COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Animedazon Spray, 2,45% p/p spray cutaneo sospensione per bovini, ovini e suini». (16A06231)
Estratto del provvedimento n. 474 del 19 luglio 2016 Medicinale veterinario ANIMEDAZON SPRAY, 2,45% p/p spray cutaneo sospensione per bovini, ovini e suini. Confezioni: A.I.C. n. 103980. Titolare A.I.C.: aniMedica GmbH, Im Südfeld 9 - 48308 Senden-Bösensell, Germania. Oggetto del provvedimento: Procedura europea n. DE/V/0120/001/II/009. Si autorizza, per il medicinale veterinario indicato in oggetto, la modifica come di seguito descritta: Adeguamento degli stampati a seguito della chiusura della «Repeat use Procedure» (DE/V/0120/001/E/001). Per effetto della suddetta variazione l'RCP deve essere modificato nei seguenti punti e gli altri stampati illustrativi nei corrispondenti paragrafi: 4.5. Precauzioni speciali per l'impiego Precauzioni speciali che devono essere adottate dalla persona che somministra il medicinale veterinario agli animali: Evitare il contatto diretto con la pelle a causa del rischio di sensibilizzazione, dermatite da contatto e possibili reazioni di ipersensibilita' alla clortetraciclina. Indossare guanti impermeabili idonei durante la manipolazione del prodotto. Il prodotto puo' causare gravi irritazioni agli occhi. Proteggere gli occhi e il viso. In caso di contatto con la pelle o gli occhi, lavare immediatamente l'area interessata con acqua fresca pulita. Se l'irritazione persiste, rivolgersi al medico. Non inalare i vapori. Usare il prodotto all'aperto o in un ambiente ben ventilato. In caso di ingestione accidentale, rivolgersi immediatamente ad un medico mostrandogli l'etichetta. Non mangiare o fumare durante la somministrazione del prodotto. Lavarsi le mani dopo l'uso. Vedere anche il paragrafo 6.4 «Speciali precauzioni per la conservazione». 4.9. Posologia e via di somministrazione Per la somministrazione cutanea. Agitare a fondo il contenitore prima di spruzzare il...
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