Contraindications
- Do not use in cases of hypersensitivity to the active substance (fluralaner or moxidectin) or to any of the excipients.
Special warnings for each target species
- Ticks and fleas need to start feeding on the host to become exposed to fluralaner; therefore, the risk of the transmission of parasite borne diseases cannot be excluded.
- Cats in areas endemic for heartworm (or those which have travelled to endemic areas) may be infected with adult heartworms. No therapeutic effect against adult Dirofilaria immitis has been established. It is therefore recommended, in accordance with good veterinary practice, that animals of 6 months of age or older and living in areas where a vector exists, should be tested for existing adult heartworm infections before application of the veterinary medicinal product for the prevention of heartworm disease.
- For the prevention of heartworm disease in cats that are only temporarily in endemic areas, the veterinary medicinal product should be applied before the first expected exposure to mosquitoes and should be continued at 12-week intervals until return to a non-endemic area. The period between treatment and return from the endemic areas should not exceed 60 days.
- For the treatment of infections with ear mites (Otodectes cynotis) or the gastrointestinal nematodes T. cati and A. tubaeforme, the need for, and the frequency of, re-treatment as well as the choice of the treatment (monosubstance or combination product) should be evaluated by the prescribing veterinarian.
- Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC 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.
- Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class under specific circumstances. Parasite control is recommended throughout the period of potential infestation risk.
- The possibility that other animals in the same household can be a source of re-infection with fleas, ear mites or gastrointestinal nematodes should be considered, and these should be treated as necessary with an appropriate veterinary medicinal product.
- Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the product in these cases has not been tested.
- No therapeutic effect against adult A. abstrusus has been established. For the treatment of pre-existing infections with adult A. abstrusus, administration of a product authorised for treatment of adult A. abstrusus is required.
Special precautions for use in animals
- Care should be taken to avoid contact with the eyes of the animal.
- Do not use directly on skin lesions.
- In the absence of available data, treatment of kittens less than 9 weeks of age and cats less than 1.2 kg bodyweight is not recommended.
- Treatment of male breeding animals is not recommended.
- This veterinary medicinal product is for topical use and should not be administered orally.
- Oral uptake of the veterinary medicinal product at the maximum recommended dose of 93 mg fluralaner + 4.65 mg moxidectin/kg body weight induced some self-limiting salivation or single incidences of vomiting immediately after administration.
- It is important to apply the dose as indicated to prevent the animal from licking and ingesting the veterinary medicinal product (see sections 4.6 and 4.9).
- Do not allow recently treated animals to groom each other.
- Do not allow treated animals to come into contact with untreated animals until the application site is dry.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
- Contact with the veterinary medicinal product should be avoided and disposable protective gloves obtained with this veterinary medicinal product at the point of sale must be worn when handling the veterinary medicinal product for the following reasons:
- Hypersensitivity reactions have been reported in a small number of people, which can potentially be serious.
- Persons with a hypersensitivity to fluralaner or to any of the excipients should avoid any exposure to the veterinary medicinal product.
- The veterinary medicinal product binds to skin and may also bind to surfaces after spillage of the product.
- Skin rashes, tingling or numbness have been reported in a small number of individuals after skin contact.
- If skin contact does occur, wash the affected area immediately with soap and water. In some cases, soap and water are not sufficient to remove the product spilled on the fingers.
- Contact with the veterinary medicinal product may also occur when handling the treated animal.
- Make sure that your animal's application site is no longer noticeable before resuming contact with the site of application. This includes cuddling the animal and sharing a bed with the animal. It takes up to 48 hours for the application site to become dry but it will be noticeable for longer.
- If skin reactions occur, consult a physician and show them the veterinary medicinal product packaging.
- People with a sensitive skin or known allergy in general e.g., to other veterinary medicinal products of this type should handle the veterinary medicinal product as well as treated animals with caution.
- This veterinary medicinal product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
- This veterinary medicinal product is harmful after ingestion. Keep the veterinary medicinal product in the original packaging until use, in order to prevent children from getting direct access to the veterinary medicinal product. A used pipette should immediately be disposed of. In case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician.
- The veterinary medicinal product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition. In case of spillage onto, for example table or floor surfaces, remove excess product using paper tissue and clean the area with detergent.
- Special precautions for the protection of the environment: Not applicable.
Adverse reactions (frequency and seriousness)
Cats.
- Common (1 to 10 animals / 100 animals treated): Skin reactions at the application site (application site alopecia, flaking skin, application site reddening and application site pruritus)#.
- Uncommon (1 to 10 animals / 1,000 animals treated): Dyspnoea (after licking the application site), Tachypnoea; Hypersalivation, Emesis, Haematemesis, Diarrhoea; Lethargy, Pyrexia; Mydriasis.
- Very rare (<1 animal / 10,000 animals treated, including isolated reports): Anorexia; Neurological disorders (e.g. tremor, ataxia).
#mild and transient
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 the national competent authority via the national reporting system. See also “Contact details” of the package leaflet.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in pregnant or lactating animals and therefore use in such animals is not recommended.
Interaction with other medicinal products and other forms of interaction
Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein. Therefore, during treatment with the veterinary medicinal product, other products that can inhibit p-glycoprotein (e.g., cyclosporine, ketoconazole, spinosad, verapamil) should only be used concomitantly according to the benefit-risk assessment of the responsible veterinarian.
