21 C.F.R. § 522.690 Dinoprost solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter (mL) of solution contains dinoprost tromethamine equivalent to 5 milligrams (mg) dinoprost. (b) Sponsors. See Nos. 000009 and 059130 in §510.600(c) of this chapter. (c) Special considerations. (1) Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. (d) Conditions of use—(1) Horses—(i) Amount. 1 mg per 100 pounds of body weight as a single intramuscular injection. (ii) Indications. For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum. (iii) Limitations. Not for use in horses intended for food. (2) Cattle—(i) Beef cattle and nonlactating dairy heifers—(A) Amount. 25 mg as an intramuscular injection either once or twice at a 10- to 12-day interval. (B) Indications. For its luteolytic effect to control timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. (ii) Beef cattle and nonlactating dairy heifers—(A) Amount. 25 mg as a single intramuscular injection. (B) Indications. For treatment of pyometra (chronic endometritis). (iii) Nonlactating cattle—(A) Amount. 25 mg as a single intramuscular injection during the first 100 days of gestation. (B) Indications. For its abortifacient effect in nonlactating cattle. (iv) Lactating dairy cattle—(A) Amount. 25 mg as a single intramuscular injection. (B) Indications. For treatment of unobserved (silent) estrus in lactating dairy cattle that have a corpus luteum. (v) Dinoprost solution as provided by No. 000009 in §510.600(c) of this chapter may be used concurrently with progesterone intravaginal inserts as in §529.1940 of this chapter. (3) Swine—(i) Amount. 10 mg as a single intramuscular injection. (ii) Indications. For parturition induction in swine when injected within 3 days of normal predicted farrowing. [67 FR 41824, June 20, 2002]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.690 Dinoprost solution.
