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.com

Website: www.dechra-eu.com

Presentation

Each ml contains:

Active substances: Chlorhexidine digluconate 20 mg, equivalent to chlorhexidine 11.26 mg.

Miconazole nitrate 20 mg, equivalent to miconazole 17.37 mg.

Excipients: Methylchloroisothiazolinone 0.0075 mg, methylisothiazolinone 0.0025 mg.

The product is a clear to slightly unclear, light yellow to light brown liquid.

Uses

For the treatment and control of seborrhoeic dermatitis associated with Malassezia pachydermatis and Staphylococcus intermedius in dogs.

As an aid in the treatment of ringworm due to Microsporum canis in the cat in conjunction with griseofulvin.

Dosage and administration

Dog: As a general rule, shampoo twice weekly until the symptoms subside, and weekly thereafter, or as necessary to keep the condition under control as advised by your veterinary surgeon.

Cat: Shampoo twice weekly for a minimum period as advised by the veterinarian or until coat brushings are negative for the culture of M. canis, whichever is the longer. The maximum length of the treatment period should not exceed 16 weeks. The advice of the veterinarian should be sought as to whether it is necessary to clip the haircoat of the cat prior to treatment.

Advice on correct administration: Wet the animal thoroughly with clean water. Apply Malaseb shampoo to the animal at several points and massage into the coat, especially around the lips, under the tail and between the toes. Make sure sufficient is used to raise a lather. Allow the animal to stand for 10 minutes then rinse off with clean water and leave to dry naturally in a warm, draught-free environment.

The 250 ml bottle provides approximately 8-16 treatments for a 15 kg dog or 5-10 treatments for a 25 kg dog, or 25 cat treatments, depending on coat thickness.

Contra-indications, warnings, etc

Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.

Adverse reactions: Exceptionally, a dog with atopy or a cat with allergic skin disease may develop a transient pruritic and/or erythematous reaction after treatment.

In very rare circumstances, dogs and cats may develop a skin reaction (itching, redness) after treatment.

If you notice any serious effects or other effects not mentioned in the data sheet, please inform your veterinary surgeon.

Special warnings: Malaseb shampoo should only be used in conjunction with griseofulvin when treating for ringworm. Shampooing cats may initially increase the recovery of M. canis by brush culture techniques.

For external use only.

Special precautions for use in animals: In case of accidental contact with eyes, rinse with plenty of water.

Do not allow the animal to lick itself during shampooing and rinsing, or before it is dried.

Take care to avoid the animal inhaling the product or getting it into the nose or mouth during shampooing.

Puppies or kittens should not come into contact with nursing females after treatment, until the coat has dried.

Cat: Both field and experimental studies have shown that environmental contamination with M. canis can be eliminated or reduced by the use of Malaseb shampoo twice weekly. In these studies, griseofulvin was administered continuously throughout the treatment period and both clinical improvement was enhanced and environmental contamination reduced compared to the use of griseofulvin alone.

Operator warnings: If known hypersensitivity to chlorhexidine, miconazole or any of the excipients exists, handle product with care.

This product can cause eye irritation. Avoid contact with the eyes. In case of accidental contact with eyes, rinse with plenty of water. If irritation persists consult your doctor.

Avoid excessive handling or stroking of treated animals immediately following treatment.

Ringworm in the cat is infectious to humans and so it is advisable to wear gloves and have arms covered during clipping and shampooing of infested cats.

When shampooing a cat, in order to avoid prolonged contact with the shampoo, wash and dry hands gently. Do not scrub.

Pregnancy: Malaseb shampoo in conjunction with griseofulvin should not be used in pregnant cats as griseofulvin is contraindicated in pregnancy.

General precautions: For animal treatment only.

Pharmaceutical precautions

Do not store above 30°C. Do not refrigerate or freeze. Keep out of the reach and sight of children.

Do not use after the expiry date stated on the label.

Shelf life after first opening the container: 3 months.

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

Legal category

POM-V

Packaging Quantities

Nature and composition of immediate packaging: 250 ml polyethylene bottle with a polypropylene screw cap.

Further information

To be supplied only on veterinary prescription.

Veterinary medicinal product authorised for use in UK and IE.

Marketing and manufacturing authorisation holder responsible for batch release: Dechra Veterinary Products A/S, Mekuvej 9, DK-7171 Uldum, Denmark.

Malaseb shampoo is manufactured under licence from Dermcare Vet, Australia, owner of the trade name Malaseb. EU patent no. 0608308.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

Marketing authorisation number

Vm 24883/4005.