Dogs

For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus). The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks.

For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for at least 5 weeks. 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 sarcoptic mange (Sarcoptes scabiei). For the treatment of ear mite infestations (Otodectes cynotis).

For the treatment of demodicosis (Demodex canis).

For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for 28 days after treatment. The effect is indirect due to the activity of the veterinary medicinal product against the vector.

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

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

Transmission of B. canis canis cannot be completely excluded since D. reticulatus ticks have to attach to the host before being killed. As an acaricidal effect against D. reticulatus may take up to 48 hours, transmission of B. canis canis during the first 48 hours cannot be excluded.

The use of the veterinary medicinal product should be based on the local epidemiological situation including knowledge of the prevalent tick species as transmission of B. canis by tick species other than D. reticulatus is possible and should be part of an integrated control program to prevent the transmission of Babesia canis.

In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.3 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.

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

Wash hands after handling the veterinary medicinal product.

The accidental ingestion of the veterinary medicinal product may potentially result in adverse effects, such as transient excitatory neurological signs. To prevent children from accessing the veterinary medicinal product, only one chewable tablet at a time should be removed from the blister pack and only when required. The blister pack should then be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Not applicable.

Not applicable.

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

gastrointestinal signs (such as vomiting, diarrhoea)1 systemic disorders (such as lethargy, anorexia)1 neurological signs (such as tremor, ataxia, convulsions)2

1Mild and transient.

2In most cases these signs are 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 the package leaflet for respective contact details.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in animals intended for breeding. Laboratory studies in rats and rabbits have not produced any evidence of any teratogenic effects.

The use in these animals is not recommended.

The use in breeding animals is not recommended.

None known.

During clinical field trials, no interactions between this veterinary medicinal product and routinely used veterinary medicinal products were observed.

In laboratory safety studies, no interactions were observed when sarolaner was co- administered with milbemycin oxime, moxidectin and pyrantel pamoate. (In these studies efficacy was not investigated).

Sarolaner is highly bound to plasma proteins and might compete with other highly bound drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and the cumarin derivative warfarin.

For oral use.

Tablets can be administered with or without food.

The veterinary medicinal product should be administered at a dose of 2–4 mg/kg bodyweight in accordance with the following table:

Bodyweight (kg)	Tablet strength (mg sarolaner)	Number of tablets to be administered
1.3–2.5	5	One
> 2.5–5	10	One
> 5–10	20	One
> 10–20	40	One
> 20–40	80	One
> 40–60	120	One
> 60	Appropriate combination of tablets

Use appropriate combination of available strengths to achieve the recommended dose of 2–4 mg/kg.

To ensure a correct dosage, bodyweight should be determined as accurately as possible.

The tablets of this veterinary medicinal product are chewable and palatable and readily consumed by dogs when offered by the owner. If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth. The tablets should not be divided.

For optimal control of tick and flea infestations, the veterinary medicinal product should be administered at monthly intervals and continue throughout the flea and/or tick season based on local epidemiological situations.

For the treatment of ear mite infestations (Otodectes cynotis) a single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

For the treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) a single dose should be administered at monthly intervals for two consecutive months.

For the treatment of demodicosis (caused by Demodex canis) the administration of a single dose once monthly for three consecutive months is efficacious and leads to a marked improvement of clinical signs. Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart. As demodicosis is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately.

In a margin of safety study, the veterinary medicinal product was administered orally to 8 week old Beagle puppies at doses of 0, 1, 3, and 5 times the maximum exposure dose of 4 mg/kg at 28 day intervals for 10 doses. No adverse effects were observed at the maximum exposure dose of 4 mg/kg. In the overdose groups, transient and self-limiting neurological signs were observed in some animals: mild tremors at 3 times the maximum exposure dose and convulsions at 5 times the maximum exposure dose. All dogs recovered without treatment.

Sarolaner is well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 5 times the recommended dose. No treatment-related clinical signs were observed.

Not applicable.