COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Equest gel orale 18,92 mg/g» gel orale per cavalli e ponies. (19A00408)
Estratto del provvedimento n. 949 del 28 dicembre 2018 Medicinale veterinario EQUEST GEL ORALE 18,92 MG/G gel orale per cavalli e ponies: 1 tubo siringa - A.I.C. n. 102720012;
10 tubi siringa confezionati singolarmente - A.I.C. n. 102720024;
20 tubi siringa - A.I.C. n. 102720036. Titolare A.I.C.: Zoetis Italia S.r.l., via Andrea Doria, 41 M - 00192 Roma. Oggetto del provvedimento: numero procedura europea: FR/V/0020/002/IB/029. Variazione di tipo IB, C.I.z Per effetto della suddetta variazione gli stampati, alla sezione «Posologia e via di somministrazione» devono essere modificati come segue: «Somministrare una singola dose orale di 400 µg di moxidectina/kg di peso corporeo, utilizzando la siringa calibrata. Prima della prima dose, tenere la siringa in maniera tale che l'estremita' con il cappuccio sia rivolta a sinistra e che siano visibili le misure del peso e le tacche di graduazione (piccole linee nere). Impostare la siringa allo zero ruotando l'anello girevole in modo che il lato sinistro sia impostato sulla prima tacca nera piena e spingere lo stantuffo, eliminando in modo sicuro la pasta che fuoriesce. Per dosare il prodotto...
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