NAME: AMFLEE COMBO 50 MG/60 MG SPOT-ON SOLUTION FOR CATS AND FERRETS ACTIVE INGREDIENTS: Each 0.5 ml pipette contains: Fipronil 50 mg, S-methoprene 60 mg. EXCIPIENTS: Butylated hydroxyanisole (E320), butylhydroxytoluene (E321), povidone (K25), polysorbate 80, ethanol 96%, diethylene glycol monoethyl ether. THERAPEUTIC INDICATIONS: Cats: use for flea infestations alone or in association with ticks and/or biting lice. Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations of adult fleas persists for 4 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) from eggs laid by adult fleas for six weeks after application. Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The product has persistent acaricidal efficacy against ticks for up to 2 weeks. Elimination of biting lice (Felicola subrostratus). The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD), where previously diagnosed by a veterinarian. Ferrets: use for flea infestations, alone or in combination with ticks. Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations of adult fleas persists for 4 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) from eggs laid by adult fleas. Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The product has persistent acaricidal efficacy of up to 2 weeks against ticks. CONTRAINDICATIONS / ADVERSE REACTIONS: In the absence of available data, the product should not be used in kittens under 8 weeks of age and/or weighing less than 1 kg. This product should not be used in ferrets under 6 months of age. Do not use in sick animals (e.g. systemic diseases, fever) or in convalescent animals. Do not use in rabbits, due to the risk of adverse reactions or even death. Do not use in case of hypersensitivity to the active substance or to any of the excipients. DOSAGE: For external use only, spot-on. One pipette of 0.5 ml per cat, corresponding to the minimum recommended dose of 5 mg/kg fipronil and 6 mg/kg s-methoprene, for topical cutaneous administration. In the absence of safety studies, the minimum treatment interval is 4 weeks. One pipette of 0.5 ml per ferret, corresponding to the minimum recommended dose of 50 mg/kg fipronil and 60 mg/kg s-methoprene, for topical cutaneous administration. The minimum treatment interval is 4 weeks. Instructions for use: remove the pipette from the bag. Hold the pipette upright, twist and remove the cap. Turn the cap upside down and replace it on the other end of the pipette. Press and twist the cap to break the seal, then remove the cap from the pipette. Part the animals fur from the back of the animal at the base of the neck, in front of the shoulder blades, until the skin is visible. Place the tip of the pipette on the skin and press the pipette several times to empty the contents completely and directly onto the skin in one spot. STORAGE: 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. WARNINGS: Fleas present on animals often infest bedding, blankets and the animals usual resting areas, such as carpets and upholstered furniture. In case of heavy infestations and at the beginning of control measures, these should be treated with an appropriate insecticide and vacuumed regularly. There is no information available on the effect of bathing/shampooing on the efficacy of the product in domestic cats and ferrets. However, based on the information available for dogs bathed from 2 days of age, after application of the product, it is not recommended to bathe the animals for two days. Avoid contact with the eyes of the animal. It is important to ensure that the product is applied to an area where the animals cannot lick it and to ensure that the animals do not lick each other after treatment. Individual attachment of ticks may occur. For this reason, the transmission of infectious diseases cannot be completely excluded if conditions are favourable. Special precautions to be taken by the person administering the veterinary medicinal product to animals: This product may cause irritation of mucous membranes, skin and eyes. Therefore, contact of the product with the mouth, skin and eyes should be avoided. People with known hypersensitivity to insecticides or alcohol should avoid contact with the product. Avoid contact of the contents with the fingers. If this happens, wash hands immediately with soap and water. In case of accidental contact with eyes, rinse immediately with plenty of clean water. Wash eyes. Wash hands after use. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. Do not smoke, drink or eat during application. Treated animals should not be handled until the application site is dry and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended to treat animals not during the day but in the evening and to not allow recently treated animals to sleep with their owners, especially children. Overdose: The risk of adverse reactions may increase in case of overdose. In cats: In safety studies conducted in the target species, no adverse reactions were observed in cats and kittens aged 8 weeks or more and weighing approximately 1 kg, treated once a month with 5 times the recommended dose for 6 consecutive months. Itching may occur after treatment. Overdose may cause the coat to become sticky at the application site. However, if this occurs, it will disappear within 24 hours of application. In ferrets: In ferrets aged 6 months or older, treated every 2 weeks for four treatments at a dose 5 times the recommended dose, weight loss was observed in some animals. TARGET SPECIES: Cats, ferrets. INTERACTIONS: None known. ADVERSE REACTIONS: Do not overdose. Cats: Among the extremely rare suspected adverse reactions, transient skin reactions at the application site (desquamation, local alopecia, pruritus, erythema) and general pruritus or alopecia have been reported after use. Hypersalivation, reversible neurological symptoms (hyperaesthesia, depression, nervous symptoms), vomiting and/or respiratory symptoms have also been observed after use. If the animal licks itself, a brief period of hypersalivation may be observed due to the nature of the vector. PREGNANCY AND LACTATION: Cats: The product can be used during pregnancy. The potential toxicity of the product in kittens under 8 weeks of age in contact with treated adults has not been documented. Particular caution is recommended in this case. Ferrets: Laboratory studies in cats have not revealed any teratogenic, fetotoxic or maternotoxic effects. The safety of the veterinary medicinal product in pregnant and lactating ferrets has not been established. Use only according to a benefit/risk assessment