CFR

522.1335—Medetomidine hydrochloride injection.

(a) Specifications. Each milliliter of sterile aqueous solution contains 1.0 milligram of medetomidine hydrochloride.

(b) Sponsor. See 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. Do not use in dogs with cardiac disease, respiratory disorders, liver or kidney diseases, dogs in shock, dogs which are severly debilitated, or dogs which are stressed due to extreme heat, cold, or fatigue. Allow agitated dogs to rest quietly before administration. Do not repeat dosing in dogs not responding satisfactorily to treatment. Do not use in breeding or pregnant animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[61 FR 21075, May 9, 1996]

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