(a) Specifications. Each milliliter (mL) of solution contains dinoprost tromethamine equivalent to 5 milligrams (mg) dinoprost.
(b) Sponsors. See Nos. 054771 and 059130 in Sec. 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.
(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.
(1) Horses--(i) Amount. 1 mg per 100 pounds of body weight as a single intramuscular injection.
(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. Do not use in horses intended for human consumption.
(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.
(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.
(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.
(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.
(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.
(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 injection as provided by No. 054771 in Sec. 510.600(c) of this chapter may also be used concurrently with gonadorelin hydrochloride injection as in Sec. 522.1077 and with progesterone intravaginal inserts as in Sec. 529.1940 of this chapter.
(3) Swine--(i) Amount. 10 mg as a single intramuscular injection.
(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, as amended at 79 FR 16187, Mar. 25, 2014; 79 FR 44278, July 31, 2014; 79 FR 64116, Oct. 28, 2014]