21 C.F.R. § 522.1698   Pentazocine lactate 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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§ 522.1698   Pentazocine lactate injection.

(a) Specifications. Each milliliter of sterile aqueous solution contains pentazocine lactate equivalent to 30 milligrams of pentazocine base.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Horses—(i) Amount. 0.15 milligram of pentazocine base per pound of body weight per day.

(ii) Indications for use. For symptomatic relief of pain due to colic.

(iii) Limitations. Administer intravenously or intramuscularly. Intravenous injections are given slowly in the jugular vein. In cases of severe pain, a second dose is recommended intramuscularly 10 to 15 minutes after the initial dose at the same level. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Dogs—(i) Amount. 0.75 to 1.50 milligrams of pentazocine base per pound of body weight.

(ii) Indications for use. For amelioration of pain accompanying postoperative recovery, fracture, trauma, and spinal disorders.

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

[42 FR 31450, June 21, 1977, as amended at 42 FR 36995, July 19, 1977; 47 FR 5409, Feb. 5, 1982; 55 FR 23076, June 6, 1990]

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