NAME EFFIPRO SPOT-ON FOR DOGS ACTIVE INGREDIENTS Fipronil 100 mg/ml EXCIPIENTS Butylhydroxyanisole E320; Butylhydroxytoluene E321 THERAPEUTIC INDICATIONS For the treatment of flea (Ctenocephalides spp.) and tick (Dermacentor reticulatus) infestations. Insecticidal efficacy against new flea infestations persists for up to 8 weeks. The product has persistent acaricidal efficacy for up to 4 weeks against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus). If certain tick species (Rhipicephalus sanguineus and Ixodes ricinus) are present at the time of administration of the product, not all ticks may be killed within 48 hours of the first application, but they may be killed within one week. The product can be used as part of a strategic treatment for the control of flea allergy dermatitis (FAD), when previously diagnosed. CONTRAINDICATIONS / ADVERSE REACTIONS: In the absence of available data, do not use in puppies under 2 months of age or weighing less than 2 kg. Do not use in sick animals (systemic diseases, fever, etc.) or convalescents. Do not use in rabbits, as adverse reactions and even death may occur. Do not use in cats, as overdose may occur. Do not use in case of hypersensitivity to the active substance or to any of the excipients. DOSAGE: 40 kg to 60 kg: 1 pipette of 4.02 ml. For dogs weighing more than 60 kg, use 2 pipettes of 2.68 ml each. Thermoformed pipettes: hold the pipette in an upright position. Shake the narrow end of the pipette to ensure that this content 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 dogs fur until the skin is visible. Place the tip of the pipette directly on the exposed skin and press gently a few times to empty the contents. Repeat this operation in one or two different places on the dogs back. Excessive wetting with the product may make the fur appear sticky at the application site. However, if this occurs, this will disappear within 24 hours of application. For optimal control of flea and/or 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. WARNINGS: Washing one hour before treatment does not affect the effectiveness of the product against fleas. Bathing or immersion in water should be avoided within two days of application of the product. Weekly immersion in water for one minute reduces the insecticide effectiveness against fleas by one week. 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 occur before the animal has finished feeding, reducing but not eliminating the risk of disease transmission. Dog fleas often also infest the animals bedding, beds or resting areas, such as carpets and pillows. In the case of severe infestations, these should be treated at the beginning of the implementation of control measures. When used as part of a strategic programme for the treatment of flea allergy dermatitis, monthly application is recommended for allergic patients and other dogs in the household. For optimal control of flea infestations in mixed animal households, all dogs and cats in the household/group should be treated with an appropriate insecticide. Animals should be accurately weighed before treatment. Avoid contact with the animals’ eyes; in case of accidental contact, rinse the eyes immediately and thoroughly with water. It is important to ensure that the product is applied to an area that cannot be easily licked by the animal and to ensure that animals do not lick each other after treatment. Do not apply the product to wounds or broken skin. Special precautions for the operator: The product may cause irritation of mucous membranes and eyes; therefore, contact of the product with these areas should be avoided. If eye irritation persists, consult a physician. Avoid contact of the contents with fingers. In this case, wash your hands with soap and water. Wash your hands after use. Animals or operators 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. It is recommended to treat animals in the evening. Other precautions: Fipronil may be harmful to aquatic organisms. Dogs should not be allowed to swim in water for 2 days after application. Overdose: No adverse reactions were observed in safety studies in the target species, in puppies aged 2 months and dogs weighing approximately 2 kg, treated with the therapeutic dose for 5 consecutive days. TARGET SPECIES: Dogs. INTERACTIONS: None known. ADVERSE REACTIONS: If licking occurs, a brief period of hypersalivation may be observed, mainly due to the nature of the excipients. Rare and suspected adverse reactions include: transient skin reactions at the application site (skin discoloration, local alopecia, pruritus, erythema), generalized pruritus and alopecia. After use, the following have been reported in rare cases: hypersalivation, reversible neurological symptoms (hyperaesthesia, depression, nervous symptoms), vomiting and respiratory symptoms. PREGNANCY AND LACTATION: Laboratory studies with fipronil have not revealed any teratogenic or embryotoxic effects. The safety of the product has not been demonstrated in pregnant or lactating bitches; therefore, use only according to a risk/benefit assessment