SUMMARY OF PRODUCT CHARACTERISTICS

Beaphar Insecticidal Dog Shampoo, 0.2% w/w.

Active substance % w/w

Permethrin (cis:trans 40:60) 0.2

Excipients % w/w

Formaldehyde 0.0675

Patent Blue V (E131) 0.00034

Quinoline Yellow (E104) 0.00044

For full list of excipients, see section 6.1

Shampoo

Bright green, clear shampoo.

4.1 Target species

Dogs and puppies over 12 weeks of age.

4.2 Indications for use, specifying the target species

For the control of fleas on dogs and puppies over 12 weeks of age.

4.3 Contra-indications

Do not use on cats

Do not use on puppies under 12 weeks of age.

Do not use on nursing females.

Do not use with other topically applied products.

Do not use on sick and convalescing animals.

Do not re-apply within 7 days of use.

4.4 Special warnings for each target species

To help prevent re-infestation, animal bedding, basket and regular resting areas (including carpets and soft furnishings) should be treated with a suitable insecticide and vacuumed regularly.

Remove fleas from young puppies and nursing females by careful use of a flea comb.

Sick and convalescing animals should be treated by a Veterinary Surgeon.

If signs of disease persist or appear after treatment, consult a Veterinary Surgeon.

4.5 Special precautions for use

For external use only.

Avoid contact with the eyes, nostrils and mouth.

This product contains formaldehyde.

Avoid contact with skin. Wear protective gloves when applying the product to your dog and wash any exposed skin after use.

Avoid contact with eyes. In case of accidental eye contact, rinse with clean, fresh water. If eye irritation persists, seek medical advice.

Treated animals should not be allowed to sleep or play with people, particularly children, until the animal is dry.

Keep away from food and drink including animal feeding stuffs.

4.6 Adverse reactions (frequency and seriousness)

Skin irritation to the 40:60 cis:trans isomer may occur in sensitive individuals.

4.7 Use during pregnancy, lactation or lay

Do not use on nursing females.

4.8 Interaction with other medicinal products and other forms of interaction

Do not use concurrently with other topical insecticides.

4.9 Amounts to be administered and administration route

Wet the coat thoroughly with warm water using the following dosing levels:

Small Dogs (1.5 - 5.0 kg) 30 ml of shampoo diluted into

300 ml of warm water.

Medium Dogs (5.1 -15.0 kg) 50 ml of shampoo diluted into

300 ml of warm water.

Large Dogs (15.1 - 30.0 kg) 70 ml of shampoo diluted into

300 ml of warm water.

Pour diluted dose carefully over dog in small quantities and work well into coat, avoiding eyes, nostrils, and mouth. Rinse thoroughly with clean water after two minutes, during which time the dog should be held.

4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary

Symptoms: Nausea, vomiting, general weakness.

Skin irritation may occur in sensitive individuals.

Emergency procedures: Consult a Veterinary Surgeon.

In case of skin irritation, wash immediately with plenty of water.

In case of ingestion, carry out gastric lavage.

No specific antidote is known.

Treatment should be symptomatic and supportive.

4.11 Withdrawal period(s)

Not applicable.

Pharmacotherapeutic group:Ectoparasiticides for topical use, incl. insecticides

ATCvet Code:QP53AC04

5.1 Pharmacodynamic properties

Permethrin is a non-systemic insecticide with contact and stomach action. It acts on sodium channels of parasite nerve axons causing initial excitement then paralysis and death.

5.2 Pharmacokinetic particulars

Mammalian toxicity is very low. The 40:60 cis:trans isomer of permethrin can have greater irritancy.

6.1 List of excipients

Formaldehyde

Patent Blue V (E131)

Quinoline Yellow (E104)

Sodium lauryl ether sulphate

Nonoxinol 6

Industrial Methylated Spirits

Perfume Solexia 2090 GB

Perfume Ambrene

Water Purified

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

6.4 Special precautions for storage

Protect from frost.

Protect from direct sunlight.

Do not store above 25°C.

6.5 Nature and composition of immediate packaging

Pack size: 100 ml/250 ml

Container: Clear, colourless PVC bottle

Closures: Polypropylene or urea formaldehyde screw cap.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate

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

Harmful to fish and crustaceans. Do not contaminate aquaria or fish bowls with the product.

Beaphar UK Ltd.

Homefield Road

Haverhill

Suffolk

CB9 8QP

UK

Vm13907/4013

VPA 10875/4/1

Date of first authorisation in UK: 9 January 1996

Date of first authorisation in Ireland: 1 October 1989

September 2010