NAME EFFIPRO 50 MG SPOT-ON SOLUTION FOR CATS ACTIVE INGREDIENTS Each 0.5 ml pipette contains the active ingredient: fipronil 50 mg. Excipients: butylhydroxyanisole E320 0.1 mg; butylhydroxytoluene E321 0.05 mg. For the full list of excipients, see section 6.1. EXCIPIENTS Butylhydroxyanisole E320, butylhydroxytoluene E321, benzyl alcohol, diethylene glycol monoethyl ether. THERAPEUTIC INDICATIONS For the treatment of flea (Ctenocephalides spp.) and tick (Dermacentor reticulatus) infestations. The product has persistent insecticidal efficacy for up to 5 weeks against fleas (Ctenocephalides felis). The product has persistent activity for up to 2 weeks against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus). If certain tick species (Rhipicephalus sanguineus, Ixodes ricinus) are present at the time of application, not all ticks may be killed within 48 hours of application, but they may be killed within one week. The product may be used as part of a strategic treatment for the control of flea allergy dermatitis (FAD) when this has been previously diagnosed by a veterinarian. CONTRAINDICATIONS / ADVERSE REACTIONS: In the absence of available data, do not use in kittens under 2 months of age or weighing less than 1 kg. Do not use in sick animals (e.g. systemic diseases, fever) or convalescent animals. Do not use in rabbits as adverse reactions and even death may occur. Do not use in case of hypersensitivity to the active substance or to any of the excipients. SAFETY IN TARGET SPECIES No adverse reactions were observed in safety studies in cats and kittens aged 2 months or older or weighing approximately 1 kg treated with 5 times the recommended dose (daily therapeutic dose administered for 5 consecutive days) for 3 consecutive months, except for pruritus and vomiting, which occurred only once. The risk of adverse reactions may increase in case of overdose. DOSAGE Route of administration and dosage For external use only. Administer one 0.5 ml pipette per animal by topical application to the skin. Directions for use: Thermoformed pipettes: Hold the pipette upright. Shake the narrow end of the pipette to ensure that it is in the widest part of the pipette. Break the seal at the top of the spot-on pipette along the marked line. Part the cat’s fur until the skin is visible. Place the tip of the pipette directly on the exposed skin and squeeze gently a few times to empty the contents. Repeat the procedure at one or two different points on the cat’s back, preferably at the base of the head and between the shoulder blades. Note: The shape of commercially available pipettes may vary, as may the pictograms on the leaflets and boxes. Polypropylene pipettes: remove the pipette from the blister. Hold the pipette upright, unscrew and pull off the cap. Turn the cap over and place the other end back on the pipette. Twist the cap to break the seal, then remove the cap from the pipette. Part the cat’s fur until the skin is visible. Place the tip of the pipette directly on the exposed skin and squeeze gently a few times to empty the contents. Repeat the procedure at one or two different points on the cat’s back, preferably at the base of the head and between the shoulder blades. It is important to ensure that the product is applied in an area where the animal cannot lick it and to ensure that the animals do not lick each other after treatment. Care should be taken to avoid overwetting the fur with the product as this will cause a sticky appearance at the application site. However, if this occurs, this will disappear within 24 hours of application. White deposits may be present at the application site for up to 48 hours after application. Treatment regimen: For optimal control of flea and tick infestations, the treatment regimen may be based on the local epidemiological situation. In the absence of safety studies, the minimum interval between treatments is 4 weeks. STORAGE: Store below 30 degrees C. Store in a dry place. Store in the original packaging. Do not remove from the blister until ready for use. Shelf life of the veterinary medicinal product as packaged for sale: 24 months. WARNINGS: Cat fleas often infest bedding, beds or resting areas of animals, such as carpets and pillows. In case of massive infestations, these should be treated with appropriate insecticides at the beginning of the implementation of control measures and cleaned regularly. The product does not prevent ticks from attaching to animals. If the animal has been treated before exposure to ticks, they will be killed within the first 24-48 hours of attachment. This will happen before the animal has finished feeding, reducing but not eliminating the risk of disease transmission. Once dead, ticks will fall off the animals; Any remaining ticks can be easily removed by gently plucking them. It is recommended to avoid frequent bathing or shampooing, as the continued efficacy of the product in these cases has not been tested. When used as part of a strategic programme for the treatment of flea allergy dermatitis, monthly application is recommended for allergic patients and other cats in the household. For optimal control of flea infestations in mixed animal groups, all dogs and cats in the household/group should be treated with an appropriate insecticide. Special precautions for use in animals: Avoid contact with the eyes of animals. In case of accidental contact with the eyes, rinse immediately with plenty of water. Do not apply the product to wounds or skin lesions. Special precautions to be taken by the person administering the product to animals: The product may cause irritation of mucous membranes and eyes; therefore, contact of the product with the mouth or eyes should be avoided. In case of accidental contact with eyes, rinse immediately with plenty of water. If eye irritation persists, seek medical advice and show the package leaflet or label. Avoid contact of the contents with fingers. If this happens, wash hands with soap and water. Wash hands after use. Do not drink, eat or smoke during application. People with known hypersensitivity to fipronil or any of the excipients should avoid contact with the veterinary medicinal product. Treated animals should not be handled until the application site is dry. Children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals should not be treated during the day, but rather in the early evening. Freshly treated animals should not sleep with their owners, especially children. Other precautions: The alcoholic excipient may have adverse effects on painted, varnished or other household surfaces or furnishings. No adverse reactions were observed in safety studies in cats and kittens aged 2 months or more or weighing approximately 1 kg, treated with 5 times the recommended dose (daily therapeutic dose administered for 5 consecutive days) for 3 consecutive months, except for pruritus and vomiting, which occurred only once. The risk of adverse reactions may increase in case of overdose. Incompatibilities: None known. TARGET SPECIES: Cats. INTERACTIONS: None known. DIAGNOSIS AND PRESCRIPTION: The product is not available exclusively through pharmacies and does not require a veterinary prescription. ADVERSE REACTIONS: In case of licking, a short period of hypersalivation may be observed, mainly due to the nature of the excipients. Extremely rare suspected adverse reactions include transient skin reactions at the site of application (flaking skin, local alopecia, pruritus, erythema), generalized pruritus and alopecia. Hypersalivation, reversible neurological symptoms (hyperaesthesia, depression, nervous symptoms) and vomiting have been reported after use. PREGNANCY AND LACTATION: Laboratory studies with fipronil have not shown any teratogenic or embryotoxic effects. No studies have been conducted with this product in pregnant or lactating cats. Use only according to the benefit/risk assessment by the responsible veterinarian