21 C.F.R. § 522.863 Ethylisobutrazine hydrochloride injection.
Title 21 - Food and Drugs
(a) Specifications. The drug is a sterile aqueous solution. Each milliliter contains 50 milligrams of ethylisobutrazine hydrochloride. (b) Sponsor. See No. 000061 in §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 §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; 62 FR 61625, Nov. 19, 1997]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.863 Ethylisobutrazine hydrochloride injection.
