爾必得舒 注射液 5 毫克/毫升

País: Taiwán

Idioma: chino

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

Ingredientes activos:

CETUXIMAB, CHIMERIC ANTIBODY

Disponible desde:

台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)

Código ATC:

L01XC06

formulario farmacéutico:

注射劑

Composición:

CETUXIMAB, CHIMERIC ANTIBODY (1013000900) MG

Unidades en paquete:

小瓶裝;;盒裝

clase:

菌　疫

tipo de receta:

限由醫師使用

Fabricado por:

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

Área terapéutica:

cetuximab

indicaciones terapéuticas:

適用於治療RAS原生型(wild-type)之轉移性直腸結腸癌患者• 與FOLFIRI (Folinic acid/ 5-FU/ Irinotecan)合併使用之第一線治療。• 與FOLFOX合併使用之第一線治療。併用encorafenib，⽤於治療帶有BRAF V600E 突變且曾接受過治療之轉移性直腸結腸癌 (CRC) 成人病人。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。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。

Resumen del producto:

有效日期: 2029/03/11; 英文品名: Erbitux 5mg/ml Solution for infusion

Fecha de autorización:

2009-03-11

Información para el usuario

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