EAZI-BREED CIDR

Pharmacia & Upjohn
Pfizer Inc.

EAZI-BREED™ CIDR (progesterone) Cattle Insert

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• Active Ingredient
• EAZI-BREED CIDR Uses
• WARNINGS
  • Human Warning
  • Environmental Warning
  • Residue Warning
• DO NOT USE
• WHEN USING THIS PRODUCT
• YOU MAY NOTICE
• DIRECTIONS
  • Lactating Dairy Cows
  • Suckled Beef Cows, Replacement Beef and Dairy Heifers
  • Insertion
  • Removal
• OTHER INFORMATION
• Inactive Ingredients
• PRINCIPAL DISPLAY PANEL - 10 Insert Bag Label

FULL PRESCRIBING INFORMATION

DRUG FACTS

Active Ingredient

Progesterone, 1.38 grams per EAZI-BREED CIDR Cattle Insert

EAZI-BREED CIDR Uses

• Synchronization of estrus in lactating dairy cows, suckled beef cows, and replacement beef and dairy heifers
• Synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus
• Advancement of first postpartum estrus in suckled beef cows
• Advancement of first pubertal estrus in replacement beef heifers

The EAZI-BREED CIDR Cattle Insert provides an exogenous source of the hormone progesterone during the 7-day administration period. Removal of the EAZI-BREED CIDR Cattle Insert on treatment Day 7 results in a rapid fall in plasma progesterone levels, which results in synchronization of estrus in those animals responding to treatment.

WARNINGS

Human Warning

Avoid contact with skin by wearing protective gloves when handling the inserts. Keep this and all medications out of the reach of children.

Environmental Warning

Store used (removed) EAZI-BREED CIDR Cattle Inserts in a plastic bag or other sealable container until they can be properly disposed in accordance with applicable local, state and Federal regulations.

Residue Warning

Neither a pre-slaughter withdrawal interval nor a milk discard time is required when this product is used according to label directions.

DO NOT USE

• in beef or dairy heifers of insufficient size or age for breeding or in cattle with abnormal, immature or infected genital tracts.
• in beef cows that are less than 20 days postpartum or in lactating dairy cows less than 40 days postpartum. The sponsor has not provided effectiveness and animal safety data for the use of this product in beef cows that are less than 20 days postpartum or in lactating dairy cows that are less than 40 days postpartum.
• an insert more than once. To prevent the potential transmission of venereal and blood borne diseases the EAZI-BREED CIDR Cattle Insert should be disposed after a single use.

WHEN USING THIS PRODUCT

• For synchronization of estrus in lactating dairy cows, you must use the EAZI-BREED CIDR Cattle Insert concurrently with an injection of 5 mL of LUTALYSE® Sterile Solution (equivalent to 5 mg/mL dinoprost) administered on Day 7, at the time of EAZI-BREED CIDR Cattle Insert removal, to assure maximum effectiveness.
• For synchronizing the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus, do not administer LUTALYSE® Sterile Solution or other prostaglandin products as they will interrupt pregnancy that may have occurred at the preceding estrus.
• For synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers, you must use the EAZI-BREED CIDR Cattle Insert concurrently with an injection of 5 mL of LUTALYSE® Sterile Solution (equivalent to 5 mg/mL dinoprost) administered on Day 6 of the 7-day administration period to assure maximum effectiveness.
• Intravaginal administration of EAZI-BREED CIDR Cattle Insert for periods greater than 7 days may result in reduced fertility.

YOU MAY NOTICE

• Increased loss of EAZI-BREED CIDR Cattle Inserts in animals housed under crowded conditions, especially in heifers. Avoid crowded conditions during treatment as other cattle, particularly heifers, may remove EAZI-BREED CIDR Cattle Inserts by pulling on the tail of the EAZI-BREED CIDR Cattle Insert. If loss rates are high re-evaluate insertion technique and cattle handling facilities.
• Clear, cloudy, yellow or bloody mucus on the outside of EAZI-BREED CIDR Cattle Insert when removed from animals. 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 Cattle Insert, and generally clears between the time of removal and insemination. Such irritation does not affect fertility at inseminations following treatment.
• Reduced pregnancy rates to inseminations conducted immediately prior to administration of EAZI-BREED CIDR Cattle Inserts used for synchronizing the return to estrus in lactating dairy cows.

DIRECTIONS

Lactating Dairy Cows

For Synchronization of Estrus in Lactating Dairy Cows

• Administer one EAZI-BREED CIDR Cattle Insert per animal and remove 7 days later (for example if administered on a Monday remove the following Monday).
• Reminder: Administer 5 mL LUTALYSE® Sterile Solution at the time of removal of the EAZI-BREED CIDR Cattle Insert.
• Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals found in estrus following normal herd practices.

