COMUNICATO - Modifica dell'autorizzazione dell'immissione in commercio del medicinale per uso veterinario «Depomix». (14A01572)
Estratto del provvedimento n. 75 del 4 febbraio 2014 Oggetto: Medicinale veterinario «Depomix» Confezioni: flacone in vetro da 100 ml - A.I.C. n. 104602014;
flacone in plastica da 100 ml - A.I.C. n. 104602026. Titolare A.I.C.: CEVA SALUTE ANIMALE S.p.a. con sede in Viale Colleoni, 15 - 20864 Agrate Brianza (MB) - Codice fiscale n. 09032600158 Variazioni raggruppate di tipo IB C.I.2 a modifica 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 presenta nuove informazioni complementari Per effetto delle suddette variazioni l'SPC e relative sezioni degli stampati vengono modificati come segue: SPC 4.2) Indicazioni per l'utilizzazione specificando le specie di destinazione: azione anti - infiammatoria;
azione anti - allergica;
azione gluconeogenica. Induzione del parto 4.5) Precauzioni speciali per l'impiego Precauzioni speciali per l'impiego negli animali Tutte le iniezioni intrarticolari devono essere precedute dal prelievo dall'articolazione di una quantita' di liquido sinoviale uguale a quella da iniettare ed essere effettuate in condizioni di rigorosa asepsi. L'uso improprio di Depomix, a causa della lunga (e spesso poco prevedibile) durata d'azione del principio attivo, puo' amplificare le reazioni avverse rendendo tale molecola fortemente «cushingoide» con ritenzione di...
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