SUGANET 25 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SUNITINIBMALAAT 33,41 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 25 mg/stuk

Beschikbaar vanaf:

Gedeon Richter Plc. Gyömröi út 19-21 1103 BUDAPEST (HONGARIJE)

INN (Algemene Internationale Benaming):

SUNITINIBMALAAT 33,41 mg/stuk SAMENSTELLING overeenkomend met ; 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) ; 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) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; WITTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGANET 12.5 MG HARD CAPSULES
SUGANET 25 MG HARD CAPSULES
SUGANET 50 MG HARD 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 Suganet is and what it is used for
2.
What you need to know before you take Suganet
3.
How to take Suganet
4.
Possible side effects
5.
How to store Suganet
6.
Contents of the pack and other information
1
WHAT SUGANET IS AND WHAT IT IS USED FOR
Suganet 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.
Suganet 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 Suganet works or why this medicine
has been prescribed for you,
ask your doctor.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUGANET
DO NOT TAKE SUGANET:
-
if you are allergic to sunitinib or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking

Productkenmerken

M1.3.1_01.SNB.cap.002.05.NL.5063.02
Page 1 of 32
1.3.1
Summary of Product Characteristics - Core
1.
NAME OF THE MEDICINAL PRODUCT
SUGANET 12,5 mg harde capsules
SUGANET 25 mg harde capsules
SUGANET 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 (light brown) body,
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)
SUGANET 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)
SUGANET is indicated for the treatment of advanced/metastatic renal
cell carcinoma (MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
SUGANET
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.002.05.NL.5063.02
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4.2
POSOLOGY AND METHOD OF