CFR

522.558—Dexmedetomidine.

(a) Specifications. Each milliliter of solution contains 0.5 milligram (mg) of dexmedetomidine hydrochloride.

(b) Sponsor. See No. 052483 in § 510.600(c) of this chapter.

(c) Conditions of use— (1) Dogs— (A) For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (µg) per square meter (/m 2) of body surface area by intravenous injection or 500 µg/m 2 of body surface area by intramuscular injection.

(B) For use as a preanesthetic to general anesthesia, administer 125 µg/m 2 of body surface area or 375 µg/m 2 of body surface area by intramuscular injection.

(ii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats— (i) Amount. 40 µg/killogram by intramuscular injection.

(ii) Indications for use. For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[72 FR 263, Jan. 4, 2007, as amended at 72 FR 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; 75 FR 60308, Sept. 30, 2010]

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