Fertagyl 2 (Canada)

This page contains information on Fertagyl 2 for veterinary use.
The information provided typically includes the following:
  • Fertagyl 2 Indications
  • Warnings and cautions for Fertagyl 2
  • Direction and dosage information for Fertagyl 2

Fertagyl 2

This treatment applies to the following species:
Manufacturer: Merck Animal Health

Gonadorelin injectable solution

Sterile

DIN 02316072

Veterinary Use Only

Description: Gonadorelin is a decapeptide composed of the sequence of amino acids: 5-oxoPro-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2. It has a molecular weight of 1182.32 g/mol and empirical formula of C55 H75 N17 O13. The molecular formula of its acetate is C55 H75 N17 O13 • C2H4O2 with a molecular weight of 1242.3 g/mol. Gonadorelin acetate (45 µg/mL) is considered to be pharmaceutically equivalent to gonadorelin diacetate tetrahydrate (50 µg/mL) as they are both equivalent to 43 µg/mL of gonadorelin.

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.

Active Ingredients: Each mL contains 45 µg gonadorelin acetate, (Ph.Eur.) equivalent to 43 µg gonadorelin. The pH is adjusted with sodium phosphate (monobasic and dibasic). Preservative: 9 mg/mL benzyl alcohol.

Indications: Fertagyl® 2 is a hormone indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinisation 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® 2 initiates the release of endogenous LH to cause ovulation and luteinisation. The average time to response is 21 days.

Dosage and Administration: The recommended dosage of Fertagyl® 2 is 2 mL per cow as a single intramuscular injection.

Warnings: Treated animals must not be slaughtered for use in food for at least 7 days after the latest treatment with this drug. No milk withholding time is required when used according to the label. Keep out of reach of children.

Pharmacology and Toxicology: Endogenous gonadorelin is synthesized and released by the hypothalamus during various stages of the bovine estrus cycle following appropriate neurogenic stimuli. It passes, via the hypophyseal portal vessels, to the anterior pituitary to affect the release of gonadotropins (e.g., LH, FSH). Synthetic gonadorelin administered intramuscularly also causes the release of endogenous LH and FSH from the anterior pituitary.

Gonadorelin has been shown to have a low level of toxicity in animals. The LD50 for mice and rats is greater than 60 µg/kg, and for dogs, greater than 600 µg/kg. Untoward effects were not noted among rats or dogs administered 120 µg/kg/day or 72 µg/kg/day intravenously for 15 days.

It had no adverse effects on heart rate, blood pressure, or ECG to unanesthetized dogs at 60 µg/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 µg/kg/day of gonadorelin to pregnant rats and rabbits during organogenesis did not cause embryotoxic or teratogenic effects.

The intramuscular administration of 1000 µg gonadorelin to normally cycling dairy cattle had no effect on hematology or blood chemistry.

Storage: Store at 2-8°C. Protect from light. Discard unused contents 28 days after first opening.

Presentation: Fertagyl® 2 is supplied in multi-dose vials containing 20 mL of sterile solution.

Product Code 072462

Intervet Canada Corp., 16750, route Transcanadienne, Kirkland, QC H9H 4M7

1 888 306-0069

NAC No.: 12082113

MERCK ANIMAL HEALTH
Intervet Canada Corp.

16750 ROUTE TRANSCANADIENNE, KIRKLAND, QC, H9H 4M7
Order Desk:   514-428-7013
Toll-Free:   866-683-7838
Fax:   Toll-free 888-498-4444; local 514-428-7014
Website:   www.merck-animal-health.ca
Every effort has been made to ensure the accuracy of the Fertagyl 2 information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-05-28

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