NAME FRONTLINE COMBO SPOT-ON DOGS PP ACTIVE INGREDIENTS Each 0.67 ml pipette contains Fipronil: 67.00 mg; (S)-methoprene: 60.30 mg; Butylhydroxyanisole (E320): 0.13 mg; Butylhydroxytoluene (E321): 0.07 mg. For the full list of excipients, see section 6.1. EXCIPIENTS Butylhydroxyanisole (E320), butylhydroxytoluene (E321), ethanol, polysorbate 80 (E433), polyvidone, diethylene glycol monoethyl ether. THERAPEUTIC INDICATIONS For the treatment of dogs weighing between 2 and 10 kg: use against infestations with fleas, ticks and biting lice. Treatment of flea infestations (Ctenocephalides spp.). Insecticidal activity against new infestations of adult fleas persists for 8 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 8 weeks after application. Treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus). The product has persistent activity against ticks for up to 4 weeks. Treatment of biting lice infestations (Trichodectes canis). FRONTLINE COMBO SPOT-ON CANI P can be used in the control program of flea allergy dermatitis (FLD). CONTRAINDICATIONS / ADVERSE REACTIONS In the absence of data, do not use the product on puppies under 8 weeks of age and/or weighing less than 2 kg. Do not use in sick (e.g. systemic diseases, fever) or convalescent animals. 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. This product is intended for dogs only. Do not use in cats and ferrets, in order to avoid overdose. SAFETY IN TARGET SPECIES In safety studies, no adverse reactions were observed in 8-week-old puppies, growing dogs and dogs weighing approximately 2 kg, treated once at doses five times the recommended dose. The risk of adverse reactions (see section 4.6) may increase in case of overdose, therefore animals should always be treated with the pipette size appropriate to their body weight. DOSAGE: One 0.67 ml pipette (P) for dogs weighing between 2 and 10 kg, corresponding to the minimum recommended dose of 6.7 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. Method of administration: Hold the pipette upright and gently tap the narrow end of the pipette so that the liquid remains in the wide part of the pipette. Break off the pre-cut end. Part the hair at the base of the animals neck, 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. Transient changes in the appearance of the fur in the area of ​​application (greasy, shaggy appearance of the fur) may be observed. STORAGE: Store below 30°C. Store in the original packaging. WARNINGS: It is recommended to avoid immersion in water or bathing for 2 days after application of the product and bathing more frequently than once a week as there are no data available to demonstrate how this affects the activity of the product. Emollient shampoos can be used before treatment, but if used weekly after application of the product, they reduce the duration of flea protection to approximately 5 weeks. Weekly bathing with medicated shampoos containing 2% chlorhexidine did not reduce the effectiveness of the product against fleas during a 6-week study. It is recommended that dogs are not allowed to swim in watercourses for 2 days after application of the product (see section 6.6). Ticks may attach to the dog. For this reason, in the worst case scenario, the transmission of infectious diseases cannot be completely excluded. Fleas on animals often infest bedding, blankets and living areas of the animal, especially carpets, curtains and upholstered furniture. In case of massive infestations and at the beginning of the antiparasitic treatment, these can be treated with a suitable insecticide and vacuumed regularly. Special precautions for use in animals: Avoid contact with the animals eyes. It is important to apply the product in an area where the animal cannot lick itself and to ensure that the animals do not lick each other after treatment. Special precautions to be taken by the person administering the 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. It is recommended to avoid contact with Frontline Combo Spot On Dogs with animals or people with known sensitivity to insecticides or alcohol. Avoid contact of the contents with hands. In this case, wash your hands with soap and water. In case of accidental contact with eyes, rinse thoroughly with water. Wash hands after use. Do not handle animals and do not allow children to play with treated animals until the application site is dry. It is therefore recommended not to treat animals during the day, but rather to treat them in the evening and, if recently treated, not to allow them to sleep with their owners, especially children. Do not smoke, drink or eat during application. In safety studies, no adverse reactions were observed in 8-week-old puppies, growing dogs and dogs weighing approximately 2 kg, treated once at doses five times the recommended dose. The risk of adverse reactions (see section 4.6) may, however, increase in case of overdose; therefore, animals should always be treated with the pipette size appropriate to their body weight. No incompatibilities are known. TARGET SPECIES: Dogs. INTERACTIONS: No interactions are known. DIAGNOSIS AND PRESCRIPTION: Sale is not reserved exclusively to pharmacies and does not require a veterinary prescription. ADVERSE REACTIONS: Among the extremely rare suspected adverse reactions, transient skin reactions at the site of application (skin discoloration, localized 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), vomiting or respiratory symptoms have also been observed. If animals lick themselves, transient hypersalivation may be observed, mainly due to the excipients of the product. Do not exceed the recommended dose. PREGNANCY AND LACTATION: The product can be used during pregnancy and lactation