21 CFR 522.690 - Dinoprost solution.

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There are 3 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.690 Dinoprost solution.
(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 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558