4.2

Indications for use, specifying the target species

For the control of fleas on cats for up to 4 months

4.3

Contraindications

Do not use on kittens under 6 months of age

4.4

Special warnings for each target species

Do not allow animals to chew the collar.

Fleas from pets often infest animals’ basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated with a suitable insecticide and vacuumed regularly. Remove fleas from young kittens and nursing queens by careful use of a flea comb.

4.5

Special precautions for use

i.

Special precautions for use in animals

None

ii.

Special precautions for the person administering the veterinary medicinal product to animals

Do not allow children to play with the collar

Do not allow children to suck or chew the collar

Do not smoke, eat or drink while handling collar

Wash hands thoroughly after handling the collar

Dimpylate is an organophosphorus compound: DO NOT handle if under medical advice not to work with ANTICHOLINESTERASES.

Do not sleep with pets wearing flea collars

If you feel unwell following the use of this product, seek medical advice

iii.

Other precautions

None

4.6

Adverse reactions (frequency and seriousness)

A slight irritation on the neck may occasionally occur.

Remove collar immediately should any signs of skin irritation or adverse reaction occur.

REMOVE COLLAR FROM CAT IMMEDIATELY SHOULD ANY SIGNS OF DROWSINESS, LISTLESSNESS OR RESPIRATORY DIFFICULTIES DEVELOP SOON AFTER FIXING OF COLLAR

4.7

Use during pregnancy, lactation or lay

Not for use on nursing or lactating queens.

4.8

Interaction with other medicinal products and other forms of interaction

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

4.9

Amount(s) to be administered and administration route

Insecticidal collar for cats, weighing 14 g and 35 cm in length

Remove collar from pack and fasten around the cat’s neck adjusting until a comfortable fit is achieved. In the fully-grown cat, correct fitting will allow one index finger to be inserted comfortably between the collar and the neck. Any excess length of collar extending beyond the buckle should be cut off and disposed of with the domestic refuse. Replace every 4 months if flea reinfestation is a risk.

4.10

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

Dimpylate is an organophosphorus compound and atropine is antidotal.

Signs of overdosage include drowsiness, listlessness or respiratory difficulty.

4.11

Withdrawal period(s)

Not applicable

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Ectoparaciticides, insecticides and repellents, ectoparaciticides for topical use, incl. insecticides, organophosphorous compounds

ATC Vet Code: QP53AF03

Insecticidal collar for cats contains diazinon as a parasiticide

5.1

Pharmacodynamic properties

Dimpylate, an organophosphorus parasiticide, is active against common fleas (Ctenocephalides) of cats. It acts mainly by inhibiting insect enzymes such as cholinesterases. This is achieved when dimpylate competes with acetylcholine, responsible for nerve impulses, by binding to the esterase site of the cholinesterase molecules.

Acetylcholine, degraded at a lower pace, accumulates and induces disorders. Because the metabolism of dimpylate in insects is very slow, irreversible poisoning is achieved.

5.2

Pharmacokinetic properties

In mammals, cholinesterase activity similarly decreases. However, this is only transitory since enzyme synthesis is resumed and dimpylate is degraded within a very-short period of time.

Dimpylate being slowly released from the collar matrix, the product remains active for up to 4 months.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Dyes

Black collar: - flash black 19976

Brown collar: - flash black 19976

- red ferric oxide

Red collar: - ariabel scarlet

Red collar: - lithol rubine K4566

Beige collar: - flash beige 40232

Green collar: - tartrazine lake (E102)

- blue alphazurine lake

- titanium dioxide

Blue collar: - flash blue 47949

Yellow collar: - titanium dioxide (E171)

- Quinoline yellow aluminium lake (E104)

Yellow collar: - flash yellow 47948

White collar: - titanium dioxide

Pink collar: - titanium dioxide

- lithol rubine K4566

- Dibutyl phthalate

- Epoxidised soya-bean oil

- Calcium state

- Polyvinyl chloride

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

Do not store above 25°C

Protect from direct sunlight

Do not remove collar from the pack until ready-to-use

6.5

Nature and composition of immediate packaging

Blister pack: pocket and lid in acrylonitrile/methyl acrylate/butadiene co-polymer.

Strip pack: paper/polyethylene/aluminium foil/polyethylene laminate.

Available in packs of single collars or Twin-pack presentations containing 2 blister packs or 2 strip packs.

Not all pack sizes may be marketed.

6.6

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

Any unsed 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.

1ère avenue – 2065 m – L.I.D

06516 Carros Cedex

France

8.

MARKETING AUTHORISATION NUMBER(S)

Vm 05653/4097

9.

DATE OF FIRST AUTHORISATION

23 January 2000

10.

DATE OF REVISION OF THE TEXT

February 2010 (ATCVet code amended)