COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario «Advantix Spot-on» per cani oltre 40 Kg fino a 60 Kg. (18A00731)
Estratto decreto n. 2 del 10 gennaio 2018 Medicinale veterinario ADVANTIX SPOT-ON per cani oltre 40 kg fino a 60 kg. Titolare A.I.C.: Bayer S.p.A., viale Certosa n. 130 - 20156 Milano. Produttore responsabile rilascio lotti: KVP Pharma + Veterinär Produkte GmbH, projensdorfer Str. 324, Kiel, 24106 Germany. Confezioni autorizzate e numeri di A.I.C.: confezione da 1 pipetta da 6,0 ml - A.I.C. n. 103629073;
confezione da 2 pipette da 6,0 ml - A.I.C. n. 103629085;
confezione da 3 pipette da 6,0 ml - A.I.C. n. 103629097;
confezione da 4 pipette da 6,0 ml - A.I.C. n. 103629109;
confezione da 6 pipette da 6,0 ml - A.I.C. n. 103629111;
confezione da 24 pipette da 6,0 ml - A.I.C. n. 103629123. Composizione: ciascuna pipetta da 6,0 ml contiene: principio attivo: imidacloprid: 600,0 mg;
permetrina (40/60): 3000,0 mg;
eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti. Specie di destinazione: cani (oltre 40 kg fino a 60 kg). Indicazioni terapeutiche. Per il trattamento e la prevenzione delle infestazioni da pulci (Ctenocephalides canis, Ctenocephalides felis). Le pulci sui cani vengono uccise entro un giorno dal trattamento. Un trattamento previene l'ulteriore infestazione da pulci per quattro settimane. Il prodotto puo' essere utilizzato come parte di una strategia di trattamento per la dermatite allergica da pulci (DAP). Per il trattamento dei pidocchi (Trichodectes canis). Il prodotto ha persistente efficacia acaricida e repellente nei confronti delle infestazioni da zecche (Rhipicephalus sanguineus e Ixodes ricinus per quattro settimane, e Dermacentor reticulatus per tre settimane). Attraverso l'azione repellente e abbattente sulla zecca vettore Rhipicephalus sanguineus, il prodotto riduce la probabilita' di trasmissione del patogeno Erlichia canis, riducendo quindi il rischio di ehrlichiosi canina. La riduzione del rischio e' stata dimostrata...
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