País: Israel
Idioma: anglès
Font: Ministry of Health
FLURALANER; MOXIDECTIN
INTERVET ( ISRAEL) LTD
SPOT-ON SOLUTION
MOXIDECTIN 14 MG / 1 ML; FLURALANER 280 MG / 1 ML
TOPICAL
Required
PATHEON MANUFACTURING SERVICES LLC , USA
For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, 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 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). For the prevention of heartworm disease caused by Dirofilaria immitis for 8 weeks.
2021-12-22
CONSUMER PACKAGE LEAFLET FOR VETERINARY MEDICINAL PRODUCT The medicine is dispensed with a veterinarian's prescription only For animal use only 1. NAME OF THE VETERINARY MEDICINAL PRODUCT, ITS FORM AND STRENGTH: Bravecto Plus 112.5 mg/5.6 mg spot-on solution veterinary for Cats Bravecto Plus 250 mg/12.5 mg spot-on solution veterinary for Cats Bravecto Plus 500 mg/25 mg spot-on solution veterinary for Cats Solution for topical (spot-on) use. 2. ACTIVE INGREDIENTS: Each 1 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 A full list of excipients is detailed in section 13 – "Additional information". 3. WHAT IS THE MEDICINAL PRODUCT INTENDED FOR: For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, 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 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_). For the prevention of heartworm disease caused by _Dirofilaria immitis_ for 8 weeks. Therapeutic group: Antiparasitic. 4. CONTRAINDICATIONS: Do not use in case of hypersensitivity to the active substan Llegiu el document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bravecto Plus 112.5 mg / 5.6 mg spot-on solution Veterinary for cats Bravecto Plus 250 mg / 12.5 mg spot-on solution Veterinary for cats Bravecto Plus 500 mg / 25 mg spot-on solution Veterinary for cats 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 and fleas, 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. 2 The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). 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_ ). For the prevention of heartworm disease caused by _Dirofilaria immitis_ for 8 weeks. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients listed in sec Llegiu el document complet