21 C.F.R. § 529.1044a Gentamicin sulfate intrauterine solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of the drug contains 50 or 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution. (b) Sponsor. See Nos. 000010, 000061, 000856, 057561, 059130, and 061623 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin. (2) It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus. (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. (4) Not for use in horses intended for food. [40 FR 13881, Mar. 27, 1975, as amended at 40 FR 48676, Oct. 17, 1975; 48 FR 31386, July 8, 1983; 52 FR 7833, Mar. 13, 1987; 58 FR 14314, Mar. 17, 1993; 59 FR 31140, June 17, 1994; 60 FR 45042, Aug. 30, 1995; 60 FR 48894, Sept. 21, 1995; 61 FR 17830, Apr. 23, 1996; 62 FR 611, Jan. 6, 1997; 62 FR 35077, June 30, 1997; 63 FR 6644, Feb. 10, 1998; 68 FR 59881, Oct. 20, 2003]
Title 21: Food and Drugs
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
§ 529.1044a Gentamicin sulfate intrauterine solution.
