Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SUNITINIB 25 mg/stuk
Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)
SUNITINIB 25 mg/stuk
Capsule, hard
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
Oraal gebruik
2020-11-26
10/2021 EPAR 1 C2-Internal PACKAGE LEAFLET: INFORMATION FOR THE USER Sunitinib Zentiva 12,5 mg, harde capsules Sunitinib Zentiva 25 mg, harde capsules Sunitinib Zentiva 37,5 mg, harde capsules Sunitinib Zentiva 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 Sunitinib Zentiva is and what it is used for 2. What you need to know before you take Sunitinib Zentiva 3. How to take Sunitinib Zentiva 4. Possible side effects 5. How to store Sunitinib Zentiva 6. Contents of the pack and other information 1. WHAT SUNITINIB ZENTIVA IS AND WHAT IT IS USED FOR Sunitinib Zentiva 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. Sunitinib Zentiva 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 Zentiva works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YO Perskaitykite visą dokumentą
10/2021 EPAR 1 C2-Internal SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Zentiva 12,5 mg, harde capsules Sunitinib Zentiva 25 mg, harde capsules Sunitinib Zentiva 37,5 mg, harde capsules Sunitinib Zentiva 50 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sunitinib Zentiva 12.5 mg hard capsules Each capsule contains 12.5 mg of sunitinib. Sunitinib Zentiva 25 mg hard capsules Each capsule contains 25 mg of sunitinib. Sunitinib Zentiva 37.5 mg hard capsules Each capsule contains 37.5 mg of sunitinib. Sunitinib Zentiva 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 (capsule). Sunitinib Zentiva 12.5 mg hard capsules (capsules) Gelatin capsules of size 4 (approximate length 14.3 mm) with orange cap and orange body, printed with white ink “12.5 mg” on the body and containing yellow to orange granules. Sunitinib Zentiva 25 mg hard capsules (capsules) Gelatin capsules of size 3 (approximate length 15.9 mm) with caramel cap and orange body, printed with white ink “25 mg” on the body and containing yellow to orange granules. Sunitinib Zentiva 37.5 mg hard capsules (capsules) Gelatin capsules of size 2 (approximate length 18.0 mm) with yellow cap and yellow body, printed with black ink “37.5 mg” on the body and containing yellow to orange granules. Sunitinib Zentiva 50 mg hard capsules (capsules) Gelatin capsules of size 1 (approximate length 19.4 mm) 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) Sunitinib Zentiva 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. 2 C2-Internal Metastatic renal cell carcinoma (MRCC) Sunitinib Zentiva is indicated for the treatm Perskaitykite visą dokumentą