Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
fluralaner, moxidectin
Intervet International B.V.
QP54AB52
fluralaner, moxidectin
Cats
Antiparasitic products, insecticides and repellents, Endectocides, Milbemycins
For cats with, or at risk from, mixed parasitic infestations by ticks or fleas and ear mites, gastrointestinal nematodes or heartworm. The veterinary medicinal product is exclusively indicated when use against ticks or fleas and one or more of the other target parasites is indicated at the same time.For the treatment of tick and flea infestations in cats providing immediate and persistent flea (Ctenocephalides felis) and tick (Ixodes ricinus) killing activity for 12 weeks. 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 flea allergy dermatitis (FAD).For the treatment of infestations with ear mites (Otodectes cynotis).For the treatment of infections with intestinal roundworm (4th stage larvae, immature adults and adults of Toxocara cati) and hookworm (4th stage larvae, immature adults and adults of Ancylostoma tubaeforme).When administered repeatedly at a 12-week interval, the product continuously prevents heartworm disease caused by Dirofilaria immitis
Revision: 8
Authorised
2018-05-08
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: BRAVECTO PLUS 112.5 MG / 5.6 MG SPOT-ON SOLUTION FOR SMALL CATS (1.2 – 2.8 KG) BRAVECTO PLUS 250 MG / 12.5 MG SPOT-ON SOLUTION FOR MEDIUM-SIZED CATS (>2.8 – 6.25 KG) BRAVECTO PLUS 500 MG / 25 MG SPOT-ON SOLUTION FOR LARGE CATS (>6.25 – 12.5 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: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Manufacturer responsible for batch release: Intervet Productions Rue de Lyons 27460 Igoville FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Bravecto Plus 112.5 mg / 5.6 mg spot-on solution for small cats (1.2 – 2.8 kg) Bravecto Plus 250 mg / 12.5 mg spot-on solution for medium-sized cats (>2.8 – 6.25 kg) Bravecto Plus 500 mg / 25 mg spot-on solution for large cats (>6.25 – 12.5 kg) Fluralaner / moxidectin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each ml of solution contains 280 mg fluralaner and 14 mg moxidectin. Each pipette delivers: BRAVECTO PLUS SPOT-ON SOLUTION PIPETTE CONTENT (ML) FLURALANER (MG) MOXIDECTIN (MG) for small cats 1.2 – 2.8kg 0.4 112.5 5.6 for medium-sized cats >2.8 – 6.25 kg 0.89 250 12.5 for large cats >6.25 – 12.5 kg 1.79 500 25 EXCIPIENT(S): Butylhydroxytoluene 1.07 mg/ml Clear colourless to yellow solution. 4. INDICATION(S) For cats with, or at risk from, mixed parasitic infestations by ticks or fleas and ear mites, gastrointestinal nematodes or heartworm. The veterinary medicinal product is exclusively indicated when use against ticks or fleas and one or more of the other target parasites is indicated at the same time. For the treatment of tick and flea infestations in cats providing immediate and persistent flea ( _Ctenocephalides felis_ ) and tick ( _Ixodes ricinus) _ killing activity for 12 weeks. 21 Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active subst Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bravecto Plus 112.5 mg / 5.6 mg spot-on solution for small cats (1.2 – 2.8 kg) Bravecto Plus 250 mg / 12.5 mg spot-on solution for medium-sized cats (>2.8 – 6.25 kg) Bravecto Plus 500 mg / 25 mg spot-on solution for large cats (>6.25 – 12.5 kg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each ml of solution contains 280 mg fluralaner and 14 mg moxidectin. Each pipette delivers: BRAVECTO PLUS SPOT-ON SOLUTION PIPETTE CONTENT (ML) FLURALANER (MG) MOXIDECTIN (MG) for small cats 1.2 – 2.8 kg 0.4 112.5 5.6 for medium-sized cats >2.8 – 6.25 kg 0.89 250 12.5 for large cats >6.25 – 12.5 kg 1.79 500 25 EXCIPIENT(S): Butylhydroxytoluene 1.07 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear colourless to yellow 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 parasitic infestations by ticks or fleas and ear mites, gastrointestinal nematodes or heartworm. The veterinary medicinal product is exclusively indicated when use against ticks or fleas and one or more of the other target parasites is indicated at the same time. For the treatment of tick and flea infestations in cats providing immediate and persistent flea ( _Ctenocephalides felis_ ) and tick ( _Ixodes ricinus) _ killing activity for 12 weeks. 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 flea allergy dermatitis (FAD). For the treatment of infestations with ear mites ( _Otodectes cynotis_ ). For the treatment of infections with intestinal roundworm (4 th stage larvae, immature adults and adults of _Toxocara cati_ ) and hookworm (4 th stage larvae, immature adults and adults of _Ancylostoma _ _tubaeforme_ ). 3 When administered repeatedly at a 12-week interval, the product co Přečtěte si celý dokument