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Title 21 → Chapter I → Subchapter E → Part 529 → §529.56

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Title 21: Food and Drugs
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

§529.56 Amikacin.

(a) Specifications. Each milliliter (mL) of solution contains 250 milligrams of amikacin as amikacin sulfate.

(b) Sponsors. See Nos. 000859 and 054771 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer 2 grams (8 mL) diluted with 200 mL of sterile physiological saline by intrauterine infusion daily for 3 consecutive days.

(2) Indications for use. For treating genital tract infections (endometritis, metritis, and pyometra) in mares caused by susceptible organisms including Escherichia coli, Pseudomonas spp., and Klebsiella spp.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[76 FR 17339, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 2014]

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