爾必得舒注射液

מדינה: טייוואן

שפה: סינית

מקור: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

מרכיב פעיל:

CETUXIMAB, CHIMERIC ANTIBODY

זמין מ:

臺灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)

קוד ATC:

L01XC06

טופס פרצבטיות:

注射劑

הרכב:

CETUXIMAB, CHIMERIC ANTIBODY (1013000900) MG

יחידות באריזה:

瓶裝

סיווג:

菌　疫

סוג מרשם:

限由醫師使用

תוצרת:

BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG BIRKENDORFER STRASSE 65, 88397 BIBERACH AN DER RISS, GERMANY DE

איזור תרפויטי:

cetuximab

סממני תרפויטית:

Erbitux與FOLFIRI(Folinic acid/5-FU/Irinotecan)合併使用於治療具表皮生長因子受體表現型(EGFR expressing)，KRAS原生型(wild-type)之轉移性直腸結腸癌病患之第一線治療。Erbitux與放射線療法合併使用，治療局部晚期之口咽癌、下咽癌及喉癌患者。Erbitux與內含platinum類之化學療法合併使用，治療復發及/或轉移性頭頸部鱗狀細胞癌患者。

leaflet_short:

註銷日期: 2014/08/01; 註銷理由: 自請註銷; 有效日期: 2015/11/10; 英文品名: ERBITUX

מצב אישור:

已註銷

תאריך אישור:

2005-11-10

עלון מידע

ERBITUX® 2 MG/ML
Active ingredient: Cetuximab
COMPOSITION
Each ml of the solution for infusion contains 2 mg cetuximab as active
substance. Each vial contains 50 ml.
Excipients: sodium dihydrogen phosphate, disodium phosphate, sodium
chloride, water for injections.
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 KRAS (Kirsten rat sarcoma 2
viral oncogene homologue) is a central down-stream signal-transducer
of
EGFR. In tumours, activation of KRAS by EGFR contributes to
EGFR-mediated
increased proliferation, survival and the production of pro-angiogenic
factors.
KRAS is one of the most frequently activated oncogenes in human
cancers.
Mutations of the KRAS gene result in constitutive activation of the
KRAS
protein 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™) was used for immunohistochemical
detection of EGFR expression in tumour material. Approximately 75% of
the patients with metastatic colorectal cancer screened for clinical
studies
had an