Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Ectoparasites need to start feeding on the host to become exposed to tigolaner; therefore, the risk of the transmission of vector borne diseases cannot be excluded.
Parasite resistance to any particular class of antiparasitics included in the fixed combination may develop following frequent, repeated use of antiparasitics of those classes under specific circumstances. The use of this veterinary medicinal product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the product. Treated animals, therefore, should not be bathed until the solution has dried.
Special precautions for use
Special precautions for use in animals
In the absence of available data, treatment of kittens under 10 weeks of age or weighing less than 1 kg is not recommended.
This veterinary medicinal product is for topical use and should not be administered in any other way e.g. orally.
Apply only onto intact skin. Apply as described in section 'Amounts to be administered and administration route' to prevent the animal from licking and ingesting the veterinary medicinal product. Avoid the treated cat or other cats in the household licking the site of application while it is wet. For signs observed after oral ingestion (e.g. licking) please refer to section 'Adverse reactions (frequency and seriousness)'.
The product may be an eye irritant. If accidental ocular contact occurs, flush the eyes immediately with clean water. If eye irritation occurs, seek veterinary advice.
There is no 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.
Acute signs of pneumonia may occur after treatment as a result of the inflammatory host response against the death of T. brevior lungworms especially in young cats.
The veterinary medicinal product should not be administered at intervals shorter than 8 weeks. Due to the product’s activity against fleas and ticks for a period of 3 months from a clinical point of view, the use of the product is not indicated at intervals shorter than three months.
No target animal safety data beyond 4 consecutive treatments are available and accumulation of tigolaner is likely. Repeated treatments should be restricted to limited individual situations according to a benefit-risk evaluation by the responsible veterinarian. Please refer to sections: 'Overdose' and 'Pharmacokinetic Particulars'.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The veterinary medicinal product may cause neurological symptoms and can transiently elevate blood glucose levels following accidental ingestion.
Do not smoke, eat or drink during application.
Wash hands after use.
Used applicators should be disposed of immediately and should not be left within the sight or reach of children.
In case of accidental contact of the applicator content to skin, wash off immediately with soap and water.
The veterinary medicinal product may be an eye irritant. 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, especially by children, seek medical advice immediately and show the package leaflet or the label to the physician.
Since foetotoxic effects are described in laboratory animals after exposure to tigolaner and emodepside, pregnant women and women intending to conceive should wear gloves to avoid direct contact with the product.
Pregnant women should avoid contact with the site of application during the first 24 hours after application of the product and until the treated area is no longer noticeable. Keep children away from treated animals during the first 24 hours after application of the product. Care should be taken not to allow children to have prolonged intensive contact with treated cats until the treated area is no longer noticeable. It is recommended to treat animals in the evening. On the day of treatment, treated animals should not be permitted to sleep in the same bed as their owner, especially children and pregnant women.
The veterinary medicinal product may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
Adverse reactions (frequency and seriousness)
Mild and transient application site reactions following administration such as scratching, erythema, thinning of hair and/or inflammation may occur in very rare cases. Cosmetic effects such as a temporary spiking of the hair at the application site are commonly observed.
Neurological disorders such as ataxia and tremor may occur in very rare cases.
Mild and transient digestive tract disorders such as hypersalivation or vomiting may occur in very rare cases. These effects are thought to occur as a result of the cat licking the application site immediately after treatment. In individual cases these signs can be accompanied by non-specific signs such as agitation, vocalisation or inappetence.
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
Foetotoxic effects are described in laboratory animals after exposure to tigolaner and emodepside. The safety of the veterinary medicinal product has not been established in pregnant or lactating cats and, therefore, use in such animals is not recommended.
Interaction with other medicinal products and other forms of interaction
Emodepside is a substrate for P-glycoprotein. Co-treatment with other substances 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
After administration of 4 consecutive treatments of up to 5 times the maximum recommended dose in kittens starting at 10 weeks of age and adult cats, a decrease in thyroid weight was noted in some male animals. In adult cats, a transient elevation in liver enzymes (AST, ALT), accompanied by multifocal liver congestion in one individual, was noted in the high dose group (5x) and an elevation in cholesterol in all overdose groups (3x, 5x). No systemic clinical signs were observed. In the high (5x) dose group, cases of local reactions at the application site occurred (alopecia, erythema, hyperplasia of the epidermis and/or inflammatory infiltrates).
There is no antidote known.