21 C.F.R. § 522.147

Current through September 30, 2024
Section 522.147 - Atipamezole
(a)Specifications. Each milliliter of solution contains 5.0 milligrams atipamezole hydrochloride.
(b)Sponsors. See Nos. 015914, 052483, 068504, and 069043 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs -
(1)Amount. Administer 3,750 mcg/m2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.
(2)Indications for use. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §522.147

61 FR 48830, Sept. 17, 1996, as amended at 64 FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007; 84 FR 8973, Mar. 13, 2019; 88 FR 84700, Dec. 6, 2023; 89 FR 42357, May 15, 2024
84 FR 8973, 3/13/2019; 88 FR 84700, 12/6/2023; 89 FR 42357, 5/15/2024