21 CFR § 522.1155 - Imidocarb powder for injection.

§ 522.1155 Imidocarb powder for injection.

(a) Specifications. The product is a sterile powder containing imidocarb dipropionate. Each milliliter of constituted solution contains 100 milligrams (mg) of imidocarb base.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Special considerations. Imidocarb dipropionate is sold only under permit issued by the Director of the National Program Planning Staff, Veterinary Services, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, to licensed or full-time State, Federal, or military veterinarians.

(d) Conditions of use in horses and zebras -

(1) Amount. For Babesia caballi infections, administer 2 mg of imidocarb base per kilogram of body weight by intramuscular injection in the neck region, repeating dosage once after 24 hours. For Babesia equi infections, administer 4 mg of imidocarb base per kilogram of body weight by intramuscular injection in the neck region, repeating dosage four times at 72-hour intervals.

(2) Indications for use. For the treatment of babesiosis (piroplasmosis) caused by Babesia caballi and Babesia equi.

(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.

[79 FR 16190, Mar. 25, 2014]

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