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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter EPart 522 → §522.2076


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


§522.2076   Romifidine.

(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) romifidine hydrochloride.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. 40 to 120 micrograms per kilogram of body weight (mcg/kg BW) intravenously for sedation and analgesia; 100 mcg/kg BW intravenously as a preanesthetic.

(2) Indications for use. For use as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedures, and minor surgical procedures in adult horses; and for use as a preanesthetic prior to the induction of general anesthesia in adult horses.

(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.

[69 FR 47363, Aug. 5, 2004, as amended at 79 FR 16195, Mar. 25, 2014]

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