21 C.F.R. § 529.1940 Progesterone intravaginal inserts.
Title 21 - Food and Drugs
(a) Specifications. Each insert contains 1.38 grams of progesterone in molded silicone over a nylon spine. (b) Sponsor. See No. 000009 in §510.600(c) of this chapter. (c) Related tolerances. See §556.540(a) of this chapter. (d) Special considerations. (1) Product labeling shall bear the following warnings: “Avoid contact with skin by wearing latex gloves when handling inserts. Store removed inserts in a plastic bag or other sealable container until they can be disposed of in accordance with applicable local, State, and Federal regulations.” (2) This product is approved with the concurrent use of dinoprost solution on day 6 of the 7-day administration period when used for indications listed in paragraph (e)(2)(i) of this section. See §522.690(c) of this chapter. (e) Conditions of use—(1) Amount. Administer one intravaginal insert per animal for 7 days. When used for indications listed in paragraph (e)(2)(i) of this section, administer 25 milligrams (mg) dinoprost (5 milliliters (mL) of 5 mg/mL solution as in §522.690(a) of this chapter) as a single intramuscular injection one day prior to insert removal. (2) Indications for use—(i) For synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, for advancement of first postpartum estrus in suckled beef cows, and for advancement of first pubertal estrus in replacement beef heifers. (ii) For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus. (3) Limitations. Do not use in animals with abnormal, immature, or infected genital tracts; or in beef cows that are fewer than 20 days postpartum; or in beef or dairy heifers of insufficient size or age for breeding. Do not use an insert more than once. To prevent the potential transmission of venereal and bloodborne diseases, the inserts should be disposed after a single use. Administration of vaginal inserts for periods greater than 7 days may result in reduced fertility. Dinoprost solution as provided by No. 000009 in §510.600(c) of this chapter. [67 FR 41824, June 20, 2002, as amended at 67 FR 51080, Aug. 7, 2002; 68 FR 57613, Oct. 6, 2003]
Title 21: Food and Drugs
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
§ 529.1940 Progesterone intravaginal inserts.
