Sunitinib Holsten 12,5 mg harde capsules

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

SUNITINIBMALAAT SAMENSTELLING overeenkomend met ; SUNITINIB

Tersedia dari:

Holsten Pharma GmbH Hanstrasse 31-35 60528 FRANKFURT AM MAIN (DUITSLAND)

INN (Nama Internasional):

SUNITINIBMALAAT COMPOSITION corresponding to ; SUNITINIB

Bentuk farmasi:

Capsule, hard

Komposisi:

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

Rute administrasi :

Oraal gebruik

Tanggal Otorisasi:

2021-07-15

Selebaran informasi

M1.3.1_03.SNB.cap.002.05.NL.5079.02
Page 1 of 9
1.3.1
Package leaflet - Core
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sunitinib Holsten 12,5 mg harde capsules
Sunitinib Holsten 25 mg harde capsules
Sunitinib Holsten 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 Holsten is and what it is used for
2.
What you need to know before you take Sunitinib Holsten
3.
How to take Sunitinib Holsten
4.
Possible side effects
5.
How to store Sunitinib Holsten
6.
Contents of the pack and other information
1
WHAT SUNITINIB HOLSTEN IS AND WHAT IT IS USED FOR
Sunitinib Holsten 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 Holsten 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 Holsten works or why
this medicine has been prescribed for you,
ask your doctor.
M1.3.1_03.SNB.cap.002.05.NL.5079.02
Page 2 o

Karakteristik produk

M1.3.1_01.SNB.cap.002.05.NL5079.02
Page 1 of 32
1.3.1
Summary of Product Characteristics - Core
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Holsten 12,5 mg harde capsules
Sunitinib Holsten 25 mg harde capsules
Sunitinib Holsten 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 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 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 Holsten 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 Holsten is indicated for the treatment of
advanced/metastatic renal cell carcinoma (MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
Sunitinib Holsten is indicated for the treatment of unresectable or
metastatic, well-differentiated pancreatic
neuroendocrine tumours (pNET) with disease progression in adults.
M1.3.1_01.SNB.cap