SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Fipralone duo 268 mg/80 mg spot-on solution for large dogs

Fiprokil duo 268 mg/80 mg spot-on solution for large dogs (FR)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One 2.68 ml pipette contains:

Active substances	2.68 ml pipette
Fipronil	268.00 mg
Pyriproxyfen	80.4 mg
Excipients
Butylhydroxyanisole	0.536 mg
Butylhydroxytoluene	0.268 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Spot-on solution.

Clear, colourless to yellowish solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs (20-40 kg)

4.2 Indications for use, specifying the target species

To be used against infestations with fleas alone or in association with ticks.

Against fleas:

Treatment and prevention of infestations by fleas (Ctenocephalides felis). One treatment prevents further infestations for 7 weeks.

Prevention of the multiplication of fleas by preventing flea eggs developing into adult fleas for 12 weeks after application.

Against ticks:

Treatment of infestations by ticks (Ixodes ricinus).

One treatment provides persistent acaricidal efficacy for 2 weeks againstIxodes ricinus, and for 4 weeks against Dermacentor reticulatusandRhipicephalus sanguineus.

If ticks of some species (Dermacentor reticulatus, Rhipicephalus sanguineus) are present at the time of application, not all ticks may be killed within 48 hours.

4.3 Contraindications

Do not use in rabbits, as adverse reactions and even death could occur.

Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.

4.4 Special warnings for each target species

Shampooing or immersion of the animal in water directly after treatment may reduce the duration of activity. The product remains effective against fleas for 5 weeks when the dog is shampooed at monthly intervals after treatment. If the dog requires shampooing, it is better to do so before treatment.

Water immersion repeated on two occasions post treatment did not affect adulticidal efficacy against fleas nor the efficacy related to the prevention of the development of flea eggs into adult fleas.

The influence of water immersion or shampooing of the dog on the efficacy of the product against ticks has not been evaluated.

At the beginning of the control measures, in the case of an infestation, the animal's basket, bedding and regular resting areas such as carpets and soft furnishings should be treated, with a suitable insecticide and vacuumed regularly.

To reduce environmental flea challenge, all animals living in the same household should also be treated with a suitable flea control product.

The product does not prevent ticks from attaching to animals. Transmission of infectious disease by ticks cannot be completely excluded if conditions are unfavourable.

Immediate efficacy has been demonstrated against Ixodes ricinus, indicating that ticks of this species are likely to be killed within 48 hours of product application. If Dermacentor reticulatusor Rhipicephalus sanguineusticks are present when the product is applied, these ticks may not be killed within the first 48 hours.

Once dead, ticks will often drop off the animal. Any remaining ticks should be carefully removed, ensuring that their mouth parts are not left within the skin.

4.5 Special precautions for use

Special precautions for use in animals

For external use only.

Animals should be weighed accurately prior to treatment.

In absence of safety data, the product should not be used in puppies less than 10 weeks old and/or weighing less than 2 kg.

Care should be taken to avoid the content of the pipette coming into contact with the eyes or mouth of the recipient dogs. In particular oral uptake due to the licking of the application site by treated or in-contact animals should be avoided.

Do not apply the product on wounds or damaged skin.

In the absence of additional safety studies, do not repeat the treatment at intervals of less than 4 weeks.

The use of the product has not been studied in sick and debilitated dogs.

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

The product may cause neurotoxicity.

The product may be harmful if swallowed.

Avoid contact with skin and mouth.

Avoid ingestion including hand-to-mouth contact.

Do not smoke, drink or eat during application.

Wash hands after use.

Treated animals should not be handled until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals should not be allowed to sleep with owners, especially children.

Keep the pipettes in the original packaging until ready for use and dispose of used pipettes immediately.

In the case of accidental skin contact, flush with water.

In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Other precautions

Fipronil and pyriproxyfen may adversely affect aquatic organisms. Dogs should be prevented from accessing streams and rivers for 48-hours following treatment (see also section 6.6).

The product may have adverse effects on painted, varnished or other household surfaces or furnishings. Allow the application site to dry before permitting contact with such materials.

4.6 Adverse reactions (frequency and seriousness)

Transient cosmetic effects such as wet appearance or slight scaling may occur at the application site.

According to the accumulated experience on these active ingredients within spot on pharmaceutical forms, transient cutaneous reactions at the application site (squamosis, local alopecia, pruritus, erythema,skin discolouration) and general pruritus or alopecia may be observed after use. In very rare instances, hypersalivation, reversible neurologic symptoms (hyperesthesia, depression, nervous symptoms), respiratory signs or vomiting might occur.

4.7 Use during pregnancy, lactation or lay

Laboratory studies using fipronil and pyriproxyfen have not shown any evidence of teratogenic or embryotoxic effect. Studies have not been carried out with this product in pregnant and lactating bitches. Use in pregnancy and lactation only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Spot-on use.

Dosage:

Apply one pipette of 2.68 ml per dog for a dog weighing from 20 to 40 kg corresponding to the minimal recommended dose of 6.7 mg fipronil /kg b.w. and 2 mg pyriproxyfen/kg b.w.

For dogs over 60 kg the appropriate combination of pipettes should be used.

Method of administration:

Remove the pipette from the overblister. Hold the pipette upright. Tap the narrow part of the pipette to ensure that the contents are within the main body of the pipette. Break the snap-off top of the spot-on pipette along the scored line.

Part the pet’s coat on base of the neck before the shoulder blades until the skin is visible. Place the tip of the pipette directly against the skin and squeeze gently several times to empty the contents. If necessary the contents of the pipette can be administered at one or two additional point(s) along the pet’s back to avoid run-off or more superficial application to the hair coat, particularly in large dogs.

Drop stop system (the product is released only by pressing the body of the pipette).