COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Wellicox 50 mg/ml», soluzione iniettabile. (18A05407)
Estratto provvedimento n. 537 del 24 luglio 2018 Medicinale veterinario WELLICOX 50 mg/ml soluzione iniettabile per bovini, suini e cavalli. Confezioni: tutte - A.I.C. n. 104491. Titolare A.I.C.: Merial SAS - 29 Avenue Tony Garnier - 69007 Lyon - Francia. Oggetto del provvedimento: Numero procedura europea: FR/V/0241/001/IB/003. Variazione Tipo IB - C.I.2.a) Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo di un medicinale generico/ibrido/biosimilare in seguito a una valutazione della stessa modifica apportata al prodotto di riferimento. Attuazione di una o piu' modifiche per le quali il titolare dell'autorizzazione all'immissione in commercio non e' tenuto a presentare nuove informazioni complementari. Si autorizzano le modifiche come di seguito descritte: Riassunto delle caratteristiche del prodotto e relativi paragrafi degli stampati illustrativi: Paragrafo 4.9 - Posologia e via di somministrazione. Bovini: 2 mg/kg p.c. di flunixin, equivalente a 2 ml di soluzione per 50 kg di peso corporeo, somministrati una volta al giorno, per via endovenosa o intramuscolare per 1-3 giorni consecutivi. Volumi superiori a 20 ml dovrebbero essere suddivisi e somministrati in almeno 2 siti di iniezione diversi. Paragrafo 4.11 - Tempi di attesa. Bovini: carni e visceri: 10 giorni (via EV) / 31 giorni (via IM);
latte: 24 ore (via EV) /36 ore (via IM). La posologia e la via di somministrazione ora autorizzate sono le seguenti: uso intramuscolare per bovini e suini;
uso endovenoso per bovini e cavalli. Il peso corporeo deve essere determinato accuratamente prima della somministrazione. Bovini: 2 mg/kg p.c. di flunixina, equivalente a 2 ml di soluzione per 50 kg di peso corporeo, somministrati una volta al giorno, per via endovenosa o intramuscolare per 1-3 giorni consecutivi. Volumi superiori a 20 ml dovrebbero essere suddivisi e somministrati in almeno 2 siti di iniezione diversi. Suini: Trattamento di supporto a una adeguata terapia antibiotica per la sindrome Mastite-Metrite-Agalassia: 2 mg/kg p.c. di flunixina, equivalente a 2...
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