Lextemy

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

bevacizumab

Tillgänglig från:

Mylan IRE Healthcare Limited

ATC-kod:

L01XC07

INN (International namn):

bevacizumab

Terapeutisk grupp:

Antineoplastic agents

Terapiområde:

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

Terapeutiska indikationer:

Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Bemyndigande status:

Withdrawn

Bipacksedel

59
B. PACKAGE LEAFLET
Medicinal product no longer authorised
60
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEXTEMY 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
bevacizumab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Lextemy is and what it is used for
2.
What you need to know before you are given Lextemy
3.
How Lextemy is given
4.
Possible side effects
5.
How to store Lextemy
6.
Contents of the pack and other information
1.
WHAT LEXTEMY IS AND WHAT IT IS USED FOR
Lextemy 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.
Lextemy is a medicine used for the treatment of adult patients with
advanced cancer in the large
bowel, i.e., in the colon or rectum. Lextemy will be administered in
combination with chemotherapy
treatment containing a fluoropyrimidine medicine.
Lextemy is also used for the treatment of adult pa

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Lextemy 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(s) with known effect
Each 4 mL vial contains 4.196 mg of sodium.
Each 16 mL vial contains 16.784 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 with a
pH of 5.70 to 6.40, an osmolality of
0.251 - 0.311 Osmol/kg and free of visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lextemy in combination with fluoropyrimidine-based chemotherapy is
indicated for treatment of adult
patients with metastatic carcinoma of the colon or rectum.
Lextemy 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.
Lextemy 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