For the treatment of tick and flea infestations in dogs.

This veterinary medicinal product is a systemic insecticide and acaricide that provides:

- immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks,

- immediate and persistent tick killing activity for 12 weeks for Ixodes ricinus, Dermacentor reticulatus and D. variabilis,

- immediate and persistent tick killing activity for 8 weeks for Rhipicephalus sanguineus.

- persistent tick killing activity from 7 days to 12 weeks after treatment for Ixodes hexagonus.

Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

For the treatment of demodicosis caused by Demodex canis.

For the treatment of sarcoptic mange (Sarcoptes scabiei var. canis) infestation.

For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for up to 12 weeks. The effect is indirect due to the veterinary medicinal product’s activity against the vector.

For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for up to 12 weeks. The effect is indirect due to the veterinary medicinal product’s activity against the vector.

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

Parasites need to start feeding on the host to become exposed to fluralaner; therefore the risk of the transmission of parasite borne diseases (including Babesia canis canis and D. caninum) cannot be completely excluded.

Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal.

The possibility that other animals in the same household can be a source of re-infection with parasites should be considered, and these should be treated as necessary with an appropriate veterinary medicinal product.

Use with caution in dogs with pre-existing epilepsy.

In the absence of available data, the veterinary medicinal product should not be used on puppies less than 8 weeks old and /or dogs weighing less than 2 kg.

The veterinary medicinal product should not be administered at intervals shorter than 8 weeks as the safety for shorter intervals has not been tested.

Keep the veterinary medicinal product in the original packaging until use, in order to prevent children from getting direct access to the veterinary medicinal product.

Hypersensitivity reactions in humans have been reported.

Do not eat, drink or smoke while handling the veterinary medicinal product.

Wash hands thoroughly with soap and water immediately after use of the veterinary medicinal product.

Not applicable.

Not applicable.

Dogs

Mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling were commonly observed in clinical trials (1.6% of treated dogs).

# mild and transient

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.

Fluralaner is highly bound to plasma proteins and might compete with other highly bound active substances such as non-steroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative warfarin. Incubation of fluralaner in the presence of carprofen or warfarin in dog plasma at maximum expected plasma concentrations did not reduce the protein binding of fluralaner, carprofen or warfarin.

During clinical field testing, no interactions between the veterinary medicinal and routinely used veterinary medicinal products were observed.

The veterinary medicinal product should be administered in accordance with the following table (corresponding to a dose of 25 – 56 mg fluralaner/kg body weight within one weight band):

The chewable tablets should not be broken or divided.

For dogs above 56 kg bodyweight, use a combination of two tablets that most closely matches the bodyweight.

Administer the veterinary medicinal product at or around the time of feeding.

The chewable tablet is well accepted by most dogs. If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth. The dog should be observed during administration to confirm that the tablet is swallowed.

For optimal control of flea infestation, the veterinary medicinal product should be administered at intervals of 12 weeks. For optimal control of tick infestation, the timing of retreatment depends on the tick species. See also section "Indications for use".

For the treatment of Demodex canis mite infestations, a single dose of the veterinary medicinal product should be administered. As demodicosis is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately.

For the treatment of sarcoptic mange infestations (Sarcoptes scabiei var. canis), a single dose of the veterinary medicinal product should be administered. The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian.

No adverse reactions were observed following oral administration to puppies aged 8 – 9 weeks and weighing 2.0 – 3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg fluralaner/kg body weight) on three occasions at shorter intervals than recommended (8-week intervals).

There were no findings on reproductive performance and no findings of concern on offspring viability when fluralaner was administered orally to Beagle dogs at overdoses of up to 3 times the maximum recommended dose (up to 168 mg/kg body weight of fluralaner).

The veterinary medicinal product was well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose (168 mg/kg body weight). No treatment-related clinical signs were observed.