Title 21

SECTION 522.224

522.224 Bupivacaine.

§ 522.224 Bupivacaine.

(a) Specifications. Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine.

(b) Sponsor. See No. 058198 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.

[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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