Sunitinib Stada 50 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SUNITINIB 50 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

L01XE04

INN (Algemene Internationale Benaming):

SUNITINIB 50 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

Therapeutisch gebied:

Sunitinib

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB STADA 12.5 MG HARDE CAPSULES
SUNITINIB STADA 25 MG HARDE CAPSULES
SUNITINIB STADA 37.5 MG HARDE CAPSULES
SUNITINIB STADA 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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sunitinib Stada 12,5 mg, harde capsules
Sunitinib Stada 25 mg, harde capsules
Sunitinib Stada 37,5 mg, harde capsules
Sunitinib Stada 50mg, harde capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib.
Excipient with known effect:
Each capsule contains 0.42 mg of sodium.
25 mg hard capsules
Each capsule contains 25 mg of sunitinib.
Excipient with known effect:
Each capsule contains 0.84 mg of sodium.
37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib.
Excipient with known effect:
Each capsule contains 1.26 mg of sodium.
50 mg hard capsules
Each capsule contains 50 mg of sunitinib.
Excipient with known effect:
Each capsule contains 1.68 mg of sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule (capsule).
12.5 mg hard capsules (capsules)
Gelatin capsules of size 4 with orange cap and orange body, printed
with white ink “12.5 mg”
on the body and containing yellow to orange granules.
25 mg hard capsules (capsules)
Gelatin capsules of size 3 with caramel cap and orange body, printed
with white ink “25 mg”
on the body and containing yellow to orange granules.
37.5 mg hard capsules (capsules)
Gelatin capsules of size 2 with yellow cap and yellow body, printed
with black ink “37.5 mg” on
the body and containing yellow to orange granules.
50 mg hard capsules (capsules)
Gelatin capsules of size 1 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 intoleranc