Zaltrap

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

aflibercept

Saatavilla:

Sanofi Winthrop Industrie

ATC-koodi:

L01XX44

INN (Kansainvälinen yleisnimi):

aflibercept

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Colorectal Neoplasms

Käyttöaiheet:

Treatment of metastatic colorectal cancer (MCRC).

Tuoteyhteenveto:

Revision: 13

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-02-01

Pakkausseloste

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZALTRAP 25 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION
aflibercept
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again, or provide it to
future healthcare providers.
•
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 ZALTRAP is and what it is used for
2.
What you need to know before you are given ZALTRAP
3.
How ZALTRAP is given
4.
Possible side effects
5.
How to store ZALTRAP
6.
Contents of the pack and other information
1.
WHAT ZALTRAP IS AND WHAT IT IS USED FOR
WHAT ZALTRAP IS AND HOW IT WORKS
ZALTRAP contains the active substance aflibercept, a protein that
works by blocking the growth of
new blood vessels within the tumour. The tumour needs nutrients and
oxygen from blood in order to
grow. By blocking the growth of blood vessels, ZALTRAP helps to stop
or slow down the growth of
the tumour.
WHAT ZALTRAP IS USED FOR
ZALTRAP is a medicine used to treat advanced cancers of the colon or
rectum (parts of the large
intestine) in adults. It will be given with other medicines called
‘chemotherapy’, including
‘5-fluorouracil’, ‘folinic acid’, and ‘irinotecan’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZALTRAP
DO NOT USE ZALTRAP
•
if you are allergic to aflibercept or any of the other ingredients of
this medicine (listed in
section 6).
•
in your eye, since it may severely damage it.
Please also read the package leaflets for the other medicines
(‘chemotherapy’) that are part of your
treatment, to see if they are suitable for you. If you are unsure, ask
your doctor, pharmacist or nurse if
there are any reasons why you cannot use these medicines.
WARNINGS AND PRECAUTIONS
Talk to your doctor, phar

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ZALTRAP 25 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate for solution for infusion contains 25 mg
aflibercept*.
One vial of 4 ml of concentrate contains 100 mg of aflibercept.
One vial of 8 ml of concentrate contains 200 mg of aflibercept.
* Aflibercept is produced in a Chinese hamster ovary (CHO) K-1
mammalian expression system by
recombinant DNA technology.
Excipient(s) with known effect:
Each 4 ml vial contains 0.484 mmol of sodium, which is 11.118 mg of
sodium, and 8 ml vial contains
0.967 mmol of sodium, which is 22.236 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid
(FOLFIRI) chemotherapy is
indicated in adults with metastatic colorectal cancer (MCRC) that is
resistant to or has progressed after
an oxaliplatin-containing regimen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ZALTRAP should be administered under the supervision of a physician
experienced in the use of
antineoplastic medicinal products.
Posology
The recommended dose of ZALTRAP, administered as an intravenous
infusion over 1 hour, is
4 mg / kg of body weight, followed by the FOLFIRI regimen. This is
considered as one treatment
cycle.
The FOLFIRI regimen to be
_ _
used is irinotecan 180
mg/m
2
intravenous infusion over 90 minutes and
folinic acid (dl racemic)
400 mg/m² intravenous infusion over 2 hours at the same time on day 1
using
3
a Y-line, followed by 5-fluorouracil (5-FU) 400 mg / m² intravenous
bolus, followed by 5-FU
2400 mg / m² continuous intravenous infusion over 46 hours.
The treatment cycle is repeated every 2 weeks.
ZALTRAP treatment should be continued until disease progression or
unacceptable toxicity occur