Code of Federal Regulations (Last Updated: October 10, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter E - Animal Drugs, Feeds, and Related Products |
Part 522 - Implantation or Injectable Dosage Form New Animal Drugs |
§ 522.690 - Dinoprost.
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§ 522.690 Dinoprost.
(a) Specifications. Each milliliter (mL) of solution contains dinoprost tromethamine equivalent to:
(1) 5 milligrams (mg) dinoprost; or
(2) 12.5 mg dinoprost.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter. as follows:
(1) No Nos. 054771 and 061133 for use of the 12.5 mg/mL product as product described in paragraph (da)(1) as in paragraph (d) of this section.
(3) No. 061133 for use of the 5 mg/mL product(2) No. 054771 for use of the 5 mg/mL product as described in paragraphs paragraph (da)(1), (2) , and (3) of this section.
paragraphs 2), (3), and (4)as in
1) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use -
(1) Cattle. Administer product products described in paragraph (ba)(1) of this section as follows:
(i) Amount. 25 mg as a single intramuscular or subcutaneous injection. an intramuscular injection of the 5 mg/mL product or as an intramuscular or subcutaneous injection of the 12.5 mg/mL product.
(ii) Indications for use. As a luteolytic agent; effective only in those cattle having a corpus luteum, i.e., those which ovulated at least 5 days prior to treatment.
(A) For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.
(B) For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.
(C) For treatment of pyometra (chronic endometritis) in cattle.
(D) For abortion in beef cows, beef heifers and replacement dairy heifers.
(E) For use with gonadorelin injection as in § 522.1077 of this chapter to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.
(F) For use with progesterone intravaginal inserts as in § 529.1940 of this chapter for synchronization of estrus in lactating dairy cows.
(G) For use with progesterone intravaginal inserts as in § 529.1940 of this chapter for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.
(2) Horses -
(. Administer product described in paragraph (a)(1) of this section as follows:
(i) Amount. 1 mg per 100 pounds of body weight as a single intramuscular injection.
(ii) Indications for use. For its luteolytic effect to control
estrus(A) For controlling the timing of estrus in
and inestrous cycling mares
.
(B) For difficult-to-breed mares (clinically anestrous mares that have a corpus luteum).
(iii) Limitations. Do not use in horses intended for human consumption.
(4) Cattle.(3) Swine -
(i) Amount.
10 mg as a single intramuscular injection.(ii) Indications for use. For parturition induction in swine when injected within 3 days of normal predicted farrowing.
b2Administer product described in paragraph (
Beef cattle and nonlactating dairy heifers - (A)1) of this section as follows:
(i)
25 mg as an intramuscular injection either once or twice at aAmount.
- to 12-day interval.10
(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. 25Bmg as a single intramuscular injection.
(
. For treatment of pyometra (chronic endometritis).ii)Indications
(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 injection as provided by No. 054771 in § 510.600(c) of this chapter may also be used concurrently with gonadorelin hydrochloride injection as in § 522.1077 and with progesterone intravaginal inserts as in § 529.1940 of this chapter.
for use. For parturition induction in swine.
[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; 80 FR 61296, Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015; 81 FR 36789, June 8, 2016; 84 FR 8973, Mar. 13, 2019; 87 FR 17945, Mar. 29, 2022]