FERTAGYL- gonadorelin injection
Merck Sharp & Dohme Corp.
ANADA 200-134 Approved by FDA
FOR THE TREATMENT OF CYSTIC OVARIES IN DAIRY CATTLE
FOR USE WITH ESTRUMATE (CLOPROSTENOL INJECTION) TO SYNCHRONIZE ESTROUS CYCLES
TO ALLOW FOR FIXED TIME ARTIFICIAL INSEMINATION (FTAI) IN LACTATING DAIRY COWS
Fertagyl is a sterile solution containing 43 mcg gonadorelin (GnRH; as gonadorelin acetate) per milliliter suitable for intramuscular or intravenous administration according to the indication. Gonadorelin is a decapeptide composed of the sequence of amino acids -
with a molecular weight of 1182.32 and empirical formula C55H75N17O13.
Gonadorelin is the hypothalamic releasing factor responsible for the release of gonadotropins (e.g., LH, FSH) from the anterior pituitary.
Synthetic gonadorelin is physiologically and chemically identical to the endogenous bovine hypothalamic releasing factor.
PHARMACOLOGY AND TOXICOLOGY
Endogenous gonadorelin is synthesized by and/or released from the hypothalamus during various stages of the bovine estrous cycle following appropriate neurogenic stimuli. It passes via the hypophyseal portal vessels, to the anterior pituitary to effect the release of gonadotropins (e.g. LH, FSH).
Synthetic gonadorelin administered intramuscularly or intravenously also causes the release of endogenous LH and FSH from the anterior pituitary. Gonadorelin acetate has been shown to be safe. The LD50 for mice and rats is greater than 60 mg/kg, and for dogs, greater than 600 mcg/kg, respectively. No untoward effects were noted among rats or dogs administered 120 mcg/kg/day intramuscularly or 72 mcg/kg/day intravenously for 15 days.
It had no adverse effects on heart rate, blood pressure or EKG, when administered to unanesthetized dogs at 60 mcg/kg. In anesthetized dogs it did not produce depression of myocardial or systemic hemodynamics or adversely affect coronary oxygen supply or myocardial oxygen requirements.
The intravenous administration of 60 mcg/kg/day gonadorelin acetate to pregnant rats and rabbits during organogenesis did not cause embryotoxic or teratogenic effects.
The intramuscular administration of 1000 mcg gonadorelin acetate to normally cycling dairy cattle had no effect on hematology or blood chemistry.
Further, gonadorelin acetate did not cause irritation at the site of intramuscular administration in dogs. The dosage administered was 72 mcg/kg/day for 7 days.
INDICATION AND DOSAGE
Fertagyl (gonadorelin) 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 luteinizing hormone (LH) such as human chorionic gonadotropin.
Fertagyl initiates release of endogenous LH to cause ovulation and luteinization.
The recommended intramuscular or intravenous dosage of Fertagyl is 86 mcg gonadorelin (2 mL)/cow.
DO NOT PUNCTURE STOPPER MORE THAN 10 TIMES
Fertagyl (gonadorelin) is indicated for use with Estrumate (cloprostenol injection) to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows.
The recommended intramuscular dosage of Fertagyl is 86 mcg gonadorelin (2 mL) per cow, used in reproductive synchrony programs similar to the following:
TARGET ANIMAL SAFETY
In addition to the target animal information presented in the section addressing pharmacology and toxicology, target animal safety of, and injection site reactions to, Fertagyl (gonadorelin) when used with Estrumate (cloprostenol injection) were evaluated during the conduct of the effectiveness field studies. The incidence of health abnormalities was not significantly greater in cows administered with Fertagyl than cows administered a placebo injection.
The effectiveness of Fertagyl (gonadorelin) for use with Estrumate (cloprostenol injection) to synchronize estrous cycles to allow for FTAI in lactating dairy cows was demonstrated in a field study at six different locations in the U.S. A total of 758 healthy, non-pregnant, primiparous or multiparous lactating dairy cows within 50-120 days postpartum were enrolled in the study. A total of 377 cows were administered Fertagyl (2mL; 86 mcg gonadorelin as the acetate salt) and 381 cows were administered an equal volume of saline as an intramuscular injection twice in the following regimen:
Day 0: 2 mL Fertagyl or saline
Day 7: 2 mL Estrumate (cloprostenol injection)
Day 9: 2 mL Fertagyl or saline
Fixed time AI was performed on Day 10, 16 ± 8 hours after the Day 9 injection. Cows were evaluated for pregnancy on 45 ± 5 days by trans-rectal ultrasound or rectal palpation. Pregnancy rate to FTAI was significantly higher (P=0.0051) in cows treated with Fertagyl (33.4%) than the pregnancy rate to FTAI to cows treated with saline (17.8%).
|Each mL of Fertagyl contains:|
|Gonadorelin (as gonadorelin acetate)||43 mcg|
|Benzyl Alcohol||9 mg|
|Sodium Chloride||7.47 mg|
|Water for Injection, USP||q.s.|
pH adjusted with sodium phosphate (monobasic and dibasic).
FOR ANIMAL USE ONLY. NOT FOR HUMAN USE. KEEP OUT OF THE REACH OF CHILDREN.
The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects in users to obtain a MSDS or for assistance call 1-800-211-3573
Fertagyl is a sterile solution containing 43 mcg gonadorelin (GnRH; as gonadorelin acetate) per milliliter suitable for intramuscular or intravenous administration according to the indication.
Fertagyl is supplied in multidose vials containing 20 mL and 100 mL of sterile solution.
INTERVET INC. (d/b/a Merck Animal Health)
Madison, NJ 07940
By: INTERVET INTERNATIONAL GmbH
Unterschleissheim – Germany
43 mcg/mL gonadorelin Sterile Solution
CAUTION: Federal law restricts this
drug to use by or on the order of a
For animal use only. Not for human
use. Keep out of reach of children.
Approved by FDA
20 mL/10 doses
|Labeler - Merck Sharp & Dohme Corp. (001317601)|
|Intervet International GMBH||328855635||MANUFACTURE|
|Aspen Oss B.V.||491017488||API MANUFACTURE|