§ 522.558 - Dexmedetomidine.

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Specifications. Each milliliter of solution contains:

0.1 milligrams (mg) dexmedetomidine hydrochloride; or

0.5 mg dexmedetomidine hydrochloride.

Sponsors. See sponsors in in § 510.600(c) of this chapter for use as in paragraph (c) of this section:

No. 026637 for use of product described in paragraph (a)(2) of this section;

No. 052483 for use of products described in paragraph (a) of this section.

Conditions of use—(1) Dogs—(i) Indications for use and amount. (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 (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.

For use as a preanesthetic to general anesthesia, administer 125 µg/m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection.

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

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

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.

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