Animal NDC 54771-1533-1 Eazi-breed Cidr Sheep Insert

Progesterone

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-1533-1
Proprietary Name Eazi-breed Cidr Sheep Insert What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Progesterone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Otc Animal Drug
Usage Information
    For induction of estrus in ewes (sheep) during seasonal anestrus:• Administer one EAZI-BREED CIDR Sheep Insert per ewe for 5 days.• After insert removal, use standard flock breeding procedures to breed ewes at induced estrus.
Active Ingredient(s)
  • Progesterone
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141302 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Eazi-breed Cidr Sheep Insert Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Drug Information



EAZI-BREED

CIDR®

(progesterone intravaginal insert) Sheep Insert

NET CONTENTS: 20 EAZI-BREED CIDR Sheep Inserts per bag Each EAZI-BREED CIDR Sheep Insert contains 0.3 gram of progesterone in molded silicone over a flexible nylon spine. Attached to each EAZI-BREED CIDR Sheep Insert is a nylon tail.

Approved by FDA under NADA # 141-302


Active Ingredient



 Progesterone, 0.3 gram per EAZI-BREED CIDR Sheep Insert


Use



Induction of estrus in ewes (sheep) during seasonal anestrus. Seasonal anestrus is when ewes do not have regular estrous cycles outside the natural breeding season. EAZI-BREED CIDR Sheep Inserts have not been tested in estrous cycling ewes.

Read booklet label before using drug for complete product information.


Warnings



Human Warning: Avoid contact with skin by wearing protective gloves when handling the inserts.
Not for Use in Humans.
Keep this and all medications out of the reach of children.

Environmental Warning: Used (removed) EAZI-BREED CIDR Sheep Inserts still contain some progesterone. Used EAZI-BREED CIDR Sheep Inserts must be stored in a sealable container until disposed. Sealed bag/container with used EAZI-BREED CIDR Sheep Inserts must be properly disposed in accordance with applicable local, state and Federal regulations.

Residue Warning: A pre-slaughter withdrawal period is not required when this product is used according to label directions.

DO NOT USE
• in ewes with abnormal, immature or infected genital tracts
• in ewes that have never lambed
• an insert more than once. To prevent the potential transmission of venereal and blood borne diseases the EAZI-BREED CIDR Sheep Insert should be disposed after a single use.

WHEN USING THIS PRODUCT
• In ewes that respond to treatment the onset of estrus generally occurs within 1 to 3 days after removal of the EAZI-BREED CIDR Sheep Insert.
• Make sure to have a sufficient number of rams to adequately breed all ewes with an induced estrus. Breeds of rams may vary in libido in the non-breeding season. Therefore a ewe to ram ratio up to 18:1 is recommended for multi-sire situations. For single sire lots, 12:1 for ram lambs and up to 18:1 for yearling rams are recommended.

YOU MAY NOTICE:
Clear, cloudy, yellow or bloody mucus on the outside of EAZI-BREED CIDR Sheep Insert when removed from ewes. The mucus may have an offensive odor. This is a result of mild irritation to the vaginal lining by the presence of the EAZI-BREED CIDR Sheep Insert, and generally clears between the time of removal and breeding. Such irritation does not affect fertility.


Other Information



Store at controlled room temperature 20° to 25° C (68° to 77° F) with excursions between 15° to 30° C (59° to 86° F). To report suspected adverse reactions or questions call Zoetis at 1-888-963-8471.


Inactive Ingredients



silicone rubber, nylon.


Directions



For induction of estrus in ewes (sheep) during seasonal anestrus:

Administer one EAZI-BREED CIDR Sheep Insert per ewe for 5 days.

After insert removal, use standard flock breeding procedures to breed ewes at induced estrus.


Insertion



Insertion:
1. Avoid contact with skin by wearing protective gloves when handling inserts.
2. Only use the specially designed EAZI-BREED CIDR Sheep Insert Applicator for administration.
3. Restrain ewes appropriately prior to administration.
4. Wash the applicator in a non-irritating antiseptic solution, and then apply a veterinary obstetrical lubricant to the end of the applicator.
5. Push the tail end of the EAZI-BREED CIDR Sheep Insert into the applicator taking care to assure the tail is extending upward through the slot of the applicator and is pointed away from the handle.
6. Fold the wings of the EAZI-BREED CIDR Sheep Insert to make it longer and continue to advance the insert into the applicator until it is fully seated with only the tips of the wings protruding from the end of the applicator (see Figure 1).
7. Lubricate the protruding tips of the wings of the EAZI-BREED CIDR Sheep Insert with veterinary obstetrical lubricant.
8. Clean the exterior of the vulva with disposable tissue.
9. Open the lips of the vulva and gently place the loaded applicator through the vulva. The slot in the applicator should face down (see Figure 2).
10. Once the loaded applicator is past the vulva slope the applicator slightly upwards (35 - 45° angle) by lowering the handle, and then forward, without forcing, until the applicator is fully inserted or resistance is felt (see Figure 3).
11. Squeeze the finger grips within the handle of the applicator to deposit the EAZI-BREED CIDR Sheep Insert in the anterior vagina (see Figure 4) and then pull the applicator backwards to remove it from the vagina.
12. With the EAZI-BREED CIDR Sheep Insert correctly placed, with the wings open in the anterior portion of the vagina, the tail of the insert should be visible, pointing downward from the vulva of the ewe.


Removal



Removal:
1. Remove EAZI-BREED CIDR Sheep Inserts by pulling, gently but firmly, on the protruding nylon tail.
2. EAZI-BREED CIDR Sheep Inserts may reverse direction within the vagina; therefore, if the nylon tail of the insert is not visible on the day of removal, check the vagina to determine if an insert is present.
3. Used (removed) EAZI-BREED CIDR Sheep Inserts must be stored in a sealable container until disposed. Sealed bag/container with used EAZI-BREED CIDR Sheep Inserts must be properly disposed in accordance with applicable local, state and Federal regulations.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.