Sunitinib Denk 25 mg, harde capsules

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

SUNITINIB 25 mg/stuk

Dostupno od:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

INN (International ime):

SUNITINIB 25 mg/stuk

Farmaceutski oblik:

Capsule, hard

Sastav:

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

Administracija rute:

Oraal gebruik

Datum autorizacije:

2020-11-26

Uputa o lijeku

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

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Denk 12,5 mg, harde capsules
Sunitinib Denk 25 mg, harde capsules
Sunitinib Denk 50 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sunitinib Denk 12,5 mg, harde capsules
Each capsule contains 12.5 mg of sunitinib.
Sunitinib Denk 25 mg, harde capsules
Each capsule contains 25 mg of sunitinib.
Sunitinib Denk 50 mg, harde capsules
Each capsule contains 50 mg of sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Sunitinib Denk 12,5 mg, harde capsules
Gelatin capsules of size 4 (approximate length 14.3 mm) with orange
cap and orange body, printed
with white ink “12.5 mg” on the body and containing yellow to
orange granules.
Sunitinib Denk 25 mg, harde capsules
Gelatin capsules of size 3 (approximate length 15.9 mm) with caramel
cap and orange body, printed
with white ink “25 mg” on the body and containing yellow to orange
granules.
Sunitinib Denk 50 mg, harde capsules
Gelatin capsules of size 1 (approximate length 19.4 mm) with caramel
cap and caramel body, printed
with white ink “50 mg” on the body and containing yellow to orange
granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)

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)
is indicated for the treatment of advanced/metastatic
renal cell carcinoma (MRCC)
in adults.
2
Pancreatic neuroendocrine tumours (pNET)
is indicated for the treatment of unresectable or
metastatic, well-differentiated
pancreatic neuroendocrine tumours (pNET) with disease progression in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy with sunitinib should be initiated by a physician experienced
in the administration of
anticancer agents.
Posology
Fo