SUMMARY OF THE PRODUCT CHARACTERISTICS

1. Name of the Veterinary medicinal product

Armitage Pet-Care Protect Flea Collar for Cats 15% w/w

2. Qualitative and quantitative composition

Active ingredient % w/w

Dimpylate 15

Each collar contains 2.1 g of dimpylate.

Excipients

The collars also contain the following pigments:

- heliogen K6911 HD 21 mg (blue strip)

- heliogen D8605 DD 14 mg (green strip)

- sicovit brown 75 105 mg (brown strip)

- sicopal brown K2595 21 mg (beige strip)

- paliogen K3911 HD 28 mg (red strip)

- paliogen K3911 HD 07 mg (pink strip)

- flash black 19976 42 mg (black strip)

- bayferrox 180 M 04.2 mg (grey strip)

- flash black 19976 01.12 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Collar.

Coloured collar of 14g – length 35 cm, available in blue, green, brown, beige, red, pink, black or grey.

Cats

4.2 Indications for use, specifying the target species

For the treatment and prevention of flea infestation in cats for up to 250 days.

4.3 Contra-indications

Do not use on kittens under 6 months of age

4.4 Special warnings for each target species

Remove collar from cat immediately should any signs of drowsiness, listlessness or respiratory difficulties develop soon after fixing of collar.

Do not allow animals to chew the collar.

For external use only.

Wash hands thoroughly after handling the collar.

Dimpylate is an organophosphorus compound. Do not handleif under medical advice not to work with ANTICHOLINESTERASES.

Do not allow children to play with collar.

Do no allow children to suck or chew the collar.

Do not sleep with pets wearing collars.

Do not smoke, eat or drink while handling the collar.

If you feel unwell after handling the collar, seek medical advice.

A slight irritation may appear on the neck due to the wearing of the collar. It is recommended to remove the collar from the animal until signs disappear.

Do not use in nursing females.

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

Do not use any other insecticide while the collar is being worn or within 7 days of removal.

One collar per animal.

Remove collar from sachet or blister and fasten around the cat’s neck, adjusting until a comfortable fit is achieved. In the fully-grown cat, correct fitting will allow one finger to be inserted between the collar and neck.

Any excess length of collar extending beyond the buckle should be cut off and disposed of in the household refuse. Leave in place until the collar effective life is exhausted. Activity remains extant against fleas for up to 250 days.

Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated with a suitable insecticide and vacuumed regularly.

Dympylate is an organophosphorus compound and atropine sulphate is antidotal.

Not applicable

5. Pharmacological properties

ATCvet code: QP53 AF03

Insecticidal collar for cats contains dympylate as a parasiticide

The product contains 15 % of dimpylate as insecticidal component. Dympylate is an organophosphorus compound which acts by inhibiting cholinesterases.

Dympylate, an organophosphorus parasiticide, is active against common fleas (Ctenocephalides).

Organophosphorus compounds act mainly by inhibiting insect enzymes such as cholinesterase responsible for degrading acetylcholine. As a result, cholinergic nerve transmission in the parasite is disrupted, inducing severe disorders such as spastic paralysis.

5.2 Pharmacokinetic properties

Due to the slow release of dympylate from the matrix of the collar, insecticidal activity remains for up to 250 days against fleas in cats.

6.1 List of excipients

HeliogenK6911 HD

Heliogen D8605 DD

Sicovit brown 75

Sicopal brown K2595

Paliogen K3911 HD

Flash black 19976

Bayferrox 180 M

Calcium carbonate

Calcium stearate

Epoxidised soya oil

Di isobutyl adipate

Calcium zinc complex LN 193R

Polyvinyl Chloride

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Store below 25 °C.

Protect from direct sunlight.

Keep away from direct heat.

6.5 Nature and composition of immediate packaging

Weight: 14 g - Length: 35 cm.

Collar available in blue, green, brown, beige, red, pink, black or grey.

The collars are packed individually in sachets or shells.

Sachet: thermo-sealed opaque white sachets composed of a four- layer

film (kraft paper, polyethylene, aluminium and polyethylene).

Shell: transparent colourless shells of acrylonitrile/methyl acrylate/butadiene terpolymer, heat sealed.

Not all pack sizes may be marketed.

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

EXTREMELY DANGEROUS to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the collar or empty packaging.

7. MARKETING AUTHORISATION HOLDER

Virbac S.A.

1^ère avenue - 2065 m - L.I.D.

06516 Carros Cedex

France

8. MARKETING AUTHORISATION NUMBER

Vm05653/4074

9. DATE OF FIRST AUTHORISATION

27 October 1999

August 2009