21 C.F.R. § 522.1462   Naloxone 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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§ 522.1462   Naloxone hydrochloride injection.

(a) Specifications. Naloxone hydrochloride injection is an aqueous sterile solution containing 0.4 milligram of naloxone hydrochloride per milliliter.

(b) Sponsor. See No. 060951 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used as a narcotic antagonist in dogs.

(2) It is administered by intravenous, intramuscular, or subcutaneous injection at an initial dose of 0.04 milligram per kilogram of body weight. When given intravenously, the dosage may be repeated at 2- to 3-minute intervals as necessary. Onset of action by intramuscular or subcutaneous injection is slightly longer than it is by intravenous injection, and repeated dosages must be administered accordingly.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 47 FR 20757, May 14, 1982; 54 FR 32632, Aug. 9, 1989; 63 FR 7701, Feb. 17, 1998]

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