21 C.F.R. § 522.224

Current through October 31, 2024
Section 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.

21 C.F.R. §522.224

81 FR 67151 , Sept. 30, 2016, as amended at 84 FR 8973 , Mar. 13, 2019; 85 FR 4208 , Jan. 24, 2020
81 FR 67151, 9/30/2016; as amended at 84 FR 8973, 3/13/2019; 85 FR 4208, 1/24/2020