Mvasi

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

bevacizumab

Saadav alates:

Amgen Technology (Ireland) UC

ATC kood:

L01XC07

INN (Rahvusvaheline Nimetus):

bevacizumab

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms

Näidustused:

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.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 carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.Mvasi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, 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.Mvasi 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.Mvasi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Toote kokkuvõte:

Revision: 14

Volitamisolek:

Authorised

Loa andmise kuupäev:

2018-01-15

Infovoldik

65
B. PACKAGE LEAFLET
66
PACKAGE LEAFLET: INFORMATION FOR THE USER
MVASI 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
bevacizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What MVASI is and what it is used for
2.
What you need to know before you use MVASI
3.
How to use MVASI
4.
Possible side effects
5.
How to store MVASI
6.
Contents of the pack and other information
1.
WHAT MVASI IS AND WHAT IT IS USED FOR
MVASI contains the active substance bevacizumab, which is a humanised
monoclonal antibody (a
type of protein that is normally made by the immune system to help
defend the body from infection
and cancer). Bevacizumab binds selectively to a protein called human
vascular endothelial growth
factor (VEGF), which is found on the lining of blood and lymph vessels
in the body. The VEGF
protein causes blood vessels to grow within tumours, these blood
vessels provide the tumour with
nutrients and oxygen. Once bevacizumab is bound to VEGF, tumour growth
is prevented by blocking
the growth of the blood vessels which provide the nutrients and oxygen
to the tumour.
MVASI is a medicine used for the treatment of adult patients with
advanced cancer in the large bowel,
i.e. in the colon or rectum. MVASI will be administered in combination
with chemotherapy treatment
containing a fluoropyrimidine medicine.
MVASI is also used for the treatment of adult patients with metastatic
breast cancer. When used for
patients with breast cancer, it will be administered with a
chemotherapy medicinal product called
paclitaxel or capecitabine.
MVASI is also used for the treatment of adult patients with advanced
non-small cell lung cancer.
MVASI will be adminis

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 humanised monoclonal antibody produced
by DNA technology in
Chinese Hamster Ovary cells.
Excipient with known effect
_ _
Each vial of 4 mL contains 5.4 mg sodium.
Each vial of 16 mL contains 21.7 mg 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 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.
MVASI in combination with capecitabine is indicated for first-line
treatment of adult patients with
metastatic breast cancer in whom treatment with other chemotherapy
options including taxanes or
anthracyclines is not considered appropriate. Patients who have
received taxane and
anthracycline-containing regimens in the adjuvant setting within the
last 12 months should be
excluded from treatment with MVASI in combination with capecitabine.
For further information as to
HER2 status, please refer to section 5.1.
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 squam