Sunitinib 12,5 mg harde capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

SUNITINIBCYCLAMAAT 18,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 12,5 mg/stuk

Beschikbaar vanaf:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

INN (Algemene Internationale Benaming):

SUNITINIBCYCLAMAAT 18,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 12,5 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

CHINOLINEGEEL (E 104) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; PONCEAU 4R (E 124) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2021-05-04

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB EGIS 12,5 MG HARDE CAPSULES
SUNITINIB EGIS 25 MG HARDE CAPSULES
SUNITINIB EGIS 50 MG HARDE 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 Sunitinib Egis is and what it is used for
2.
What you need to know before you take Sunitinib Egis
3.
How to take Sunitinib Egis
4.
Possible side effects
5.
How to store Sunitinib Egis
6.
Contents of the pack and other information
1.
WHAT SUNITINIB EGIS IS AND WHAT IT IS USED FOR
Sunitinib Egis hard capsules contain the active substance Sunitinib
Egis, 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.
Sunitinib Egis 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 Sunitinib Egis works or why this
medicine has been prescribed
for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB EGIS
DO NOT TAKE SUNITINIB EGIS:
•
if you are allergic to Sunitinib Egis or

Productkenmerken

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Egis 12,5 mg harde capsules
Sunitinib Egis 25 mg harde capsules
Sunitinib Egis 50 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sunitinib Egis 12.5 mg hard capsules
Each capsule contains sunitinib cyclamate, equivalent to 12.5 mg of
sunitinib.
Sunitinib Egis 25 mg hard capsules
Each capsule contains sunitinib cyclamate, equivalent to 25 mg of
sunitinib.
Sunitinib Egis 50 mg hard capsules
Each capsule contains sunitinib cyclamate, equivalent to 50 mg of
sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Sunitinib Egis 12.5 mg hard capsules
Unmarked self-closing Coni Snap type, size “3” hard gelatine
capsule with opaque, medium orange
coloured cap and opaque, rich yellow coloured body filled with orange
coloured granules. The
length of the capsule is about 15.9 mm.
Sunitinib Egis 25 mg hard capsules
Unmarked self-closing Coni Snap type, size “2” hard gelatine
capsule with opaque, medium orange
coloured cap and green coloured body filled with orange coloured
granules. The length of the
capsule is about 18 mm.
Sunitinib Egis 50 mg hard capsules
Unmarked self-closing Coni Snap type, size “0” hard gelatine
capsule with opaque, medium orange
coloured cap and opaque, medium orange coloured body filled with
orange coloured granules. The
length of the capsule is about 21.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sunitinib Egis 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)
Sunitinib Egis is indicated for the treatment of advanced/metastatic
renal cell carcinoma (MRCC)
in adults.
Pancreatic neuroendocrine tumours (pNET)
Sunitinib Egis is indicated for the treatment of unresectable or
metastatic, well-differentiated
pancreatic neuroen