21 C.F.R. § 522.2424 Sodium thiamylal for injection.
Title 21 - Food and Drugs
(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 and 000856 in §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 §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; 62 FR 35076, June 30, 1997]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.2424 Sodium thiamylal for injection.
