Food and Drug Administration, HHS § 522.1244

(4) Restricted to use by or on the (c) Sponsor. See Code No. 000856 in order of a licensed veterinarian. § 510.600(c) of this chapter. [40 FR 13858, Mar. 27, 1975, as amended at 53 (d) Special considerations. Store in a FR 27851, July 25, 1988; 64 FR 403, Jan. 5, 1999] cool place. Protect from light. Do not use if precipitate appears. § 522.1222 hydrochloride (e) Conditions of use. (1) It is used in injectable dosage forms. cats as the sole anesthetic agent for ovariohysterectomy and general sur- § 522.1222a Ketamine. gery. (a) Specifications. Each milliliter con- (2) It is administered tains ketamine hydrochloride equiva- intramuscularly at a recommended lent to 100 milligrams (mg) ketamine dose from 15 to 20 milligrams ketamine base activity. base per pound of body weight, depend- (b) Sponsors. See Nos. 000010, 059130, ing on the effect desired. 061690, 026637, and 063286 in § 510.600(c) of (3) Federal law restricts this drug to this chapter. use by or on the order of a licensed vet- (c) Special considerations. Federal law erinarian. restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 59342, Dec. 23, 1975, as amended at 42 (d) Conditions of use—(1) Cats—(i) FR 3838, Jan. 21, 1977; 53 FR 27851, July 25, Amount. 5 to 15 mg/pound body weight 1988] intramuscularly, depending on the ef- § 522.1225 Ketoprofen solution. fect desired. (ii) Indications for use. For restraint (a) Specifications. Each milliliter of or as the sole anesthetic agent in diag- sterile aqueous solution contains 100 nostic or minor, brief surgical proce- milligrams of ketoprofen. dures that do not require skeletal mus- (b) Sponsor. See 000856 in 21 CFR cle relaxation. 510.600(c) of this chapter. (2) Subhuman primates—(i) Amount. 3 (c) Conditions of use in horses—(1) to 15 mg/kilogram body weight Amount. 1.0 milligram per pound of intramuscularly, depending upon the body weight once daily for up to 5 days. species, general condition, and age of (2) Indications for use. For alleviation the subject. of inflammation and pain associated (ii) Indications for use. For restraint. with musculoskeletal disorders in [67 FR 17283, Apr. 10, 2002, as amended at 73 horses. FR 8192, Feb. 13, 2008; 74 FR 36111, July 22, (3) Limitations. For intravenous use 2009; 74 FR 66573, Dec. 16, 2009; 75 FR 10167, only. Do not use in breeding animals. Mar. 5, 2010] Effects on fertility, , or fetal health have not been determined. Not § 522.1222b Ketamine hydrochloride for use in horses intended for food. Fed- with hydrochloride and eral law restricts this drug to use by or aminopentamide hydrogen sulfate injection. on the order of a licensed veterinarian. (a) Chemical name. Ketamine hydro- [55 FR 40653, Oct. 4, 1990] chloride, (±),-2-(o-chlorophenyl)-2- (methylamino) cyclohexanone hydro- § 522.1228 [Reserved] chloride, with promazine hydro- chloride, 10-[3-(dimethylamino) propyl] § 522.1244 phosphate injec- tion. monohydrochloride, and aminopentamide hydrogen sulfate. (a) Specifications. Each milliliter of (b) Specifications. The drug is a sterile sterile aqueous solution contains aqueous solution and each milliliter levamisole phosphate equivalent to contains: Ketamine hydrochloride 136.5 or 182 milligrams of levamisole equivalent to 100 milligrams ketamine hydrochloride (13.65 or 18.2 percent). base activity, 7.5 milligrams of (b) Sponsor. See Nos. 000061 and 057561 promazine hydrochloride, and 0.0625 in § 510.600 of this chapter for use of milligram of aminopentamide hydro- 13.65 percent injection, and see No. gen sulfate, with 1:10,000 benzethonium 053501 for use of 13.65 and 18.2 percent chloride. injection.

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