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.
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