Equidacent

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

bevacizumab

Dostupné z:

Centus Biotherapeutics Europe Limited

ATC kód:

L01XC07

INN (Medzinárodný Name):

bevacizumab

Terapeutické skupiny:

Antineoplastic agents

Terapeutické oblasti:

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

Terapeutické indikácie:

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 Equidacent 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, 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 IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1).Bevacizumab, 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.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.

Prehľad produktov:

Revision: 3

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2020-09-24

Príbalový leták

60
B.
PACKAGE LEAFLET
Medicinal product no longer authorised
61
PACKAGE LEAFLET: INFORMATION FOR THE USER
EQUIDACENT 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 Equidacent is and what it is used for
2.
What you need to know before you use Equidacent
3.
How to use Equidacent
4.
Possible side effects
5.
How to store Equidacent
6.
Contents of the pack and other information
1.
WHAT EQUIDACENT IS AND WHAT IT IS USED FOR
Equidacent 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.
ADVANCED CANCER IN THE LARGE BOWEL
Equidacent is a medicine used for the treatment of adult patients with
advanced cancer in the large
bowel, i.e., in the colon or rectum. Equidacent will be administered
in combination with chemotherapy
treatment

Súhrn charakteristických

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
Equidacent 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(s) with known effect
Each vial of 4 mL of concentrate contains 191 mg sorbitol (E420).
Each vial of 16 mL of concentrate contains 764 mg sorbitol (E420).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to opalescent, colourless to pale brownish-yellowish solution.
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
t