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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter EPart 522 → §522.2470


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


§522.2470   Tiletamine and zolazepam for injection.

(a) Specifications. The drug is a sterile powder. Each milliliter of constituted solution contains tiletamine hydrochloride equivalent to 50 milligrams (mg) of tiletamine base and zolazepam hydrochloride equivalent to 50 mg of zolazepam base.

(b) Sponsors. See sponsors in §510.600(c) of this chapter:

(1) No. 054771 for use as in paragraph (c) of this section.

(2) Nos. 026637 and 051311 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii) and (c)(2) of this section.

(c) Conditions of use—(1) Dogs—(i) Amount. Expressed as milligrams of the drug combination:

(A) An initial intramuscular dosage of 3 to 4.5 milligrams per pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of body weight for minor procedures of short duration such as repair of lacerations and wounds, castrations, and other procedures requiring mild to moderate analgesia. Supplemental doses when required should be less than the initial dose and the total dose given should not exceed 12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of body weight.

(B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg) body weight to effect for induction of anesthesia followed by maintenance with an inhalant anesthetic.

(ii) Indications for use. (A) Intramuscular administration in dogs for restraint and minor procedures of short duration (30 minutes average) requiring mild to moderate analgesia.

(B) Intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. An initial intramuscular dosage of 4.4 to 5.4 mg/lb of body weight is recommended for such procedures as dentistry, treatment of abscesses, foreign body removal, and related types of surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring mild to moderate analgesia, such as repair of lacerations, castrations, and other procedures of short duration. Initial dosages of 6.5 to 7.2 mg/lb of body weight are recommended for ovariohysterectomy and onychectomy. When supplemental doses are required, such individual supplemental doses should be given in increments that are less than the initial dose and the total dose given (initial dose plus supplemental doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb of body weight.

(ii) Indications for use. For restraint or for anesthesia combined with muscle relaxation.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16197, Mar. 25, 2014, as amended at 83 FR 14587, Apr. 5, 2018]

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