Autorizzazione all'immissione in commercio della specialita' medicinale
Estratto determinazione A.I.C./N n. 799 del 4 luglio 2006
Descrizione del medicinale e attribuzione numero A.I.C.
E' autorizzata l'immissione in commercio del medicinale AMIODARONE PHT PHARMA, nella forma e confezione: ´150 mg/ 3 ml soluzione iniettabile per uso endovenosoª 5 fiale 3 ml.
Titolare A.I.C.: PHT Pharma S.r.l. con sede legale e domicilio fiscale in via Tonale, 20, 20125 - Milano, Italia, codice fiscale 01586950519.
Confezione: ´150 mg/3 ml soluzione iniettabile per uso endovenosoª 5 fiale 3 ml.
A.I.C. n. 036852010 (in base 10), 134N9B (in base 32).
Forma farmaceutica: soluzione iniettabile.
Validita' prodotto integro: 3 anni dalla data di fabbricazione.
Produttore e responsabile del rilascio dei lotti: I.S.F. S.p.a. - 00156 Roma, Italia, via Tiburtina 1040 (tutte le fasi eccetto controlli assenza pirogeni); Biolab S.p.a. - 20090 Vimodrone (Milano), Italia, via Bruno Buozzi, 2 (controlli assenza pirogeni).
Composizione: una fiala contiene:
principio attivo: amiodarone cloridrato 150 mg;
eccipienti: alcool benzilico 60,6 mg; polisorbato 80 300 mg; acqua per preparazioni iniettabili q.b. a 3 ml.
Indicazioni terapeutiche: amiodarone cloridrato per via endovenosa deve essere utilizzato quando e' richiesta una risposta rapida o quando la somministrazione orale non e' possibile - Terapia e prevenzione di gravi disturbi del ritmo resistenti alle altre terapie specifiche: tachicardie sopraventricolari (parossistiche e non parossistiche), extrasistoli atriali, flutter e fibrillazione atriale - Tachicardie parossistiche sopraventricolari...
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