COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Tilosina 24% Liquida Chemifarma SPA». (14A06265)
Estratto del provvedimento n. 561 del 4 luglio 2014 Medicinale veterinario "TILOSINA 24% LIQUIDA CHEMIFARMA SPA "- A.I.C. n. 102714 Titolare: Chemifarma SpA, con sede legale in Forli', Via Eugenio Servadei 16 - codice fiscale 00659370407 Modifica: Variazione di tipo II N.C.II.3 variazione del tempo di attesa per carne e visceri di broilers Si autorizza, per la specialita' medicinale indicata in oggetto, la variazione di cui sopra. Per effetto della suddetta variazione il Riassunto delle Caratteristiche del prodotto (RCP) e l'etichetta -foglio -illustrativo sono modificati come segue: RCP paragrafo 4.11: Tempo di attesa ed Etichetta -foglio illustrativo punto 8: "Broilers: Carne e visceri: da 2 a 0 giorni Uso non consentito in uccelli che producono uova destinate al consumo umano". Per adeguamento alle linee guida EMA il Riassunto delle Caratteristiche del prodotto (RCP) e l'etichetta -foglio -illustrativo sono modificati come segue: RCP paragrafo 4.2-Indicazioni per l'utilizzazione ed etichetta - foglio illustrativo punto 6 "Broiler e tacchini:malattia cronica respiratoria sostenuta da agenti patogeni sensibili alla tilosina" RCP paragrafo 4.3-Controindicazioni ed etichetta-foglio illustrativo corrispondente punto 9 "Non usare in animali con ipersensibilita' nota alla tilosina ed agli altri antibiotici macrolidi e ad uno qualsiasi degli eccipienti. Non usare il prodotto contemporaneamente ad altri macrolidi o lincosamidi (vedi par. 4.8). Non usare nel caso sia nota una resistenza alla tilosina o una resistenza crociata ad altri macrolidi. Non usare in animali con disfunzioni epatiche. Non usare nei cavalli. Non usare nei soggetti in cui siano stati inoculati vaccini sensibili alla tilosina in concomitanza o nella settimana antecedente" RCP paragrafo 4.5 Precauzioni speciali che devono essere adottate dalla persona che somministra il medicinale veterinario agli animali ed etichetta -foglio illustrativo corrispondente punto 9 "La tilosina puo' provocare irritazione. Inoltre, macrolidi quali la tilosina possono...
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