NAME FRONTLINE COMBO SPOT-ON DOGS XL ACTIVE INGREDIENTS Each 4.02 ml pipette contains Fipronil: 402.00 mg (S)-methoprene: 361.80 mg; Butylhydroxyanisole (E320): 0.80 mg; Butylhydroxytoluene (E321): 0.40 mg. For a full list of excipients, see section 6.1. EXCIPIENTS Butylhydroxyanisole (E320), butylhydroxytoluene (E321), ethanol, polysorbate 80, polyvidone, diethylene glycol monoethyl ether. THERAPEUTIC INDICATIONS For the treatment of dogs weighing more than 40 kg: insert TABLE FRONTLINE COMBO SPOT-ON DOGS XL can be used in the control program of flea allergy dermatitis (FAD). CONTRAINDICATIONS / ADVERSE REACTIONS In the absence of data, do not use the product in puppies under 8 weeks of age. 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 to avoid overdose. SAFETY IN TARGET SPECIES: In safety studies, no adverse reactions were observed in puppies aged 8 weeks, 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. DOSAGE: One pipette (XL) of 4.02 ml for dogs weighing more than 40 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 end. Break off the pre-cut end. Part the hair at the base of the animal's neck, between the shoulder blades, and expose the skin. Place the tip of the pipette on the skin and squeeze the pipette several times until it is completely empty, applying the product directly to the skin in a single spot. Transient changes in the appearance of the fur in the area of ​​application (greasy, frizzy appearance of the hair) may be observed. STORAGE: Store below 30°C. Store in the original packaging. Shelf life of the veterinary medicinal product as packaged for sale: 36 months. 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 prior to treatment, but if used weekly after application, they reduce the duration of flea protection to approximately 5 weeks. Weekly bathing with medicated shampoos containing 2% chlorhexidine did not reduce the efficacy of the product against fleas in a 6-week study. It is recommended that dogs are not allowed to swim in water for 2 days after application of the product (see section 6.6). Individual ticks may attach to the dog. For this reason, in the worst case scenario, the transmission of infectious diseases cannot be completely ruled out. Fleas on animals often infest bedding, blankets and living areas of the animal, especially carpets, curtains and upholstered furniture. In the case of massive infestations and at the beginning of the antiparasitic treatment, these can be treated with a specific insecticide and vacuumed regularly. Special precautions for use in animals: Avoid contact with the animal's eyes. It is important to apply the product in an area where the animal cannot lick it 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 the mucous membranes, skin and eyes. It is therefore advisable to avoid contact with the mouth, skin and eyes. It is recommended to avoid contact with Frontline Combo Spot-On Dogs on animals or people with known sensitivity to insecticides or alcohol. Avoid contact of the contents with hands. If this happens, wash your hands with soap and water. In case of accidental contact with the eyes, rinse thoroughly with water. Wash your hands after use. Do not touch the animals and do not allow children 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. If they have recently been treated, do not 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 higher than 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 appropriate to their body weight. No incompatibilities are known. TARGET SPECIES: Dogs. INTERACTIONS: No interactions 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.