Krajina: Európska únia
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
sunitinib
Pfizer Limited
L01EX01
sunitinib
Antineoplastic agents
Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Gastrointestinal stromal tumour (GIST)Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.Metastatic renal cell carcinoma (MRCC)Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.Pancreatic neuroendocrine tumours (pNET)Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.Experience with Sutent as first-line treatment is limited (see section 5.1).
Revision: 39
Authorised
2006-07-19
59 B. PACKAGE LEAFLET 60 PACKAGE LEAFLET: INFORMATION FOR THE USER SUTENT 12.5 MG HARD CAPSULES SUTENT 25 MG HARD CAPSULES SUTENT 37.5 MG HARD CAPSULES SUTENT 50 MG HARD 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 Sutent is and what it is used for 2. What you need to know before you take Sutent 3. How to take Sutent 4. Possible side effects 5. How to store Sutent 6. Contents of the pack and other information 1. WHAT SUTENT IS AND WHAT IT IS USED FOR Sutent 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. Sutent 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 Sutent works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUTENT DO NOT TAKE SUTENT - If you are allergic to sunitinib or any of the other ingredients of Sutent (listed in section 6). 61 WARNINGS AND PRECAUT Prečítajte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 12.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib. 25 mg hard capsules Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib. 37.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib. 50 mg hard capsules Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Sutent 12.5 mg hard capsules Gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, and containing yellow to orange granules. Sutent 25 mg hard capsules Gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, and containing yellow to orange granules. Sutent 37.5 mg hard capsules Gelatin capsules with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body, and containing yellow to orange granules. Sutent 50 mg hard capsules Gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, and containing yellow to orange granules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastrointestinal stromal tumour (GIST) Sutent 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) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. 3 Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, Prečítajte si celý dokument