[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.536]

[Page 225]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 522.536  Detomidine hydrochloride injection.

    (a) Specification. Each milliliter of sterile aqueous solution 
contains 10 milligrams of detomidine hydrochloride.
    (b) Sponsor. See 052483 in Sec. 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]