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NAME SCALIBOR PROTECTORBAND 1,000 G MEDICATED COLLAR FOR DOGS ACTIVE INGREDIENTS A 65 cm white collar contains the active substance: deltamethrin 1,000 g. Excipients: titanium dioxide (E171) 0.375 g. EXCIPIENTS Titanium dioxide (E171), Ca-Zn organic soap mixture, epoxidized soybean oil, diisooctyl adipate, triphenyl phosphate, polyvinyl chloride. THERAPEUTIC INDICATIONS For the treatment and prevention of tick infestations (Ixodes ricinus, Rhipicephalus sanguineus) for 6 months. For the treatment and prevention of flea infestations (Ctenocephalides felis) for 4 months. The veterinary medicinal product provides a repellent (anti-feeding) effect against mosquitoes (Culex pipiens pipiens) for 6 months. The veterinary medicinal product provides a repellent (anti-feeding) effect against sand flies (Phlebotomus perniciosus) for 12 months. The veterinary medicinal product reduces the risk of transmission of the pathogen Leishmania infantum by its repellent effect against the vector (Phlebotomus perniciosus). The veterinary medicinal product can therefore be considered part of a leishmaniasis prevention programme in dogs. After application of the collar, the presence of individual ticks may be observed, as the repellent effect of the veterinary medicinal product against ticks is limited. The parasites will die once exposed to the active substance present on the dog. Therefore, it is unlikely that the bees will be able to complete their blood meal. CONTRAINDICATIONS / ADVERSE EFFECTS: Do not use in dogs with known hypersensitivity to the active substance. Do not use in puppies under 7 weeks of age. Do not use in cats. Do not apply the collar to animals with extensive skin lesions. SAFETY IN TARGET SPECIES: If the collar is accidentally ingested by a dog, the following symptoms may be observed: lack of coordination, tremors and hypersalivation. These symptoms are reversible within 48 hours. Treatment can only be symptomatic, as there is no known specific antidote. DOSAGE: External use. Use one collar per dog; adjust the collar around the animals neck without tightening it. Cut off the excess, leaving 5 cm of the clip. The collar should be applied preferably 1 week before the animals are introduced into an infested environment, as full activity is achieved after 1 week. It is recommended to treat all dogs present in the same environment. Bathing does not affect the effectiveness of the collar. The collar can be used on puppies over 7 weeks of age. STORAGE: Store below 25 degrees C. Shelf life of the veterinary medicinal product as packaged for sale: 36 months. WARNINGS: The use of this product should take into account local information on the susceptibility of the target parasites, if available. Unnecessary use of antiparasitics or use not in accordance with the instructions provided in the SPC may increase the selective pressure of resistance and may lead to reduced efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the species and parasite load or the risk of infestation based on the epidemiological characteristics, for each individual animal. Special precautions for safe use in the target species: In case of marked local irritation or allergic reaction, remove the collar immediately. After treatment, the presence of ticks and individual insects (fleas, sand flies, mosquitoes) cannot be completely excluded. Therefore, the transmission of infectious diseases (including L. infantum) cannot be completely excluded. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Wash hands with cold water and soap after applying the collar. Do not allow children to play with the collar or put it in their mouth. Avoid contact with eyes or mouth. If the collar comes into contact with eyes, rinse thoroughly with water. People with known sensitivity to deltamethrin or other components of the collar should avoid contact with the product. If eye or skin irritation persists or if the product is accidentally ingested, seek medical advice immediately and show the package leaflet. Treated dogs should not sleep in contact with people, especially children. Special precautions for the environment: Although occasional contact with water does not reduce the effectiveness of the collar, it should always be removed before bathing or swimming to avoid adverse effects on aquatic organisms. Dogs should not enter water for the first 5 days after application of the collar. If the dog accidentally ingests the collar, the following symptoms may be observed: incoordination, tremors, hypersalivation. These symptoms are reversible within 48 hours. Treatment can only be symptomatic, as there are no known specific antidotes. Major incompatibilities: None known. TARGET SPECIES: Dogs. INTERACTIONS: Do not use with other ectoparasiticides containing organophosphates. ADVERSE EFFECTS: Dogs. Rare (1 to 10 animals in 10,000 animals treated): localized skin reaction (itching/scratching, erythema/rash, hair loss) ^1, hypersensitivity reaction ^1. Very rare (< 1 animal/10,000 animals treated, including isolated reports): behavioural disorders (lethargy, hyperactivity) ^2, digestive tract disorders (vomiting, diarrhoea, hypersalivation), neurological disorders (ataxia, muscle tremors) ^3. ^1 affecting the neck or skin in general and which may indicate a local or general hypersensitivity reaction. ^2 often associated with skin irritation. ^3 disappear within 48 hours of removing the collar. If any of these symptoms occur, remove the collar. Treatment is symptomatic as there is no known specific antidote. Reporting of adverse events is important as it allows the continued monitoring of the safety of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to the marketing authorisation holder or his local representative or to the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details. PREGNANCY AND LACTATION: Pregnancy and lactation: Can be used during pregnancy and lactation. No adverse reactions were observed in pregnant bitches that wore the collar throughout pregnancy and lactation. No symptoms were observed in puppies born to these bitches until weaning
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