Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
fluralaner
Intervet International B.V
QP53BE02
fluralaner
Dogs; Cats
Ectoparasiticides for systemic use, Isoxazolines
Dogs:- For the treatment of tick and flea infestations;The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).- For the treatment of demodicosis caused by Demodex canis;- For the treatment of sarcoptic mange (Sarcoptes scabiei var. canis) infestation.- For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus. [chewable tablets only]Cats:- For the treatment of tick and flea infestations;The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).- For the treatment of infestations with ear mites (Otodectes cynotis).
Revision: 17
Authorised
2014-02-11
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: BRAVECTO 112.5 MG CHEWABLE TABLETS FOR VERY SMALL DOGS (2–4.5 KG) BRAVECTO 250 MG CHEWABLE TABLETS FOR SMALL DOGS (>4.5–10 KG) BRAVECTO 500 MG CHEWABLE TABLETS FOR MEDIUM-SIZED DOGS (>10–20 KG) BRAVECTO 1,000 MG CHEWABLE TABLETS FOR LARGE DOGS (>20–40 KG) BRAVECTO 1,400 MG CHEWABLE TABLETS FOR VERY LARGE DOGS (>40–56 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: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Manufacturer responsible for batch release: Intervet GesmbH Siemensstrasse 107 1210 Vienna Austria 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Bravecto 112.5 mg chewable tablets for very small dogs (2 – 4.5 kg) Bravecto 250 mg chewable tablets for small dogs (>4.5 – 10 kg) Bravecto 500 mg chewable tablets for medium-sized dogs (>10 – 20 kg) Bravecto 1,000 mg chewable tablets for large dogs (>20 – 40 kg) Bravecto 1,400 mg chewable tablets for very large dogs (>40 – 56 kg) fluralaner 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Each chewable tablet of Bravecto contains: BRAVECTO CHEWABLE TABLETS FLURALANER (MG) for very small dogs (2 – 4.5 kg) 112.5 for small dogs (>4.5 – 10 kg) 250 for medium-sized dogs (>10 – 20 kg) 500 for large dogs (>20 – 40 kg) 1,000 for very large dogs (>40 – 56 kg) 1,400 Light to dark brown tablet with a smooth or slightly rough surface and circular shape. Some marbling, speckles or both may be visible. 4. INDICATIONS For the treatment of tick and flea infestations on dogs. This veterinary medicinal product is a systemic insecticide and acaricide that provides - immediate and persistent flea ( _Ctenocephalides felis_ ) killing activity for 12 weeks, 42 - immediate and persistent tick killing activity for 12 weeks for _ Ixodes ricinus, Dermacentor _ _reticulatus _ and _ D. variabilis;_ - immediate and persistent tick killing activ Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bravecto 112.5 mg chewable tablets for very small dogs (2 – 4.5 kg) Bravecto 250 mg chewable tablets for small dogs (>4.5 – 10 kg) Bravecto 500 mg chewable tablets for medium-sized dogs (>10 – 20 kg) Bravecto 1,000 mg chewable tablets for large dogs (>20 – 40 kg) Bravecto 1,400 mg chewable tablets for very large dogs (>40 – 56 kg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each chewable tablet contains: BRAVECTO CHEWABLE TABLETS FLURALANER (MG) for very small dogs (2 – 4.5 kg) 112.5 for small dogs (>4.5 – 10 kg) 250 for medium-sized dogs (>10 – 20 kg) 500 for large dogs (>20 – 40 kg) 1,000 for very large dogs (>40 – 56 kg) 1,400 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Light to dark brown tablet with a smooth or slightly rough surface and circular shape. Some marbling, speckles or both may be visible. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of tick and flea infestations in dogs. This veterinary medicinal product is a systemic insecticide and acaricide that provides: - immediate and persistent flea ( _Ctenocephalides felis_ ) killing activity for 12 weeks, - immediate and persistent tick killing activity for 12 weeks for _ Ixodes ricinus, Dermacentor _ _reticulatus _ and _ D. variabilis,_ - immediate and persistent tick killing activity for 8 weeks for _Rhipicephalus sanguineus_ . Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). For the treatment of demodicosis caused by _Demodex_ _canis_ . For the treatment of sarcoptic mange ( _Sarcoptes scabiei_ _ _ var. _ canis_ ) infestation. For reduction of the risk of infection with _Babesia canis canis_ via transmission by _Dermacentor _ _reticulatus_ fo Lesen Sie das vollständige Dokument