Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
emodepside, praziquantel, Tigolaner
Vétoquinol SA
QP52AA51
emodepside, praziquantel, tigolaner
Cats
Anthelmintics,
For cats with, or at risk from, mixed parasitic infestations.The veterinary medicinal product is exclusively indicated when ectoparasites, cestodes and nematodes are targeted at the same time.
Authorised
2021-11-11
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: Felpreva spot-on solution for small cats (1.0 - 2.5 kg) Felpreva spot-on solution for medium cats (> 2.5 – 5.0 kg) Felpreva spot-on solution for large cats (> 5.0 – 8.0 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 and manufacturer responsible for batch release: Vetoquinol S.A. Magny-Vernois 70200 Lure France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Felpreva spot-on solution for small cats (1.0 - 2.5 kg) Felpreva spot-on solution for medium cats (> 2.5 – 5.0 kg) Felpreva spot-on solution for large cats (> 5.0 – 8.0 kg) tigolaner/emodepside/praziquantel 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each spot-on applicator delivers: FELPREVA SPOT-ON SOLUTION VOLUME OF UNIT DOSE [ML] TIGOLANER [MG] EMODEPSIDE [MG] PRAZIQUANTEL [MG] for small cats (1.0 - 2.5 kg) 0.37 36.22 7.53 30.12 for medium cats (> 2.5 – 5.0 kg) 0.74 72.45 15.06 60.24 for large cats (> 5.0 – 8.0 kg) 1.18 115.52 24.01 96.05 EXCIPIENTS: 2.63 mg/ml butylhydroxyanisole (E320) and 1.10 mg/ml butylhydroxytoluene (E321) as antioxidants. Spot-on solution. Clear yellow to red solution. Change in colour may occur during storage. This phenomenon does not affect product quality. 4. INDICATION(S) For cats with, or at risk from, mixed parasitic infections/ infestations. The veterinary medicinal product is exclusively indicated when ectoparasites, cestodes and nematodes are targeted at the same time. Ectoparasites For the treatment of flea (_Ctenocephalides felis_) and tick (_Ixodes ricinus, Ixodes holocyclus_) infestations in cats providing immediate and persistent killing activity for 13 weeks. The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). For the treatment of mild to moderate cases of notoedric mange (caused by _Notoedres cati_). For the treatment of ear Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Felpreva spot-on solution for small cats (1.0 - 2.5 kg) Felpreva spot-on solution for medium cats (> 2.5 – 5.0kg) Felpreva spot-on solution for large cats (> 5.0 – 8.0 kg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Each spot-on applicator delivers: VOLUME OF UNIT DOSE [ML] TIGOLANER EMODEPSIDE PRAZIQUANTEL Felpreva for small cats (1.0 - 2.5 kg) 0.37 ml 36.22 mg 7.53 mg 30.12 mg Felpreva for medium cats (> 2.5 – 5.0 kg) 0.74 ml 72.45 mg 15.06 mg 60.24 mg Felpreva for large cats (> 5.0 –8.0 kg) 1.18 ml 115.52 mg 24.01 mg 96.05 mg EXCIPIENTS: 2.63 mg/ml butylhydroxyanisole (E320) and 1.10 mg/ml butylhydroxytoluene (E321) as antioxidants. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear yellow to red solution. Change in colour may occur during storage. This phenomenon does not affect product quality. 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 parasitic infestations/infections. The veterinary medicinal product is exclusively indicated when ectoparasites, cestodes and nematodes are targeted at the same time. Ectoparasites For the treatment of flea (_Ctenocephalides felis_) and tick (_Ixodes ricinus, Ixodes holocyclus_) infestations in cats providing immediate and persistent killing activity for 13 weeks. The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). For the treatment of mild to moderate cases of notoedric mange (_Notoedres cati_). For the treatment of ear mite infestations (_Otodectes cynotis_) 3 Gastrointestinal roundworms (nematodes) For the treatment of infections with: _Toxocara cati _(mature adult, immature adult, L4 and L3) _Toxascaris leonina_ (mature adult, immature adult and L4) _Ancylostoma tubaeforme_ (mature adult, immature adult and L4) L Les hele dokumentet