Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SUNITINIBCYCLAMAAT 72,5 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 50 mg/stuk
Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)
SUNITINIBCYCLAMAAT 72,5 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 50 mg/stuk
Capsule, hard
CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
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 Olvassa el a teljes dokumentumot
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 Olvassa el a teljes dokumentumot