§522.1338. Medetomidine and vatinoxan.
21 C.F.R. § 522.1338
Specifications. Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride.
Sponsor. See No. 043264 in § 510.600(c) of this chapter.
Conditions of use—
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.
Indications for use. For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[87 FR 58962, Sept. 29, 2022, as amended at 87 FR 76421, Dec. 14, 2022]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
Amendments
[87 FR 58962, Sept. 29, 2022, as amended at 87 FR 76421, Dec. 14, 2022]