Simparica Chewable Tablets for Dogs contain Sarolaner and are used for:
- the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis) in dogs. Simparica has immediate and persistent flea killing activity against new infestations for at least 5 weeks. Simparica can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
- the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus). Simparica has immediate and persistent tick killing activity for at least 5 weeks.
- the treatment of sarcoptic mange (Sarcoptes scabiei).
- the treatment of ear mite infestations (Otodectes cynotis).
- the treatment of demodicosis (Demodex canis).
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.
- Parasites need to start feeding on the host to become exposed to sarolaner; therefore, the transmission of infectious parasite-borne diseases cannot be excluded.
- 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.
- Mild and transient gastrointestinal signs such as vomiting and diarrhoea, and systemic disorders such as lethargy, anorexia/inappetence may occur in very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports) based on post-marketing safety experience. These signs typically resolve without treatment. Neurological disorders such as tremor, ataxia or convulsion may occur in very rare cases based on post-marketing safety experience. In most cases these signs are transient.
- The safety of Simparica 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. Use only according to the benefit/risk assessment by the responsible veterinarian.
- Simparica has been administered orally to 8 week old Beagle puppies at doses of 0, 1, 3, and 5 times the maximum dose of 4 mg/kg at 28 day intervals for 10 doses. No adverse effects were observed at the maximum 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 dose and convulsions at 5 times the maximum 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.
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