Maa: Alankomaat
Kieli: hollanti
Lähde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SUNITINIBCYCLAMAAT 18,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 12,5 mg/stuk
Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)
SUNITINIBCYCLAMAAT 18,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 12,5 mg/stuk
Capsule, hard
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)
Oraal gebruik
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER SUNITINIB EGIS 12,5 MG HARDE CAPSULES SUNITINIB EGIS 25 MG HARDE CAPSULES SUNITINIB EGIS 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 Sunitinib Egis is and what it is used for 2. What you need to know before you take Sunitinib Egis 3. How to take Sunitinib Egis 4. Possible side effects 5. How to store Sunitinib Egis 6. Contents of the pack and other information 1. WHAT SUNITINIB EGIS IS AND WHAT IT IS USED FOR Sunitinib Egis hard capsules contain the active substance Sunitinib Egis, 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 Egis 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 Egis works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB EGIS DO NOT TAKE SUNITINIB EGIS: • if you are allergic to Sunitinib Egis or Lue koko asiakirja
SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Egis 12,5 mg harde capsules Sunitinib Egis 25 mg harde capsules Sunitinib Egis 50 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sunitinib Egis 12.5 mg hard capsules Each capsule contains sunitinib cyclamate, equivalent to 12.5 mg of sunitinib. Sunitinib Egis 25 mg hard capsules Each capsule contains sunitinib cyclamate, equivalent to 25 mg of sunitinib. Sunitinib Egis 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 Sunitinib Egis 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. Sunitinib Egis 25 mg hard capsules Unmarked self-closing Coni Snap type, size “2” hard gelatine capsule with opaque, medium orange coloured cap and green coloured body filled with orange coloured granules. The length of the capsule is about 18 mm. Sunitinib Egis 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) Sunitinib Egis 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) Sunitinib Egis is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Egis is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroen Lue koko asiakirja