OvaCyst

Company: Henry Schein^® Animal Health

ANADA 200-069, Approved by FDA

50 mcg/mL

(Gonadorelin Diacetate Tetrahydrate)

Sterile Solution

FOR INJECTION

For the treatment of cystic ovaries in cattle

OvaCyst Caution

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

Description

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

INDICATIONS AND DOSAGE: OvaCyst™ (Gonadorelin) is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are nonovulated 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. OvaCyst™ initiates release of endogenous LH to cause ovulation and luteinization.

The recommended intravenous or intramuscular dosage of OvaCyst™ is 2 mL (100 mcg)/cow.

Each mL of OvaCyst™ contains:

pH adjusted with potassium phosphate (monobasic and dibasic).

Store between 15°C and 30°C (59°F and 86°F)

How Supplied

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

OvaCyst™ is supplied in multi-dose vials containing 12 mL or 36 mL of sterile solution.

For Animal Use Only

Not for Human Use

KEEP OUT OF REACH OF CHILDREN

NET CONTENTS: 12 mL Multi Dose Vial, 36 mL Multi Dose Vial

OvaCyst™ is a trademark of IVX Animal Health, Inc.

Manufactured by IVX Animal Health, Inc., St. Joseph, MO 64503

Manufactured for: HENRY SCHEIN ANIMAL HEALTH, DUBLIN, OHIO 43017

600034

Rev. 12-02

CPN: 10822065