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Food and Drug Administration, HHS § 522.52

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Food and Drug Administration, HHS § 522.52 Food and Drug Administration, HHS § 522.52 522.1660 Oxytetracycline injectable dosage 522.2473 Tiludronate. forms. 522.2474 Tolazoline. 522.1660a Oxytetracycline solution, 200 mil- 522.2476 Trenbolone acetate. ligrams/milliliter. 522.2477 Trenbolone acetate and estradiol. 522.1660b Oxytetracycline solution, 300 mil- 522.2478 Trenbolone acetate and estradiol ligrams/milliliter. benzoate. 522.1662 Oxytetracycline hydrochloride im- 522.2483 Triamcinolone. plantation or injectable dosage forms. 522.2582 Triflupromazine. 522.1662a Oxytetracycline hydrochloride in- 522.2610 Trimethoprim and sulfadiazine. jection. 522.2615 Tripelennamine. 522.1662b Oxytetracycline hydrochloride 522.2630 Tulathromycin. with lidocaine injection. 522.2640 Tylosin. 522.1662 Oxytetracycline and flunixin. 522.2662 Xylazine. 522.1680 Oxytocin. 522.2670 Yohimbine. 522.1684 Pegbovigrastim. 522.2680 Zeranol. 522.1696 Penicillin G procaine injectable 522.2690 Zinc gluconate. dosage forms. AUTHORITY: 21 U.S.C. 360b. 522.1696a Penicillin G benzathine and peni- cillin G procaine suspension. SOURCE: 40 FR 13858, Mar. 27, 1975, unless 522.1696b Penicillin G procaine aqueous sus- otherwise noted. pension. 522.1696c Penicillin G procaine in oil. § 522.23 Acepromazine. 522.1698 Pentazocine. (a) Specifications. Each milliliter of 522.1704 Pentobarbital. 522.1720 Phenylbutazone. solution contains 10 milligrams (mg) 522.1820 Pituitary luteinizing hormone pow- acepromazine maleate. der for injection. (b) Sponsors. See Nos. 000010 and 522.1850 Polysulfated glycosaminoglycan. 000859 in § 510.600(c) of this chapter: 522.1862 Pralidoxime powder for injection. (c) Conditions of use in dogs, cats, and 522.1870 Praziquantel. horses—(1) Amount. Dogs: 0.25 to 0.5 mg 522.1881 Prednisolone acetate. per pound (/lb) of body weight; Cats: 0.5 522.1883 Prednisolone sodium phosphate. to 1.0 mg/lb of body weight; Horses: 2.0 522.1884 Prednisolone sodium succinate. 522.1885 Prednisolone tertiary butylacetate. to 4.0 mg per 100 lbs of body weight. 522.1890 Sterile prednisone suspension. (2) Indications for use. For use as a 522.1920 Prochlorperazine and isopropamide. tranquilizer and as a preanesthetic 522.1940 Progesterone and estradiol ben- agent. zoate. (3) Limitations. Do not use in horses 522.1962 Promazine. intended for human consumption. Fed- 522.2002 Propiopromazine. eral law restricts this drug to use by or 522.2005 Propofol. 522.2012 Prostalene. on the order of a licensed veterinarian. 522.2063 Pyrilamine. [75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, 522.2075 Robenacoxib. 2013; 79 FR 16182, Mar. 25, 2014] 522.2076 Romifidine. 522.2100 Selenium and vitamin E. § 522.52 Alfaxalone. 522.2112 Sometribove zinc suspension. 522.2120 Spectinomycin dihydrochloride in- (a) Specifications. Each milliliter con- jection. tains 10 milligrams (mg) alfaxalone. 522.2121 Spectinomycin sulfate. (b) Sponsor. See No. 049480 in 522.2150 Stanozolol. § 510.600(c) of this chapter. 522.2200 Sulfachlorpyridazine. (c) Conditions of use in cats and dogs— 522.2220 Sulfadimethoxine. (1) Amount—(i) Cats—(A) Induction of 522.2240 Sulfaethoxypyridazine. general anesthesia. Administer by intra- 522.2260 Sulfamethazine. 522.2340 Sulfomyxin. venous injection over approximately 60 522.2404 Thialbarbitone sodium for injec- seconds or until clinical signs show the tion. onset of anesthesia, 2.2 to 9.7 mg/kilo- 522.2424 Thiamylal. gram (kg) for cats that did not receive 522.2444 Thiopental injectable dosage forms. a preanesthetic or 1.0 to 10.8 mg/kg for 522.2444a Thiopental powder for injection. cats that received a preanesthetic. 522.2444b Thiopental and pentobarbital pow- (B) Maintenance of general anesthesia der for injection. 