AMFLEE combo 50 mg/60 mg spot-on solution for cats and ferrets Fipronil, S-methoprene Active substances: Fipronil 50 mg S-methoprene 60mg Excipients: Butylhydroxyanisole (E320) 0.1 mg Butylhydroxytoluene (E321) 0.05 mg Yellow, transparent solution. Directions kitten For use against flea infestations, or mixed infestations with ticks and/or malophagous lice: - elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas is 4 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal action), larvae and pupae (larvicidal action) originating from eggs laid by adult fleas, persists for 6 weeks after application. - elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The product has a persistent acaricidal efficacy of up to 2 weeks against ticks. - elimination of malophagous lice (Felicola subrostratus). The product can be used as part of a treatment strategy to control flea allergy dermatitis (FAD), previously diagnosed by your veterinarian. ferrets For use against flea infestations, or mixed tick infestations: elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against reinfestations with adult fleas is 4 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal action), larvae and pupae (larvicidal action) originating from eggs laid by adult fleas. - elimination of ticks (Ixodes ricinus). The product has a persistent acaricidal efficacy of up to 4 weeks against ticks. CONTRAINDICATIONS In the absence of available data, the product should not be administered to kittens less than 8 weeks of age and/or weighing less than 1 kg. The product should not be administered to ferrets less than 6 months of age. Do not administer the product to sick animals (systemic diseases, fever) or to those in convalescence. Do not administer the product to rabbits due to the risk of serious adverse reactions or even death. Do not use in case of hypersensitivity to the active substance or to any of the excipients. ADVERSE REACTIONS Avoid overdose. kitten Among the very rare suspected adverse reactions, transient skin reactions at the site of application of the product (hair discoloration and loss, itching and erythema) and general itching or alopecia may be observed. Reversible neurological symptoms (hyperaesthesia, depression, other neurological signs), hypersalivation or vomiting have been observed after use. If animals lick the administration site, short-term hypersalivation may occur, mainly due to the excipients. If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinary surgeon. TARGET SPECIES Cats, ferrets. DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION For external use only, spot-on application. Amounts to administer: The contents of one pipette of 0.5 ml/cat, corresponding to the minimum recommended dose of 5 mg/kg fipronil and 6 mg/kg S-methoprene, are applied topically to the skin. The contents of a 0.5 ml pipette/ferret, corresponding to a dose of 50 mg fipronil and 60 mg S-methoprene, are applied locally to the skin. Method of administration: Remove a pipette from the packaging. Hold the pipette upright with the tip pointing upwards and unscrew the pipette cap. With the other end of the stopper thus removed, pierce the pipette seal, then remove the cap. Remove the animals hair from the midline between the shoulders to make the skin visible. Place the tip of the pipette on the skin and squeeze the tube several times to empty it directly onto the skin, in one spot. RECOMMENDATIONS ON CORRECT ADMINISTRATION The minimum interval between applications is 4 weeks. WAITING TIME Thats not the case. SPECIAL STORAGE PRECAUTIONS Keep out of sight and reach of children. Store in the original package in order to protect from light and moisture. This veterinary medicinal product does not require any special temperature storage conditions. Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP. The expiry date refers to the last day of that month. SPECIAL WARNING(S) Pet fleas often infest the animals bedding, bedding and regular resting areas, such as carpets and other soft materials, which should be treated, in case of massive infestation and when initiating control measures, with an appropriate insecticide and vacuumed regularly. No data are available on the effect of bathing/shampooing on the efficacy of the product in cats and ferrets. However, based on the information available for dogs shampooed 2 days after application, it is not recommended to bathe animals for 2 days after application. Avoid contact of the product with the eyes of animals. It is important to ensure that the product is applied in a protected area where the animal cannot lick it and animals should be avoided from licking each other after treatment. Sporadic tick infestations may occur. Thus, it is impossible to completely rule out the transmission of infectious diseases under unfavorable conditions. In cats, the product can be used during pregnancy. The potential toxicity of the product for cats under 8 weeks of age in contact with a treated cat is not documented. In this case, special care is required. In ferrets: Laboratory studies in cats have not shown any teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been established in ferrets during pregnancy and lactation. Use the product only after a benefit/risk assessment by the responsible veterinarian. In cats, overdose causes clumping of hair at the application site. However, this clumping will disappear 24 hours after application. In ferrets over 6 months of age treated once every 2 weeks, in four treatment sessions, with doses 5 times higher than the recommended dose, a decrease in body weight was observed. The risk of side effects may increase in case of overdose (see section 6 Side effects) Special precautions to be taken by the person administering the veterinary medicinal product to animals The product may cause irritation of mucous membranes, skin and eyes. Therefore, avoid contact of the product with the mouth, skin and eyes. People with known hypersensitivity to insecticides or alcohol should avoid contact with the product. Avoid direct hand contact with the product. In case of accidental contact, wash hands with soap and water. In case of contact with eyes, rinse thoroughly with clean water. Wash hands after use. In case of accidental ingestion, seek medical advice immediately and show the product leaflet or the product box. Do not smoke, drink or eat while applying the product. Do not touch treated animals and do not let children play with them until the application site of the product has dried. Therefore, it is not recommended to apply the treatment during the day but in the evening before going to bed, and animals should not be allowed to sleep with their owners, especially children. Product compliance information Product compliance information Product safety Manufacturer information Personal information Product safety information Currently, product safety information is not available. Manufacturer information Currently, manufacturer information is not available. Responsible person information Currently, information about the person responsible is not available. n Presentation type: Pipette Action: Ticks, Fleas, Lice Pieces Set: 3 pieces Cat Weight: No n Quantity: 3 Pipettes