Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
Unnecessary use of antiparasitics or use deviating from the instructions provided 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.
Parasites need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of parasite borne diseases cannot be excluded.
The possibility that other animals in the same household can be a source of re-infestation with fleas and/or ticks should be considered, and these animals should be treated with an appropriate product at the same time.
All stages of fleas can infest the dog’s bedding and regular resting areas such as carpets and soft furnishings. In case of massive flea infestation and at the beginning of the control measures, these areas should be treated with a suitable environmental product and then vacuumed regularly.
Activity of the veterinary medicinal product is not affected if treated dogs are exposed to water.
Special precautions for use
Special precautions for safe use in the target species
In the absence of available data, a veterinary surgeon should be consulted before commencing treatment of puppies less than 8 weeks of age and/or dogs less than 2 kg bodyweight.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may be harmful following ingestion.
To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister. Return the blister with the remaining chewable tablets into the cardboard box.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after handling the veterinary medicinal product.
Special precautions for the protection of the environment:
The active substance is mostly excreted in the faeces (poo) and may be toxic to non-target organisms. To avoid contamination of the environment, ensure that dog faeces are bagged up and disposed of safely.
Other precautions:
Not applicable.
Adverse events
Very rare (<1 animal / 10 000 animals treated, including isolated reports): | Neurological disorders (convulsions1, ataxia1 and muscle tremors1). Pruritus1. Lethargy1, anorexia1. Digestive tract disorders2 (vomiting1, diarrhoea1). |
1 Most reported adverse events were self-limiting and of short duration.
2 Usually mild.
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.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used in pregnant and lactating female dogs.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects.
Fertility:
Can be used in breeding female dogs. The safety of the veterinary medicinal product has not been established in breeding males. In breeding males, a veterinary surgeon should be consulted before commencing treatment.
Laboratory studies in rats and rabbits have not produced any evidence of any adverse effect on the reproductive capacity of males.
Interaction with other medicinal products and other forms of interaction
None known.
Symptoms of overdose (and where applicable emergency procedures and antidotes
No adverse events were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of 2-4 weeks.
Withdrawal periods
Not applicable.