Egotux 25 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SUNITINIB 25 mg/stuk

INN (Algemene Internationale Benaming):

SUNITINIB 25 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; WITTE INKT, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; WITTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-12-01

Bijsluiter

PIL_Sunitinib 12.5 mg, 25 mg, 37.5 mg & 50 mg hard
capsules_NL/H/5558/001-004
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EGOTUX 12,5 MG HARDE CAPSULES
EGOTUX 25 MG HARDE CAPSULES
EGOTUX 37,5 MG HARDE CAPSULES
EGOTUX 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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] 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.
[Product Name] 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 [Product Name] works or why this
medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAM

Productkenmerken

SmPC Sunitinib 12.5 mg, 25 mg, 37.5 mg & 50 mg hard capsules
NL/H/5558/001-004
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Egotux 12,5 mg harde capsules
Egotux 25 mg harde capsules
Egotux 37,5 mg harde capsules
Egotux 50 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib
25 mg hard capsules
Each capsule contains 25 mg of sunitinib
37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib
50 mg hard capsules
Each capsule contains 50 mg of sunitinib
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
[Product Name] 12.5 mg hard capsules
Hard capsules with orange cap and orange body, printed with white ink
‘SB 12.5’ and
white line on the body, containing yellow to orange granules, with a
nominal length of
approximately 14.3 mm.
[Product Name] 25 mg hard capsules
Hard capsules with caramel cap and orange body, printed with white ink
‘SB 25’ and
white line on the body, containing yellow to orange granules, with a
nominal length of
approximately 15.9 mm.
[Product Name] 37.5 mg hard capsules
Hard capsules with yellow cap and yellow body, printed with black ink
‘SB 37.5’ and
black line on the body, containing yellow to orange granules, with a
nominal length of
approximately 18.0 mm.
[Product Name] 50 mg hard capsules
Hard capsules with caramel cap and caramel body, printed with white
ink ‘SB 50’ and
white line on the body, containing yellow to orange granules, with a
nominal length of
approximately 19.4 mm.
SmPC Sunitinib 12.5 mg, 25 mg, 37.5 mg & 50 mg hard capsules
NL/H/5558/001-004
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
[Product Name] 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)
[Product Name] is indicated for the treatment