CYSTORELIN

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

CYSTORELIN

This treatment applies to the following species:
Manufacturer: Merial

gonadorelin diacetate tetrahydrate injection, solution

FOR INJECTION

For the treatment of cystic ovaries in cattle

CYSTORELIN Caution

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Description

CYSTORELIN® is a sterile solution containing 50 micrograms of gonadorelin (GnRH) diacetate tetrahydrate per milliliter suitable for intramuscular or intravenous administration. Gonadorelin is a decapeptide composed of the sequence of amino acids-

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

a molecular weight of 1182.32 and empirical formula C55H75N17O13. The diacetate tetrahydrate ester has a molecular weight of 1374.48 and empirical formula C59H91N17O21.

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 and/or released from 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 effect the release of gonadotropins (e.g. LH, FSH). Synthetic gonadorelin administered intravenously or intramuscularly also causes the release of endogenous LH or FSH from the anterior pituitary.

Gonadorelin diacetate tetrahydrate 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 or 72 mcg/kg/day intravenously for 15 days.

It has no adverse effects on heart rate, blood pressure, or EKG to unanesthetized dogs at 60 mcg/kg. In anesthetized dogs it did not produce depression of myocardial or system hemodynamics or adversely affect coronary oxygen supply or myocardial oxygen requirements.

The intravenous administration of 60 mcg/kg/day of gonadorelin diacetate tetrahydrate to pregnant rats and rabbits during organogenesis did not cause embryotoxic or teratogenic effects.

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

Further, CYSTORELIN does not cause irritation at the site of intramuscular administration in dogs. The dosage administered was 72 mcg/kg/day for seven (7) days.

CYSTORELIN Indications And Dosage

CYSTORELIN® 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. CYSTORELIN initiates release of endogenous LH to cause ovulation and luteinization.

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

Each mL of CYSTORELIN contains:

Gonadorelin diacetate tetrahydrate

50 mcg

Benzyl Alcohol

9 mg

Sodium Chloride

7.47 mg

Water for Injection, U.S.P.

q.s.

pH adjusted with potassium phosphate (monobasic and dibasic).

Precautions

Not for use in humans.

Keep this and all drugs out of reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects in users, to obtain an MSDS, or for assistance call 1-888-637-4251.

KEEP REFRIGERATED: 2-8°C (36-46°F).

Discard remaining product 90 days after first use.

HOW SUPPLIED

CYSTORELIN is available in a concentration of 50 mcg/mL pH adjusted with potassium phosphate (monobasic and dibasic).

CYSTORELIN is supplied in multi-dose vials containing 10 mL and 30 mL of sterile solution.

Marketed by: Merial LLC, Duluth, GA 30096-4640 U.S.A.

Technical Support 1-888-637-4251

® CYSTORELIN and the Cattle Head Logo are registered trademarks of Merial.

© 2010 Merial. All Rights Reserved.

Rev. 01/2010

1050-2907-00

NADA 098-379, Approved by FDA

FOR ANIMAL USE ONLY

NET CONTENTS:

Item No.

1 × 10 mL

82830201

10 × 30 mL - Carton contains 150 doses

72010

NAC No.: 11110084

MERIAL LTD.
3239 SATELLITE BLVD., DULUTH, GA, 30096
Telephone:   888-637-4251
Website:   www.merial.com
Every effort has been made to ensure the accuracy of the CYSTORELIN information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-09-05

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