Contraindications
Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings
Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the veterinary medicinal product. Treated animals therefore should not be bathed until the solution has dried.
In the absence of the risk of co-infection with nematodes and cestodes, a narrow spectrum product should be used.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Special precautions for safe use in the target species:
Apply only to the skin surface and on intact skin. Do not administer orally or parenterally. Avoid the treated cat or other cats in the household licking the site of application while it is wet. There is limited experience on the use of the veterinary medicinal product in sick and debilitated animals, thus the veterinary medicinal product should only be used based on a benefit-risk assessment for these animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Do not smoke, eat or drink during application.
Avoid direct contact with application area while it is wet. Keep children away from treated animals during that time.
Once opened, use the entire contents of the pipette immediately.
Dispose of any used pipettes immediately after use.
Wash hands after use.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with plenty of water.
If skin or eye symptoms persist, or in case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Care should be taken not to allow children to have prolonged intensive contact (for example, by sleeping) with treated cats during the first 24 hours after application of the veterinary medicinal product.
Other precautions:
The solvent in this veterinary medicinal product may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the WOAH, specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Adverse events
Very rare (≤1 animal / 10,000 animals treated, including isolated reports): Systemic disorders (anorexia, lethargy), Digestive tract disorders (salivation, vomiting, diarrhoea)1, Neurological disorders (e.g. ataxia, tremor)1,2,3, Behavioural disorders (e.g. hyperactivity, anxiety, vocalisation), Application site disorders (alopecia, pruritus and/or inflammation)3
1As a result of the cat licking the application site immediately after treatment.
2Mild signs.
3Transient signs.
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Salivation, vomiting and neurological signs (tremor) were observed occasionally when the veterinary medicinal product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens. These symptoms were thought to occur as a result of the cat licking the application site. The symptoms were completely reversible. There is no known specific antidote.
Interaction with other medicinal products and other forms of interaction
Emodepside is a substrate for P-glycoprotein. Co-treatment with other drugs that are P-glycoprotein substrates/inhibitors (for example, ivermectin and other antiparasitic macrocyclic lactones, erythromycin, prednisolone and cyclosporine) could give rise to pharmacokinetic drug interactions. The potential clinical consequences of such interactions have not been investigated.