Regulin

Introduction

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

Regulin® is a yellow cylindrical implant containing 18 mg melatonin. It is presented in a plastic cartridge containing 25 implants.

Uses

Regulin® improves the reproductive performance of pure bred and crossbred lowland sheep which are to be mated early in the season before the usual peak of reproductive activity. When used as directed, it stimulates the early onset of natural reproductive activity, giving improved reproductive performance of flocks mated early in the season. Regulin® is recommended for use in Suffolk and Suffolk cross type flocks intended to start lambing between early December and mid January and in Mule and halfbred flocks starting lambing between late December and mid February.

Dosage and administration

Dose

One implant per ewe.

Administration

Use the Regulin® implanter to administer one implant subcutaneously near the base of the ear.

Period of use

In Suffolk and Suffolk cross types Regulin® should be used from mid May to late June for ram introduction in late June and July. In Mule and halfbred flocks Regulin® should be administered from early June to late July for ram introduction from mid July to late August.

Do not use Regulin® at times other than those recommended.

Treatment regime

Day 1 (30 weeks before intended start of lambing): As the presence of any ram (and also male goats) will interfere with the ovulatory process, isolate ewes from all males. The ewes should be out of sight, sound and smell. Separating males into the next field from females is not adequate.

Day 7: Implant ewes at the base of the ear; ewes must remain isolated from male sheep and goats.

Day 42 (35 days after implantation): The period between implanting and introduction of the males must be no less than 30 days and no more than 40 days. Introduce rams, but expect a delay of 14-21 days before mating activity commences. Vasectomised rams may be used for the first 14 days to ensure a more compact lambing period. The peak of mating activity will occur 25-35 days after introducing the rams.

Contra-indications, warnings, etc

Use by subcutaneous implantation at the base of the ear only. Avoid damaging implants. Use only sharp undamaged needles.

Only use Regulin® on adult ewes or shearlings.

Regulin® will not be effective on sexually immature animals.

Use of Regulin® in ewes suckling lambs at foot may not give optimum results.

Do not use at times other than those recommended.

Variable results may be seen following use of the product, associated with the management systems involved. Keep out of the reach of children. For animal treatment only.

Care should be taken to avoid accidental self-injection. In the case of accidental self-injection, seek medical advice immediately.

Unused product should be disposed of in accordance with any guidance from an appropriate waste regulation authority.

Withdrawal periods

Milk: Zero hours

Meat: Zero days

Pharmaceutical precautions

The product is sterile. Only open each blister section when required. To maintain sterility opened product must be discarded at the end of treatment.

Legal category

POM-VPS

Packaging Quantities

One pack of 2 cartridges each containing 25 implants.

Further information

Regulin® implants contain melatonin, a natural secretion of the pineal gland. Melatonin is the day length messenger by which all animals recognise different seasons. The pineal gland only produces melatonin during hours of darkness. As days shorten, the amount of melatonin secreted increases and this signals the reproductive system to increase activity, producing a natural peak in breeding performance in the autumn. Regulin® works by mimicking this effect; each implant slowly releases melatonin over an extended period. Regulin® only overcomes the effects of seasonality. If there are any other adverse influences on reproduction present within a flock, the full benefit of Regulin® treatment may be reduced or even eliminated.

Marketing authorisation number

Vm 15052/4011.