BEVACIZUMAB KAMADA

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

BEVACIZUMAB

Tilgjengelig fra:

KAMADA LTD, ISRAEL

ATC-kode:

L01FG01

Legemiddelform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sammensetning:

BEVACIZUMAB 25 MG/ML

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

MABXIENCE RESEARCH S.L., SPAIN

Terapeutisk område:

BEVACIZUMAB

Indikasjoner:

- Bevacizumab Kamada in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.- Bevacizumab Kamada 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. - Bevacizumab Kamada in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and /or metastatic renal cell cancer.- Bevacizumab Kamada in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.- Bevacizumab Kamada as a single agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.- Bevacizumab Kamada 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).- Bevacizumab Kamada 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.- Bevacizumab Kamada in combination with 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 - Bevacizumab Kamada 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 Kamada 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.

Autorisasjon dato:

2022-11-27

Preparatomtale

1
BEVACIZUMAB KAMADA
Concentrate for solution for intravenous infusion
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bevacizumab Kamada, 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 (sterile concentrate).
Colourless to yellowish or brownish liquid with opalescence.
Bevacizumab Kamada is a biosimilar medicinal product that has been
demonstrated to be similar in
quality, safety, and efficacy to the reference medicinal product
Avastin. Please be aware of any
differences in the indications between the biosimilar medicinal
product and the reference medicinal
product. Information regarding biosimilar products can be found on the
website of the Ministry of Health:
https://www.gov.il/he/Departments/General/biosimilar.
Bevacizumab Kamada is not approved to be interchangeable.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Bevacizumab Kamada in combination with fluoropyrimidine-based
chemotherapy is indicated for
treatment of patients with metastatic carcinoma of the colon or
rectum.
Bevacizumab Kamada 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.
Bevacizumab Kamada in combination with interferon alfa-2a is indicated
for first line treatment of patients
with advanced and/or metastatic renal cell cancer.
Bevacizumab Kamada in combination with paclitaxel is indicated for
first-line treatment of patients with
metastatic breast cancer. For f