Technical Data Sheets

advantage

Advantage® Spot-on solution for dogs and cats (UK, Germany, France, Italy, Austria, Ireland: pet rabbits). Composition: 1 ml solution contains 100 mg imidacloprid and 1 mg butyl-hydroxytoluene. Pipettes of 0.4 ml, 1.0 ml, 2.5 ml or 4.0 ml for dogs and 0.4 ml or 0.8 ml for cats (UK, Germany, France, Italy, Austria, Ireland: pet rabbits). Indications for use: For the treatment and prevention of flea (Ctenocephalides canis, Ctenocephalides felis) infestation and for the treatment of biting lice (Trichodectes canis) on dogs and cats (UK, Germany, France, Italy, Austria, Ireland: for the treatment of flea infestation on pet rabbits). Fleas are killed within 24 hours following application. One application remains effective for up to 4 weeks against fleas. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). Contraindications, warnings: In the absence of available data, the product should not be used on puppies of less than 8 weeks or kittens of less than 7 weeks of age (UK only: do not use on pet rabbits of less than 10 weeks of age). Care should be taken to avoid the contents of the tube coming into contact with the eye or mouth of the user or recipient animals. Withdrawal period: Not applicable. Marketing authorization holder: Local Bayer affiliates.

advantix

Advantix® Spot-on solution for dogs. Composition: 1 tube for dogs up to 4 kg body weight contains 0.4 ml solution containing 40 mg imidacloprid, 200 mg permethrin and 0.4 mg butylhydroxytoluene. 1 tube for dogs over 4 up to 10 kg body weight contains 1.0 ml solution containing 100 mg imidacloprid, 500 mg permethrin and 1.0 mg butylhydroxytoluene. 1 tube for dogs over 10 up to 25 kg body weight contains 2.5 ml solution containing 250 mg imidacloprid, 1250 mg permethrin and 2.5 mg butylhydroxytoluene. 1 tube for dogs over 25 kg weight contains 4.0 ml solution containing 400 mg imidacloprid, 2000 mg permethrin and 4.0 mg butylhydroxytoluene. Indications for use: For the treatment and prevention of flea (Ctenocephalides canis) infestation. Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for 4 weeks. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). The product has a persistent acaricidal and repellent efficacy for 4 weeks (Rhipicephalus sanguineus, Ixodes ricinus) or 3 weeks (Dermacentor reticulatus), respectively, against tick infestations. Ticks already on the dog may not be killed within 2 days after treatment and may remain attached and visible. Therefore the removal of ticks already on the dog at the time of treatment is recommended, in order to prevent them from attaching and having a blood meal. One treatment provides repellent (anti-feeding) activity against sand flies for 2 weeks (Phlebotomus papatasi) or 3 weeks (Phlebotomus perniciosus), respectively, against mosquitoes for 2 (Aedes aegypti) and 4 (Culex pipiens) weeks respectively and stable flies (Stomoxys calcitrans) for 4 weeks. Contraindications: In the absence of available data the product should not be used on puppies of less than 7 weeks of age and 1.5 kg of weight. Do not use on cats. Undesirable effects: On rare occasions, reaction in dogs may include transient skin sensitivity (including pruritus, alopecia and erythema at the application site) or lethargy. Poisoning following inadvertent oral uptake in dogs is unlikely but may occur in very rare cases. In this event, neurological signs such as tremor and lethargy can occur. Treatment should be symptomatic under veterinary medical attention. There is no known specific antidote. Special warnings for target species: There may be an attachment of single ticks or bites by single sand flies or mosquitoes. For this reason, a transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable. Withdrawal period: Not applicable. Advantix Marketing Authorizations are held by local Bayer entities, D-51368 Leverkusen, Germany.

advocate

Advocate® Spot-on solution for dogs, cats and ferrets. Composition: Advocate® for cats and ferrets contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin. 1 pipette for cats up to 4 kg body weight and ferrets contains 0.4 ml solution, containing 40 mg imidacloprid and 4.0 mg moxidectin. 1 pipette for cats over 4 up to 8 kg body weight contains 0.8 ml solution containing 80 mg imidacloprid and 8.0 mg moxidectin. Advocate® for dogs contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin. One pipette for dogs up to 4 kg body weight contains 0.4 ml solution, containing 40 mg imidacloprid and 10 mg moxidectin. One pipette for dogs over 4 up to 10 kg body weight contains 1.0 ml solution, containing 100 mg imidacloprid and 25 mg moxidectin. 1 pipette for dogs over 10 up to 25 kg body weight contains 2.5 ml solution, containing 250 mg imidaclopride and 62.5 mg moxidectin. 1 pipette for dogs over 25 up to 40 kg weight contains 4.0 ml solution, containing 400 mg imidacloprid and 100 mg moxidectin. Excipients: Benzylalcohol, butylhydroxytoluene 1 mg/ml (E321; as antioxidant), propylene carbonate. Indications for use: For dogs suffering from, or at risk from, mixed parasitic infections: For the treatment and prevention of flea infestation (Ctenocephalides canis), treatment of biting lice (Trichodectes canis), treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis), prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis) treatment of circulating microfilariae (Dirofilaria immitis), treatment of cutaneous dirofilariosis (adult stages of Dirofilaria repens), prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens), reduction of circulating microfilariae (Dirofilaria repens),prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum), treatment of Angiostrongylus vasorum and Crenosoma vulpis, prevention of spirocercosis (Spirocerca lupi), and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis). For cats suffering from, or at risk from, mixed parasitic infections: For the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of ear mite infestation (Otodectes cynotis), treatment of notoedric mange (Notoedres cati), prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis) and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme). For ferrets suffering, or at risk from, mixed parasitic infections: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis). Contraindications: Do not use in puppies under 7 weeks of age and kittens under 9 weeks of age. Do not use in case of hypersensitivity to the active substances or to any of the excipients. Do not use on canaries. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment by the responsible veterinarian. Treatment of dogs and cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment. Adverse reactions: Use of the product may result in transient pruritus in dogs and cats. On rare occasions, greasy hair, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment, neurological signs(most of which are transient) may be observed in very rare cases. The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application sites. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence. For dogs only: A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnea and dyspnea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.In case of accidental oral uptake, symptomatic treatment should be administered by a veterinary surgeon. There is no known specific antidote. The use of activated charcoal may be beneficial. Available only on prescription. Marketing authorization holder: Bayer Animal Health GmbH, D-51368 Leverkusen, Germany

