Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
sarolaner
Zoetis Belgium SA
QP53BE03
sarolaner
Dogs
Ectoparasiticides for systemic use
For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus,Ixodes ricinus and Rhipicephalus sanguineus). The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks. For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for at least 5 weeks. The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). For the treatment of sarcoptic mange (Sarcoptes scabiei). For the treatment of ear mite infestations (Otodectes cynotis). For the treatment of demodicosis (Demodex canis). Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.,
Revision: 1
Authorised
2018-01-31
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: MIPET EASECTO CHEWABLE TABLETS FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT MiPet Easecto 5 mg chewable tablets for dogs 1.3–2.5 kg MiPet Easecto 10 mg chewable tablets for dogs >2.5–5 kg MiPet Easecto 20 mg chewable tablets for dogs >5–10 kg MiPet Easecto 40 mg chewable tablets for dogs >10–20 kg MiPet Easecto 80 mg chewable tablets for dogs >20–40 kg MiPet Easecto 120 mg chewable tablets for dogs >40–60 kg sarolaner 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains: MiPet Easecto chewable tablets sarolaner (mg) for dogs 1.3–2.5 kg 5 for dogs >2.5–5 kg 10 for dogs >5–10 kg 20 for dogs >10–20 kg 40 for dogs >20–40 kg 80 for dogs >40–60 kg 120 Mottled brown coloured, square shaped chewable tablets with rounded edges. The number embossed on one side refers to the strength (mg) of the tablet: “5”, “10”, ”20”, “40”, “80” or “120”. 4. INDICATION(S) For the treatment of tick infestations ( _Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus_ and _Rhipicephalus sanguineus_ ). The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks. For the treatment of flea infestations ( _Ctenocephalides felis _ and _ Ctenocephalides canis_ ). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for at least 5 weeks. The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). For the treatment of sarcoptic mange ( _Sarcoptes scabiei_ ). For the treatment of ear mite infestations ( _Otodectes cynotis_ ). 17 For the treatment of demodicosis ( Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MiPet Easecto 5 mg chewable tablets for dogs 1.3–2.5 kg MiPet Easecto 10 mg chewable tablets for dogs >2.5–5 kg MiPet Easecto 20 mg chewable tablets for dogs >5–10 kg MiPet Easecto 40 mg chewable tablets for dogs >10–20 kg MiPet Easecto 80 mg chewable tablets for dogs >20–40 kg MiPet Easecto 120 mg chewable tablets for dogs >40–60 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: MiPet Easecto chewable tablets sarolaner (mg) for dogs 1.3–2.5 kg 5 for dogs >2.5–5 kg 10 for dogs >5–10 kg 20 for dogs >10–20 kg 40 for dogs >20–40 kg 80 for dogs >40–60 kg 120 EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablets. Mottled brown coloured, square shaped chewable tablets with rounded edges. The number embossed on one side refers to the strength (mg) of the tablets: “5”, “10”, ”20”, “40”, “80” or “120”. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of tick infestations ( _Dermacentor reticulatus, Ixodes hexagonus,_ _ _ _Ixodes ricinus_ and _Rhipicephalus sanguineus_ ). The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks. For the treatment of flea infestations ( _Ctenocephalides felis _ and _ Ctenocephalides canis_ ). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for at least 5 weeks. The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). For the treatment of sarcoptic mange ( _Sarcoptes scabiei_ ). For the treatment of ear mite infestations ( _Otodectes cynotis_ ). 3 For the treatment of demodicosis ( _Demodex canis_ ). Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. 4.3 CONTRAINDICATI Pročitajte cijeli dokument