Bob Martin 15% W/W Flea And Tick Collar For Dogs Over 12 Weeks Old

Summary

Revised: 22 July 2009

AN: 02106/2008

SUMMARY OF PRODUCT CHARACTERISTICS
1.	NAME OF THE VETERINARY MEDICINAL PRODUCT
	Bob Martin 15 % w/w Flea and Tick Collar for Dogs over 12 weeks old
2.	QUALITATIVE AND QUANTITATIVE COMPOSITION
	Active ingredient: Dimpylate ……………………………………………………….. Excipients: Flash black 19976 0.026% w/w……………………………….. Flash black 19976 0.0087% w/w and ferric oxide red (E172) 0.035% w/w …………………………... Ariabel scarlet 0.5% w/w or lithol rubine K4566 0.1% w/w …. Flash beige 40232 0.3% w/w ………………………………….. Tartrazine lake (E102) 0.28% w/w, blue alphazurine lake 0.12% w/w and titanium dioxide (E171) 0.1% w/w ………….. Flash blue 47949 0.16% w/w ………………………………….. Titanium dioxide (E171) 0.12% w/w and quinoline yellow aluminium lake (E104) 0.48% w/w or flash yellow 47948 0.3% w/w ………………………………….. Titanium dioxide (E171) 0.15% w/w …………………………... Titanium dioxide (E171) 0.45% w/w and lithol rubine K4566 0.001% w/w ………………………………..		15% w/w (3.6g per collar of 24g) (6.15g per collar of 41g) Black collar Brown collar Red collar Beige collar Green collar Blue collar Yellow collar White collar Pink collar

	For a full list of excipients, see section 6.1
3.	PHARMACEUTICAL FORM
	Collar. Coloured plastic strip provided with a buckle.
4.	CLINICAL PARTICULARS
4.1	Target species
	Dogs.
4.2	Indications for use, specifying the target species
	For the control of fleas and ticks on dogs for up to 5 months
4.3	Contraindications
	Do not use on puppies under 12 weeks of age.
4.4	Special warnings for each target species
	Do not allow animals to chew the collar. 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.
4.5	Special precautions for use
i.		Special precautions for use in animals
		For external use only.
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. Do not sleep with pets wearing collars. Dimpylate is an organophosphorus compound: DO NOT handle if under medical advice not to work with ANTICHOLINESTERASES. 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)
	Remove the collar immediately should any signs of skin irritation or adverse reactions occur. Remove THE collar from dog immediately should any signs of drowsiness, listlessness, TREMOR, HYPERSALIVATION or respiratory difficulties develop soon after fixing of collar.
4.7	Use during pregnancy, lactation or lay
	Not for use on nursing or lactating bitches. Remove fleas from young puppies and nursing bitches by careful use of a flea comb.
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 weighing 24 g and 60 cm in length, for dogs Insecticidal collar weighing 41 g and 65 cm in length, for large dogs. Remove the collar from the sachet/blister and fasten around the dog’s neck. When fitted to the growing dog, ensure the collar is loosened as the animal grows. In the fully-grown dog, a correct fitting will allow two fingers to be inserted between the collar and the neck. Any excess length of collar extending beyond the buckle should be cut and disposed of with the domestic refuse. The collar does not need to be removed when the animal is being bathed as the insecticidal activity remains unaffected by water. Leave in place until the collar effective life is exhausted. Replace after 5 months if reinfestation with fleas or ticks is a risk.
4.10	Overdose (symptoms, emergency procedures, antidotes), if necessary
	Dimpylate is an organophosphorus insecticide and atropine is antidotal. Remove the collar immediately if any signs of skin irritation or adverse reactions occur. Signs of over dosage include drowsiness, listlessness, tremor, hypersalivation or respiratory difficulties.
4.11	Withdrawal period
	Not applicable
5.	PHARMACOLOGICAL PROPERTIES
	ATC Vet Code: QP53AF03 The product contains diazinon as a parasiticide
5.1	Pharmacodynamic properties
	Dimpylate, an organophosphorus parasticide, is active against common fleas (Ctenocephalides) and ticks (Rhipicephalus or Dermacentor) of dogs. 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 particulars
	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 5 months.

6.	PHARMACEUTICAL PARTICULARS
6.1	List of excipients
	Flash black 19976 Ferric oxide red (E172) Ariabel scarlet Lithol rubine Flash beige Tartrazine lake (E102) Blue alphazurine lake Titanium dioxide (E171) Flash blue Quinoline yellow aluminium lake (E104) Flash yellow Polyvinyl Chloride Calcium Stearate Epoxidised Soya Bean Oil Dibutyl Phthalate
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 remove the collar from the pack until ready-to-use. Do not store above 25°C. Protect from direct sunlight.
6.5	Nature and composition of immediate packaging
	Blister pack of one 24g or 41g collar: pocket and lid in acrylonitrile/methyl acrylate/butadiene co-polymer on backing card. Sachet: paper/polyethylene/aluminium foil/polyethylene laminate. Box containing one or two sachets of one 24g or 41g collar. Not all collar 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 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 – 2065m – L.I.D. 06516 Carros Cedex France
8.	MARKETING AUTHORISATION NUMBER(S)
	Vm 05653/4091
9.	DATE OF FIRST AUTHORISATION
	Date: 23/01/2000
10.	DATE OF REVISION OF THE TEXT
	Date: July 2009