Sunitinib betapharm 37,5 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SUNITINIBMALAAT 50,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 37,5 mg/stuk

Beschikbaar vanaf:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

INN (Algemene Internationale Benaming):

SUNITINIBMALAAT 50,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 37,5 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

M1.3.1_03.SNB.cap.001.05.core
Page 1 of 10
1.3.1
Package leaflet - Core
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sunitinib betapharm 12,5 mg harde capsules
Sunitinib betapharm 25 mg harde capsules
Sunitinib betapharm 37,5 mg harde capsules
Sunitinib betapharm 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 betapharm is and what it is used for
2.
What you need to know before you take Sunitinib betapharm
3.
How to take Sunitinib betapharm
4.
Possible side effects
5.
How to store Sunitinib betapharm
6.
Contents of the pack and other information
1
WHAT SUNITINIB BETAPHARM IS AND WHAT IT IS USED FOR
Sunitinib betapharm 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.
Sunitinib betapharm 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 betapharm works or why
this medicine has been prescribed for
you, a

Productkenmerken

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1.3.1
Summary of Product Characteristics - Core
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib betapharm 12,5 mg harde capsules
Sunitinib betapharm 25 mg harde capsules
Sunitinib betapharm 37,5 mg harde capsules
Sunitinib betapharm 50 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains sunitinib malate, equivalent to 12.5 mg of
sunitinib.
Each capsule contains sunitinib malate, equivalent to 25 mg of
sunitinib.
Each capsule contains sunitinib malate, equivalent to 37.5 mg of
sunitinib.
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 (capsule).
Sunitinib 12.5 mg capsule
Hard gelatine capsule with orange cap and orange body, printed with
white imprint “SNB” and “12.5” on the
body. The capsule is filled with orange powder. Capsule size: 4
(length of approximately 14 mm).
Sunitinib 25 mg capsule
Hard gelatine capsule with caramel (light brown) cap and orange body,
printed with white imprint “SNB” and
“25” on the body. The capsule is filled with orange powder.
Capsule size: 3 (length of approximately 16 mm).
Sunitinib 37.5 mg capsule
Hard gelatine capsule with yellow cap and yellow body, printed with
black imprint “SNB” and “37.5” on the
body. The capsule is filled with orange powder. Capsule size: 2
(length of approximately 18 mm).
Sunitinib 50 mg capsule
Hard gelatine capsule with caramel cap and caramel body (light brown),
printed with black imprint “SNB” and
“50” on the body. The capsule is filled with orange powder.
Capsule size: 1EL (elongated; length of approximately
20 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sunitinib Betapharm 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.
M1.3.1_01.SNB.cap.0