Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: VMD (Veterinary Medicines Directorate)
Fluralaner
MSD Animal Health UK Limited
QP53BE02
Fluralaner
Spot-on solution
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Ectoparasiticide
Authorized
2016-05-17
Revised: January 2024 AN: 02555/2022 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bravecto 1,400 mg spot-on solution for very large dogs (>40 – 56 kg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each ml contains 280 mg fluralaner. Each pipette delivers: PIPETTE CONTENT (ML) FLURALANER (MG) for very large dogs >40 – 56 kg 5.0 1,400 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 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 _and_ Ctenocephalides canis_) killing activity for 12 weeks, and - immediate and persistent tick (_Ixodes ricinus, Rhipicephalus sanguineus _and_ _ _Dermacentor reticulatus_) 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 the control of flea allergy dermatitis (FAD). Revised: January 2024 AN: 02555/2022 Page 2 of 8 For the treatment of demodicosis caused by _Demodex_ _canis_. For the treatment of sarcoptic mange (_Sarcoptes scabiei _var_. canis_) infestation. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Parasites need to start feeding on the host to become exposed to fluralaner; therefore the risk of the transmission of parasite borne diseases cannot be excluded. Unnecessary use of antiparasitics or use deviating from the instructions given may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the ris Prečítajte si celý dokument