NAME 8 KG ACTIVE INGREDIENTS One 70 cm (45 g) collar contains 4.5 g imidacloprid and 2.03 g flumethrin as active ingredients. Excipients: For a full list of excipients, see section 6.1. EXCIPIENTS Titanium dioxide (E 171), black iron oxide (E 172), dibutyl adipate, propylene glycol dicaprylcaprate, epoxidized soybean oil, stearic acid, polyvinyl chloride. THERAPEUTIC INDICATIONS For the treatment and prevention of flea infestations (Ctenocephalides felis, C. canis) for 7-8 months. Protects the animals environment from developing flea larvae for 8 months. Seresto can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). The product has persistent acaricidal (killing) efficacy against tick infestations (Ixodes ricinus, Rhipicephalus sanguineus, Dermacentor reticulatus) for 8 months and repellent (anti-feeding) efficacy against tick infestations (Ixodes ricinus, Rhipicephalus sanguineus). The product is effective against larvae, nymphs and adult ticks. Ticks already present on the dog before treatment may not be killed within 48 hours of application of the collar and may remain attached and visible. It is therefore recommended to remove ticks already present on the dog at the time of application. Prevention of new tick infestations begins within two days of application of the collar. The product provides indirect protection against the transmission of the pathogens Babesia canis vogeli and Ehrlichia canis by the tick vector Rhipicephalus sanguineus, thus reducing the risk of canine babesiosis and canine ehrlichiosis for 7 months. Reduction of the risk of infection with Leishmania infantum by transmission by sand flies for up to 8 months. For the treatment of biting/chewing lice infestation (Trichodectes canis). CONTRAINDICATIONS / ADVERSE EFFECTS Do not treat puppies under 7 weeks of age. Do not use in animals with hypersensitivity to the active substances or to any of the excipients. SAFETY IN TARGET SPECIES Due to the nature of the collar, overdose is unlikely and no signs of overdose should be expected. An overdose of 5 collars around the neck has been studied in adult dogs for 8 months and in puppies aged 7 weeks for 6 months, with no other adverse events observed, except for slight hair loss and mild skin reactions. In the unlikely event that the animal eats the collar, mild gastrointestinal symptoms (e.g. loose stools) may occur. DOSAGE: For cutaneous use. Apply one collar per animal around the neck. For dogs over 8 kg, apply a 70 cm long collar. For small dogs with a body weight of up to 8 kg, apply a 38 cm long collar for dogs <= 8 kg. For external use only. Remove the collar from the protective bag just before use. Unroll the collar and ensure that there are no loose plastic connectors inside the collar. Adjust the collar around the animals neck without overtightening it (as a guide, you should be able to fit two fingers between the collar and the animals neck). Insert the excess collar through the loop and cut off any excess length exceeding 2 cm. The collar should be worn continuously for a protection period of 8 months and should be removed after the treatment period. Check the fit periodically and adjust if necessary, particularly when puppies are growing rapidly. This collar is equipped with a safety locking mechanism. In the extremely rare case that a dog becomes entangled, the animals own strength is usually sufficient to loosen the collar, allowing it to be released quickly. STORAGE: This veterinary medicinal product does not require any special storage conditions. Shelf life of the veterinary medicinal product as packaged for sale: 5 years. WARNINGS: Ticks will generally be killed and fall off the host within 24-48 hours of infestation, without having taken a blood meal. It is not possible to exclude the possibility that some ticks may attach after treatment. Therefore, if conditions are unfavourable, the transmission of infectious diseases by ticks cannot be completely excluded. Although a significant reduction in the incidence of Leishmania infantum in dogs has been demonstrated, the product has shown variable repellent (anti-feeding) and insecticidal efficacy against the sandfly Phlebotomus perniciosus. Consequently, sandfly bites may occur and transmission of Leishmania infantum cannot be completely excluded. The collar should be applied shortly before the start of the sandfly vector activity period corresponding to the Leishmania infantum transmission season and worn continuously during the risk period. Ideally, the collar should be applied before the start of the flea or tick season. As with all long-term topical products, periods of excessive seasonal hair loss may cause a slight and transient reduction in efficacy due to the loss of some of the active ingredients bound to the coat. The replenishment of the active ingredients in the collar begins immediately, restoring full efficacy without any further treatment or replacement of the collar. For optimal flea control in heavily infested households, it may be necessary to treat the area with an appropriate insecticide. The product is water-resistant and remains effective even if the animal gets wet. However, prolonged and intense exposure to water, as well as heavy shampooing, should be avoided as the duration of activity may be reduced. Studies show that monthly shampooing or immersion in water does not significantly reduce the 8-month duration of efficacy against ticks after redistribution of the active ingredients in the coat, while the efficacy of the product against fleas gradually decreases from the fifth month onwards. The influence of shampooing or immersion in water on the transmission of canine leishmaniasis has not been studied. Special precautions for use in animals: Not applicable. Special precautions to be taken by the person administering the product to animals: Keep the pouch containing the collar in the packaging until use. As with all veterinary medicinal products, do not allow young children to play with the collar or put it in their mouth. Do not allow animals wearing the collar to sleep in the same bed as their owner, especially children. Imidacloprid and flumethrin are continuously released from the collar onto the skin and fur while it is worn. The product may cause hypersensitivity reactions in some individuals. People with known hypersensitivity (allergy) to the components of the collar should avoid contact with the veterinary medicinal product. In very rare cases, the product may cause irritation of the skin, eyes and respiratory tract in some individuals. If eye irritation occurs, rinse thoroughly with cold water. If skin irritation occurs, wash with cold water and soap. If symptoms persist, seek medical advice and show the package leaflet or label. Discard any residue or scraps from the collar immediately (see section 4.9). After applying the collar, wash your hands with cold water. Due to the nature of the collar, overdose is unlikely and no signs of overdose should be expected. An overdose of 5 collars around the neck has been studied in adult dogs for 8 months and in 7-week-old puppies for 6 months, with no adverse effects observed other than slight hair loss and mild skin reactions. In the unlikely event that the animal eats the collar, mild gastrointestinal symptoms (e.g. loose stools) may occur. Incompatibilities: None known. TARGET SPECIES (8 kg). INTERACTIONS: None known. DIAGNOSIS AND PRESCRIPTION: Sale is not reserved exclusively to pharmacies and does not require a veterinary prescription. ADVERSE EFFECTS: In rare cases, behavioral disorders may be observed in animals not accustomed to wearing collars in the first few days after application. These may include hiding, vocalization, hyperactivity, excessive licking and/or grooming or scratching at the application site. In very rare cases, aggression has been reported after application of the collar. Make sure the collar is properly adjusted. Application site reactions such as itching, erythema and hair loss may occur. These reactions have been reported to be rare and usually resolve within 1-2 weeks. In individual cases, temporary removal of the collar may be recommended until symptoms have resolved. In very rare cases, application site reactions such as dermatitis, inflammation, eczema, lesions or hemorrhages may occur. In these cases, removal of the collar is recommended. In rare cases, neurological symptoms such as ataxia, seizures and tremors may occur. In these cases, it is recommended to remove the collar. In addition, in rare cases, dogs may initially show mild and transient reactions such as depression, changes in appetite, salivation, vomiting and diarrhea. 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 1,000 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) PREGNANCY AND LACTATION Laboratory studies with flumethrin and imidacloprid in rats and rabbits did not produce any effect on fertility or reproduction and did not indicate any teratogenic or foetotoxic effects. However, in target animals, the tolerability of the veterinary medicinal product during pregnancy and lactation has not been established and therefore, in the absence of available data, the product is not recommended in pregnant or lactating bitches