Ország: Málta
Nyelv: angol
Forrás: Malta Medicines Authority
SUNITINIB
Medichem, S.A. Fructuós Gelabert 6-8, 08970, Sant Joan Despí, (Barcellona), Spain
L01XE01
SUNITINIB 50 mg
HARD CAPSULE
SUNITINIB 50 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2017-12-20
PACKAGE LEAFLET: INFORMATION FOR THE USER SUNITINIB MEDICHEM 12.5 MG HARD CAPSULES SUNITINIB MEDICHEM 25 MG HARD CAPSULES SUNITINIB MEDICHEM 37.5 MG HARD CAPSULES SUNITINIB MEDICHEM 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 Sunitinib Medichem is and what it is used for 2. What you need to know before you take Sunitinib Medichem 3. How to take Sunitinib Medichem 4. Possible side effects 5. How to store Sunitinib Medichem 6. Contents of the pack and other information 1. WHAT SUNITINIB MEDICHEM IS AND WHAT IT IS USED FOR Sunitinib Medichem 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 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 works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB MEDICHEM DO NOT TAKE SUNITINIB MEDICHE Olvassa el a teljes dokumentumot
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Medichem 12.5 mg hard capsules Sunitinib Medichem 25 mg hard capsules Sunitinib Medichem 37.5 mg hard capsules Sunitinib Medichem 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. Sunitinib Medichem 12.5 mg hard capsules Gelatine capsules with orange cap and orange body and containing yellow to orange granules. Sunitinib Medichem 25 mg hard capsules Gelatine capsules with caramel cap and orange body and containing yellow to orange granules. Sunitinib Medichem 37.5 mg hard capsules Gelatine capsules with yellow cap and yellow body and containing yellow to orange granules. Sunitinib Medichem 50 mg hard capsules Gelatine capsules with caramel cap and caramel body and containing yellow to orange granules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastrointestinal Stromal Tumour (GIST) Sunitinib 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 is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in 2 adults. Pancreatic Neuroendocrine Tumours (pNET) Sunitinib 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 admi Olvassa el a teljes dokumentumot