Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SUNITINIB 37,5 mg/stuk
SUNITINIB 37,5 mg/stuk
Capsule, hard
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; 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) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT
Oraal gebruik
2022-12-01
PIL_Sunitinib 12.5 mg, 25 mg, 37.5 mg & 50 mg hard capsules_NL/H/5558/001-004 1 PACKAGE LEAFLET: INFORMATION FOR THE USER EGOTUX 12,5 MG HARDE CAPSULES EGOTUX 25 MG HARDE CAPSULES EGOTUX 37,5 MG HARDE CAPSULES EGOTUX 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] 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. [Product Name] 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 [Product Name] works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAM Läs hela dokumentet
SmPC Sunitinib 12.5 mg, 25 mg, 37.5 mg & 50 mg hard capsules NL/H/5558/001-004 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Egotux 12,5 mg harde capsules Egotux 25 mg harde capsules Egotux 37,5 mg harde capsules Egotux 50 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 12.5 mg hard capsules Each capsule contains 12.5 mg of sunitinib 25 mg hard capsules Each capsule contains 25 mg of sunitinib 37.5 mg hard capsules Each capsule contains 37.5 mg of sunitinib 50 mg hard capsules Each capsule contains 50 mg of sunitinib For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. [Product Name] 12.5 mg hard capsules Hard capsules with orange cap and orange body, printed with white ink ‘SB 12.5’ and white line on the body, containing yellow to orange granules, with a nominal length of approximately 14.3 mm. [Product Name] 25 mg hard capsules Hard capsules with caramel cap and orange body, printed with white ink ‘SB 25’ and white line on the body, containing yellow to orange granules, with a nominal length of approximately 15.9 mm. [Product Name] 37.5 mg hard capsules Hard capsules with yellow cap and yellow body, printed with black ink ‘SB 37.5’ and black line on the body, containing yellow to orange granules, with a nominal length of approximately 18.0 mm. [Product Name] 50 mg hard capsules Hard capsules with caramel cap and caramel body, printed with white ink ‘SB 50’ and white line on the body, containing yellow to orange granules, with a nominal length of approximately 19.4 mm. SmPC Sunitinib 12.5 mg, 25 mg, 37.5 mg & 50 mg hard capsules NL/H/5558/001-004 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastrointestinal stromal tumour (GIST) [Product Name] 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) [Product Name] is indicated for the treatment Läs hela dokumentet