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 (/m 2 ) 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. [87 FR 58962, Sept. 29, 2022, as amended at 87 FR 76421, Dec. 14, 2022]