§522.224. Bupivacaine.
21 C.F.R. § 522.224
Specifications. Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine.
Sponsor. See No. 058198 in § 510.600(c) of this chapter.
Conditions of use—
Dogs—
Amount. 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. For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery.
Cats—
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.
Indications for use. For use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy.
Notes, amendments, and revision history
Amendments
[81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 4208, Jan. 24, 2020]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
Amendments
[81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 4208, Jan. 24, 2020]