SUMMARY OF PRODUCTS CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Dog Flea Collar with Dimpylate 15% w/w.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance % w/w mg/collar

Dimpylate (as dimpylate stabilised) 15.0 3600

Excipients % w/w mg/collar

Brown collar: Ferric oxide red (E172) 0.08 19.2

Charcoal, vegetable (E153) 0.02 4.8

For full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Collar.

Coloured flea collar fitted with safety buckle.

4.

CLINICAL PARTICULARS

4.1

Target species

Dogs.

4.2

Indications for use, specifying the target species

Treatment of dogs infested with fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).

4.3

Contraindications

No other insecticide should be used with the collar or within 7 days of removal.

Do not allow the collar to come into contact with nursing females.

Do not use the collar on dogs younger than 12 weeks.

4.4

Special warnings for each target species

Remove collar if any sign of skin irritation occurs.

Check the collar is not too tight, to ensure against irritation.

Do not allow animals to chew the collar.

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

4.5

Special precautions for use

i.

Special precautions for use in animals

For external use only.

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

ii.

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

Do not remove collar from pack until ready to use.

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.

Do not sleep with pets wearing collars.

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

Avoid excessive handling of the collar.

Cut off any excess collar with scissors and dispose of safely.

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

iii.

Other precautions

To help prevent reinfestation, animals’ bedding and regular resting areas, including carpets and soft furnishings, should be treated with a suitable insecticide and vacuumed regularly.

After fitting the collar, do not allow dogs to swim in ponds or other small bodies of water. This will not adversely affect the activity of the collar but is potentially dangerous to aquatic life.

4.6

Adverse reactions (frequency and seriousness)

Typical adverse reactions to organophosphorus compounds are rare.

4.7

Use during pregnancy, lactation or lay

Do not allow contact with nursing females.

4.8

Interaction with other medicinal products and other forms of interaction

Do not combine with other organophosphorus compounds or medicines which are not compatible with organophosphorus compounds.

4.9

Amount(s) to be administered and administration route

One collar per animal to be fastened around the neck. Fasten the collar around the dog’s neck, ensuring a comfortable fit; two fingers should fit easily under the collar. Loosen the collar as the dog grows bigger. Cut off excess collar extending beyond buckle and dispose of with the household refuse. Replace collar after 4 months if flea and tick re-infestation is a risk.

4.10

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

Symptoms: Tearing, salivation, muscle twitches, vomiting, loss of reflexes, coma, cyanosis.

Emergency procedure: Remove collar.

Antidote: Atropine.

4.11

Withdrawal period

Not applicable.

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Ectoparasiticides for topical use, incl. insecticides.

ATC Vet Code: QP53AF03

Pharmacodynamic properties

5.1

The collar is applied around the cat’s neck. The collar constantly releases dimpylate over a four month period. Fleas on the skin of the animal come into contact with the dimpylate and are killed.

Pharmacokinetic properties

5.2

Dimpylate is an organophosphorus compound with a non-systemic action.

Environmental properties

5.3

PHARMACEUTICAL PARTICULARS

6.

List of excipients

6.1

Charcoal Vegetable (E153)

Ferric Oxide Red (E172)

Polyvinyl chloride

Dibutyl phthalate

Epoxidised Soya Bean Oil

Calcium Stearate

Incompatibilities

6.2

Morphine, theophylline, aminophylline, large amounts of intravenous fluids, phenothiazine drugs, pyrantel palmoate.

Shelf life

6.3

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

Special precautions for storage

6.4

Protect from direct sunlight.

Do not store above 25°C.

Do not remove the collar from the pack until you are ready to fit it.

Nature and composition of immediate packaging

6.5

Paper/aluminium foil/low density polyethylene sachet, containing one PVC collar.

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

6.6

Any 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.

MARKETING AUTHORISATION HOLDER

7

Bob Martin (UK) Ltd.

Wemberham Lane

Yatton, Somerset

BS49 4BS, U.K.

MARKETING AUTHORISATION NUMBER

8.

Vm: 00715/4112

DATE OF FIRST AUTHORISATION

9.

Date: 27 August 2010

DATE OF REVISION OF THE TEXT

10.

Date: October 2013