COMUNICATO - Autorizzazione all'immissione in commercio della specialita' medicinale per uso umano 'Accusol'
Estratto determinazione n. 495 del 24 maggio 2007
Medicinale: ACCUSOL.
Titolare A.I.C.: Baxter S.p.a. - Viale Tiziano, 25 - Roma.
Confezione:
35 soluzione per emofiltrazione, emodialisi ed emodiafiltrazione 2 sacche a doppia camera da 5000 ml - A.I.C. n. 037200019/M (in base 10) 13H84M (in base 32).
Forma farmaceutica: soluzione per emofiltrazione, emodialisi ed emodiafiltrazione.
Composizione: ogni soluzione per 1000 ml di accusol contiene:
principio attivo: Camera grande "A": g. 0,343 di calcio cloruro biidrato, g. 0,136 di magnesio cloruro esaidrato, g. 7,66 di sodio cloruro.
Camera piccola "B" g. 12,9 di sodio bicarbonato.
eccipienti: acqua per preparazioni iniettabili, acido cloridrico (correttore di pH), sodio idrossido (correttore di pH).
Produzione:
Baxter Healthcare S.A. - County Mayo - Castlebar (Irlanda);
Bieffe Medital S.p.A. via Nuova Provinciale s/n - 23034 Grosotto (Sondrio).
Indicazioni terapeutiche: accusol e' indicato per il trattamento dell'insufficienza renale acuta e cronica, come soluzione sostitutiva nella emofiltrazione e emodiafiltrazione, e come soluzione per dialisi nella emodialisi e nella emodiafiltrazione.
Classificazione ai fini della rimborsabilita'
Confezione:
35 soluzione per emofiltrazione, emodialisi ed emodiafiltrazione 2 sacche a doppia camera da 5000 ml -...
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