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CETUXIMAB, CHIMERIC ANTIBODY
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CETUXIMAB, CHIMERIC ANTIBODY (1013000900) MG
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BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG BIRKENDORFER STRASSE 65, 88397 BIBERACH AN DER RISS, GERMANY DE
cetuximab
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有效日期: 2029/03/11; 英文å“å: Erbitux 5mg/ml Solution for infusion
2009-03-11
PAGE 1 7872371539 ERBITUX ® 5 MG/ML SOLUTION FOR INFUSION Active ingredient: Cetuximab COMPOSITION Each ml of the solution for infusion contains 5 mg cetuximab as active substance. Each vial contains 20 ml. EXCIPIENTS: Sodium chloride Glycine Polysorbate 80 Citric acid monohydrate Sodium hydroxide Water for injection PROPERTIES Mechanism of action The Epidermal Growth Factor Receptor (EGFR) is part of signalling pathways involved in the control of cell survival, cell cycle progression, angiogenesis, cell migration and cellular invasion/metastasis. Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the EGFR. It binds to the EGFR with an approximately 5- to 10fold higher affinity than endogenous ligands and blocks the receptor’s function. It induces the internalisation of EGFR and may thereby lead to down regulation of EGFR. Cetuximab also targets cytotoxic immune effector cells towards EGFR-expressing tumour cells (antibody dependent cell-mediated cytotoxicity, ADCC). Cetuximab does not bind to other receptors belonging to the HER family. The protein product of the proto-oncogene RAS (rat sarcoma) is a central down-stream signal-transducer of EGFR. In tumours, activation of RAS by EGFR contributes to EGFR-mediated increased proliferation, survival and the production of pro-angiogenic factors. RAS is one of the most frequently activated family of oncogenes in human cancers. Mutations of RAS genes at certain hot-spots on exons 2, 3 and 4 result in constitutive activation of RAS proteins independently of EGFR signalling. Pharmacodynamic effects Cetuximab inhibits the proliferation of human tumour cells that express EGFR and induces apoptosis. It also inhibits the production of angiogenic factors, blocks endothelial cell migration and causes a reduction in tumour neo-vascularisation and metastasis. Colorectal cancer A diagnostic assay (EGFR pharmDx TM ) was used for immunohistochemical detection of EGFR expression in tumour material. Approximately 75% of the patients with metasta ×§×¨× ×ת המסמך השל×