ZIRABEV

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

BEVACIZUMAB

Disponible des:

PFIZER PHARMACEUTICALS ISRAEL LTD

Codi ATC:

L01FG01

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

BEVACIZUMAB 25 MG / 1 ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

PHARMACIA & UPJOHN COMPANY LLC, USA

Área terapéutica:

BEVACIZUMAB

indicaciones terapéuticas:

Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.Zirabev in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.Zirabev, 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.Zirabev, 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. Zirabev in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and/or metastatic renal cell cancer.Zirabev, as a single agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy. Zirabev, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced (International Federation of Gynecology and Obstetrics (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). Zirabev, in combination with carboplatin and gemcitabine is indicated for 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.Zirabev 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.Zirabev, in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Data d'autorització:

2021-03-09

Fitxa tècnica

Zirabev; 25mg/ml; Concentrate for solution for infusion LPD CC 23
February 2022
1
2022-0075499; 2022-0076224
ZIRABEV
®
1.
NAME OF THE MEDICINAL PRODUCT
Zirabev
®
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.
Excipient with known effect
Each 4 ml vial contains 3.0 mg of sodium.
Each 16 ml vial contains 12.1 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to slightly opalescent, colourless to pale brown liquid.
Zirabev is a biosimilar medicinal product that has been demonstrated
to be similar in quality, safety
and efficacy to the reference medicinal product Avastin. More detailed
information regarding
biosimilar medicinal products is available on the website of the
Ministry of Health
http://www.health.gov.il/hozer/dr_127.pdf
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zirabev in combination with fluoropyrimidine-based chemotherapy is
indicated for treatment of
patients with metastatic carcinoma of the colon or rectum.
Zirabev 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.
Zirabev, 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.
Zirabev, in combination with erlotinib, is indicated for first-line
treatment of adult patients with
unresectable advanced, metastatic or recurrent non-s