Electronic Code of Federal Regulations

Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

§522.224   Bupivacaine.

(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.

[81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8973, Mar. 13, 2019]