WARNINGS: It is recommended to avoid water immersion or baths for 2 days after applying the product and baths more frequently than once a week, as there is no data available to demonstrate how this interferes with the product’s activity. Soothing shampoos can be used before treatment, but if used weekly after application, they reduce the duration of flea protection to about 5 weeks. Weekly baths with 2% chlorhexidine medicated shampoo did not reduce the product’s effectiveness against fleas during a 6-week study. It is advised not to allow dogs to swim in watercourses for 2 days after applying the product. Individual ticks may attach to the dog. Therefore, in the worst cases, the transmission of infectious diseases cannot be completely excluded. Fleas on animals often infest the animal’s bedding, blankets, and areas where the animal lives, particularly carpets, curtains, and upholstery; these can be treated with a suitable insecticide and regularly cleaned with a vacuum cleaner in cases of massive infestations and at the beginning of antiparasitic treatment. Special precautions for use in animals: avoid contact with the animal’s eyes. It is important that the product is applied in an area where the animal cannot lick itself and ensure that animals do not lick each other after treatment. Special precautions to be taken by the person administering the product to the animals: the product may cause irritation to mucous membranes, skin, and eyes. Therefore, avoid contact with the mouth, skin, and eyes. Avoid contact with Frontline Combo Spot On Dogs for animals or people with known sensitivities to insecticides or alcohol. Avoid letting the contents come into contact with hands. In such cases, wash hands with soap and water. In case of accidental contact with eyes, rinse thoroughly with water. Wash hands after use. Do not touch animals and do not let children play with treated animals until the application site is dry. It is therefore recommended not to treat animals during the day, but to treat them in the evening and, if just treated, not to let them sleep with their owners, especially with children. Do not smoke, drink, or eat during application. In safety studies, no side effects were observed in puppies 8 weeks of age, growing dogs, and dogs weighing about 2 kg, treated once at doses five times higher than the recommended dose. The risk of side effects may increase in case of overdose, so animals should always be treated with the pipette corresponding to their body weight. No known incompatibilities. THERAPEUTIC CATEGORY: Ectoparasiticides for topical use including insecticides QP53. STORAGE: Store below 30 degrees C. Keep in the original packaging. Shelf life of the veterinary medicinal product packaged for sale: 36 months. CONTRAINDICATIONS/ADVERSE EFFECTS: In the absence of data, do not use the product in puppies under 8 weeks of age. Do not use in sick animals (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 exclusively for dogs. Do not use in cats and ferrets to avoid overdose phenomena. NAME: FRONTLINE COMBO SPOT-ON DOGS XL. DIAGNOSIS AND PRESCRIPTION: Sale is not restricted exclusively to pharmacies and is not subject to veterinary prescription obligation. EXCIPIENTS: BHT (E320), BHA (E321), ethanol, polysorbate 80, povidone, monoethyl ether of diethylene glycol. UNDESIRABLE EFFECTS: Among the extremely rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, local hair loss, itching, redness) and diffuse itching or hair loss after application have been reported. Hypersalivation, reversible neurological symptoms (increased sensitivity to stimuli, lethargy, 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. INDICATIONS: For the treatment of dogs weighing over 40 kg: see FRONTLINE COMBO SPOT-ON DOGS XL TABLE. It can be used in the program for the control of Flea Allergy Dermatitis (FAD). INTERACTIONS: No known interactions. DOSAGE: One pipette of 4.02 ml (XL) for dogs weighing over 40 kg, corresponding to the minimum recommended dose of 6.7 mg/kg of fipronil and 6 mg/kg of (S)-methoprene, for topical cutaneous application. In the absence of safety data, the minimum treatment interval should be 4 weeks. Administration method: Hold the pipette upright and gently tap the narrow part of the pipette so that the liquid remains in the wide part of the pipette. Break the pre-cut tip. 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 completely empty, applying the product in one spot directly onto the skin. Transitory changes in the appearance of the coat in the application area (greasy and tousled appearance of the hair) may be observed. ACTIVE INGREDIENTS: Each 4.02 ml pipette contains Fipronil: 402.00 mg (S)-methoprene: 361.80 mg; BHT (E320): 0.80 mg; BHA (E321): 0.40 mg. For the complete list of excipients, see section 6.1. SAFETY IN TARGET SPECIES: In safety studies, no side effects were observed in puppies 8 weeks of age, growing dogs, and dogs weighing about 2 kg, treated once at doses five times higher than the recommended dose. The risk of side effects may increase in case of overdose, so animals should always be treated with the pipette corresponding to their body weight. TARGET SPECIES: Dogs. WAITING TIME: Not applicable. USE/ROUTE OF ADMINISTRATION: Hold the pipette upright and gently tap the narrow part of the pipette so that the liquid remains in the wide part of the pipette. Break the pre-cut tip. 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 completely empty, applying the product in one spot directly onto the skin.