21 C.F.R. § 529.50 Amikacin sulfate intrauterine solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of sterile aqueous solution contains 250 milligrams of amikacin (as the sulfate). (b) Sponsor. See No. 000856 and 059130 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Two grams (8 milliliters) diluted with 200 milliliters of sterile physiological saline per day for 3 consecutive days. (2) Indications for use. For treating genital tract infections (endometritis, metritis, and pyometra) in mares when caused by susceptible organisms including E. coli, Pseudomonas spp., and Klebsiella spp. (3) Limitations. For intrauterine infusion in the horse only. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [48 FR 9640, Mar. 8, 1983, as amended at 53 FR 27852, July 25, 1988; 62 FR 15110, Mar. 31, 1997; 62 FR 23358, Apr. 30, 1997]
Title 21: Food and Drugs
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
§ 529.50 Amikacin sulfate intrauterine solution.
