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NAME SERESTO 1.25 G + 0.56 G, COLLAR FOR CATS ACTIVE INGREDIENTS One 38 cm (12.5 g) collar contains 1.25 g imidacloprid and 0.56 g flumethrin as active ingredients. For the 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 Cats: For the treatment and prevention of flea infestation (Ctenocephalides felis) for 7-8 months. Protects the animals environment from developing flea larvae for 10 weeks. Seresto can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). The product has persistent acaricidal (knockdown) (Ixodes ricinus, Rhipicephalus turanicus) and repellent (anti-feeding) efficacy against tick infestations (Ixodes ricinus) for 8 months. The product is effective against larvae, nymphs and adult ticks. Ticks already present on the cat 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 cat at the time of application. Prevention of new tick infestations begins within two days of application of the collar. CONTRAINDICATIONS / ADVERSE EFFECTS Do not treat kittens under 10 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 cats for 8 months and in 10-week-old kittens for 6 months without any adverse events other than those already described in section 4.6. In the unlikely event that the animal swallows the collar, mild gastrointestinal symptoms (e.g. loose stools) may occur. DOSAGE: Cutaneous use. One collar should be applied around the neck per animal. For cats, a 38 cm long collar should be applied. For external use only. Remove the collar from the protective pouch just before use. Unroll the collar and ensure that there is no residue of the plastic connectors inside the collar. Adjust the collar around the animal’s neck without tightening it too much (as a guide, you should be able to fit two fingers between the collar and the animal’s neck). Feed the excess collar through the loop and cut off any excess length that exceeds 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 kittens are growing rapidly. This collar is equipped with a safety locking mechanism. In the very rare case that a cat becomes entangled, the animal’s 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 ingested blood. 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. 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 hair loss may cause a slight and transient reduction in efficacy due to the loss of some of the active ingredients bound to the hair. 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 a suitable insecticide. The product is water resistant and remains effective even if the animal gets wet. However, prolonged and intense exposure to water and 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 fur, while the efficacy of the product against fleas gradually decreases from the fifth month onwards. Special precautions for use in animals: Not applicable. Special precautions to be taken by the person administering the veterinary medicinal product to animals. Keep the sachet containing the collar in the package 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 the collar is worn. The product may cause hypersensitivity reactions in some people: 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 people. If eye irritation occurs, rinse thoroughly with cold water. If skin irritation occurs, wash the skin with cold water and soap. If symptoms persist, seek medical advice and show the package leaflet or label. Dispose of 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 was studied in adult cats for 8 months and in 10-week-old kittens for 6 months, without any adverse events other than those already described in section 4.6. In the unlikely event that the animal eats the collar, mild gastrointestinal symptoms (e.g. loose stools) may occur. Incompatibilities: No incompatibilities known. TARGET SPECIES: Cats. INTERACTIONS: None known. DIAGNOSIS AND PRESCRIBING: Sale is not reserved exclusively to pharmacies and does not require a veterinary prescription. ADVERSE REACTIONS: In rare cases, behavioral disorders may be observed in animals accustomed to wearing collars in the first 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. Ensure that the collar is properly adjusted. Application site reactions such as itching, erythema and hair loss may occur. These reactions have been reported to be uncommon and usually resolve within 1-2 weeks. In individual cases, temporary removal of the collar may be recommended until symptoms resolve. In rare cases, application site reactions such as dermatitis, inflammation, eczema, lesions or bleeding may occur. In these cases, removal of the collar is recommended. In addition, in rare cases, mild and transient reactions such as depression, changes in appetite, salivation, vomiting and diarrhoea may occur initially. As with other topical applications, allergic contact dermatitis may occur in hypersensitive animals. 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 reveal any teratogenic or foetotoxic effects. However, the tolerability of the veterinary medicinal product during pregnancy and lactation in the target animals has not been established and therefore, in the absence of available data, the product is not recommended for use in pregnant or lactating cats
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