Страна: Індонезія
мова: індонезійська
Джерело: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BORTEZOMIB
SOHO INDUSTRI PHARMASI - Indonesia
BORTEZOMIB
1 MG
SERBUK INJEKSI
DUS, 1 VIAL @ 1 MG
2015-11-19
VELCADE® bortezomib QUALITATIVE AND QUANTITATIVE COMPOSITION Velcade (bortezomib) for Injection is an antineoplastic agent available for intravenous injection (IV) or subcutaneous (SC). Each single use vial contains: • 1.0 mg of bortezomib as a sterile lyophilized powder. Inactive ingredient: 10 mg mannitol, USP/EP (IV use only), or • 3.5 mg of bortezomib as a sterile lyophilized powder. Inactive ingredient: 35 mg mannitol, USP/EP (IV or SC use). PHARMACEUTICAL FORM Velcade (bortezomib) for Injection is supplied as individually cartooned 5 mL vials containing 1 mg of bortezomib, or 10 mL vials containing 3.5 mg of bortezomib as a white to off-white cake or powder. • 1.0 mg single use vial • 3.5 mg single use vial PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES MECHANISM OF ACTION Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The ubiquitin-proteasome pathway plays an essential role in regulating the intracellular concentration of specific proteins, thereby maintaining homeostasis within cells. Inhibition of the 26S proteasome prevents this targeted proteolysis which can affect multiple signaling cascades within the cell. This disruption of normal homeostatic mechanisms can lead to cell death_. _ Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types _in vitro_. Bortezomib causes a delay in tumor growth in vivo in nonclinical tumor models, including multiple myeloma. Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function. These effects have been observed in patients with multiple myeloma affected by an advanced osteolytic disease and treated with bortezomib. CLINICAL TRIALS PHASE 2 CLINICAL STUDIES IN RELAPSED MULTIPLE MYELOMA: The safety and efficacy of Velcade IV were evaluated in an open-label, single-arm, Прочитайте повний документ