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21 C.F.R. § 522.1503   Neostigmine methylsulfate 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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§ 522.1503   Neostigmine methylsulfate injection.

(a) Specifications. Neostigmine methylsulfate injection contains two milligrams of neostigmine methylsulfate in each milliliter of sterile aqueous solution.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is intended for use for treating rumen atony; initiating peristalsis which causes evacuation of the bowel; emptying the urinary bladder; and stimulating skeletal muscle contractions. It is a curare antagonist.

(2) It is administered to cattle and horses at a dosage level of 1 milligram per 100 pounds of body weight subcutaneously. It is administered to sheep at a dosage level of 1 to 11/2 milligrams per 100 pounds body weight subcutaneously. It is administered to swine at a dosage level of 2 to 3 milligrams per 100 pounds body weight intramuscularly. These doses may be repeated as indicated.

(3) The drug is contraindicated in mechanical, intestinal or urinary obstruction, late pregnancy, and in animals treated with other cholinesterase inhibitors.

(4) Not for use in animals producing milk, since this use will result in contamination of the milk.

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

[40 FR 13858, Mar. 27, 1975, as amended at 62 FR 61625, Nov. 19, 1997]

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