subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.558"
section_subject: "Dexmedetomidine."
cfr_reference: "21 CFR 522.558"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. Each milliliter of solution contains:
(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.