Introduction

Company name: Dechra Veterinary Products

Address: (A business unit of Dechra Pharmaceuticals PLC)

Cartmel Drive

Harlescott

Shrewsbury SY1 3TB

Telephone: 01743 441632

Fax: 01743 462111

Email: info@dechra-uk.com

Website: www.dechra-uk.com

Presentation

The veterinary medicinal product is a subcutaneous implant containing 2.1 mg Deslorelin (as Deslorelin Acetate).

Uses

In mares: zootechnical treatment for the induction of ovulation within 48 hours, during oestrus in normally cycling mares (in sexual season), with an ovarian follicle greater than 30 mm diameter.

Target species: Horses (non-pregnant mares).

Dosage and administration

Place one implant subcutaneously in the neck of a mare that has been determined by rectal palpation and/or ultrasonography to have an ovarian follicle greater than 30 mm in diameter.

Select the implant site by locating an area of the neck midway between the head and shoulder. Prepare the implantation site by thoroughly cleaning the skin with an appropriate disinfectant. Insert the entire length of the needle subcutaneously and fully depress the syringe plunger. Slowly withdraw the needle while pressing the skin at the insertion site. Examine the syringe and needle to ascertain that the implant has not remained within the syringe or needle. It may be possible to palpate the implant in situ.

Do not attempt to re-use the implanter.

The biocompatible implant is absorbed and does not require removal.

Contra-indications, warnings, etc

Do not use in horses producing milk for human consumption.

Localised swelling and mild fibrosis at the site of implantation has been observed in some mares, accompanied by a slight increase in sensitivity to touch and an elevated skin temperature. These effects are transient and usually resolve without treatment within 2 to 5 days.

Some mares implanted with the veterinary medicinal product (Deslorelin) may experience an increased dioestrus period following use.

Mares should be implanted with the veterinary medicinal product when a developing ovarian follicle greater than 30 mm in diameter has been detected by rectal palpation and/or ultrasonography. In larger breeds, it may be necessary to wait until the dominant follicle has progressed to 35 mm in diameter before administration of the veterinary medicinal product.

Treated mares should be bred or inseminated within the next 48 hours. The mare should be monitored to ensure that ovulation has occurred and that further breedings are not required. If ovulation does not occur within 48 hours of implantation, continue breeding according to routine management procedures.

It has been noted that follicles were significantly smaller before ovulation for Deslorelin treated mares compared with placebo mares. However, treatment had no effect on the percentage of mares pregnant at days 18 or 50.

For all trials that evaluated conception and pregnancy rate, there were no differences between Deslorelin-treated and non-treated mares at the end of the study.

Efficacy has not been established for mares in vernal (spring) transition phase.

Do not use if the foil pouch is broken.

Only one implant should be implanted per mare during a given oestrus.

The veterinary medicinal product has not been tested in mares less than three (3) years of age.

There is no requirement for use of the veterinary medicinal product during pregnancy.

In safety and tolerance studies, the only systemic adverse effect seen in mares receiving up to 10 implants simultaneously was suppression of ovarian activity.

Use only in mares fit for reproduction.

Do not use during pregnancy.

Operator warnings: Pregnant women should not administer the veterinary medicinal product as GnRH analogues have been shown to be foetotoxic in laboratory animals.

When administering the veterinary medicinal product, take care to avoid accidental self-injection by ensuring that animals are suitably restrained and the application needle is shielded until the moment of implantation.

In the case of accidental self-injection, seek medical assistance immediately, with a view to having the implant removed, as GnRH analogues may have adverse effects on the male and female reproductive systems.

Although skin contact with the veterinary medicinal product is unlikely, should this occur, wash the exposed area immediately with soap and water, as GnRH analogues may be absorbed through the skin.

General precautions: For animal treatment only.

Withdrawal period: Horse meat - 7 days.

Do not use in mares producing milk for human consumption.

Pharmaceutical precautions

Store in a refrigerator (2°C - 8°C). Keep out of the reach and sight of children.

Disposal: Any unused product or waste materials should be disposed of in accordance with national requirements.

Legal category

POM-V

Packaging Quantities

5 preloaded syringes (implanters) per carton.

Further information

To be supplied only on veterinary prescription.

Manufacturer for the batch release: Dales Pharmaceuticals, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, UK.

Marketing authorisation number

Vm 01732/4128.