21 C.F.R. § 522.2076 Romifidine.
Title 21 - Food and Drugs
(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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for horses intended for human consumption. [69 FR 47363, Aug. 5, 2004]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.2076 Romifidine.
