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Code of Federal Regulations Title 21. Food and Drugs § 21.522.558 Dexmedetomidine

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Specifications. Each milliliter of solution contains:

(1) 0.1 milligrams (mg) dexmedetomidine hydrochloride;  or

(2) 0.5 mg dexmedetomidine hydrochloride.

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

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

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

(c) 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.

(B) 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.

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.522.558 Dexmedetomidine - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-522-558/

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