غونادوريلين

Cattle (dairy)

Used in reproductive synchrony programs similar to the following: Administer the first FERTAGYL injection (2 mL) on Day 0. Administer 2 mL of ESTRUMATE (500 mcg cloprostenol, as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first FERTAGYL injection. Administer the second FERTAGYL injection (2 mL) 30 to 72 hours after the ESTRUMATE injection. Perform FTAI 8 to 24 hours after the second FERTAGYL injection, or inseminate cows on detected estrus using standard herd practices.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FERTAGYL®

Cattle (dairy)

The drug is used for the treatment of ovarian cysts.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FERTAGYL®

Beef Cows

For use with cloprostenol sodium to synchronize estrous cycles to allow for FTAI in beef cows.

FERTAGYL®

Dairy cattle

For the treatment of ovarian follicular cysts in dairy cattle

Federal law restricts this drug to use by or on the order of a licensed veterinarian

GONAbreed®

Lactating dairy cows and beef cows

For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.

OvaCyst™

The drug is used for the treatment of ovarian cysts.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Fertelin™

Cattle (beef cows, replacement dairy and beef heifers)

For the treatment of ovarian follicular cysts in cattle.

For intramuscular use only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Factrel® Injection

Cattle (lactating dairy)

For use with LUTALYSE® INJECTION (dinoprost tromethamine injectable solution) to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

For intramuscular use only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Factrel® Injection

INDICATIONS FOR USE: Cystic Ovaries GONAbreed is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus. Historically, cystic ovaries have responded to an exogenous source of LH such as human chorionic gonadotrophin. GONAbreed initiates release of endogenous LH to cause ovulation and luteinization. Reproductive Synchrony GONAbreed is indicated for use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.

GONABREED

For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers. The treatment effect of FACTREL Injection when used in lactating dairy cows, beef cows, and replacement dairy and beef heifers is a reduction in the number of days to first estrus. For use with LUTALYSE® (dinoprost tromethamine injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

Factrel® Injection

INDICATIONS FOR USE:

fertagyl® (gonadorelin) 43 mcg/mL gonadorelin Injectable Solution

Not for use in humans. Keep out of reach of children. WITHDRAWAL PERIODS: No withdrawal period or milk discard time is required when used according to the labeling. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or www.fda.gov/reportanimalae.

CYSTORELIN® (gonadorelin) 50 mcg/mL gonadorelin diacetate tetrahydrate Injectable Solution

No withdrawal period or milk discard time is required when used according to labeling.

Factrel® Injection

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Factrel® Injection

WARNING AND PRECAUTIONS: Not for use in humans. Keep out of reach of children.

fertagyl® (gonadorelin) 43 mcg/mL gonadorelin Injectable Solution

For use in animals only. Not for human use. Keep out of reach of children.

Factrel® Injection

Cattle (dairy)

100 micrograms gonadorelin acetate per cow. Administer as a single intramuscular or intravenous injection.

Intravenous, Intramuscular

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FERTAGYL®

Cattle (dairy)

The recommended intramuscular dosage of FERTAGYL is 86 mcg gonadorelin (2 mL) per cow.

Intravenous, Intramuscular

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FERTAGYL®

Beef Cows

Reproductive Synchrony For beef cows, the intramuscular dosage of FERTAGYL® is 86 mcg gonadorelin (2 mL) per cow, used in reproductive synchrony programs similar to the following: Administer the first FERTAGYL® injection (2 mL) on Day 0. Administer 500 mcg cloprostenol (as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first FERTAGYL® injection. Administer the second FERTAGYL® injection (2 mL) 30 to 72 hours after the cloprostenol sodium injection. Perform FTAI 0 to 24 hours after the second FERTAGYL® injection, or inseminate cows on detected estrus using standard herd practices.

Intravenous, Intramuscular

FERTAGYL®

Dairy cattle

The intravenous or intramuscular dosage of CYSTORELIN is 100 mcg gonadorelin diacetate tetrahydrate (2 mL) per cow.

Intravenous, Intramuscular

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CYSTORELIN®

Dairy cattle

100 mcg (1 mL) per cow intravenously or intramuscularly

Intramuscular, Intravenous

Federal law restricts this drug to use by or on the order of a licensed veterinarian

GONAbreed®

Lactating dairy cows and beef cows

Reproductive Synchrony The intramuscular dosage of OvaCyst® is 100 mcg gonadorelin diacetate tetraydrate (2 mL) per cow, used in reproductive synchrony programs similar to the following: Administer the first OvaCyst® injection (2 mL) at Time 0. Administer the 500 mcg cloprostenol (as cloprestenol sodium) by intramuscular injection 6 to 8 days after the first OvaCyst® injection. Administer the second OvaCyst® injection (2 mL) 30 to 72 hours after the cloprostenol sodium injection. Perform FTAI 0 to 24 hours after the second OvaCyst® injection, or inseminate cows on detected estrus using standard herd practices.

Intramuscular, Intravenous

OvaCyst™

Lactating dairy cows and beef cows

The intramuscular dosage of CYSTORELIN is 100 mcg gonadorelin diacetate tetrahydrate (2 mL) per cow, used in reproductive synchrony programs similar to the following: Administer the first CYSTORELIN injection (2 mL) at Time 0. Administer 500 mcg cloprostenol (as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first CYSTORELIN injection. Administer the second CYSTORELIN injection (2 mL) 30 to 72 hours after the cloprostenol sodium injection. Perform FTAI 0 to 24 hours after the second CYSTORELIN injection, or inseminate cows on detected estrus using standard herd practices.

