AVASTIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BEVACIZUMAB

Available from:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC code:

L01FG01

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

BEVACIZUMAB 25 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Therapeutic group:

BEVACIZUMAB

Therapeutic area:

BEVACIZUMAB

Therapeutic indications:

- Avastin in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.- Avastin in addition to platinum - based chemotherapy is indicated for first - line treatment of patients with unresectable advanced metastatic or recurrent non- small cell lung cancer other than predominantly squamous cell histology. - Avastin in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and /or metastatic renal cell cancer. - Avastin in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.- Avastin as asingle agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.- Avastin, in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of advanced (FIGO stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are at high risk for recurrence (residual disease after debulking).- Avastin, 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.- Avastin ( Bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated 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 - Avastin ( Bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for treatment of patients with persistent, recurrent, or metastatic carcinoma of the cervix.- Bevacizumab, 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. - Bevacizumab, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Authorization date:

2014-08-31

Patient Information leaflet

Avastin 25mg/ml
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:
1.
Avastin in combination with fluoropyrimidine-based chemotherapy is
indicated for
treatment of patients with metastatic carcinoma of the colon or
rectum.
2.
Avastin in addition to platinum-based chemotherapy is indicated for
first - line treatment
of patients with unresectable advanced metastatic or recurrent non-
small cell lung
cancer other than predominantly squamous cell histology.
3.
Avastin in combination with interferon alfa-2a is indicated for first
line treatment of
patients with advanced and /or metastatic renal cell cancer.
4.
Avastin in combination with paclitaxel is indicated for first-line
treatment of patients with
metastatic breast cancer.
5.
Avastin as a single agent, is indicated for the treatment of
glioblastoma in patients with
progressive disease following prior therapy.
6.
Avastin, in combination with carboplatin and paclitaxel, is indicated
for the front-line
treatment of advanced (FIGO stages III B, III C and IV) epithelial
ovarian, fallopian tube,
or primary peritoneal cancer in patients who are at high risk for
recurrence (residual
disease after debulking).
7.
Avastin, 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 pri

Summary of Product characteristics

Page 1 of 49
Avastin PI version
10
AVASTIN
®




BEVACIZUMAB
Concentrate for solution for intravenous infusion
1.
NAME OF THE MEDICINAL PRODUCT
Avastin 25 mg/ml concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 25 mg of bevacizumab*.
Each 4 ml vial contains 100 mg of bevacizumab.
Each 16 ml vial contains 400 mg of bevacizumab.
For dilution and other handling recommendations, see section 6.6.
* Bevacizumab is a recombinant humanised 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, colourless to pale brown liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avastin (bevacizumab) in combination with fluoropyrimidine-based
chemotherapy is indicated
for treatment of patients with metastatic carcinoma of the colon or
rectum.
Avastin in combination with paclitaxel is indicated for first-line
treatment of patients with
metastatic breast cancer. For further information as to human
epidermal growth factor receptor
2 (HER2) status, please refer to section 5.1.
Avastin, in addition to platinum-based chemotherapy, is indicated for
first-line treatment of
patients with unresectable advanced, metastatic or recurrent non-small
cell lung cancer other
than predominantly squamous cell histology.
Avastin, 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).
Avastin in combination with interferon alfa-2a is indicated for first
line treatment of patients with
advanced and/or metastatic renal cell cancer.
Avastin, as a single agent, is indicated for the treatment of
glioblastoma in patients with
progressive disease following prior therapy.
AVASTIN
®
Concentrate for Soluti