21 C.F.R. § 522.1820   Pituitary luteinizing hormone for 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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§ 522.1820   Pituitary luteinizing hormone for injection.

(a) Specifications. The drug is a lyophilized pituitary extract. Each 6-milliliter vial contains an amount equivalent to 25 milligrams of standard pituitary luteinizing hormone and is reconstituted for use by addition of 5 milliliters of 0.9 percent aqueous sodium chloride solution.

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

(c) Conditions of use. (1) The drug is an aid in the treatment of breeding disorders related to pituitary hypofunction in cattle, horses, swine, sheep, and dogs.

(2) Preferably given by intravenous injection, it may be administered subcutaneously; dosage is as follows: Cattle and horses, 25 mg; swine, 5 mg; sheep, 2.5 mg, and dogs, 1.0 mg. Treatment may be repeated in 1 to 4 weeks, or as indicated.

(3) 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 52 FR 7832, Mar. 13, 1987]

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