Introduction

vet00501

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

A sterile aqueous solution for injection containing 50 µg/ml gonadorelin (as diacetate) for administration to breeding cattle. The product also contains benzyl alcohol 15 mg/ml as a preservative.

Uses

For the treatment of repeat breeding syndrome.

A repeat breeding cow or heifer is an animal that has been inseminated at least 2 or 3 times without becoming pregnant, despite having regular normal oestrus cycles (18 – 24 days), normal oestrus behaviour and no clinical abnormalities of the reproductive tract

Dosage and administration

Should be administered by intramuscular injection at a rate of 100 µg of gonadorelin (as diacetate) per animal in one single injection (i.e. 2 ml of Ovarelin® per animal). Ovarelin® should be injected during oestrus.

Gonadorelin is the synthetic equivalent of natural gonadtrophin realising hormone (GnRH), and administration results in the release of both LH and FSH from the pituitary, which will induce follicular maturation and subsequent ovulation.

To improve significantly the pregnancy rates, the following timing of injection and insemination should be followed:

•Injection should be performed between 4 and 10 hours after oestrus detection.

•Artificial insemination has to be carried out after the injection of Ovarelin®.

Contra-indications, warnings, etc

None.

Special precautions to be taken by the person administering the medicinal product to animals

Care should be taken when handling the product to avoid self-injection.

Accidental spillage on the skin or eyes should be washed off with plenty of water. Users known to be hypersensitive to GnRH analogues should not use this product.

Use during pregnancy and lactation

Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic or embryotoxic effects. Observations in pregnant cows receiving the product in early pregnancy have not shown evidence of negative effects on bovine embryos. Inadvertent administration to a pregnant animal is unlikely to result in adverse effects

Withdrawal period

Meat and offal: zero days

Milk: zero hours

For animal treatment only.

Keep out of the reach and sight of children.

Any unused product or waste material should be disposed of in accordance with national requirements.

Pharmaceutical precautions

Store below 25°C. Protect from light.

Following removal of the first dose, use the product within 28 days.

Discard unused material.

Legal category

POM-V

Packaging Quantities

Box containing 1 glass vial of 4 ml

Box containing 1 glass vial of 10 ml

Box containing 1 glass vial of 20 ml

Box containing 1 glass vial of 50 ml

Not all pack sizes may be marketed.