JOHNSON'S VETERINARY PRODUCTS LTD

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF PRODUCT:

Johnson's Anti-Pest Insect Spray.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:

Active Ingredients: Pyrethrum Extract 25% 0.8% w/w

Piperonyl Butoxide 1.0% w/w

3. PHARMACEUTICAL FORM:

Cutaneous spray solution.

4. PHARMACOLOGICAL PROPERTIES:

Pyrethrins/Piperonyl Butoxide

The plant Pyrethrum is a chrysanthemum; the powdered, dried flower heads contain active principles mainly in the form of pyrethrins. Pyrethrins have insecticidal activity producing both knock-down and mortality in a range of insects, and low mammalian toxicity. Common names: Dalmatian insect powder and Persian insect powder.

Piperonyl butoxide acts as a synergist when combined with pyrethrin and prolongs its action.

5. CLINICAL PARTICULARS:

5.1 Target Species:

Dogs and Cats over 12 weeks of age, also Pigeons.

5.2 Indications for Use:

Insecticidal spray to kill fleas on dogs and cats over 12 weeks of age and mites and lice on pigeons.

5.3 Contra-Indications:

Do not exceed stated dose.

Dogs & Cats: Do not use on puppies or kittens under 12 weeks of age or on nursing bitches or queens.

Pigeons: Do not use on pigeons intended for human consumption.

Do not spray on delicate underwings, but use a suitable insect powder. Do not spray closer than 15" (38cms).

All target species: If signs of disease persist or appear, consult a Veterinary Surgeon promptly.

5.4 Undesirable effects:

Self grooming in cats may cause transient salivation.

5.5 Special Precautions for Use:

Extremely flammable. Pressurised contained: Protect from sunlight and do not expose to temperatures exceeding 50ºC. Do not pierce or burn even after use. Do not spray on a naked flame or any incandescent material. Keep away from sources of ignition – No smoking.

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5.6 Use during pregnancy and lactation:

Do not use on nursing bitches or queens.

5.7 Interaction with other medicaments and other forms of interaction:

None reported.

5.8 Posology and method of administration:

Directions for use: DOGS AND CATS: Shake can before use. Spray from a distance of about 12" (30cms), all over body, commencing at tail, while brushing against lie of coat to permit spray penetration. Avoid eyes and other sensitive areas. Repeat every 3‑4 days if necessary until infestation is cleared. Keep animal under observation for 30 minutes after treatment, then brush and comb to remove dead fleas.

DOGS: Spray small dogs for about 6 seconds, medium dogs for about 9 seconds and large dogs for about 14 seconds.

CATS: This spray may be used with caution on cats but spray only for 3‑5 seconds (NO MORE) according to size. Comb coat back into place and towel lightly to remove all excess spray. DO NOT ALLOW CAT TO GROOM UNTIL THIS HAS BEEN DONE AND COAT IS DRY. Some cats are sensitive to aerosols, in which case use a cat flea powder or cat flea collar.

PIGEONS: Spray each bird for 3‑5 seconds only according to size. Spray lightly at rear of bird from about 15" (38cms), parting feathers. Avoid eyes. Avoid spraying over food and water containers. Repeat every 3‑4 days until infestation is cleared. Use occasionally as a precaution, particularly after racing or showing. To help prevent reinfestation, also allow spray to fall on surroundings e.g. baskets, fittings, lofts. NOTE: Most effective way of treatment: one person holds bird, protecting its eyes with one hand, while second person parts feathers and applies spray.

Fleas from dogs & cats often infest animals' bedding, also carpets, soft furnishings and regular resting areas which should be treated with a suitable insecticide and vacuumed regularly. Wash and change pet bedding regularly.

5.9 Overdose (symptoms, emergency procedures, antidotes) (if necessary):

None stated.

5.10 Special warnings for each target species:

For external use only.

DOGS & CATS:

HAZARD WARNING: Keep treated animals away from fires and other sources of heat for at least 30 minutes following spraying and until the fur is totally dry.

Remove fleas from young animals and nursing bitches and queens by careful use of a flea comb.

PIGEONS:

Red Mite: as a periodic preventative and in cases of heavy infestation, the entire loft and fittings should be treated with a long-acting acaricide.

5.11 Withdrawal periods:

Not applicable to companion animals.

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5.12 Special precautions to be taken by the person administering the product to animals:

Do not breathe spray mist.

Use in well ventilated area.

Do not smoke when using this product.

Keep treated animals away from fires and other sources of heat for at least 30 minutes following spraying and until feathers/fur are totally dry.

Avoid contact with eyes. In case of accidental eye contact, wash eyes with copious amounts of water. If irritation persists, seek medical advice.

Do not handle the product if you are allergic to the active ingredients detailed below.

Wash hands after use.

Keep away from food and drink.

6. PHARMACEUTICAL PARTICULARS:

6.1 Incompatibilities (major):

6.2 Shelf-life:

30 months from date of manufacture when stored below 25C.

6.3 Special precautions for storage:

Do not store above 25C.

EXTREMELY FLAMMABLE. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material.

6.4 Nature and contents of container:

Pack Size: 150ml and 250ml

Container: Unlined tinplate aerosol can.

Closure/Dosing device: Valve and actuator delivering 0.85g product per second.

6.5 Name and Address of Licence Holder/Marketing Company:

Johnson's Veterinary Products Ltd

5 Reddicap Trading Estate

Sutton Coldfield

West Midlands B75 7DF

6.6 Special precautions for the disposal of unused product or waste materials, if any:

None.

Harmful to fish and crustaceans. Do not contaminate aquaria and fish bowls with the product. Dogs should not be allowed to swim until the fur is totally dry.

7.0 Final Information

MA No. Vm01759/4047

Date of last revision of SPC: 24.10.03

Date renewal issued: 21.03.03

Conditions of supply: GSL

May be sold or supplied otherwise than by or under the supervision of a pharmacist as a medicinal product on a General Sales List.

Issue No.	Date Issued:	Signed:	Position:	Reason for Issue:
03	24.10.03		QP	Revised per MA Renewal issued 21 March 2003.