Klertis 12,5 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SUNITINIBCYCLAMAAT 18,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 12,5 mg/stuk

Beschikbaar vanaf:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

INN (Algemene Internationale Benaming):

SUNITINIBCYCLAMAAT 18,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 12,5 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

CHINOLINEGEEL (E 104) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; PONCEAU 4R (E 124) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2021-05-04

Bijsluiter

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

Productkenmerken

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Klertis 12,5 mg harde capsules
Klertis 25 mg harde capsules
Klertis 50 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Klertis 12.5 mg hard capsules
Each capsule contains sunitinib cyclamate, equivalent to 12.5 mg of
sunitinib.
Klertis 25 mg hard capsules
Each capsule contains sunitinib cyclamate, equivalent to 25 mg of
sunitinib.
Klertis 50 mg hard capsules
Each capsule contains sunitinib cyclamate, equivalent to 50 mg of
sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Klertis 12.5 mg hard capsules
Unmarked self-closing Coni Snap type, size “3” hard gelatine
capsule with opaque, medium orange
coloured cap and opaque, rich yellow coloured body filled with orange
coloured granules. The
length of the capsule is about 15.9 mm.
Klertis 25 mg hard capsules
Unmarked self-closing Coni Snap type, size “2” hard gelatine
capsule with opaque, medium orange
coloured cap and olive green coloured body filled with orange coloured
granules. The length of the
capsule is about 18 mm.
Klertis 50 mg hard capsules
Unmarked self-closing Coni Snap type, size “0” hard gelatine
capsule with opaque, medium orange
coloured cap and opaque, medium orange coloured body filled with
orange coloured granules. The
length of the capsule is about 21.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Klertis 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)
Klertis is indicated for the treatment of advanced/metastatic renal
cell carcinoma (MRCC) in
adults.
Pancreatic neuroendocrine tumours (pNET)
Klertis is indicated for the treatment of unresectable or metastatic,
well-differentiated pancreatic
neuroendocrine tumours (pNET) with disease progression in adults.
4.2
POSOLOGY AND ME