§ 522.1338 Medetomidine and vatinoxan.
Primary source
Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
(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]
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