מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: VMD (Veterinary Medicines Directorate)
Fluralaner, Moxidectin
MSD Animal Health UK Limited
QP54AB52
Fluralaner, Moxidectin
Spot-on solution
POM-V - Prescription Only Medicine – Veterinarian
Cats
Endectocide
Authorized
2018-05-08
Revised: September 2023 AN: 01530/2022 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 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) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: 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 EXCIPIENTS: 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, heartworm or lungworm. The veterinary medicinal product is only 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 veterinary medicinal 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_). Revised: September 2023 AN: 01530/2022 Page 2 of 9 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_). When administered repeatedly at a 12-week interval, the veterinary medicinal product continuously prevents heartworm disease caused by _Dirofilaria immitis_ (see details in section 4.9). Prevention of aelurostrongylosis (by preventing קרא את המסמך השלם