Sunitinib Zentiva 25 mg, harde capsules

País: Holanda

Língua: holandês

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

Ingredientes ativos:

SUNITINIB 25 mg/stuk

Disponível em:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

DCI (Denominação Comum Internacional):

SUNITINIB 25 mg/stuk

Forma farmacêutica:

Capsule, hard

Composição:

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

Via de administração:

Oraal gebruik

Data de autorização:

2020-11-26

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Sunitinib Zentiva 12,5 mg, harde capsules
Sunitinib Zentiva 25 mg, harde capsules
Sunitinib Zentiva 37,5 mg, harde capsules
Sunitinib Zentiva 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 Sunitinib Zentiva is and what it is used for
2.
What you need to know before you take Sunitinib Zentiva
3.
How to take Sunitinib Zentiva
4.
Possible side effects
5.
How to store Sunitinib Zentiva
6.
Contents of the pack and other information
1.
WHAT SUNITINIB ZENTIVA IS AND WHAT IT IS USED FOR
Sunitinib Zentiva 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 Zentiva 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 Zentiva works or why
this medicine has been prescribed
for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YO

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Zentiva 12,5 mg, harde capsules
Sunitinib Zentiva 25 mg, harde capsules
Sunitinib Zentiva 37,5 mg, harde capsules
Sunitinib Zentiva 50 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sunitinib Zentiva 12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib.
Sunitinib Zentiva 25 mg hard capsules
Each capsule contains 25 mg of sunitinib.
Sunitinib Zentiva 37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib.
Sunitinib Zentiva 50 mg hard 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 Zentiva 12.5 mg hard capsules (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 Zentiva 25 mg hard capsules (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 Zentiva 37.5 mg hard capsules (capsules)
Gelatin capsules of size 2 (approximate length 18.0 mm) with yellow
cap and yellow body, printed with
black ink “37.5 mg” on the body and containing yellow to orange
granules.
Sunitinib Zentiva 50 mg hard capsules (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)
Sunitinib
Zentiva
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.
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Metastatic renal cell carcinoma (MRCC)
Sunitinib Zentiva is indicated for the treatm