seresto

Seresto® collar for cats and dogs: Two Compositions: One collar for cats and dogs up to 8 kg body weight (38 cm length) and one collar for dogs over 8 kg body weight (70 cm length) contains 10 % imidacloprid and 4.5 % flumethrin as active substances; excipients: titanium dioxide and iron oxide black. Indications for use: Cats: For the treatment and prevention of flea (Ctenocephalides felis) infestation for 7 to 8 months. Efficacy against fleas starts immediately after application of the collar. Protects the animal’s immediate surroundings against flea larvae development for 10 weeks. Collar can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). The product has persistent acaricidal (killing) efficacy (Ixodes ricinus, Rhipicephalus turanicus) and repellent (anti-feeding) efficacy against tick infestations (Ixodes ricinus) for 8 months. It is effective against larvae, nymphs and adult ticks. Ticks already on the cat prior to treatment may not be killed within 48 hours after collar application and may remain attached and visible. Therefore, removal of ticks already on the cat at the time of application is recommended. The prevention of infestations with new ticks starts within 2 days after application of the collar. Apply collar before the beginning of the flea or tick season. Dogs: For the treatment and prevention of flea (Ctenocephalides canis) infestation for 7 to 8 months. Flea efficacy starts immediately after application of the collar. Protects the surroundings against flea larval development for 8 months. Collar can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). Persistent acaricidal (killing) efficacy against tick infestations (Ixodes ricinus, Rhipicephalus sanguineus, Dermacentor reticulatus) and repellent (anti-feeding) efficacy against tick infestations (Ixodes ricinus, Rhipicephalus sanguineus) for 8 months and effective against larvae, nymphs and adult ticks. Ticks already on the dog prior to treatment may not be killed within 48 hours after collar application and may remain attached and visible. Therefore, removal of ticks already on the dog at the time of application is recommended. The prevention of infestations with new ticks starts within two days after application of the collar. For treatment of biting/chewing lice (Trichodectes canis) infestation. Ideally, the collar should be applied before the beginning of the flea or tick season. Contraindications: Do not treat kittens less than 10 weeks of age. Do not treat puppies less than 7 weeks of age. Do not use in case of known hypersensitivity to the active substances or to any of the excipients. Special precautions for use: The product is water-resistant; it remains effective if the animal becomes wet. However, prolonged, intense exposure to water or extensive shampooing should be avoided as the duration of activity may be reduced. Studies show that monthly shampooing or water immersion does not significantly shorten the 8 months efficacy duration for ticks after redistribution of the active substances in the coat, whereas the product’s flea efficacy gradually decreased, starting in the 5th month. As with any veterinary medicinal products, do not allow small children to play with the collar or to put it into their mouths. Pets wearing the collar should not be allowed to sleep in the same bed as their owners, especially children. People with known sensitivity to the ingredients of the collar should avoid contact with the collar. Wash hands with cold water after fitting the collar. Adverse reactions: Occasionally slight pruritus and/or erythema may be observed in animals that are not used to wearing collars on the first few days after fitting. Ensure that the collar is not fitted too tightly. Slight hair loss and mild skin reactions may occur at the application site which usually recover within 1 to 2 weeks without the need for collar removal. In single cases, a temporary collar removal may be recommended until the symptoms have disappeared. In cats, initially, slight and transient reactions as depression, change of food intake, salivation, vomiting and diarrhea might occur in rare cases. As in other topical applications, allergic contact dermatitis might occur in hypersensitive animals. Laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not produced any effects on fertility or reproduction and showed no teratogenic or foetotoxic effects. However, the safety of the veterinary medicinal product has not been established in target animals during pregnancy and lactation, and in the absence of available data, the product is therefore not recommended in pregnant and lactating bitches or queens. No interaction with other medicinal products and other forms of interaction are known. Due to the nature of the collar, overdosage is unlikely and signs of overdosage are not to be expected. An overdosage of five collars around the neck was investigated in adult cats and dogs for an 8-month period and in 10-week-old kittens and 7-week-old puppies for a 6-month period and no other adverse effects were observed. In the unlikely event of oral uptake of the collar, mild gastrointestinal signs (e.g., loose stool) may occur. Withdrawal period: Not applicable. Marketing authorization holder: Local Bayer affiliates.