Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
eprinomectin, fipronil, praziquantel, (S)-methoprene
Boehringer Ingelheim Vetmedica GmbH
QP54AA54
eprinomectin, fipronil, praziquantel, (S)-methoprene
Cats
Antiparasitic products, insecticides and repellents, Avermectins, Eprinomectin, combinations,
For cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites. The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.EctoparasitesTreatment and prevention of infestations by fleas (Ctenocephalides felis). Elimination of fleas within 24 hours. One treatment prevents further infestations for at least one month.Prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month.The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).Treatment and prevention of infestations by ticks (Ixodes ricinus). Elimination of ticks within 48 hours. One treatment prevents further infestations for up to 3 weeks.Treatment of notoedric mange (Notoedres cati).CestodesTreatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis, Joyeuxiella pasqualei (adult), and Joyeuxiella fuhrmanni (adult)).NematodesTreatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, adults of Toxascaris leonina, L4 larvae and adults of Ancylostoma tubaeforme and Ancylostoma ceylanicum, and adults of Ancylostoma brazilienze).Treatment of infestations with feline lungworms (L3 larvae, L4 larvae and adults of Aelurostrongylus abstrusus, L4 larvae and adults of Troglostrongylus brevior).Treatment of infestations with vesical worms (Capillaria plica).Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
Revision: 10
Authorised
2013-12-04
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET : BROADLINE SPOT-ON SOLUTION FOR CATS < 2.5 KG BROADLINE SPOT-ON SOLUTION FOR CATS 2.5–7.5 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: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY Manufacturer responsible for batch release: Boehringer Ingelheim Animal Health France SCS 4 Chemin du Calquet, 31000 Toulouse FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT BROADLINE spot-on solution for cats < 2.5 kg BROADLINE spot-on solution for cats 2.5–7.5 kg 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each unit dose (applicator) delivers: Volume of unit dose (ml) Fipronil (mg) (S)-methoprene (mg) Eprinomectin (mg) Praziquantel (mg) Cats <2.5 kg 0.3 24.9 30.0 1.20 24.9 Cats 2.5-7.5 kg 0.9 74.7 90.0 3.60 74.7 Excipient: Butylhydroxytoluene (E321) 1 mg/ml. Spot-on solution. 4. INDICATIONS For cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites. The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time. Ectoparasites - Treatment and prevention of infestations by fleas ( _Ctenocephalides felis)_ . Elimination of fleas within 24 hours. One treatment prevents further infestations for at least one month. - Prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month. - The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). - Treatment and prevention of infestations by ticks ( _Ixodes ricinus)_ . Elimination of ticks within 48 hours. One treatment prevents further infestations for up to 3 weeks. - Treatment of notoedric mange ( _Notoedres cati_ ). 21 Cestodes - Treatment of infestations with tapeworms ( _Dipylidium caninum_ , _Taenia taeniaeformis_ , _Echinococcus multilocularis_ , _Joyeuxiella pasq Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BROADLINE spot-on solution for cats < 2.5 kg BROADLINE spot-on solution for cats 2.5-7.5 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Each unit dose applicator delivers: Volume of unit dose (ml) Fipronil (mg) (S)-methoprene (mg) Eprinomectin (mg) Praziquantel (mg) Cats <2.5 kg 0.3 24.9 30.0 1.20 24.9 Cats 2.5–7.5 kg 0.9 74.7 90.0 3.60 74.7 EXCIPIENTS: Butylhydroxytoluene (E321) 1 mg/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear colourless to yellow to red/brown solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites. The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time. Ectoparasites - Treatment and prevention of infestations by fleas ( _Ctenocephalides felis)_ . Elimination of fleas within 24 hours. One treatment prevents further infestations for at least one month. - Prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month. - The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). - Treatment and prevention of infestations by ticks ( _Ixodes ricinus)_ . Elimination of ticks within 48 hours. One treatment prevents further infestations for up to 3 weeks. - Treatment of notoedric mange ( _Notoedres cati_ ). Cestodes - Treatment of infestations with tapeworms ( _Dipylidium caninum_ , _Taenia taeniaeformis_ , _Echinococcus multilocularis_ _, Joyeuxiella pasqualei _ (adult), and _ Joyeuxiella fuhrmanni (_ adult _))_ . 3 Nematodes - Treatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of _Toxocara _ _cati_ , adults of _Toxascaris leonina,_ L4 larvae and adults of _Ancylostoma tubaeforme Đọc toàn bộ tài liệu