21 C.F.R. § 522.1465   Naltrexone hydrochloride injection.


Title 21 - Food and Drugs


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

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§ 522.1465   Naltrexone hydrochloride injection.

(a) Specifications. Each milliliter of sterile aqueous solution contains 50 milligrams of naltrexone hydrochloride.

(b) Sponsor. See 053923 in §510.600(c) of this chapter.

(c) Conditions of use in elk and moose—(1) Amount. 100 milligrams of naltrexone hydrochloride for each milligram of carfentanil citrate administered. One-quarter of the dose should be administered intravenously and three-quarters of the dose should be administered subcutaneously.

(2) Indications for use. As an antagonist to carfentanil citrate immobilization in free-ranging or confined elk and moose (Cervidae).

(3) Limitations. Available data are inadequate to recommend use in pregnant animals. Avoid using during breeding season. Do not use in domestic food-producing animals. Do not use in free-ranging animals for 45 days before or during hunting season. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[62 FR 5320, Feb. 5, 1997]

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