Equifulvin Granules

Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

White to off-white granules containing 7.5% w/w Griseofulvin BP. Presented in 500g and 1kg packs. Polyethylene bag inside a polypropylene container. Granules containing 7.5% w/w Griseofulvin.

Uses

Griseofulvin is antifungal antibiotic for the treatment of ringworm in horses caused by Trichophyton spp. and Microsporum spp. After absorption from the gastro-intestinal tract, griseofulvin is concentrated in the newly formed keratin enabling the cells of the skin and hair to resist fungal attack.

Dosage and administration

Equifulvin Granules should be administered orally, by direct addition into feed. Equifulvin Granules should be added to the feed ration so that the required dose is contained in the amount each animal will consume in one feed.

The recommended dose is 10g griseofulvin per kg bodyweight daily for 7 consecutive days. This is achieved by administering 10g Equifulvin Granules per 75kg bodyweight daily.

To aid dosing, a five gram measuring scoop is included in the pack. Add to feed immediately before administration.

Contra-indications, warnings, etc

Equifulvin Granules must not be used for the treatment of pregnant mares. In accordance with the Horse passport legislation (Commission Decision 2000/68/EC as implemented in national legislation) a 6 month withdrawal period applies to the use of this product. Impervious gloves must be worn when handling this product or feed containing this product. The product or feed containing the product must not be handled by women with child-bearing potential. Other systemic fungal infections including those caused by Candida albicans and Aspergillus spp. do not respond to griseofulvin therapy. Long-term administration of high doses of griseofulvin with food has been reported to be hepatotoxic in cats and induce hepatomas in mice and thyroid tumours in rats but not hamsters. The clinical significance of these findings for men or the target species is not known. Do not use in horses with severe hepatic impairment. Keep out of the reach and site of children. For animal treatment only.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Pharmaceutical precautions

Store below 25°C. Do not freeze. Protect from light. Store separately from animal feeds. Keep out of the reach and sight of children.

Legal category

POM-V

Packaging Quantities

500g and 1kg packs. Polyethylene bag inside a polypropylene container.

Not all pack sizes may be marketed.

Further information

Prophylactic therapy is advised for in-contact animals only. The normal 7-day course is recommended. Buildings occupied by infected animals should be thoroughly cleaned and disinfected; all equipment used during the treatment should also be cleaned and disinfected. These measures will minimise risk of infection.

Marketing authorisation number

Vm 00015/4025.

Significant Changes