OvaCyst

Bayer HealthCare LLC

OvaCyst™ (gonadorelin diacetate tetrahydrate)

FULL PRESCRIBING INFORMATION: CONTENTS*

• OVACYST DESCRIPTION:
• PHARMACOLOGY AND TOXICOLOGY:
• INDICATIONS AND DOSAGE:
• PRECAUTIONS:
• HOW SUPPLIED:
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• PACKAGE/LABEL INSERT
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FULL PRESCRIBING INFORMATION

Sterile Solution

50mcg/mL

For Animal Use Only

Not for Human Use

For the treatment of cystic ovaries in cattle

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

KEEP OUT OF REACH OF CHILDREN

ANADA 200-069 Approved by FDA

Net Contents: 12mL or 36mL

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, OvaCyst™ 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™ 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. OvaCyst™ initiates release of endogenous LH to cause ovulation and luteinization.

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

Each mL of OvaCyst™ contains:

Gonadorelin diacetate tetrahydrate…………………………..50 mcg
Benzyl Alcohol……………………………………………….9 mg
Sodium Chloride……………………………………………...7.48 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 1-800-255-6826.

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.

Bayer (reg'd), the Bayer Cross (reg'd) and OvaCyst are trademarks of Bayer.

Manufactured For Bayer HealthCare LLC Shawnee Mission, KS 66201

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

OvaCyst™

(gonadorelin diacetate tetrahydrate)

(50 mcg/mL)

Sterile Solution

For Animal Use Only

Not For Human Use

Caution: Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian.

KEEP OUT OF THE REACH OF CHILDREN

ANADA 200-069, Approved by FDA

veterinarian.

Net Contents: 12mL

PACKAGE/LABEL INSERT

PACKAGE/LABEL SHIPPER LABEL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

OvaCyst™

(gonadorelin diacetate tetrahydrate)

(50 mcg/mL)

Sterile Solution

For Animal Use Only

Not For Human Use

Caution: Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian.

KEEP OUT OF THE REACH OF CHILDREN

ANADA 200-069, Approved by FDA

Net Contents 36mL

PACKAGE/LABEL INSERT

PACKAGE/LABEL SHIPPER LABEL