MVASI

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

BEVACIZUMAB

可用日期:

AMGEN EUROPE B.V.

ATC代码:

L01FG01

药物剂型:

CONCENTRATE FOR SOLUTION FOR INFUSION

组成:

BEVACIZUMAB 25 MG / 1 ML

给药途径:

I.V

处方类型:

Required

厂商:

AMGEN EUROPE B.V., NETHERLANDS

治疗领域:

BEVACIZUMAB

疗效迹象:

MVASI in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.MVASI in addition to platinum - based chemotherapy is indicated for first - line treatment of adult patients with unresectable advanced metastatic or recurrent non- small cell lung cancer other than predominantly squamous cell histology.MVASI in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.MVASI in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. MVASI as a single agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.MVASI in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who are at high risk for recurrence (residual disease after debulking).MVASI in combination with carboplatin and gemcitabine, is indicated for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.MVASI in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin isindicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.MVASI in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated, in patients who cannot receive platinum therapy, for treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.MVASI, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.

授权日期:

2020-04-07

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产品特点

1
Public
1.
NAME OF THE MEDICINAL PRODUCT
_ _
MVASI 25 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 25 mg of bevacizumab*.
Each vial of 4 mL of concentrate contains 100 mg of bevacizumab.
Each vial of 16 mL of concentrate contains 400 mg of bevacizumab.
For dilution and other handling recommendations, see section 6.6.
*Bevacizumab is a recombinant humanized monoclonal antibody produced
by DNA technology in
Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent, colorless to slightly yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MVASI in combination with fluoropyrimidine-based chemotherapy is
indicated for treatment of adult
patients with metastatic carcinoma of the colon or rectum.
MVASI in combination with paclitaxel is indicated for first-line
treatment of adult patients with
metastatic breast cancer. For further information as to human
epidermal growth factor receptor
2 (HER2) status, please refer to section 5.1.
2
Public
MVASI, in addition to platinum-based chemotherapy, is indicated for
first-line treatment of adult
patients with unresectable advanced, metastatic or recurrent non-small
cell lung cancer other than
predominantly squamous cell histology.
MVASI, in combination with erlotinib, is indicated for first-line
treatment of adult patients with
unresectable advanced, metastatic or recurrent non-squamous non-small
cell lung cancer with
Epidermal Growth Factor Receptor (EGFR) activating mutations (see
section 5.1).
MVASI in combination with interferon alfa-2a is indicated for
first-line treatment of adult patients
with advanced and/or metastatic renal cell cancer.
MVASI, as a single agent, is indicated for the treatment of
glioblastoma in patients with progressive
disease following prior therapy.
MVASI, in combination with carboplatin and paclitaxel, is indicated
for the front-line treatment of
adv