Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DURVALUMAB
ASTRAZENECA INDONESIA - Indonesia
DURVALUMAB
500 MG
LARUTAN KONSENTRAT UNTUK INFUS
DUS, 1 VIAL @ 10 ML
CATALENT INDIANA LLC - United States of America
2020-10-31
1 of 31 PROPOSED PACKAGING MATERIAL Code Imfinzi 120 mg & 500 mg – PI-01.02 Submission NDA Renewal Variation change detail no.: MU-121496-146080 and MU-124598-150201_ _ Code of previous version N/A Changes Posology Update 1500 mg Q4W for NSCLC indication, Table 2. Management of Adverse Effect (dose modification, Addition Myasthenia Gravis and Update Diabetes Melitus type 1), Pancreatitits Reference CDS version: CPIL version: SmPC country/version/date: EU Q4W SmPC v8.0 GRL approval : 30 January 2022 Name & Date FTA (13 October 2022) IMFINZI™ DURVALUMAB CONCENTRATED SOLUTION FOR INFUSION 1 NAME OF THE MEDICINAL PRODUCT IMFINZI 120 mg Infusion IMFINZI 500 mg Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of IMFINZI concentrated solution for infusion contains either 120 mg or 500 mg of durvalumab. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Sterile, preservative free, clear to opalescent and free from visible particles, colourless to slightly yellow, concentrated solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) IMFINZI (durvalumab) is indicated for the treatment of patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. DISETUJUI OLEH BPOM: 14/09/2023 EREG10042212200291-92 2 of 31 SMALL CELL LUNG CANCER (SCLC) IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first- line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). 4.2 DOSE AND METHOD OF ADMINISTRATION IMFINZI is for single use in one patient only. Discard any residue. Posology The recommended dose for IMFINZI monotherapy and IMFINZI in combination with chemotherapy is presented in Table 1. IMFINZI is administered as an intravenous infusion over 1 hour. TABLE 1. RECOMMENDED DOSE OF IMFINZI INDICATION RECOMMENDED IMFINZI DOSE DURATION OF THERAPY Locally Advanced NSCLC 10 mg/kg every 2 week Preberite celoten dokument