Kraj: Indonezja
Język: indonezyjski
Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
VINORELBINE TARTRATE
MENARINI INDRIA LABORATORIES - Indonesia
VINORELBINE TARTRATE
41.55 MG
KAPSUL LUNAK
DUS, 1 BLISTER @ 1 KAPSUL LUNAK
CATALENT GERMANY EBERBACH GMBH - Federal Republic of Germany
2021-05-26
Instruction for use! Read carefully! NAVELBINE® 20 mg — 30 mg Soft capsule Vinorelbine (as tartrate) COMPOSITION The active substance is vinorelbine (as tartrate) 20 or 30 mg. The other ingredients are: The solution contains: ethanol anhydrous; purified water; glycerol, macrogol 400. The capsule shell contains: gelatin; glycerol 85 0 %; sorbitol/sorbitan (anidrisorb 85/70); triglycerides, medium chain and PHOSAL 53 MCT (phosphatidylcholine; glycerides; ethanol anhydrous) and colouring agents (El 71-titanium dioxide and E172 red and/or yellow iron oxide depending on the strength). The edible printing ink contains: cochineal extract (E120), hypromellose, propylene glycol. PHARMACOTHERAPEUTIC GROUP Cytostatic - Antineoplastic drug MECHANISM OF ACTION Navelbine is a cytostatic antineoplastic of the vinca alkaloid group. The molecular target of its activity is tubulin/microtubules dynamic equilibrium. Navelbine inhibits the polymerization of tubulin. It acts preferentially on mitotic microtubules and affects axonal microtubules only at high concentration. The effects on tubulin spiralization are lower than with vincristine. Navelbine blocks mitosis in phase G2+M and induces cell death at interphase or at the following mitosis. INDICATION 1. For non-small-cell lung cancer: In combination with platinum based therapy for the treatment of inoperable or stage IIIb or IV non-small cell lung cancer. 2. For breast cancer - In mono-therapy for the treatment of metastatic or relapsed breast cancer after of refractory to an anthracycline containing regimen. - In combination with capecitabine for the treatment of metastatic or relapsed breast cancer after or refractory to an anthracycline containing regimen. DISETUJUI OLEH BPOM: 18/02/2022 EREG10043712100054 EREG10043712100055 CONTRAINDICATIONS • Known hypersensitivity to vinorelbine or other vinca alkaloids or to any of the constituents. • Disease significantly affecting absorption. • Previous significant surgical resection of stomach or small bowel. • Neutrophil coun Przeczytaj cały dokument