ZESUVA 25 mg, harde capsules

국가: 네덜란드

언어: 네덜란드어

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

유효 성분:

SUNITINIB 25 mg/stuk

제공처:

Zentiva a.s. U. Kabelovny 130 10237 PRAGUE (TSJECHIË)

ATC 코드:

L01XE04

INN (국제 이름):

SUNITINIB 25 mg/stuk

약제 형태:

Capsule, hard

구성:

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

관리 경로:

Oraal gebruik

치료 영역:

Sunitinib

승인 날짜:

1900-01-01

환자 정보 전단

33
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZESUVA 12,5 MG, HARDE CAPSULES
ZESUVA 25 MG, HARDE CAPSULES
ZESUVA 37,5 MG, HARDE CAPSULES
ZESUVA 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 ZESUVA is and what it is used for
2.
What you need to know before you take ZESUVA
3.
How to take ZESUVA
4.
Possible side effects
5.
How to store ZESUVA
6.
Contents of the pack and other information
1.
WHAT ZESUVA IS AND WHAT IT IS USED FOR
ZESUVA 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.
ZESUVA 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 ZESUVA works or why this medicine
has been prescribed for
you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZESUVA
DO NOT TAKE ZESUVA:
-
if you are allergic to sunitinib or any of the other ingredients of
this medicine (listed in section
6).
WARNINGS AND PR

제품 특성 요약

NL/H/4252/001-004 05/2023 Renewal R/001
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
ZESUVA 12,5 mg harde capsules
ZESUVA 25 mg harde capsules
ZESUVA 37,5 mg harde capsules
ZESUVA 50 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZESUVA 12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib.
Excipient with known effect:
Each capsule contains 0.42 mg of sodium.
ZESUVA 25 mg hard capsules
Each capsule contains 25 mg of sunitinib.
Excipient with known effect:
Each capsule contains 0.84 mg of sodium.
ZESUVA 37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib.
Excipient with known effect:
Each capsule contains 1.26 mg of sodium.
ZESUVA 50 mg hard capsules
Each capsule contains 50 mg of sunitinib.
Excipient with known effect:
Each capsule contains 1.68 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
ZESUVA 12.5 mg hard capsules (capsules)
Gelatin capsules of size 4 with orange cap and orange body, printed
with white ink “12.5 mg” on the
body and containing yellow to orange granules.
ZESUVA 25 mg hard capsules (capsules)
Gelatin capsules of size 3 with caramel cap and orange body, printed
with white ink “25 mg” on the
body and containing yellow to orange granules.
ZESUVA 37.5 mg hard capsules (capsules)
Gelatin capsules of size 2 with yellow cap and yellow body, printed
with black ink “37.5 mg” on the
body and containing yellow to orange granules.
2
ZESUVA 50 mg hard capsules (capsules)
Gelatin capsules of size 1 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)
ZESUVA 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)
ZESUVA is indicated for the t