metadata toggle
Contra-indications, warnings, etc
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.
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 for 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.
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 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.
User warnings:
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 label to the physician.