21 C.F.R. § 522.1338

Current through October 31, 2024
Section 522.1338 - Medetomidine and vatinoxan
(a)Specifications. Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride.
(b)Sponsor. See No. 043264 in § 510.600(c) of this chapter.
(c)Conditions of use -
(1)Amount. Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m2) BSA or use the dosing table provided in labeling.
(2)Indications for use. For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §522.1338

87 FR 58962 , Sept. 29, 2022, as amended at 87 FR 76421 , Dec. 14, 2022
87 FR 58962, 9/29/2022; as amended at 87 FR 76421, 12/14/2022