Sunitinib Mylan 37,5 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SUNITINIB 37,5 mg/stuk

Beschikbaar vanaf:

Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN

ATC-code:

L01XE04

INN (Algemene Internationale Benaming):

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) ; MANNITOL (D-) (E 421) ; 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) ; MANNITOL (D-) (E 421) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Sunitinib

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB MYLAN 12,5 MG, HARDE CAPSULES
SUNITINIB MYLAN 25 MG, HARDE CAPSULES
SUNITINIB MYLAN 37,5 MG, HARDE CAPSULES
SUNITINIB MYLAN 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 yo

Productkenmerken

SAMENVATTING VAN DE PRODUCTKENMERKEN
Sunitinib Mylan 12,5mg, 25mg, 37,5mg, 50mg, harde capsules
RVG 123584, 123597-598-599
December 2023
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Mylan 12,5 mg, harde capsules
Sunitinib Mylan 25 mg, harde capsules
Sunitinib Mylan 37,5 mg, harde capsules
Sunitinib Mylan 50 mg, 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 0.4 mg of sodium.
25 mg hard capsules
Each capsule contains 25 mg of sunitinib.
Excipient with known effect:
Each capsule contains 0.8 mg of sodium.
37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib.
Excipient with known effect:
Each capsule contains 1.3 mg of sodium.
50 mg hard capsules
Each capsule contains 50 mg of sunitinib.
Excipient with known effect:
Each capsule contains 1.7 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 14.2 mm ± 0.5 mm size 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 15.9 mm ± 0.5 mm with caramel cap and orange
body, printed with white ink “25
mg” on the body and containing yellow to orange granules.
SAMENVATTING VAN DE PRODUCTKENMERKEN
Sunitinib Mylan 12,5mg, 25mg, 37,5mg, 50mg, harde capsules
RVG 123584, 123597-598-599
December 2023
2
37.5 mg hard capsules (capsules)
Gelatin capsules of 17.9 mm ± 0.5 mm size 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 19.3 mm ± 0.5 mm size with caramel cap and
caramel body, printed with white ink
“50 mg” on the body and c