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e-CFR data is current as of July 30, 2020

Title 21Chapter ISubchapter EPart 522 → §522.56


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.56   Amikacin.

(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of amikacin as amikacin sulfate.

(b) Sponsor. See No. 069043 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. 5 mg/pound (lb) of body weight twice daily by intramuscular or subcutaneous injection.

(2) Indications for use. For treatment of genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli and Proteus spp. and skin and soft tissue infections caused by susceptible strains of Pseudomonas spp. and E. coli.

(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 17338, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 16183, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016]

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