País: Països Baixos
Idioma: neerlandès
Font: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SUNITINIB 12,5 mg/stuk
Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)
SUNITINIB 12,5 mg/stuk
Capsule, hard
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE ROOD (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 ROOD (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
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SUNITINIB DENK 12,5 MG, HARDE CAPSULES SUNITINIB DENK 25 MG, HARDE CAPSULES SUNITINIB DENK 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. Whatis and what it is used for 2. What you need to know before you take Llegiu el document complet3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR 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. 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 works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE : - if you are allergic to sunitinib or any of the o
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Denk 12,5 mg, harde capsules Sunitinib Denk 25 mg, harde capsules Sunitinib Denk 50 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sunitinib Denk 12,5 mg, harde capsules Each capsule contains 12.5 mg of sunitinib. Sunitinib Denk 25 mg, harde capsules Each capsule contains 25 mg of sunitinib. Sunitinib Denk 50 mg, harde 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 Denk 12,5 mg, harde 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 Denk 25 mg, harde 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 Denk 50 mg, harde 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)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) Llegiu el document completis indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. 2 Pancreatic neuroendocrine tumours (pNET) is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy with sunitinib should be initiated by a physician experienced in the administration of anticancer agents. Posology Fo