NAME FRONTLINE COMBO SPOT-ON CATS ACTIVE INGREDIENTS Each 0.5 ml pipette contains: fipronil 50.00 mg, (S)-methoprene 60.00 mg, butylhydroxyanisole (E320) 0.10 mg, butylhydroxytoluene (E321) 0.05 mg. For a full list of excipients, see section 6.1. EXCIPIENTS Butylhydroxyanisole (E320), butylhydroxytoluene (E321), ethanol, polysorbate 80 (E433), polyvidone, diethylene glycol monoethyl ether. THERAPEUTIC INDICATIONS In cats: for use against flea infestations, alone or in combination with ticks and biting lice. Eliminates fleas (Ctenocephalides spp.). Insecticidal activity against new infestations of adult fleas persists for 4 weeks. Prevents flea multiplication by inhibiting the development of eggs (ovicidal activity), pupae and larvae (larvicidal activity) hatched from eggs laid by adult fleas for 6 weeks after application. Eliminates ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The product has persistent activity against ticks for up to 2 weeks (based on experimental data). Eliminates biting lice (Felicola subrostratus). Frontline Combo Spot-on Cats can be used in the control program of flea allergy dermatitis (FLD). In ferrets: for use against flea infestations, alone or in combination with ticks. Eliminates fleas (Ctenocephalides spp.). Insecticidal activity against new infestations of adult fleas persists for 4 weeks. Prevents flea multiplication by inhibiting the development of eggs (ovicidal activity), pupae and larvae (larvicidal activity) hatched from eggs laid by adult fleas. Eliminates ticks (Ixodes ricinus). The product has acaricidal activity against ticks that persists for 4 weeks (based on experimental data). CONTRAINDICATIONS / ADVERSE EFFECTS: In the absence of data, do not use the product in kittens under 8 weeks of age and/or weighing less than 1 kg. Do not use the product in ferrets under 6 months of age. Do not use in sick animals (e.g. systemic diseases, fever) or convalescents. Do not use in rabbits, as potentially fatal adverse reactions may occur. In the absence of studies, it is recommended not to use the product in species other than the target species. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. SAFETY IN TARGET SPECIES: The risk of adverse reactions (see section 4.6) may increase in case of overdose. In cats: In safety studies, no adverse reactions were observed in cats and kittens 8 weeks of age and older and weighing approximately 1 kg, treated once a month at doses five times the recommended dose for six consecutive months. Itching may occur after treatment. Application of a higher than recommended dose results in a wet and sticky appearance of the hair at the application site. However, if this occurs, it will disappear within 24 hours of application. In ferrets: In ferrets 6 months of age and older, treated four times every 2 weeks at doses five times the recommended dose, a decrease in body weight was observed in some subjects. DOSAGE: For external use only. Spot-on application. 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 application. In the absence of safety data, the minimum treatment interval should be 4 weeks. One pipette of 0.5 ml per ferret, corresponding to 50 mg fipronil and 60 mg (S)-methoprene, for topical cutaneous application. The minimum treatment interval should be 4 weeks. Administration: Hold the pipette upright and tap the narrow end gently so that the liquid remains in the wide end of the pipette. Break off the pre-cut end. Part the hair at the base of the neck, on the back of the animal, between the shoulder blades and expose the skin. Place the tip of the pipette on the skin and press the pipette several times until it is completely empty, applying the product directly to a single spot on the skin. STORAGE: Store below 30 degrees C. Store in the original packaging. Shelf life of the veterinary medicinal product as packaged for sale: 36 months. WARNINGS: Avoid contact with the animals eyes. Other animals living in the same household should also be treated with an appropriate product. Special precautions for use in animals: It is important that the product is applied to an area where the animal cannot lick itself and care should be taken that the animals do not lick each other after treatment. In cats and ferrets, there is no information available on the extent to which immersion in water or bathing may affect the activity of the product. However, based on data obtained from dogs bathed starting 2 days after application of the product, it is recommended to avoid bathing for 2 days after application. Individual ticks may attach to the cat. Therefore, under unfavourable conditions, the transmission of infectious diseases cannot be completely excluded. Fleas present on animals often infest the pets bedding, bedding and living areas, especially carpets, curtains and soft furnishings. In case of heavy infestations and at the beginning of the antiparasitic treatment, these should be treated with an appropriate insecticide and vacuumed regularly. The potential toxicity of Frontline Combo Spot-On Cats to kittens under 8 weeks of age in contact with a treated mother has not been documented. Particular caution is recommended in this case. 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. It is therefore recommended to avoid contact with the mouth, skin and eyes. People with known hypersensitivity to insecticides or alcohol should avoid contact with the product. Avoid contact of the contents with hands. If this happens, wash hands with soap and water. In case of accidental contact with eyes, rinse thoroughly with water. Wash hands after use. Do not handle animals or allow children to play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day but in the evening and, if recently treated, they should not be allowed to sleep with their owners, especially children. Do not smoke, drink or eat during application. The risk of adverse reactions (see section 4.6) may increase in case of overdose. In cats: In safety studies, no adverse reactions were observed in cats and kittens aged 8 weeks and over and weighing approximately 1 kg, treated once a month at doses five times the recommended dose for six consecutive months. Itching may occur after treatment. Applying a dose higher than the recommended dose results in a wet and sticky appearance of the hair at the application site. However, if it occurs, it will disappear within 24 hours of application. In ferrets: In ferrets aged 6 months and over, treated four times every 2 weeks at doses five times the recommended dose, a decrease in body weight was observed in some subjects. Incompatibilities: No incompatibilities known. TARGET SPECIES: Cats and ferrets. INTERACTIONS: No interactions known. DIAGNOSIS AND PRESCRIPTION: Sale is not reserved exclusively to pharmacies and does not require a veterinary prescription. ADVERSE REACTIONS: Do not exceed the recommended dose. Among the extremely rare suspected adverse reactions, transient skin reactions at the application site (desquamation, local hair loss, itching, redness) and itching or widespread hair loss after application have been described. Hypersalivation, reversible neurological symptoms (increased sensitivity to stimulation, depression, other nervous symptoms) or vomiting have also been observed. If animals lick themselves, transient hypersalivation may be observed, mainly due to the excipients of the product. The frequency of adverse reactions is defined using the following convention: very common (more than 1 in 10 animals treated displaying adverse reactions); 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). PREGNANCY AND LACTATION In cats: The product can be used during pregnancy. For treatment during lactation, see section 4.5. In ferrets: Laboratory studies in cats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been established during pregnancy and lactation in ferrets. Use only according to the benefit/risk assessment by the responsible veterinarian