FDA Structured Product Label
EAZI-BREED™ CIDR® Cattle Insert
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
- Sponsor
- Zoetis Inc.
- NADA
- 141-200
- Status
- OTC
- Form
- Insert
- Route
- Intravaginal
- Species
- Beef cows and beef heifers (female breeding stock) • Dairy cows and heifers (female breeding stock)
Composition / specifications
Each insert contains 1.38 grams of progesterone in molded silicone over a nylon spine.
Lactating Dairy Cows
Indication
For synchronization of estrus in lactating dairy cows.
Dosage
Administer one intravaginal insert per animal for 7 days. Administer 25 milligrams dinoprost (5 milliliters of 5 milligrams per milliliter solution) as a single intramuscular injection insert removal, on Day 7 of the 7 day administration period.
Limitations
This product is approved for concurrent use of dinoprost solution on day 7 of the 7-day administration period when used for the following indications: For synchronization of estrus in lactating dairy cows.
Do not use in animals with abnormal, immature, or infected genital tracts; or in dairy cows that are fewer than 40 days postpartum for synchronization of estrus or synchronization of the return to estrus; or in anestrous lactating dairy cows less than 42 days or greater than 78 days postpartum for induction of estrous cycles. 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.
Product labeling shall bear the following warnings: "Avoid contact with skin by wearing protective gloves when handling inserts. Store used (removed) inserts in a plastic bag or other sealable container until they can be properly disposed in accordance with applicable local, State, and Federal regulations.
Indication
For induction of estrous cycles in anestrous lactating dairy cows.
Dosage
Administer one intravaginal insert per anestrous cow and remove 7 days later.
Limitations
Do not use in animals with abnormal, immature, or infected genital tracts; or in dairy cows that are fewer than 40 days postpartum for synchronization of estrus or synchronization of the return to estrus; or in anestrous lactating dairy cows less than 42 days or greater than 78 days postpartum for induction of estrous cycles. 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
Product labeling shall bear the following warnings: "Avoid contact with skin by wearing protective gloves when handling inserts. Store used (removed) inserts in a plastic bag or other sealable container until they can be properly disposed in accordance with applicable local, State, and Federal regulations..
Indication
For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus.
Dosage
Administer one intravaginal insert per animal 14 +/- 1 days after insemination. Remove intravaginal insert 7 days later.
Limitations
Do not use in animals with abnormal, immature, or infected genital tracts; or in dairy cows that are fewer than 40 days postpartum for synchronization of estrus or synchronization of the return to estrus; or in anestrous lactating dairy cows less than 42 days or greater than 78 days postpartum for induction of estrous cycles. 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
Product labeling shall bear the following warnings: "Avoid contact with skin by wearing protective gloves when handling inserts. Store used (removed) inserts in a plastic bag or other sealable container until they can be properly disposed in accordance with applicable local, State, and Federal regulations..
Suckled Beef Cows, Replacement Beef and Dairy Heifers
Indication
For the advancement of first pubertal estrus in replacement beef heifers.
Dosage
Administer one intravaginal insert per animal for 7 days. Administer 25 milligrams dinoprost (5 milliliters of 5 milligrams per milliliter solution) as a single intramuscular injection one day prior to insert removal, on Day 6 of the 7 day administration period.
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 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.
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.
Product labeling shall bear the following warnings: "Avoid contact with skin by wearing protective gloves when handling inserts. Store used (removed) inserts in a plastic bag or other sealable container until they can be properly disposed in accordance with applicable local, State, and Federal regulations.
Indication
For synchronization of estrus in suckled beef cows and replacement beef and dairy heifers.
Dosage
Administer one intravaginal insert per animal for 7 days. Administer 25 milligrams dinoprost (5 milliliters of 5 milligrams per milliliter solution) as a single intramuscular injection one day prior to insert removal, on Day 6 of the 7 day administration period.
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 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.
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.
Product labeling shall bear the following warnings: "Avoid contact with skin by wearing protective gloves when handling inserts. Store used (removed) inserts in a plastic bag or other sealable container until they can be properly disposed in accordance with applicable local, State, and Federal regulations.
Indication
For advancement of first postpartum estrus in suckled beef cows.
Dosage
Administer one intravaginal insert per animal for 7 days. Administer 25 milligrams dinoprost (5 milliliters of 5 milligrams per milliliter solution) as a single intramuscular injection one day prior to insert removal, on Day 6 of the 7 day administration period.
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 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.
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.
Product labeling shall bear the following warnings: "Avoid contact with skin by wearing protective gloves when handling inserts. Store used (removed) inserts in a plastic bag or other sealable container until they can be properly disposed in accordance with applicable local, State, and Federal regulations.