COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Tilosina 20% liquido Chemifarma» 200 mg/ml. (15A00543)
Estratto del provvedimento n. 9 dell'8 gennaio 2015 Oggetto: «Tilosina 20% liquido Chemifarma» 200 mg/ml, soluzione uso orale per suini, broilers e vitelli da latte AIC n. 103385. Titolare: Chemifarma S.p.A. con sede legale e domicilio fiscale in Forli' - §§Via Don Eugenio Servadei, 16 - codice fiscale n. 00659370407. Variazione di tipo IB. Si autorizzano le modifiche come di seguito descritte: adeguamento del riassunto delle caratteristiche del prodotto alle linee guida EMEA/CVMP/SAGAM/383441/2005 revised guideline on the spc for antimicrobial products. Per effetto della suddetta variazione gli stampati devono essere modificati con l'aggiunta delle frasi di seguito indicate: 1. Denominazione del medicinale veterinario: «Tilosina 20% liquido Chemifarma» 200 mg/ml, soluzione uso orale per suini, broilers e vitelli da latte. 4.3. Controndicazioni: Non usare in animali con ipersensibilita' nota alla tilosina o ad uno qualsiasi degli eccipienti. 4.4. Avvertenze speciali per ciascuna specie di destinazione: L'utilizzo ripetuto o protratto va evitato, migliorando le prassi di gestione e mediante pulizia e disinfezione. 4.5. Precauzioni speciali per l'impiego L'utilizzo del prodotto dovrebbe essere basato su test di sensibilita' nei confronti dei batteri isolati dagli animali. Se cio' non fosse possibile la terapia dovrebbe essere basata su informazioni epidemiologiche locali (regionali, aziendali) circa la sensibilita' dei batteri target. L'uso improprio del prodotto potrebbe incrementare la prevalenza di batteri resistenti alla tilosina e...
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