COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Urbason Solubile». (13A04212)
Estratto determinazione V &
A n. 595 del 16 aprile 2013 Titolare A.I.C.: SANOFI-AVENTIS S.p.a. con sede legale e domicilio fiscale in viale Luigi Bodio n. 37/B, 20158 - Milano - Codice fiscale n. 00832400154 Medicinale: URBASON SOLUBILE. Variazione A.I.C.: C.I.6.a Modifica o modifiche della o delle indicazioni terapeutiche Aggiunta di una nuova indicazione terapeutica o modifica di un'indicazione approvata. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: E' autorizzata la modifica delle indicazioni terapeutiche che variano. Da: Terapia glucocorticoidea in tutte quelle situazioni di emergenza, come ad esempio nella terapia delle gravi forme di shock, nelle quali e' necessaria la somministrazione endovenosa di alte dosi di corticosteroidi;
A: Terapia glucocorticoidea in tutte quelle situazioni di emergenza, come ad esempio nella terapia delle gravi forme di shock, nelle quali e' necessaria la somministrazione endovenosa di alte dosi di corticosteroidi. Recidive acute della sclerosi multipla. E' inoltre autorizzata la modifica della Posologia che varia. Da: La posologia dell'Urbason solubile va stabilita, come in ogni terapia con glucocorticoidi, in base alla gravita' del quadro morboso ed alla diversa risposta dei pazienti al trattamento. In generale con la somministrazione di 250-500 mg si ottengono risultati soddisfacenti. Nello shock cardiogeno possono risultare di maggior efficacia posologie pari a 1000 mg e piu' di metilprednisolone. La posologia di mantenimento deve essere sempre la minima capace di controllare la sintomatologia;
la riduzione posologica va fatta sempre...
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