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: "522.224"
section_subject: "Bupivacaine."
cfr_reference: "21 CFR 522.224"
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 (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine.
(b)Sponsor. See No. 086026 in § 510.600(c) of this chapter.
(c)Conditions of use—(1) Dogs—(i) Amount. Administer 5.3 mg/kg (0.4 mL/kg) by infiltration injection into the tissue layers at the time of incisional closure.
(ii)Indications for use. For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery.
(2)Cats—(i) Amount. Administer 5.3 mg/kg per forelimb (0.4 mL/kg per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve block prior to onychectomy.
(ii)Indications for use. For use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy.