NAME ADVANTAGE 40 MG SPOT-ON SOLUTION FOR SMALL CATS AND SMALL RABBITS ACTIVE INGREDIENTS Each 0.4 ml pipette contains the active ingredient: imidacloprid 40 mg. Excipient(s): butylhydroxytoluene (E 321) 0.4 mg; benzyl alcohol (E 1519) 332.8 mg. For the full list of excipients, see section 6.1. EXCIPIENTS Butylhydroxytoluene (E 321), benzyl alcohol (E 1519), propylene carbonate. THERAPEUTIC INDICATIONS For cats under 4 kg: Prevention and treatment of flea infestations (Ctenocephalides felis). For rabbits under 4 kg: Treatment of flea infestations. Fleas are eliminated within one day of treatment. One treatment prevents further flea infestation for 3-4 weeks in cats and up to one week in rabbits. In cats, the veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD), if previously diagnosed by a veterinarian. CONTRAINDICATIONS / ADVERSE EFFECTS Do not treat unweaned kittens less than 8 weeks of age. Do not use in rabbits less than 10 weeks of age. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. SAFETY IN TARGET SPECIES In cats, no adverse clinical signs were observed using doses up to five times the therapeutic level, weekly, for eight consecutive weeks. In rabbits, no adverse clinical signs were observed using doses up to 45 mg/kg body weight (four times the therapeutic level), weekly, for four consecutive weeks. In rare cases of overdose or if the animal licks the treated fur, nervous system disorders (such as spasms, tremors, ataxia, mydriasis, miosis, lethargy) may occur in cats. Intoxication after accidental oral ingestion is unlikely in animals. In this case, treatment should be symptomatic under veterinary supervision. There is no known specific antidote, but the administration of activated charcoal may be beneficial. DOSAGE: This veterinary medicinal product is for topical use and should not be administered orally. Animals should be weighed accurately before treatment. Dosage and dosing schedule: Cat/rabbit (kg body weight): < 4 kg; product: advantage 40 for small cats and small rabbits; number of pipettes: 1 ≤ 0.4 ml; imidacloprid (mg/kg body weight): minimum 10. Method of administration: Remove a pipette from the packaging. Holding the pipette in an upright position, twist and remove the cap. Use the inverted cap to twist and remove the seal from the pipette. Administration to cats: Part the fur on the cat’s neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times until all the contents are emptied directly onto the skin. Administration to rabbits: Part the fur on the rabbit’s neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times until all the contents are emptied directly onto the skin. STORAGE: This veterinary medicinal product does not require any special storage conditions. Keep the blister in the outer carton. Shelf life of the veterinary medicinal product as packaged for sale: 5 years. WARNINGS: Re-infestation caused by the development of new fleas present in the environment may continue to occur for six weeks or more after the start of treatment. Therefore, multiple treatments may be necessary, depending on the level of fleas in the environment. To help reduce environmental flea infestation, additional treatment against adult fleas and their developmental stages is recommended. To further reduce environmental flea infestation, it is recommended to treat all cats and rabbits in the household. Treatment of nursing cats and rabbits controls flea infestations in both the mother and her kittens. The veterinary medicinal product remains effective even if the animal gets wet, for example after exposure to heavy rain. However, depending on the presence of fleas in the environment, additional treatment may be necessary. In such cases, do not treat more frequently than once a week. Special precautions for use in animals: This veterinary medicinal product is for topical use and should not be administered orally. Apply only to intact skin. Precautions should be taken to avoid contact of the contents of the pipette with the eyes or mouth of the treated animal. Do not allow recently treated animals to brush each other. Any collars should be removed before applying the product. Before reapplying the collar, the treated area should be visually inspected to ensure that it is dry. Special precautions to be taken by the person administering the veterinary medicinal product to animals: People with known hypersensitivity to imidacloprid should avoid contact with the veterinary medicinal product. This product contains benzyl alcohol and may, in rare cases, cause skin sensitization or transient skin reactions (e.g. irritation, tingling). Avoid contact of the product with skin, eyes or mouth. Do not massage the application site. Do not eat, drink or smoke during application. Wash any skin contamination with soap and water. If the product comes into contact with the eyes, they should be rinsed thoroughly with water. If skin or eye irritation persists, seek medical attention. In case of accidental ingestion of the product, seek medical attention immediately. After application, do not pet or brush animals until the application site is dry. Wash hands thoroughly after use. Other precautions: The solvent contained in this veterinary medicinal product may stain some materials, including leather, fabrics, plastics and polished surfaces. Allow the application site to dry before allowing contact with such materials. In cats, no adverse clinical signs were observed using doses up to five times the therapeutic level, administered weekly, for eight consecutive weeks. In rabbits, no adverse clinical signs were observed using doses up to 45 mg/kg body weight (four times the therapeutic level), administered weekly, for four consecutive weeks. In rare cases of overdose or if the animal licks the treated fur, nervous system disorders (such as spasms, tremors, ataxia, mydriasis, miosis, lethargy) may occur in cats. Poisoning following accidental oral ingestion in animals is unlikely. In this case, treatment should be symptomatic under veterinary supervision. There are no known specific antidotes, but administration of activated charcoal may be beneficial. Major incompatibilities: None known. TARGET SPECIES: Cats and rabbits. INTERACTIONS: No incompatibilities have been observed between this veterinary medicinal product, at double the recommended dose, and the following commonly used veterinary medicinal products: lufenuron, pyrantel and praziquantel (cats). The compatibility of the veterinary medicinal product has also been demonstrated with a wide range of routine treatments under field conditions, including vaccination. DIAGNOSIS AND PRESCRIBING: This product is not available exclusively through pharmacies and does not require a veterinary prescription. ADVERSE REACTIONS: The veterinary medicinal product has a bitter taste and salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within a few minutes without treatment. In very rare cases (less than 1 in 10,000 animals treated, including isolated reports), skin reactions such as hair loss, redness, itching and skin lesions may occur in cats and rabbits. In cats, agitation, excessive salivation and nervous signs such as incoordination, tremors and depression have been observed, although in exceptional cases. Oral ingestion may cause other gastrointestinal signs (vomiting and diarrhoea), which have been observed very rarely based on post-marketing data. 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: No reproductive toxicity was observed in rats and no primary embryotoxicity or teratogenic toxicity was observed in studies in rats and rabbits. Studies in pregnant and lactating cats and their offspring are limited. Evidence to date suggests that no adverse effects are to be expected in these animals