Zirabev

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

bevacizumab

Διαθέσιμο από:

Pfizer Europe MA EEIG

Φαρμακολογική κατηγορία (ATC):

L01XC07

INN (Διεθνής Όνομα):

bevacizumab

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms

Θεραπευτικές ενδείξεις:

Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.Zirabev 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.Zirabev, 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.Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.Zirabev, 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.

Περίληψη προϊόντος:

Revision: 13

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2019-02-14

Φύλλο οδηγιών χρήσης

63
B. PACKAGE LEAFLET
64
Package leaflet: Information for the user
Zirabev 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 Zirabev is and what it is used for
2.
What you need to know before you use Zirabev
3.
How to use Zirabev
4.
Possible side effects
5.
How to store Zirabev
6.
Contents of the pack and other information
1.
What Zirabev is and what it is used for
Zirabev 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.
Zirabev is a medicine used for the treatment of adult patients with
advanced cancer in the large bowel,
i.e., in the colon or rectum. Zirabev will be administered in
combination with chemotherapy treatment
containing a fluoropyrimidine medicine.
Zirabev 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.
Zirabev is also used for the treatment of adult patients with advanced
non-small cell lung

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Zirabev in combination with fluoropyrimidine-based chemotherapy is
indicated for treatment of adult
patients with metastatic carcinoma of the colon or rectum.
Zirabev 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.
Zirabev 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 Zirabev in combination with capecitabine. For
further information as to HER2
status, please refer to section 5.1.
Zirabev 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.
Zirabev in comb