SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

JOHNSON’S FLEA GUARD COLLAR FOR CATS

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Diazinon 2.1g (15% W/W) per collar

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Collar

Matrix:

On the active strip, a reflecting band may be stuck.

4. CLINICAL PARTICULARS

4.1 Target species

Cats

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.

If signs of disease persist or appear, consult your veterinary surgeon.

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

Do not allow animals to chew the collar.

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Do not remove collar from the 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 flea 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.

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

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 Amounts to be administered and administration route

Insecticidal Collar for cats weighing 14 g and 35 cm in length.

Remove collar from sachet 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 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

Diazinon 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

Insecticidal collar for cats contains Diazinon as a parasiticide.

Therapeutic group: ectoparasiticides for topical use, organophosphorus compounds.

ATc Vet Code: QP53AF03

Diazinon, 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 Diazinon 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 Diazinon in insects is very slow, irreversible poisoning is achieved.

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

Diazinon being slowly released from the collar’s matrix, the product remains acti ve for up to 4 months.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Dyes
Flash Black 19976	for black collar
Flash Black 19976 and Red Ferric oxide	for brown collar
Ariabel Scarlet or Lithol Rubine K4566	for red collar
Flash Beige 40232	for beige collar
Tartrazine lake (E102), blue alphazurine lake and titanium dioxide	for green collar
Flash Blue 47949	for blue collar
Titanium dioxide (E171) and quinoline Yellow Certolake or Flash Yellow 47948®	for yellow collar
Titanium dioxide	for white collar
Titanium dioxide and Lithol Rubine K4566	for pink collar

6.2 Incompatibilities

Not known.

6.3 Shelf life

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.

Twin pack presentations containing 2 blister packs or 2 strip packs.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product 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 - 2065m – L.I.D.

06516 Carros

France

8. MARKETING AUTHORISATION NUMBER

Vm 05653/4093

9. DATE OF FIRST AUTHORISATION

23 January 2000

10. DATE OF REVISION OF THE TEXT

September 2016

29 September 2016