Complete Up To Date Information about EAZI-Breed™ CIDR Cattle Insert.
NADA Number: 141-200 | |
| Proprietary Name |
EAZI-Breed™ CIDR® Cattle Insert |
|---|---|
| Sponsor |
Pharmacia & Upjohn Co. |
| Sponsor Address |
a Division of Pfizer, Inc. 235 East 42nd St. New York, NY 10017 USA |
| Ingredients |
Progesterone |
| Species |
Cattle, dairy, cows and heifers (female breeding stock) Cattle, beef, cows and heifers (female breeding stock) |
| Routes of Administration |
Intravaginally |
| Dose Form |
Insert |
| Drug Form |
Insert |
| Dispensing Status |
OTC |
| Patent Number |
4678463 6423039 6663608 |
| Exclusivity |
Granted for the use in synchronizing the return to estrus in lactating dairy cows which were inseminated during the immediately proceeding estrus. Granted for the use as an intravaginal route of the insert in cattle. |
|
Dosage Amount, Indications & Limitations |
529.1940 Progesterone intravaginal inserts. Specifications Each insert contains 1.38 grams of progesterone in molded silicone over a nylon spine. Special considerations: 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.'' This product is approved with the concurrent use of dinoprost solution on day 6 of the 7-day administration period when used for indications: 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 the advancement of first pubertal estrus in replacement beef heifers. Cattle, beef cows and heifers: Conditions of use: Amount: Administer one intravaginal insert per animal for 7 days. When used for synchronization of estrus in suckled beef cows and heifers or for advancement of first pubertal estrus in replacement beef heifers, administer 25 milligrams dinoprost (5 milliliters of 5 milligrams per milliliter solution) as in Sec. 522.690(a) of this chapter) as a single intramuscular injection one day prior to insert removal. Indications: 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. 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 heifers of insufficient size or age for breeding. Do not use an insert more than once. To prevent the potential transmission of venereal and blood borne 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. Cattle, dairy cows and heifers: Conditions of use: Amount: Administer one intravaginal insert per animal for 7 days. When used for synchronization of estrus in dairy heifers, administer 25 milligrams dinoprost (5 milliliters of 5 milligrams per milliliter solution) as in Sec. 522.690(a) of this chapter) as a single intramuscular injection one day prior to insert removal. Indications: For synchronization of estrus in dairy heifers. Also, for synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus. Limitations: Do not use in animals with abnormal, immature, or infected genital tracts; or in 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 blood borne 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. |
| Tolerances |
No residues of progesterone are permitted in excess of the following increments above the concentrations of progesterone naturally present in untreated animals: a. Steers and calves (uncooked edible tissues): (1) 3 parts per billion for muscle. (2) 12 parts per billion for fat. (3) 9 parts per billion for kidney. (4) 6 parts per billion for liver. b. Lambs (uncooked edible tissues): (1) 3 parts per billion for muscle. (2) 15 parts per billion for fat, kidney, and liver. |