COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Poulvac Ilt» vaccino vivo liofilizzato per polli. (14A06635)
Estratto del provvedimento n. 645 del 5 agosto 2014 Medicinale veterinario POULVAC ILT vaccino vivo liofilizzato per polli. Confezioni: 10 flaconi da 1000 dosi - A.I.C. n. 101462012;
1 flacone da 1000 dosi - A.I.C. n. 101462024. Titolare A.I.C.: Zoetis Italia S.r.l. con sede legale e domicilio fiscale in via Andrea Doria, 41 M - 00192 Roma. Modifica: Variazione tipo II unforseen (modifica del paragrafo 4.9 dell'RCP e 9 del foglietto illustrativo). Si autorizzano, le modifiche proposte, ovvero modificare la seguente frase contenuta nei paragrafi 4.9 dell'RCP e paragrafo 9 del foglietto illustrativo: "Ricostituire il contenuto di un flacone di vaccino con un flacone di "Diluente Poulvac ILT" o con 30 ml di acqua per preparazioni iniettabili" in "Ricostituire il contenuto di un flacone di vaccino con 30 ml di acqua per preparazioni iniettabili". Per effetto della suddetta variazione, RCP e il foglietto illustrativo devono essere modificati come segue: 4.9 RCP "Posologia e via di somministrazione" e paragrafo 9 "Avvertenze per una corretta somministrazione" del foglietto illustrativo 1 dose/capo (0,03 ml) di vaccino ricostituito da somministrare per instillazione oculare, da 10 giorni fino a 3 settimane prima dell'inizio della deposizione. Gli animali destinati alla riproduzione vanno rivaccinati a 16-20 settimane di eta' e comunque 3 settimane prima dell'inizio della deposizione. Ricostituzione del vaccino per...
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