COMUNICATO - Autorizzazione all''immissione in commercio del medicinale per uso umano «Prorilis» (10A13515)
Estratto determinazione n. 1895/2010 del 2 novembre 2010
Medicinale: PRORILIS.
Titolare A.I.C.: Rottapharm S.p.A. - Galleria Unione 5 - 20122 Milano.
Confezione:
500 mg compresse a rilascio modificato 3 compresse in blister PVC/AL/PCTFE - A.I.C. n. 039376015/M (in base 10), 15KQ3R (in base 32).
Forma farmaceutica: compressa a rilascio modificato.
Composizione: una compressa rivestita contiene:
principio attivo: 500 mg di ciprofloxacina;
eccipienti:
contenuto della compressa: ossido di polietilene, povidone, magnesio stearato;
rivestimento della compressa: Opadry Blue, Ipromellosa, Titanio diossido (E171), Lacca di alluminio blu brillante FCF (E133), Macrogol, Polisorbato 80.
Controllo e rilascio: Rottapharm Ltd. Damastown Industrial Park, Mulhuddart, Dublin 15 - Ireland - Madaus GmbH, Lutticher Strasse 5, 53842 Troisdorf - Germany.
Confezionamento primario e secondario:
Rottapharm Ltd. Damastown Industrial Park, Mulhuddart, Dublin 15 - Ireland - Madaus GmbH, Lutticher Strasse 5, 53842 Troisdorf - Germany.
Produzione: Madaus GmbH, Lutticher Strasse 5, 53842 Troisdorf - Germany.
Indicazioni terapeutiche: infezioni acute non complicate delle vie urinarie (uUTI, cistiti acute) nelle donne. La Ciprofloxacina puo' essere considerata come un'alternativa ai farmaci di prima scelta nel caso in cui si evidenzi una resistenza individuale e/o regionale agli stessi.
A donne che assumono fluorochinoloni, compresa la Ciprofloxacina, da circa 6 mesi dalla diagnosi di cistite acuta, dovrebbe essere prescritto un farmaco appartenente a una differente classe terapeutica.
Si raccomanda...
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