NAME ADVANTIX SPOT-ON FOR DOGS UP TO 4 KG ACTIVE INGREDIENTS Each 0.4 ml pipette contains Imidacloprid: 40.0 mg. Permethrin (40/60): 200.0 mg. Excipient(s): Butylated hydroxytoluene (E321): 0.4 mg. For a full list of excipients, see section 6.1. EXCIPIENTS Butylated hydroxytoluene (E321), N-methylpyrrolidone, Miglyol 812, Citric acid (E330). THERAPEUTIC INDICATIONS For the treatment and prevention of flea infestations (Ctenocephalides canis, Ctenocephalides felis). Fleas in dogs are eliminated within one day of treatment. One treatment prevents further flea infestation for four weeks. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). For the treatment of lice (Trichodectes canis). The product has acaricidal and persistent repellent efficacy against tick infestations (Rhipicephalus sanguineus and Ixodes ricinus for four weeks and Dermacentor reticulatus for three weeks). By its repellent action and neutralization of the tick vector Rhipicephalus sanguineus, the product reduces the likelihood of transmission of the pathogen Ehrlichia canis, thus reducing the risk of canine ehrlichiosis. The risk reduction has been demonstrated in studies from the third day after application of the product and persists for 4 weeks. Ticks already present on the dog may not be destroyed within two days of treatment and may remain attached and visible. It is therefore recommended to remove any ticks already present on the dog at the time of treatment to prevent them from attaching and feeding on blood. One treatment provides repellent activity (anti-feeding) against sand flies (Phlebotomus papatasi) for two weeks and Phlebotomus perniciosus for three weeks, mosquitoes (Aedes aegypti for two weeks and Culex pipiens for four weeks) and sand flies (Stomoxys calcitrans) for four weeks. Reduction of the risk of infection with Leishmania infantum by transmission by sand flies (Phlebotomus perniciosus) for up to 3 weeks. The effect is indirect, determined by the activity of the product against the vector. CONTRAINDICATIONS / ADVERSE EFFECTS In the absence of available data, the product should not be used in puppies under 7 weeks of age or weighing less than 1.5 kg. Do not use in case of hypersensitivity to the active substances or to any of the excipients.) Do not use in cats (see section 4.5 - Special precautions for use) SAFETY IN TARGET SPECIES No adverse clinical signs were observed in healthy puppies or adult dogs exposed to a 5-fold overdose or in puppies whose dams were treated with a 3-fold overdose of the product. DOSAGE The minimum recommended dose is: 10 mg/kg body weight (bw) of imidacloprid and 50 mg/kg body weight (bw) of permethrin. Dosage regimen for Advantix Spot-on. Dogs (kg body weight): <= 4 kg; trade name: advantix spot-on for dogs up to 4 kg; volume: 0.4 ml; imidacloprid: minimum 10 mg/kg body weight; permethrin: minimum 50 mg/kg body weight. Dogs (kg body weight): >4 kg <= 10 kg; Trade name: Advantix spot-on for dogs over 4 kg and up to 10 kg; volume: 1.0 ml; imidacloprid: 10 - 25 mg/kg body weight; permethrin: 50 - 125 mg/kg body weight. Dogs (kg body weight): >10 kg <= 25 kg; Trade name: Advantix spot-on for dogs over 10 kg and up to 25 kg; volume: 2.5 ml; imidacloprid: 10 - 25 mg/kg body weight; permethrin: 50 - 125 mg/kg body weight. Dogs (kg body weight): >25 kg <= 40 kg; Trade name: Advantix spot-on for dogs over 25 kg to 40 kg; volume: 4.0 ml; imidacloprid: 10 - 16 mg/kg body weight; Permethrin: 50 - 80 mg/kg body weight. To reduce reinfestation due to new fleas, it is recommended to treat all dogs in the household. Other animals living in the same household should be treated with an appropriate product. To help reduce the threat to the environment, it is recommended to use an additional treatment against adult fleas and their developmental stages. The product remains effective if the animal gets wet. However, intense and prolonged exposure to water should be avoided. Frequent exposure to water may reduce the persistence of efficacy. In such cases, do not repeat the treatment more often than once a week. If the dog requires shampooing, it is recommended to do so before applying Advantix or at least two weeks after application to optimize the effectiveness of the product. In case of lice infestation, another visit to the veterinarian is recommended 30 days after treatment, as some animals may require a second treatment. To protect a dog throughout the sandfly season, treatment should be continued as directed at all times. For cutaneous use only. Apply only to intact skin. Administration method for short tip pipettes: Remove pipette from packaging. Holding pipette upright, twist and remove cap. Turn cap inside out and replace opposite end on pipette. Twist cap to break seal, then remove cap from pipette. For dogs weighing 10 kg or less: With dog standing on all fours, part fur between shoulder blades until skin is visible. Place tip of pipette on skin and press firmly several times until contents are emptied directly onto skin. For dogs over 10 kg: With the dog standing on all fours, apply the entire contents of the Advantix pipette evenly to four spots on the upper back, from the shoulders to the base of the tail. At each spot, part the fur until the skin is visible. Place the tip of the pipette on the skin and press gently to empty some of the solution onto the skin. Do not apply too much solution to any one spot as this may cause some of the solution to run down the sides of the dog. Administration method for long tip pipettes: Remove a pipette from the packaging. Holding the pipette upright, twist and remove the cap. For dogs weighing 10 kg or less: With the dog standing on all fours, part the fur between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and press firmly several times until the contents are emptied directly onto the skin. For dogs over 10 kg: With the dog standing on all fours, apply the entire contents of the Advantix pipette evenly to four sites on the upper back, starting at the shoulders and ending at the base of the tail. At each site, part the fur until the skin is visible. Place the tip of the pipette on the skin and press gently to empty some of the solution onto the skin. Do not apply too much