Imaverol 100 mg/ml Concentrate for Cutaneous Emulsion

Introduction

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@its.jnj.com

Presentation

Brown-yellow, clear, viscous liquid containing 100 mg enilconazole per ml. For cutaneous use after dilution.

Uses

Imaverol is a synthetic antimycotic. It is indicated for the treatment of dermatomycoses in cattle, horses and dogs induced by the following pathogenic fungi: Trichophyton verrucosum, Trichophyton mentagrophytes, Trichophyton equinum, Microsporum canis, Microsporum gypseum.

Dosage and administration

The concentrated Imaverol solution should be diluted by adding 1 part to 50 parts of warm water, to provide a 0.2 % w/v (2 mg per ml) emulsion. Dermatophytes will extend into the hair follicles. Possible crusts must therefore be removed with a hard brush, which has been soaked in the diluted Imaverol emulsion. It is highly recommended that the animal be sprayed entirely at the first treatment so as to reach the subclinical lesions as well.

Cattle

Depending on the nature of the lesions, cattle should be treated 3 to 4 times at 3-day intervals. The animals should either be washed with the diluted emulsion or the emulsion should be applied to them with a sprayer or high-pressure cleaning unit.

Horse

The lesions and surrounding skin should be washed with the diluted emulsion 4 times, at 3-day intervals.

Dog

The animals should be washed with the diluted emulsion 4 times, at 3-day intervals. While doing this, one should rub thoroughly in the direction opposite to the hair growth to make sure that the skin is thoroughly wet. For the same reason, it is recommended that long-haired dogs be clipped before treatment.

Alternatively dogs may be dipped thoroughly in a bath containing the prepared emulsion.

Contra-indications, warnings, etc

For external use only.

Withdrawal periods

Cattle:

Meat and milk: 0 (zero) days

Horse:

Meat: 0 (zero) days

Operator warnings

Wear suitable protective clothing including impermeable rubber gloves and safety glasses. If the concentrated solution comes into contact with the skin, remove any contaminated clothing immediately and wash skin generously with soap and water.

In the event of accidental eye exposure, flush eye thoroughly with running water. If irritation persists, seek medical attention. In the event of accidental ingestion, flush mouth with plenty of running water and seek medical advice.

Wash hands after use.

Disposal

Any unused product and empty containers should be disposed of in accordance with guidance from your local waste regulation authority. Do not allow the product to contaminate streams or water supplies.

For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Do not store above 25 °C. Keep in an adequately ventilated area. Solution which has been diluted should be used within 6 weeks.Keep the bottle in the outer carton

Legal category

POM-VPS

Packaging Quantities

100 ml bottles.

Further information

Nil

Marketing authorisation number

Vm 00242/4011.