NAME OF THE VETERINARY MEDICINAL PRODUCT FIPROKILL 67MG spot-on solution for small dogs (10-20 kg) Fipronil  One pipette contains:Active substance: Fipronil 67 mg Excipients: Butylhydroxyanisole E320 0.134 mg Butylhydroxytoluene E321 0.067 mg Spot-on solution. Clear, pale amber solution. Directions Treatment of flea (Ctenocephalides spp.) and tick (Rhipicephalus sanguineus and Ixodes ricinus) infestations. Insecticidal efficacy against new infestations with adult fleas persists for up to 2 months. The product has a persistent acaricidal effect effective for one month against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus). Ixodes ricinus and Rhipicephalus sanguineus ticks will normally be killed within the first 48 hours of the first application of the product. For established infestations of Dermacentor reticulatus an immediate acaricidal effect has not been demonstrated, however ticks will normally be killed within a week of the first application of the product. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD), where it has been previously diagnosed by a veterinarian.  CONTRAINDICATIONS Do not use in puppies less than 2 months old, or puppies or dogs weighing less than 2 kg. Do not use in sick animals (systemic diseases, fever) or convalescent animals. Do not use in rabbits, as it may cause adverse reactions and even death of the animal. This product is specifically indicated for dogs. Do not use in cats as this may lead to overdose. Do not use in case of hypersensitivity to the active substance or to any of the excipients.  ADVERSE REACTIONS The frequency of adverse reactions is defined using the following convention: - Very common (more than 1 in 10 animals treated displaying adverse reactions) - Common (more than 1 but less than 10 animals in 100 animals treated) - Uncommon (more than 1 but less than 10 animals in 1000 animals treated) - Rare (more than 1 but less than 10 animals in 10,000 animals treated) - Very rare (less than 1 animal in 10,000 animals treated, including isolated reports) If the animal licks the application site, a brief period of hypersalivation may be observed mainly due to the nature of the excipients. Among the suspected, extremely rare adverse reactions after use, transient skin reactions (desquamation, local alopecia, pruritus, erythema) and pruritus or general alopecia have been reported at the application site. Exceptionally, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms), vomiting or respiratory symptoms have been observed after use. If you notice any adverse reactions, even those not already included in this leaflet or you think that the medicine has not had any effect, please inform your veterinarian.  TARGET SPECIES Dogs. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATIONRoute of administration and dosage: For external use only. Administer by spot application to the skin, depending on body weight, as follows: Body weight Dose 2 – 10 kg 1 pipette Fiprokill 67 mg spot-on solution for small dogs 10 – 20 kg 1 pipette Fiprokill 134 mg spot-on solution for medium-sized dogs 20 – 40 kg 1 pipette Fiprokill 268 mg spot-on solution for large dogs 40 – 60 kg 1 pipette Fiprokill 402 mg spot-on solution for very large dogs Over 60 kg The appropriate combination of Fiprokill spot-on solution must be used. Method of administration: Remove the pipette from the pouch. Hold the pipette with the tip pointing upwards. Tap the narrow part of the pipette gently to make sure the solution is in the main body of the pipette. Twist the tip of the pipette. Part the animals fur until the skin is visible. Place the tip of the pipette on the visible skin and gently squeeze the pipette to empty the contents into two points along the animals back, preferably at the base of the head and 2-3 cm further back, emptying approximately half the volume at each point. Squeeze the pipette several times to ensure complete dosing. It is important to ensure that the product is applied to a surface where the animal cannot lick it and that the animals cannot lick each other after treatment. Care should be taken to avoid over-wetting the hair with the product as this will cause the hair to appear sticky at the treatment site. However, if this occurs, it will disappear within 24 hours of application. Also, crusting and crystalline deposits may be observed on the hair at the application site for up to 48 hours after application. Treatment regimen: For optimal control of flea and/or tick infestations, the treatment schedule may be based on the local epidemiological situation. In the absence of safety studies, the minimum treatment interval is 4 weeks. RECOMMENDATIONS ON CORRECT ADMINISTRATION Before treatment, animals should be weighed accurately to ensure that the correct pipette size is applied. Discard any open pipettes. WAITING TIME Thats not the case. SPECIAL STORAGE PRECAUTIONS Do not store above 25°C. Store in a dry place. Store in the original packaging. Keep out of sight and reach of children. Do not use this veterinary medicinal product after the expiry date which is stated on the carton and pipette after “EXP”. The expiry date refers to the last day of that month. SPECIAL WARNINGS Avoid frequent swimming/bathing or shampooing of the animal, as the products continued effectiveness in these cases has not been tested. 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 24-48 hours of attachment. This will usually occur before the ticks feed, minimising but not eliminating the risk of disease transmission. Once dead, ticks will usually fall off the animal and any remaining ticks can be easily removed. Fleas on animals often infest the animals basket, bed or normal resting areas, such as carpets or sofas, which should be treated, in the case of massive infestations and at the beginning of control measures, with a suitable insecticide and vacuumed regularly. When used as part of a flea allergy dermatitis (FAD) treatment strategy, monthly application is recommended for allergy sufferers and other dogs and cats in the shelter. To control flea infestations in multi-species shelters, all dogs and cats in the shelter should be treated with the appropriate insecticide.  Special precautions for use in animals Before treatment, animals should be weighed accurately to ensure that the correct pipette size is applied. Avoid contact with the animals eyes. In case of accidental contact with the eyes, rinse immediately and thoroughly with water. Do not apply to wounds or damaged skin. Use during pregnancy or lactation only on the advice of a veterinarian and after assessing the benefit/risk balance. The risk of adverse effects may increase in case of overdose. It is important to ensure that the product is applied to an area where the animal cannot lick it and to ensure that animals cannot lick each other after treatment.  Special precautions to be taken by the person administering the veterinary medicinal product to animals This product may cause irritation of the mucous membranes and eyes. Therefore, contact of the product with the mouth or eyes should be avoided. In case of accidental contact with the eyes, rinse immediately and thoroughly with water. If eye irritation persists, seek medical advice and show the package leaflet to the doctor. Avoid contact of contents with skin. If this occurs, wash hands with soap and water. Wash hands after use. Animals or 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 and children should be kept away from the animals until the site is dry. It is therefore recommended that animals should not be treated during the day, but should be treated early in the evening and recently treated animals should not be allowed to sleep with their owners, especially children. If the product is accidentally swallowed, contact a doctor immediately and show the package leaflet. Do not smoke, drink or eat while applying the product. For veterinary use only. Other precautions Fipronil may cause adverse effects on aquatic organisms. Dogs should not be allowed to swim in watercourses (rivers, streams, lakes or ponds) for 2 days after application. The product may affect painted, varnished or other surfaces or furniture. This product is flammable. Keep away from heat, sparks, open flames or other ignition sources.  SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from the use of such veterinary medicinal products should be disposed of in accordance with local requirements. Medicines should not be thrown away in wastewater or household waste. Ask your veterinarian for information on how to dispose of medicines no longer required. These measures help protect the environment. PRESENTATION Cardboard box with 3 pipettes. Product compliance information Product compliance information Product safety Manufacturer information Personal information Product safety information Currently, product safety information is not available. Manufacturer information Currently, manufacturer information is not available. Responsible person information Currently, information about the person responsible is not available. n Action: Ticks, Fleas, Lice Presentation type: Pipette Pieces Set: 3 pieces Dog Weight: 10-20 kg Brand Name: Chanelle n Quantity: 3 Pipettes