Medine.co.uk

Bob Martin 15% W/W Flea Collar For Cats

Revised: February 2010

(ATCVet code amended)

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT


Bob Martin 15% w/w Flea Collar for Cats

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION


Active ingredient

Each collar contains:

Dimpylate 15% w/w ………..


Excipients

Black collar: - Flash black 19976- 0.026 % w/w…………………………

Brown collar:- flash black 19976- 0.0087 % w/w……………………….

- red ferric oxide 0.035 % w/w……………………………...

Red collar: - ariabel scarlet 0.5 % w/w…………………………….......

Red collar: -lithol rubine K4566- 0.1 % w/w…………………………….

Beige collar: - flash beige 40232- 0.3 % w/w…………………………….

Green collar: - tartrazine lake (E102) 0.28 % w/w………………….......

- blue alphazurine lake 0.12 % w/w……………………….

- titanium dioxide 0.1 % w/w………………………………

Blue collar: - flash blue 47949- 0.16 % w/w………………………......

Yellow collar: - titanium dioxide (E171) 0.12 % w/w…………………….

- Quinoline yellow aluminium lake (E104) 0.48 % w/w. ..

Yellow collar: - flash yellow 47948- 0.30 % w/w…………………………

White collar: - titanium dioxide 0.15 % w/w………………………….......

Pink collar: - titanium dioide 0.45 % w/w……………………………...

- lithol rubine K4566- 0.001 % w/w………………………..


On the active strip, a reflecting band may be stuck


For a full list of excipients, see section 6.1



2.1 g


0.00364 g

0.001218 g

0.0049 g

0.07 g

0.014 g

0.042 g

0.0392 g

0.0168 g

0.014 g

0.0224 g

0.0168 g

0.0672 g

0.042 g

0.021 g

0.063 g

0.00014 g

3.

PHARMACEUTICAL FORM


Collar.

Colour supple plastic strip provided with a buckle

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.

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)




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