Portrazza
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-07-2021
Charakterystyka produktu
(SPC)
27-07-2021
Sprawozdanie z oceny publicznego
(PAR)
27-07-2021
Składnik aktywny:
necitumumab
Dostępny od:
Eli Lilly Nederland B.V.
Kod ATC:
L01
INN (International Nazwa):
necitumumab
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Carcinoma, Non-Small-Cell Lung
Wskazania:
Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.
Podsumowanie produktu:
Revision: 3
Status autoryzacji:
Withdrawn
Data autoryzacji:
2016-02-15
Ulotka dla pacjenta
26
B. PACKAGE LEAFLET
Medicinal product no longer authorised
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
PORTRAZZA 800 MG CONCENTRATE FOR SOLUTION FOR INFUSION
necitumumab
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 ARE GIVEN 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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Portrazza is and what it is used for
2.
What you need to know before you are given Portrazza
3.
How you are given Portrazza
4.
Possible side effects
5.
How to store Portrazza
6.
Contents of the pack and other information
1.
WHAT PORTRAZZA IS AND WHAT IT IS USED FOR
Portrazza contains the active substance necitumumab, which belongs to
a group of substances called
monoclonal antibodies.
Necitumumab recognises and binds specifically to a protein on the
surface of some cancer cells. The
protein is known as epidermal growth factor receptor (EGFR). Other
body proteins (called growth
factors) can attach to the EGFR and stimulate the cancer cell to grow
and divide. Necitumumab
hinders other proteins from binding to the EGFR and thus prevents the
cancer cell from growth and
division.
Portrazza is used in combination with other anti-cancer medicines for
the treatment of adults with
certain type of lung cancer at an advanced stage (squamous non-small
cell lung cancer), whose cancer
cells have the EGFR protein on their surface. The anti-cancer
medicines it is combined with are
gemcitabine and cisplatin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PORTRAZZA
_ _
YOU MUST NOT BE GIVEN PORTRAZZA
-
if you have ever had a severe allergic reaction to
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Charakterystyka produktu
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
Portrazza 800 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mL vial contains 800 mg of necitumumab.
Each mL of concentrate for solution for infusion contains 16 mg of
necitumumab.
The concentrate must be diluted before use (see section 6.6).
Necitumumab is a human IgG1 monoclonal antibody produced in murine
(NS0) cells by recombinant
DNA technology.
Excipient with known effect
Each 50 mL vial contains approximately 76 mg 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 and colourless to slightly yellow liquid,
with pH 6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Portrazza in combination with gemcitabine and cisplatin chemotherapy
is indicated for the treatment
of adult patients with locally advanced or metastatic epidermal growth
factor receptor (EGFR)
expressing squamous non-small cell lung cancer who have not received
prior chemotherapy for this
condition.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Necitumumab therapy must be administered under the supervision of a
physician qualified in the use
of anti-cancer chemotherapy.
Appropriate medical resources for the treatment of severe infusion
reactions should be available
during necitumumab infusions. Availability of resuscitation equipment
must be ensured.
Posology
_ _
Portrazza is administered in addition to gemcitabine and
cisplatin-based chemotherapy for up to
6 cycles of treatment followed by Portrazza as a single agent in
patients whose disease has not
progressed, until disease progression or unacceptable toxicity.
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