Label: FERTAGYL- gonadorelin injection

  • NDC Code(s): 57926-477-07, 57926-477-67
  • Packager: Merck Sharp & Dohme Corp.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated August 31, 2015

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  • SPL UNCLASSIFIED SECTION

    ANADA 200-134 Approved by FDA
    159942 R1

    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

  • SPL UNCLASSIFIED SECTION

    CAUTION

    FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN.

  • DESCRIPTION

    DESCRIPTION

    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 -

    5-oxoPro-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2

    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.

  • ANIMAL PHARMACOLOGY & OR TOXICOLOGY

    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.

  • VETERINARY INDICATIONS

    INDICATION AND DOSAGE

    Cystic Ovaries

    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

    Reproductive Synchrony

    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:

    • Administer the first Fertagyl injection (2 mL) on Day 0
    • Administer 2mL of Estrumate (500 mcg cloprostenol, as cloprostenol sodium) by intramuscular injection 6-8 days after the first Fertagyl injection
    • Administer the second Fertagyl injection (2mL) 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.
  • SPL UNCLASSIFIED SECTION

    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.

  • SPL UNCLASSIFIED SECTION

    EFFECTIVENESS

    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 Alcohol9 mg
    Sodium Chloride7.47 mg
    Water for Injection, USPq.s.

    pH adjusted with sodium phosphate (monobasic and dibasic).

  • STORAGE AND HANDLING

    STORAGE CONDITIONS: Keep refrigerated: 2°-8°C (36°-46°F).

    USE WITHIN 28 DAYS OF FIRST USE

  • PRECAUTIONS

    PRECAUTIONS

    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

  • HOW SUPPLIED

    HOW SUPPLIED

    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.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    INTERVET INC. (d/b/a Merck Animal Health)
    Madison, NJ 07940
    By: INTERVET INTERNATIONAL GmbH
    Unterschleissheim – Germany

  • PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton

    MERCK
    Animal Health

    20 mL

    fertagyl®
    (gonadorelin)

    43 mcg/mL gonadorelin Sterile Solution

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

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

    ANADA 200-134,
    Approved by FDA

    Net Contents:
    20 mL/10 doses

    MERCK
    Animal Health

    PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    FERTAGYL 
    gonadorelin injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57926-477
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GONADORELIN (UNII: 9O7312W37G) (GONADORELIN - UNII:9O7312W37G) GONADORELIN43 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Phosphate, Monobasic, Dihydrate (UNII: 5QWK665956)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-477-071 in 1 CARTON
    120 mL in 1 VIAL, MULTI-DOSE
    2NDC:57926-477-671 in 1 CARTON
    2100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20013406/17/1996
    Labeler - Merck Sharp & Dohme Corp. (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet International GMBH328855635MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Aspen Oss B.V.491017488API MANUFACTURE