Sutent

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

sunitinib

Saatavilla:

Pfizer Limited

ATC-koodi:

L01EX01

INN (Kansainvälinen yleisnimi):

sunitinib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors

Käyttöaiheet:

Gastrointestinal stromal tumour (GIST)Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.Metastatic renal cell carcinoma (MRCC)Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.Pancreatic neuroendocrine tumours (pNET)Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.Experience with Sutent as first-line treatment is limited (see section 5.1).

Tuoteyhteenveto:

Revision: 39

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-07-19

Pakkausseloste

59
B. PACKAGE LEAFLET
60
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUTENT 12.5 MG HARD CAPSULES
SUTENT 25 MG HARD CAPSULES
SUTENT 37.5 MG HARD CAPSULES
SUTENT 50 MG HARD CAPSULES
sunitinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 Sutent is and what it is used for
2.
What you need to know before you take Sutent
3.
How to take Sutent
4.
Possible side effects
5.
How to store Sutent
6.
Contents of the pack and other information
1.
WHAT SUTENT IS AND WHAT IT IS USED FOR
Sutent contains the active substance sunitinib, which is a protein
kinase inhibitor. It is
used to treat
cancer by preventing the activity of a special group of proteins which
are known to be involved in the
growth and spread of cancer cells.
Sutent is used to treat adults with the following types of cancer:
-
Gastrointestinal stromal tumour (GIST), a type of cancer of the
stomach and bowel, where
imatinib (another anticancer medicine) no longer works or you cannot
take imatinib.
-
Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that
has spread to other parts
of the body.
-
Pancreatic neuroendocrine tumours (pNET) (tumours of the
hormone-producing cells in the
pancreas) that have progressed or cannot be removed with surgery.
If you have any questions about how Sutent works or why this medicine
has been prescribed for you,
ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUTENT
DO NOT TAKE SUTENT
-
If you are allergic to sunitinib or any of the other ingredients of
Sutent (listed in section 6).
61
WARNINGS AND PRECAUT

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Sutent 12.5 mg hard capsules
Sutent 25 mg hard capsules
Sutent 37.5 mg hard capsules
Sutent 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
12.5 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 12.5 mg of
sunitinib.
25 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 25 mg of
sunitinib.
37.5 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 37.5 mg of
sunitinib.
50 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 50 mg of
sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Sutent 12.5 mg hard capsules
Gelatin capsules with orange cap and orange body, printed with white
ink “Pfizer” on the cap,
“STN 12.5 mg” on the body, and containing yellow to orange
granules.
Sutent 25 mg hard capsules
Gelatin capsules with caramel cap and orange body, printed with white
ink “Pfizer” on the cap,
“STN 25 mg” on the body, and containing yellow to orange granules.
Sutent 37.5 mg hard capsules
Gelatin capsules with yellow cap and yellow body, printed with black
ink “Pfizer” on the cap,
“STN 37.5 mg” on the body, and containing yellow to orange
granules.
Sutent 50 mg hard capsules
Gelatin capsule with caramel cap and caramel body, printed with white
ink “Pfizer” on the cap,
“STN 50 mg” on the body, and containing yellow to orange granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sutent is indicated for the treatment of unresectable and/or
metastatic malignant
gastrointestinal
stromal tumour (GIST) in adults after failure of imatinib treatment
due to resistance or intolerance.
Metastatic renal cell carcinoma (MRCC)
Sutent is indicated for the treatment of advanced/metastatic renal
cell carcinoma (MRCC) in adults.
3
Pancreatic neuroendocrine tumours (pNET)
Sutent is indicated for the treatment of unresectable or metastatic,