21 C.F.R. § 522.536 Detomidine hydrochloride injection.
Title 21 - Food and Drugs
(a) Specification. Each milliliter of sterile aqueous solution contains 10 milligrams of detomidine hydrochloride. (b) Sponsor. See 052483 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount. For sedation, analgesia, or sedation and analgesia: 20 or 40 micrograms per kilogram (0.2 or 0.4 milliliter per 100 kilogram or 220 pounds) by body weight, depending on depth and duration required. (2) Indication for use. As a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings. (3) Limitations. For sedation administer intraveneously (IV) or intramuscularly (IM); for analgesia by IV; for both sedation and analgesia by IV. Do not use in horses with pre-existing atrioventricular or sinoauricular block, with severe coronary insufficiency, cerebrovascular disease, respiratory disease, or chronic renal failure. Do not use in breeding animals. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [54 FR 50365, Dec. 6, 1989; 54 FR 51551, Dec. 15, 1989]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.536 Detomidine hydrochloride injection.
