CFR

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. 000061 in § 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

Code of Federal Regulations

Footnote(s): 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.

(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

Code of Federal Regulations

[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]

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