Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
SUNITINIB
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
L01EX01
SUNITINIB 12.5 mg
HARD CAPSULE
SUNITINIB 12.5 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2019-05-28
PACKAGE LEAFLET: INFORMATION FOR THE USER SUNITINIB SANDOZ 12.5 MG HARD CAPSULES SUNITINIB SANDOZ 25 MG HARD CAPSULES SUNITINIB SANDOZ 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sunitinib Sandoz is and what it is used for 2. What you need to know before you take Sunitinib Sandoz 3. How to take Sunitinib Sandoz 4. Possible side effects 5. How to store Sunitinib Sandoz 6. Contents of the pack and other information 1. WHAT SUNITINIB SANDOZ IS AND WHAT IT IS USED FOR Sunitinib Sandoz 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 Sandoz 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 Sandoz works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB SANDOZ DO NOT TAKE SUNITINIB SANDOZ: - if you are allergic to sunitin Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Sandoz 12.5 mg hard capsules Sunitinib Sandoz 25 mg hard capsules Sunitinib Sandoz 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Sunitinib Sandoz 12.5 mg hard capsules Each capsule contains 12.5 mg of sunitinib. Excipient with known effect: Each capsule contains 0.42 mg of sodium. Sunitinib Sandoz 25 mg hard capsules Each capsule contains 25 mg of sunitinib. Excipient with known effect: Each capsule contains 0.84 mg of sodium. Sunitinib Sandoz 50 mg hard capsules Each capsule contains 50 mg of sunitinib. Excipient with known effect: Each capsule contains 1.68 mg of sodium. Sunitinib Sandoz 12.5 mg hard capsules (capsules) Gelatin capsules of size 4 with orange cap and orange body, printed with white ink “12.5 mg” on the body and containing yellow to orange granules. Sunitinib Sandoz 25 mg hard capsules (capsules) Gelatin capsules of size 3 with caramel cap and orange body, printed with white ink “25 mg” on the body and containing yellow to orange granules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastrointestinal stromal tumour (GIST) Sunitinib Sandoz 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 Sandoz is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Sandoz 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 For GIST and MRCC, the recommended dose of Διαβάστε το πλήρες έγγραφο