Avastin

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

bevacizumab

Διαθέσιμο από:

Roche Registration GmbH

Φαρμακολογική κατηγορία (ATC):

L01FG01

INN (Διεθνής Όνομα):

bevacizumab

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

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

Θεραπευτικές ενδείξεις:

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.Bevacizumab 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.Bevacizumab 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 Avastin in combination with capecitabine. For further information as to HER2 status.Bevacizumab, 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.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 interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.Bevacizumab, 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 III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.Bevacizumab, 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.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.Bevacizumab, 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: 63

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2005-01-12

Φύλλο οδηγιών χρήσης

66
B. PACKAGE LEAFLET
67
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVASTIN 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 Avastin is and what it is used for
2.
What you need to know before you use Avastin
3.
How to use Avastin
4.
Possible side effects
5.
How to store Avastin
6.
Contents of the pack and other information
1.
WHAT AVASTIN IS AND WHAT IT IS USED FOR
Avastin 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.
Avastin is a medicine used for the treatment of adult patients with
advanced cancer in the large bowel,
i.e., in the colon or rectum. Avastin will be administered in
combination with chemotherapy treatment
containing a fluoropyrimidine medicine.
Avastin 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.
Avastin is also used for the treatment of adult patients with advanced
non-small cell lun

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Bevacizumab in combination with fluoropyrimidine-based chemotherapy is
indicated for treatment of
adult patients with metastatic carcinoma of the colon or rectum.
Bevacizumab 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.
Bevacizumab 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 Avastin in combination with capecitabine. For further
information as to HER2 status,
please refer to section 5.1.
Bevacizumab, 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.
Bevacizumab, in combination with erlotinib, is indicated for
first-line treatment of adult patients with
unresectable advanced, meta