(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.