Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
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 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.
When treating infestations of parasites, all in-contact 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 product is not affected if treated dogs are exposed to water.
Special precautions for use
Special precautions for use in animals
In the absence of available data, a veterinary surgeon should be consulted before 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 carton.
Wash hands after handling the product.
Other precautions
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.
Adverse reactions (frequency and seriousness)
Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, anorexia, and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely. Most reported adverse reactions were self-limiting and of short duration.
The frequency of adverse reactions is defined using the following convention:
∙ very common (more than 1 in 10 animals treated displaying adverse reaction(s))
∙ common (more than 1 but less than 10 animals in 100 animals treated)
∙ uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
∙ rare (more than 1 but less than 10 animals in 10,000 animals treated)
∙ very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Can be used in breeding, pregnant and lactating female dogs.
The safety of the veterinary medicinal product has not been established in breeding males.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males.
Consult a veterinary surgeon before treatment of breeding males.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions 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 two to four weeks.
Withdrawal period(s)
Not applicable.