COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Enzaprost 5 mg/ml» soluzione iniettabile per bovini e suini. (18A05283)
Estratto provvedimento n. 506 del 16 luglio 2018 Medicinale veterinario ENZAPROST 5 mg/ml Soluzione iniettabile per bovini e suini (A.I.C. n. 103659). Titolare A.I.C.: Ceva Salute Animale S.p.A. Viale Colleoni, 15 - 20864 Agrate Brianza (MB) - Italia. Oggetto del provvedimento: Numero procedura europea: UK/V/0184/001/IB/015. Variazione di tipo IB, C.I.z. Si autorizza, per il medicinale veterinario indicato in oggetto, la modifica del punto 4.6 Reazioni avverse del RCP e dei corrispondenti punti degli altri stampati illustrativi, come di seguito indicato: RCP . Punto 4.6 Reazioni avverse (frequenza e gravita'), viene cosi' autorizzato: Bovini: L'aumento della temperatura rettale (ipertermia) e' stato riportato molto raramente. Tuttavia, i cambiamenti della temperatura rettale sono stati transitori in tutti i casi osservati e non sono stati dannosi per gli animali. Una salivazione limitata e' stata osservata in alcuni casi. Gli effetti collaterali tendono a scomparire entro un'ora dalla somministrazione di PGF2α. Nei bovini, se usato per l'induzione del parto, la ritenzione delle membrane fetali puo' verificarsi piu' frequentemente, a seconda del tempo di utilizzo del prodotto. Suini: Effetti collaterali transitori quali aumento della temperatura corporea, dolore al sito di iniezione, aumento della frequenza respiratoria, aumentata salivazione, stimolo alla defecazione e minzione, arrossamenti cutanei, dispnea, lieve atassia, spasmi addominali e vomito si verificano occasionalmente dopo somministrazione di dinoprost nelle scrofe gravide e nelle scrofette. Queste...
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