Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
dinotefuran, pyriproxyfen, permethrin
Ceva Sante Animale
QP53AC54
dinotefuran, permethrin, and pyriproxyfen
Dogs
permethrin, combinations
Treatment and prevention of flea infestation (Ctenocephalides felis and Ctenocephalides canis).Treatment and prevention of tick infestation (Rhipicephalus sanguineus, Dermacentor reticulatus, Ixodes ricinus).Prevention of biting from sand flies (Phlebotomus perniciosus), mosquitoes (Culex pipiens, Aedes aegypti) and stable flies (Stomoxys calcitrans).Treatment of mosquito (Aedes aegypti) and stable fly (Stomoxys calcitrans) infestation.
Revision: 7
Authorised
2013-12-04
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: VECTRA 3D SPOT-ON SOLUTION FOR DOGS 1.5–4 KG VECTRA 3D SPOT-ON SOLUTION FOR DOGS > 4–10 KG VECTRA 3D SPOT-ON SOLUTION FOR DOGS > 10–25 KG VECTRA 3D SPOT-ON SOLUTION FOR DOGS > 25–40 KG VECTRA 3D SPOT-ON SOLUTION FOR DOGS > 40 KG 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Ceva Santé Animale, 10, av. de La Ballastière, 33500 Libourne, France Manufacturer responsible for batch release: Ceva Santé Animale, 10, av. de La Ballastière, 33500 Libourne, France AB7 SANTE, Chemin des Monges, 31450 Deyme, France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Vectra 3D spot-on solution for dogs 1.5–4 kg Vectra 3D spot-on solution for dogs > 4 – 10 kg Vectra 3D spot-on solution for dogs > 10 – 25 kg Vectra 3D spot-on solution for dogs > 25 – 40 kg Vectra 3D spot-on solution for dogs > 40 kg dinotefuran / pyriproxyfen / permethrin 3. STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS Each ml contains 54 mg dinotefuran, 4.84 mg pyriproxyfen and 397 mg permethrin. Each spot-on applicator delivers: Weight of dog (kg) Colour of applicator cap Volume (ml) Dinotefuran (mg) Pyriproxyfen (mg) Permethrin (mg) for dogs 1.5 – 4 kg Yellow 0.8 44 3.9 317 for dogs > 4 – 10 kg Teal 1.6 87 7.7 635 for dogs > 10 – 25 kg Blue 3.6 196 17.4 1,429 for dogs > 25 – 40 kg Purple 4.7 256 22.7 1,865 for dogs > 40 kg Red 8.0 436 38.7 3,175 The veterinary medicine is a pale-yellow spot-on solution, packaged in single dose spot-on applicators. 4. INDICATION(S) Fleas: This veterinary medicine kills fleas on infested animals and prevents further infestations for one month. It is effective against the following fleas found on dogs _(Ctenocephalides canis _ and 20 _Ctenocephalides felis_ ). This veterinary medicine also prevents the multiplication of fleas for two months after use by inhibiting flea egg hatching (ovicidal activity) and by inhibiting t read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vectra 3D spot-on solution for dogs 1.5–4 kg Vectra 3D spot-on solution for dogs > 4–10 kg Vectra 3D spot-on solution for dogs > 10–25 kg Vectra 3D spot-on solution for dogs > 25–40 kg Vectra 3D spot-on solution for dogs > 40 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Each ml contains 54 mg dinotefuran, 4.84 mg pyriproxyfen and 397 mg permethrin. Each spot-on applicator delivers: Weight of dog (kg) Colour of applicator cap Volume (ml) Dinotefuran (mg) Pyriproxyfen (mg) Permethrin (mg) for dogs 1.5–4 kg Yellow 0.8 44 3.9 317 for dogs > 4–10 kg Teal 1.6 87 7.7 635 for dogs > 10–25 kg Blue 3.6 196 17.4 1,429 for dogs > 25–40 kg Purple 4.7 256 22.7 1,865 for dogs > 40 kg Red 8.0 436 38.7 3,175 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Pale-yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Fleas: Treatment and prevention of flea infestation ( _Ctenocephalides felis_ and _Ctenocephalides canis_ ). The treatment prevents flea infestation for one month. It also prevents multiplication of fleas for two months after application by inhibiting egg hatching (ovicidal activity) and by inhibiting the emergence of adults from eggs laid by adult fleas (larvicidal activity). Ticks: The veterinary medicinal product has persistent acaricidal and repellent efficacy against tick infestations ( _Rhipicephalus sanguineus_ and _Ixodes ricinus_ for one month, and _Dermacentor _ _reticulatus_ for up to three weeks) _. _ 3 If ticks are present when the veterinary medicinal product is applied, the ticks may not all be killed within the first 48 hours, but they may be killed within a week. To remove ticks, it is recommended to use an appropriate tick removal device. Sand flies, mosquitoes and stable flies: The treatment provides persistent repellent (anti-feeding) activity. It prevents biting from read_full_document