COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Empressin» (18A06609)
Estratto determina n. 1585/2018 del 3 ottobre 2018 Medicinale: EMPRESSIN. Titolare A.I.C.: Orpha-Devel Handels Und Vertriebs GmbH - Wintergasse 85/1B - A-3002 Purkersdorf - Austria. Confezioni e numeri di A.I.C.: «40 U.I./2 ml concentrato per soluzione per infusione» 5 fiale in vetro - A.I.C. n. 046314011 (in base 10);
40 U.I./2 ml concentrato per soluzione per infusione
10 fiale in vetro - A.I.C. n. 046314023 (in base 10);
Forma farmaceutica: concentrato per soluzione per infusione. Validita' prodotto integro: 18 mesi. Condizioni particolari di conservazione: conservare in frigorifero (2°C - 8°C). Una volta aperto, deve essere diluito e usato immediatamente. Principio attivo: argipressina acetato 40 I.U./2 ml. Eccipienti: cloruro di sodio;
acido acetico glaciale per la regolazione del pH;
acqua per preparazioni iniettabili. Produttore del principio attivo: BCN Peptides SA Poligono Industrial Els Vinyets-Els Fogars II Sant Quinti' de Mediona, 08777 - Barcellona, Spagna. Produttore del prodotto finito: produzione: Haupt Pharma Wülfing GmbH Bethelner Landstrasse 18 31028 Gronau/Leine, Germania. Confezionamento primario e secondario: Haupt Pharma Wülfing GmbH Bethelner Landstrasse 18 31028 Gronau/Leine, Germania. Controllo dei lotti: Haupt Pharma Wülfing GmbH Bethelner Landstrasse 18 31028 Gronau/Leine, Germania. Rilascio lotti: Amomed Pharma GmbH Storchengasse 1, 1150 Vienna Austria. Indicazioni terapeutiche: Empressin e' indicato per il trattamento dell'ipotensione refrattaria alle catecolamine conseguente a shock settico in pazienti di eta' superiore ai 18 anni. E' presente un'ipotensione refrattaria alle catecolamine se la pressione arteriosa media non puo' essere stabilizzata ai valori ottimali nonostante un adeguato reintegro del volume e la somministrazione di catecolamine. Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1 risultano collocate, in virtu' dell'art. 12, comma 5, del decreto-legge 13 settembre 2012, n. 158, convertito, con...
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