Wilko Silent Action Dog Flea Spray Vm 16516-4009 SPC 7 Mar 05

Summary of Product Characteristics Vm 16516/4009 Wilko Silent Action Dog Flea Spray 18 August 2006

1. Name of the Veterinary Medicinal Product Wilko Silent Action Dog Flea Spray

2. Qualitative and quantitative composition Active Ingredient % w/w Pyrethrum Extract 25% 1.00 (equivalent to Pyrethrins 0.25) Piperonyl Butoxide 1.25

3. Pharmaceutical form Cutaneous solution.

4. Pharmacological properties Wilko Silent Action Dog Flea Spray contains a liquid formulation with the active ingredient Pyrethrins (from Pyrethrum (25%) Extract). The pyrethroids possess potent insecticidal activity with much lower mammalian toxicity. Pyrethrum is rapidly toxic to many insects, including fleas.

ATC Vet Code: QP53AC51

5. Clinical Particulars

5.1 Target species Dogs

5.2 Therapeutic indications For the control of fleas on dogs.

5.3 Contra-indications Dogs: Do not use on puppies under 12 weeks of age.

5.4 Undesirable effects None known

5.5 Special precautions for use For external use only. Avoid the eyes. Do not use if your dog is unwell or recovering from an illness. Do not allow treated dogs to swim for 24 hours after application of the product.

5.6 Use during pregnancy or lactation Do not use on nursing females.

5.7 Interaction with other medicaments Do not use any other insecticide on the dog within 7 days of treatment.

5.8 Posology and method of administration Dogs: Remove the protective cover. Comb the animal’s coat the wrong way and spray into the roots of the coat and the skin from a distance of about 15cm (6”) working from the rear to the head. Avoid the eyes and other sensitive areas. Comb the coat back into place and towel lightly to remove all excess spray. DO NOT ALLOW THE DOG TO GROOM UNTIL THIS IS DONE AND THE COAT IS DRY. Keep treated animals away from fires and other sources of heat for at least 30 minutes following spraying and until the coat is totally dry. Repeat after 3 – 4 days if any re-infestation is apparent. Recommendation: Use 25 pumps of the spray for a small dog (e.g. Terrier) Use 35 pumps of the spray for a medium sized dog (e.g. Collie) Use 50 pumps of the spray for a large dog (e.g. Alsatian)

5.9 Overdose Summary of Product Characteristics Vm 16516/4009 Wilko Silent Action Dog Flea Spray 18 August 2006

Not applicable.

5.10 Special warnings for each target species General precautions: To help prevent reinfestation, dog’s bedding and regular resting areas including carpets and soft furnishings should be treated with a suitable insecticide and vacuumed regularly. Remove fleas from puppies and from nursing females by careful use of a flea comb.

5.11 Withdrawal periods Not applicable

5.12 Special safety precautions to be taken by the person administering the product to animals Operator warnings: Flammable Do not spray on a naked flame or other incandescent material. Do not smoke when using this product. Do not breathe spray mist. Use in a well-ventilated area. Avoid contact with eyes. In case of accidental eye contact, wash eyes with copious amounts of water. If irritation persists, seek medical attention. Wash hands and exposed skin after use. Persons with known hypersensitivity to the ingredients in the product should not handle the product. Avoid handling treated animals until coat appears dry. It is preferable to treat during the evening. Recently treated animals should not be allowed to play or sleep with people, particularly children. Keep away from food, drink and animal feedingstuffs.

6. Pharmaceutical particulars

6.1 Incompatibilities (major) None

6.2 Shelf Life 5 years.

6.3 Special precautions for storing Do not store above 25°C.

6.4 Nature and contents of the container 150ml of liquid formulation contained within a white high-density polyethylene bottle fitted with a fingertip pump dispenser delivering 190 microlitres per pump depression. The bottle is labelled according to the conditions of the licence.

6.5 Special precautions for the disposal of unused medicinal product or waste materials if any Any unused product or waste material should be disposed of in accordance with national requirements. Dangerous to fish and aquatic life. Do not use spray in areas containing aquaria, fish tanks and bowls. Do not contaminate aquaria, fishbowls, ponds or waterways with the product.

7. Additional Information Name or style and permanent address or registered place of business of the holder of the marketing authorisation: Sinclair Animal and Household Care Ltd. Ropery Road Gainsborough Lincolnshire DN21 2QB

MA No.: Vm 16516/4009 Date of last revision of SPC: 18 August 2006 Date of issue/last renewal: 13 September 2006