21 CFR 522.1335 - Medetomidine.
(a)Specifications. Each milliliter of solution contains 1.0 milligrams of medetomidine hydrochloride.
(b)Sponsor. See Nos. 015914 and 052483 in § 510.600(c) of this chapter.
(c)Conditions of use -
(1)Amount. 750 micrograms intravenously (IV) or 1,000 micrograms intramuscularly per square meter of body surface. The IV route is more efficacious for dental care.
(2)Indications for use. As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.