solution to any one site as this may cause some of the solution to run down the sides of the dog. STORAGE: Do not freeze. Short tip pipette: After opening the foil pouch, store in a dry place at a temperature not exceeding 30 degrees C. Long tip pipette: After opening the foil pouch, the product should be applied to the dogs skin. Short tip pipette (blister pipettes in the pouch). Shelf life of the veterinary medicinal product packaged in the foil pouch: 5 years. Shelf life of the veterinary medicinal product packaged in the foil pouch: 5 years. Shelf life of the product after opening the foil pouch: 2 years (all pipettes must be used within 2 years of opening the foil pouch or before the expiry date printed on the pipette, whichever is shorter). Shelf life of the opened pipette: not applicable. After opening, the entire contents of the pipette must be applied to the skin of the animal. Pipette with long applicator nozzle (in individual pouches). Shelf life of the product in the foil pouch: 3 years. Shelf life of the opened pipette: not applicable. After opening, the entire contents of the pipette must be applied to the skin of the dog. WARNINGS: Individual ticks may attach or individual sand flies or mosquitoes may bite. Therefore, under adverse conditions, the transmission of infectious diseases by these parasites cannot be completely excluded. It is recommended to apply the treatment at least 3 days before the expected exposure to E. canis. As regards E. canis, studies have shown a reduced risk of canine ehrlichiosis in dogs exposed to Rhipicephalus sanguineus ticks infected with E. canis, starting 3 days after application of the product and persisting for 4 weeks. Immediate protection against sandfly bites is not documented. Dogs treated to reduce the risk of infection with Leishmania infantum by sandfly (P. perniciosus) should be kept in a protected environment for the first 24 hours after the initial treatment. i) Special precautions for use in animals: Care should be taken to avoid contact of the contents of the pipette with the eyes or mouth of treated dogs. Care should be taken to ensure correct administration of the product as described in paragraph 4.9. In particular, oral absorption caused by licking of the application site by treated animals or animals coming into contact with them should be prevented. Do not use in cats. This product is highly toxic to cats and may be fatal due to the unique physiology of cats, which are unable to metabolise certain compounds, including permethrin. To prevent accidental exposure to the product, keep treated dogs away from cats after treatment and until the application site is dry. It is important to ensure that cats do not lick the application site of a dog treated with this product. If this happens, seek veterinary advice immediately. Consult a veterinary surgeon before using the product on sick or debilitated dogs. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals: Avoid contact with skin, eyes or mouth. Do not eat, drink or smoke during application. Wash hands thoroughly after use. In case of accidental spillage on the skin, wash immediately with soap and water. People with known skin sensitivities may be particularly sensitive to this product. The predominant clinical symptoms, which may occur in extremely rare cases, are transient sensory skin irritations such as tingling, burning or numbness. If the product accidentally comes into contact with the eyes, they should be rinsed thoroughly with water. If skin or eye irritation persists, seek medical advice immediately and show the package leaflet to the doctor. Do not swallow. In case of accidental ingestion, seek medical advice immediately and show the package leaflet to the doctor or the label. Treated dogs should not be handled, especially by children, until the application site is dry. This can be ensured, for example, by treating dogs in the evening. Recently treated dogs should not be allowed to sleep with their owners, especially children. To prevent children from accessing the pipettes, keep the pipettes in their original packaging until use and discard used pipettes immediately. iii) Other precautions: As the product is hazardous to aquatic organisms, under no circumstances should treated dogs be allowed to enter any surface water for at least 48 hours after treatment. The solvent contained in Advantix Spot-on may stain some materials including leather, fabrics, plastic and polished surfaces. Allow the application site to dry before allowing contact with such materials. No adverse clinical signs were observed in healthy puppies or adult dogs exposed to a 5-fold overdose or in puppies whose dams were treated with a 3-fold overdose. Incompatibilities: None known. TARGET SPECIES: Dogs (up to 4 kg): For dogs weighing more than 4 kg, use the appropriate Advantix Spot-on product (see section 4.9). INTERACTIONS: None known. DIAGNOSIS AND PRESCRIPTION: Sale is not reserved exclusively to pharmacies and is not subject to the need for a veterinary prescription. ADVERSE REACTIONS: In clinical studies, itching at the application site, changes in the coat (e.g. oily coat) and vomiting were observed less frequently. Other reactions, such as redness, inflammation and hair loss at the application site and diarrhoea, have been reported rarely. In very rare cases, reactions in dogs, including transient skin sensitivity (scratching and rubbing) or lethargy, have been reported in spontaneous reports (pharmacovigilance). These reactions generally resolve spontaneously. In very rare cases, dogs may show behavioural changes (agitation, restlessness, whining or rolling movements), gastrointestinal symptoms (hypersalivation, decreased appetite) and neurological signs such as staggering and spasms in dogs sensitive to permethrin. These signs are generally transient and resolve spontaneously. Intoxication following accidental oral ingestion in dogs is unlikely, although this may occur in very rare cases. If this occurs, neurological signs such as tremors and lethargy may occur. Treatment should be symptomatic. There is no known specific antidote. 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: Can be used during pregnancy and lactation