21 CFR § 522.460 - Cloprostenol.
(a) Specifications. Each milliliter of solution contains cloprostenol sodium equivalent to:
(1) 125 micrograms (µg) of cloprostenol; or
(2) 250 µg of cloprostenol.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter.
(1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) of this section.
(2) No. 000061 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (viii) and (c)(2) of this section.
(3) No. 068504 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (vii), (c)(1)(ix), and (c)(2) of this section.
(c) Conditions of use in cattle—(1) Amount and indications for use.
(i) Administer 375 µg by intramuscular injection to induce abortion in pregnant feedlot heifers from 1 week after mating until 4 1/2 months of gestation.
(ii) Administer 500 µg by intramuscular injection for unobserved or non-detected estrus in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(iii) Administer 500 µg by intramuscular injection for treatment of pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(iv) Administer 500 µg by intramuscular injection for treatment of mummified fetus in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(v) Administer 500 µg by intramuscular injection for treatment of luteal cysts in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(vi) Administer 500 µg by intramuscular injection for abortion of beef cows, lactating dairy cows, and replacement beef and dairy heifers from 1 week after mating until 5 months of gestation. Not for use in heifers placed in feedlots.
(vii) Administer 500 µg by intramuscular injection as a single injection regimen or double injection regimen with a second injection 11 days after the first injection, for estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(viii) For use with gonadorelin acetate to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows: administer to each cow 86 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg gonadorelin by intramuscular injection. Gonadorelin acetate as provided in § 522.1077(a)(1) of this chapter.
(ix) For use with gonadorelin to synchronize estrous cycles to allow for FTAI in lactating dairy cows: administer to each cow by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by gonadorelin by intramuscular injection. Gonadorelin as provided in § 522.1077(a)(1) through (3) of this chapter.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.