For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus

• Administer one EAZI-BREED CIDR Cattle Insert per animal 14±1 days after insemination. Remove EAZI-BREED CIDR Cattle Insert 7 days later (for example, if administered on a Monday remove on the following Monday).
• Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus.
• Reminder: Do not administer LUTALYSE® Sterile Solution or other prostaglandin products to cows for synchronization of the return to estrus, as this will interrupt pregnancy that may have occurred at the immediately previous insemination.

Suckled Beef Cows, Replacement Beef and Dairy Heifers

For synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers:

• Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday).
• Inject 5 mL LUTALYSE® Sterile Solution (equivalent to 5 mg/mL dinoprost) 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 day administration period.
• Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus.

Insertion

• Avoid contact with skin by wearing protective gloves when handling inserts.
• Only use the specially designed EAZI-BREED CIDR Cattle Insert Applicator for administration.
• Restrain cattle appropriately (head catch, squeeze chute, gate, etc.) prior to administration.
• Wash the EAZI-BREED CIDR Cattle Insert Applicator in a non-irritating antiseptic solution, and then lubricate the front portion of the EAZI-BREED CIDR Cattle Insert Applicator with a veterinary obstetrical lubricant.
• Push the flexible tail end of the EAZI-BREED CIDR Cattle Insert into the EAZI-BREED CIDR Cattle Insert Applicator taking care to assure the tail is extending upward through the slot of the EAZI-BREED CIDR Cattle Insert Applicator and is pointed toward the handle.
• Fold the wings of the EAZI-BREED CIDR Cattle Insert to make it longer and continue to advance the EAZI-BREED CIDR Cattle Insert into the applicator until it is fully seated. When fully seated only the tips of the wings should protrude (one half inch) from the end of the EAZI-BREED CIDR Cattle Insert Applicator (see Figure 1 below).
• Lubricate the protruding tips of the wings of the EAZI-BREED CIDR Cattle Insert with veterinary obstetrical lubricant.
• Lift the tail of the animal and clean the exterior of the vulva.
• Open the lips of the vulva and gently place the loaded EAZI-BREED CIDR Cattle Insert Applicator through the vulva. The slot in the EAZI-BREED CIDR Cattle Insert Applicator should face upwards (see Figure 2 below).
• Once the loaded EAZI-BREED CIDR Cattle Insert Applicator is past the vulva slope the EAZI-BREED CIDR Cattle Insert Applicator slightly upwards (35-45° angle) by lowering the handle, and then forward, without forcing, until the EAZI-BREED CIDR Cattle Insert Applicator is fully inserted or resistance is felt (see Figure 3 below).
• Squeeze the finger grips within the handle of the EAZI-BREED CIDR Cattle Insert Applicator to deposit the EAZI-BREED CIDR Cattle Insert in the anterior vagina (see Figure 4 below) and then pull the EAZI-BREED CIDR Cattle Insert Applicator backwards to remove it from the vagina.
• With the EAZI-BREED CIDR Cattle Insert correctly placed, with the wings open in the anterior portion of the vagina, the tail of the EAZI-BREED CIDR Cattle Insert should be visible, pointing downward from the vulva of the animal. Tails of EAZI-BREED CIDR Cattle Inserts that protrude more than 2.5 inches from the vulva may be clipped to minimize removal by other animals.

Removal

• Remove EAZI-BREED CIDR Cattle Inserts by pulling, gently but firmly, on the protruding polyester tail.
• EAZI-BREED CIDR Cattle Inserts have been reported to reverse direction within the vagina; therefore, if the polyester tail of the insert is not visible on the day of removal, check the vagina to determine if an insert is present.
• Used (removed) EAZI-BREED CIDR Cattle Inserts still contain some progesterone. Used EAZI-BREED CIDR Cattle Inserts must be stored in a sealable container until disposed. Sealed bag/container with used EAZI-BREED CIDR Cattle Inserts must be properly disposed in accordance with applicable local, state and Federal regulations.

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 Pfizer Animal Health at 1-800-366-5288.

Made in New Zealand
Distributed by: Pharmacia & Upjohn Company
Division of Pfizer Inc
New York, NY 10017

1421000
11165700

Lot Number:
Expiration Date:

Inactive Ingredients

silicone rubber, nylon and polyester.

EAZI-BREED is a trademark and CIDR is a registered trademark of DEC International, NZ, Ltd.
LUTALYSE is a registered trademark of Pharmacia & Upjohn Company

39006604-01/10

PRINCIPAL DISPLAY PANEL - 10 Insert Bag Label

EAZI-BREED™
CIDR^®
(progesterone)

Cattle Insert

NET CONTENTS

10 EAZI-BREED CIDR Cattle Inserts per bag
Each EAZI-BREED CIDR Cattle Insert contains 1.38 grams of progesterone in molded silicone over
a flexible nylon spine. Attached to each EAZI-BREED CIDR Cattle Insert is a polyester tail.

NADA #141-200, Approved by FDA

Pfizer