec. 510.600(c) of this chapter for use in
horses, wild deer, elk, dogs, and cats. See 054273 in Sec. 510.600(c) of
this chapter for use in horses only.
(c) Conditions of use. (1) The drug is used in horses, wild deer,
elk, dogs, and cats to produce sedation, as an analgesic, and a
preanesthetic to local anesthesia. It may also be used in horses, dogs,
and cats as a preanesthetic to general anesthesia.
(2) It is administered as follows:
(i) To horses from a solution containing 100 milligrams of xylazine
per milliliter, intravenously at 0.5 milligram per pound of body weight,
or intramuscularly at 1.0 milligram per pound of body weight.
(ii) To dogs and cats from a solution containing 20 milligrams of
xylazine per milliliter; intravenously at 0.5 milligram per pound of
body weight or intramuscularly or subcutaneously at 1.0 milligram per
pound of body weight. In dogs over 50 pounds, a dosage of 0.5 mg. per
pound administered intramuscularly may provide sufficient sedation and/
or analgesia for most procedures.
[[Page 312]]
(iii) To wild deer and elk from a solution containing 100 milligrams
of xylazine (as xylazine hydrochloride) per milliliter, intramuscularly,
by hand syringe or syringe dart, in the heavy muscles of the croup or
shoulder as follows:
(a) Fallow deer, 2 to 4 milligrams per pound.
(b) Mule deer, sika deer, and whitedeer, 1 to 2 milligrams per
pound.
(c) Elk, 0.25 to 0.5 milligram per pound.
(3) Not to be administered to food-producing animals.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 24884, June 21, 1976;
41 FR 28265, July 9, 1976; 53 FR 4848, Feb. 18, 1988; 53 FR 23608, June
23, 1988; 53 FR 40728, Oct. 18, 1988; 55 FR 18724, May 4, 1990; 55 FR
32616, Aug. 10, 1990; 59 FR 14367, Mar. 28, 1994; 60 FR 33110, June 27,
1995; 60 FR 35122 and 35123, July 6, 1995]
Sec. 522.2670 Yohimbine injectable.
(a) Specifications. Each milliliter of sterile aqueous solution
contains either 2 or 5 milligrams of yohimbine (as hydrochloride).
(b) Sponsor. See 061690 in Sec. 510.600(c) of this chapter for use
of 2 milligrams per milliliter solution in dogs.
(1) Amount. 0.05 milligram per pound (0.11 milligram per kilogram)
of body weight.
(2) Indications for use. To reverse the effects of xylazine in dogs.
(3) Limitations. For intravenous use in dogs only. Not for use in
food-producing animals. Safety of use in pregnant dogs or in dogs
intended for breeding has not been established. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(c) Sponsor. See 053923 in Sec. 510.600(c) of this chapter for use
of 5 milligrams per milliliter solution in deer and elk.
(1) Amount. 0.2 to 0.3 milligram per kilogram of body weight.
(2) Indications for use. As an antagonist to xylazine sedation in
free ranging or confined members of the family Cervidae (deer and elk).
(3) Limitations. For intravenous use only. Do not use in domestic
food-producing animals. Do not use for 30 days before or during hunting
season. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[58 FR 8543, Feb. 16, 1993; as amended at 60 FR 57832, Nov. 22, 1995]
Sec. 522.2680 Zeranol.
(a) Specifications. Each pellet contains 12 milligrams of zeranol.
(b) Sponsor. See 011716 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.760 of this chapter.
(d) Conditions of use. For use as a subcutaneous ear implant as
follows:
(1) Beef cattle--(i) Amount. 36 milligrams (three 12-milligram
pellets) per animal.
(ii) Indications for use--(A) For increased rate of weight gain and
improved feed conversion in weaned beef calves, growing beef cattle,
feedlot steers, and feedlot heifers.
(B) For increased rate of weight gain in suckling calves.
(iii) Limitations. Implant subcutaneously in ear only. Do not use in
bulls intended for reproduction or in dairy animals. Do not use before 1
month of age or after weaning in heifers intended for reproduction.
(2) Feedlot lambs--(i) Amount. 12 milligrams (1 pellet) per animal.
(ii) Indications for use. For increased rate of weight gain and
improved feed conversion.
(iii) Limitations. Implant subcutaneously in ear only. Do not use in
breeding animals. Do not implant animals within 40 days of slaughter.
(3) Steers--(i) Amount. 72 milligrams (six 12-milligram pellets)
per animal.
(ii) Indications for use. For increased rate of weight gain in
steers fed in confinement for slaughter.
(iii) Limitations. Implant subcutaneously in ear only.
[59 FR 19639, Apr. 25, 1994; 60 FR 26360, May 17, 1995]