COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Irinotecan Actavis» (11A12429)
Estratto determinazione n. 2573/2011 del 13 settembre 2011
Medicinale: IRINOTECAN ACTAVIS.
Titolare A.I.C.: Actavis Italy S.p.a., via L. Pasteur n. 10 - 20014 Nerviano (Milano).
Confezione: 20 mg/ml concentrato per soluzione per infusione 1 flaconcino in vetro da 15 ml, A.I.C. n. 038143044/M (in base 10), 14D124 (in base 32).
Forma farmaceutica: concentrato per soluzione per infusione.
Composizione: un ml di concentrato contiene:
principio attivo: 20 mg di irinotecan cloridrato triidrato equivalenti a 17,33 mg di irinotecan. Ciascun flaconcino da 2 ml, 5 ml, 15 ml o 25 ml di «Irinotecan Actavis» contiene 40 mg, 100 mg, 300 mg o 500 mg, rispettivamente di irinotecan cloridrato triidrato;
eccipienti: sorbitolo E420, acido lattico, sodio idrossido (pH 3,5), acido cloridrico (pH 3,5 quando richiesto), acqua per preparazioni iniettabili.
Produzione, confezionamento, controllo, rilascio:
S.C. Sindan - Pharma S.r.l. - 11 Ion Mihalache Blvd, - 011171 Bucarest - Romania;
Actavis Italy S.p.a., via L. Pasteur n. 10 - 20014 Nerviano (Milano).
Rilascio dei lotti: Actavis Nordic A/S - Ørnegårdsvej 16 - DK-2820 Gentofte - Danimarca.
Indicazioni terapeutiche: «Irinotecan Actavis» e' indicato per il trattamento di pazienti con tumore del colon-retto in stadio avanzato:
in associazione con 5-fluorouracile e acido folinico in pazienti senza precedente chemioterapia per malattia in stadio avanzato;
in monoterapia in pazienti che non hanno risposto ad uno schema terapeutico con 5-fluorouracile.
L'irinotecan in associazione con il cetuximab e' indicato per il trattamento di pazienti con tumore metastatico del colon-retto che esprime il recettore per il fattore di crescita epidermica (EGFR) dopo il fallimento di una terapia citotossica comprendente l'irinotecan.
L'irinotecan in...
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