Intravenous, Intramuscular

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CYSTORELIN®

Lactating dairy cows and beef cows

The recommended intramuscular dosage of Gonabreed™ is 100 mcg (1 mL) per cow, used in reproductive synchrony regimens similar to the following: 1. Administer the first Gonabreed™ injection (1 mL) at Time 0. 2. Administer 500 mcg cloprostenol (as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first Gonabreed™ injection. 3. Administer the second Gonabreed™ injection (1 mL) 30 to 72 hours after the cloprostenol sodium injection. 4. Perform FTAI 0 to 24 hours after the second Gonabreed™ injection, or inseminate cows on detected estrus using standard herd practices.

Intramuscular, Intravenous

Federal law restricts this drug to use by or on the order of a licensed veterinarian

GONAbreed®

100 micrograms per cow. Administer as a single intramuscular or intravenous injection.

Intramuscular, Intravenous

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Fertelin™

Cattle (beef cows, replacement dairy and beef heifers)

100 mcg (2 mL) per cow by intramuscular injection.

For intramuscular use only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Factrel® Injection

Cattle (lactating dairy)

100 - 200 mcg (2 - 4 mL) per cow by intramuscular injection

For intramuscular use only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Factrel® Injection

For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers: Administer 2 mL of FACTREL Injection as a single intramuscular injection. For use with LUTALYSE (dinoprost tromethamine injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer 2 to 4 mL FACTREL Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework: • Administer the first dose of FACTREL Injection (2-4 mL) at Day 0 • Administer LUTALYSE (25 mg dinoprost, as dinoprost tromethamine injection) Injection by intramuscular injection 6-8 days after the first dose of FACTREL Injection. • Administer a second dose of FACTREL Injection (2-4 mL) 30 to 72 hours after the LUTALYSE injection. • Perform FTAI 0 to 24 hours after the second dose of FACTREL Injection, or inseminate cows on detected estrus using standard herd practices. Below are three examples of treatment regimens for FTAI that fit within the dosage regimen framework described immediately above: Example 1 Example 2 Example 3 Day 0 (Monday) 1st FACTREL 1st FACTREL 1st FACTREL Day 7 (the following Monday) LUTALYSE LUTALYSE LUTALYSE Day 9 (Wednesday) 2nd FACTREL + FTAI at 48 hours after LUTALYSE 2nd FACTREL 48 hours after LUTALYSE 2nd FACTREL 56 hours after LUTALYSE Day 10 (Thursday) FTAI 24 hours after 2nd FACTREL FTAI 18 hours after 2nd FACTREL

INTRAMUSCULAR

Factrel® Injection

DOSAGE AND ADMINISTRATION Cystic Ovaries The intravenous or intramuscular dosage of OvaCyst is 100 mcg gonadorelin diacetate tetrahydrate (2 mL) per cow. Reproductive Synchrony The intramuscular dosage of OvaCyst is 100 mcg gonadorelin diacetate tetrahydrate (2 mL) per cow, used in reproductive synchrony programs similar to the following: Administer the first OvaCyst injection (2 mL) at Time 0. Administer the 500 mcg cloprostenol (as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first OvaCyst injection. Administered the second OvaCyst injection (2 mL) 30 to 72 hours after the cloprostenol sodium injection. Perform FTAI 0 to 24 hours after the second OvaCyst injection, or inseminate cows on detected estrus using standard herd practices.

INTRAVENOUS, INTRAMUSCULAR

FDA application 200-069

Cystic Ovaries The intravenous or intramuscular dosage of CYSTORELIN is 100 mcg gonadorelin diacetate tetrahydrate (2 mL) per cow. Reproductive Synchrony The intramuscular dosage of CYSTORELIN is 100 mcg gonadorelin diacetate tetrahydrate (2 mL) per cow, used in reproductive synchrony programs similar to the following: 1. Administer the first CYSTORELIN injection (2 mL) at Time 0. 2. Administer 500 mcg cloprostenol (as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first CYSTORELIN injection. 3. Administer the second CYSTORELIN injection (2 mL) 30 to 72 hours after the cloprostenol sodium injection. 4. Perform FTAI 0 to 24 hours after the second CYSTORELIN injection, or inseminate cows on detected estrus using standard herd practices.

INTRAVENOUS, INTRAMUSCULAR

CYSTORELIN® (gonadorelin) 50 mcg/mL gonadorelin diacetate tetrahydrate Injectable Solution

DOSAGE AND ADMINISTRATION Cystic Ovaries The intravenous or intramuscular dosage of GONAbreed is 100 mcg gonadorelin acetate (1 mL) per cow. Reproductive Synchrony The intramuscular dosage of GONAbreed is 100 mcg gonadorelin acetate (1 mL) per cow, used in reproductive synchrony programs similar to the following: 1. Administer the first GONAbreed injection (1 mL) at Time 0. 2. Administer 500 mcg cloprostenol (as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first GONAbreed injection. 3. Administer the second GONAbreed injection (1 mL) 30 to 72 hours after the cloprostenol sodium injection. 4. Perform FTAI 0 to 24 hours after the second GONAbreed injection, or inseminate cows on detected estrus using standard herd practices.

INTRAMUSCULAR, INTRAVENOUS

GONABREED

DOSAGE AND ADMINISTRATION:

INTRAMUSCULAR, INTRAVENOUS

fertagyl® (gonadorelin) 43 mcg/mL gonadorelin Injectable Solution