Grisol-V Granules

Introduction

Company name: Vétoquinol UK Ltd

Address: Vétoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

Telephone: 01280 814500

Fax: 01280 825460

Email: office@vetoquinol.co.uk

Website: www.vetoquinol.co.uk

Presentation

White to off-white granules for addition to feeds, containing 7.5% w/w Griseofulvin

Uses

For the treatment of ringworm in horses caused by Trichophyton spp. and Microsporum spp.

Other systemic fungal infections including those caused by Candida albicans and Aspergillus spp. do not respond to griseofulvin therapy.

Dosage and administration

Administer orally, by addition to the feed ration. The pack is supplied with a 5ml scoop. 3 level scoops contain approximately 10g of the product.

The recommended dose rate is 10mg griseofulvin per kg bodyweight daily for 7 consecutive days. This is achieved by administering 10g of product per 75kg bodyweight daily. Discard any remaining medicated feed. In severe cases, treatment may be continued for an additional 7 days at the same dose rate.

Contra-indications, warnings, etc

Not to be used for the treatment of pregnant mares.

Do not use in horses with severe hepatic impairment.

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. Mix thoroughly with the total feed ration so that the required dose is contained in the amount each animal will consume at one feed. Add to feed immediately prior to administration. Discard any remaining medicated feed.

May be used for the treatment of groups of animals or for individuals. For dosing, animals should be approximately equal in bodyweight. Adequate trough space should be available and shy feeders should be fed individually to ensure adequate dosage.

Prophylactic therapy is advised for in-contact animals only. The normal 7-day course is recommended.

Keep horses away from infected cattle.

Withdrawal period

Do not use in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.

Operator warnings

When handling this product or feed containing the product, wear impervious gloves and either a half-mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN140 with filter to EN143.

The product or feed containing the product must not be handled by women of childbearing potential.

General precautions

Long-term administration of high doses of griseofulvin with feed has been reported to be hepatotoxic in cats and to induce hepatomas in mice and thyroid tumours in rats but not in hamsters. The clinical significance of these findings for man or the target species is not known. Griseofulvin may be teratogenic.

Not to be used for the treatment of pregnant mares. It can be safely administered to lactating animals.

Pharmaceutical precautions

Store below 25°C.

Protect from light.

Store away from food, drink and animal feedstuffs.

Add to feed immediately prior to administration. Discard any remaining medicated feed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

500 g pot and 1kg and 2.5kg buckets. One 5ml scoop. Not all pack sizes may be marketed.

Further information

Pharmacological Properties

ATC vet code: QD014408

Griseofulvin is an antifungal antibiotic which is absorbed over a prolonged period from the gastrointestinal tract and is deposited in the keratin precursor cells. It concentrates in the stratum corneum of the skin, in the nail and in the hair thus preventing fungal invasion of newly forming cells.

Marketing authorisation number

Vm 08007/4022.