§ 522.224 Bupivacaine.
Primary source
Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
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Specifications.(a) Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of useDogsAmount.(c) —(1) —(i) Administer 5.3 mg/kg (0.4 mL/kg) by infiltration injection into the tissue layers at the time of incisional closure.
Indications for use.(ii) For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery.
CatsAmount.(2) —(i) 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.
Indications for use.(ii) For use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy.
[81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 4208, Jan. 24, 2020]
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