Country: European Union
Language: English
Source: EMA (European Medicines Agency)
emodepside, praziquantel
Vetoquinol S.A.
QP52AA51
emodepside, praziquantel
Dogs; Cats
Antiparasitic products, insecticides and repellents
CatsFor cats suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:Roundworms (Nematodes)Toxocara cati (mature adult, immature adult, L4 and L3);Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring;Toxascaris leonina (mature adult, immature adult and L4);Ancylostoma tubaeforme (mature adult, immature adult and L4).Tapeworms (Cestodes)Dipylidium caninum (mature adult and immature adult);Taenia taeniaeformis (adult);Echinococcus multilocularis (adult).LungwormsAelurostrongylus abstrusus (adult).DogsFor dogs suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:Roundworms (nematodes):Toxocara canis (mature adult, immature adult, L4 and L3);Toxascaris leonina (mature adult, immature adult and L4);Ancylostoma caninum (mature adult and immature adult);Uncinaria stenocephala (mature adult and immature adult);Trichuris vulpis (mature adult, immature adult and L4);Tapeworms (Cestodes):Dipylidium caninum;Taenia spp.;Echinococcus multilocularis (mature adult and immature);Echinococcus granulosus (mature adult and immature).
Revision: 19
Authorised
2005-07-27
63 B. PACKAGE LEAFLET 64 [Single-dose pipettes] PACKAGE LEAFLET PROFENDER 30 MG / 7.5 MG SPOT-ON SOLUTION FOR SMALL CATS PROFENDER 60 MG / 15 MG SPOT-ON SOLUTION FOR MEDIUM CATS PROFENDER 96 MG / 24 MG SPOT-ON SOLUTION FOR LARGE CATS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Vetoquinol S.A. Magny-Vernois 70200 Lure France Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324 24106 Kiel Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Profender 30 mg / 7.5 mg spot-on solution for small cats Profender 60 mg / 15 mg spot-on solution for medium cats Profender 96 mg / 24 mg spot-on solution for large cats Praziquantel / Emodepside 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS ACTIVE SUBSTANCES: Profender contains 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel. Each unit dose (pipette) of Profender contains: VOLUME EMODEPSIDE PRAZIQUANTEL Profender for Small Cats ( 0.5 - 2.5 kg) 0.35 ml 7.5 mg 30 mg Profender for Medium Cats (> 2.5 – 5 kg) 0.70 ml 15 mg 60 mg Profender for Large Cats (> 5 – 8 kg) 1.12 ml 24 mg 96 mg EXCIPIENTS: 5.4 mg/ml butylhydroxyanisole (E320; as antioxidant) 65 4. INDICATIONS For cats suffering from, or at risk from, mixed parasitic infections caused by roundworms, tapeworms and lungworms of the following species: Roundworms (Nematodes) _Toxocara cati_ (mature adult, immature adult, L4 and L3) _Toxocara cati_ (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring _Toxascaris leonina_ (mature adult, immature adult and L4) _Ancylostoma tubaeforme_ (mature adult, immature adult and L4) Tapeworms (Cestodes) _Dipylidium caninum_ (mature adult and immature adult) _Taenia taeniaeformis_ (adult) _Echinococcus multilocularis_ (adult) Lungworms _Aelurostrongylus abstrusus_ (adult) 5. CONTRAINDICATIONS Do not use in kittens under 8 weeks of Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 [Single-dose pipettes] 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Profender 30 mg/7.5 mg spot-on solution for small cats Profender 60 mg/15 mg spot-on solution for medium cats Profender 96 mg/24 mg spot-on solution for large cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Profender contains 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel. Each unit dose (pipette) of Profender contains: VOLUME EMODEPSIDE PRAZIQUANTEL Profender for Small Cats ( 0.5 - 2.5 kg) 0.35 ml 7.5 mg 30 mg Profender for Medium Cats (> 2.5 – 5 kg) 0.70 ml 15 mg 60 mg Profender for Large Cats (> 5 – 8 kg) 1.12 ml 24 mg 96 mg EXCIPIENTS: 5.4 mg/ml butylhydroxyanisole (E320; as antioxidant) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear yellow to brown solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For cats suffering from, or at risk from, mixed parasitic infections caused by roundworms, tapeworms and lungworms of the following species: Roundworms (Nematodes) _Toxocara cati_ (mature adult, immature adult, L4 and L3) _Toxocara cati_ (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring_ _ _Toxascaris leonina_ (mature adult, immature adult and L4) 3 _Ancylostoma tubaeforme_ (mature adult, immature adult and L4) Tapeworms (Cestodes) _Dipylidium caninum_ (mature adult and immature adult) _Taenia taeniaeformis_ (adult) _Echinococcus multilocularis_ (adult) Lungworms _Aelurostrongylus abstrusus_ (adult) 4.3 CONTRAINDICATIONS Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the product. Treated animals therefore should not be bathed until the solutio Read the complete document