522.2460 Tildipirosin. following induction. Administer an in- 522.2470 Tiletamine and zolazepam for injec- travenous bolus containing 1.1 to 1.3 tion. mg/kg to provide an additional 7 to 8 522.2471 Tilmicosin. minutes of anesthesia in 269 VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00279 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 522.56 21 CFR Ch. I (4–1–19 Edition) preanesthetized cats; a dose containing § 522.62 Aminopentamide. 1.4 to 1.5 mg/kg provides an additional (a) Specifications. Each milliliter of 3 to 5 minutes anesthesia in solution contains 0.5 milligram (mg) unpreanesthetized cats. aminopentamide hydrogen sulfate. (ii) Dogs—(A) Induction of general an- (b) Sponsor. See No. 054771 in esthesia. Administer by intravenous in- § 510.600(c) of this chapter. jection over approximately 60 seconds or until clinical signs show the onset of (c) Conditions of use in dogs and cats— anesthesia, 1.5 to 4.5 mg/kg for dogs (1) Amount. Administer by subcuta- that did not receive a preanesthetic or neous or intramuscular injection every 0.2 to 3.5 mg/kg for dogs that received 8 to 12 hours as follows: For animals a preanesthetic. weighing up to 10 pounds (lbs): 0.1 mg; (B) Maintenance of general anesthesia For animals weighing 11 to 20 lbs: 0.2 following induction. Administer an in- mg; For animals weighing 21 to 50 lbs: travenous bolus containing 1.2 to 1.4 0.3 mg; For animals weighing 51 to 100 mg/kg to provide an additional 6 to 8 lbs: 0.4 mg; For animals weighing over minutes of anesthesia in 100 lbs: 0.5 mg. Dosage may be gradu- preanesthetized dogs; a dose of 1.5 to ally increased up to a maximum of five 2.2 mg/kg provides an additional 6 to 8 times the suggested dosage. Following minutes of anesthesia in parenteral use, dosage may be contin- unpreanesthetized dogs. ued by oral administration of tablets. (2) Indications for use. For the induc- (2) Indications for use. For the treat- tion and maintenance of anesthesia ment of vomiting and/or diarrhea, nau- and for induction of anesthesia fol- sea, acute abdominal visceral spasm, lowed by maintenance with an inhalant pylorospasm, or hypertrophic gastritis. anesthetic, in dogs and cats. (3) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. Alfaxalone is a [79 FR 16183, Mar. 25, 2014] Class IV controlled substance. [77 FR 64717, Oct. 23, 2012, as amended at 79 § 522.82 Aminopropazine. FR 64116, Oct. 28, 2014] (a) Specifications. Each milliliter of solution contains aminopropazine fu- § 522.56 Amikacin. marate equivalent to 25 milligrams (a) Specifications. Each milliliter of (mg) aminopropazine base. solution contains 50 milligrams (mg) of (b) Sponsor. See No. 000061 in amikacin as amikacin sulfate. § 510.600(c) of this chapter. (b) Sponsor. See No. 069043 in (c) Conditions of use—(1) Dogs and § 510.600(c) of this chapter. cats—(i) Amount. 1 to 2 mg per pound of (c) Conditions of use in dogs—(1) body weight, repeated every 12 hours as Amount. 5 mg/pound (lb) of body weight indicated, by intramuscular or intra- twice daily by intramuscular or sub- venous injection. cutaneous injection. (ii) Indications for use. For reducing (2) Indications for use. For treatment excessive smooth muscle contractions, of genitourinary tract infections (cys- such as occur in urethral spasms asso- titis) caused by susceptible strains of ciated with urolithiasis. Escherichia coli and Proteus spp. and (iii) Limitations. Federal law restricts skin and soft tissue infections caused this drug to use by or on the order of a by susceptible strains of Pseudomonas licensed veterinarian. spp. and E. coli. (2) Horses—(i) Amount. Administer (3) Limitations. Do not use in horses 0.25 mg per pound of body weight, re- intended for human consumption. Fed- peated every 12 hours as indicated, by eral law restricts this drug to use by or intramuscular or intravenous injec- on the order of a licensed veterinarian. tion. [76 FR 17338, Mar. 29, 2011, as amended at 78 (ii) Indications for use. For reducing FR 17597, Mar. 22, 2013; 79 FR 16183, Mar. 25, excessive smooth muscle contractions, 2014; 81 FR 17608, Mar. 30, 2016] such as occur in colic spasms. 270 VerDate Sep<11>2014 15:32 May 15, 2019 Jkt 247075 PO 00000 Frm 00280 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB.
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