מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
sunitinib
Accord Healthcare S.L.U.
L01EX01
sunitinib
Antineoplastic agents
Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Gastrointestinal stromal tumour (GIST)Sunitinib Accord 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 Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.Pancreatic neuroendocrine tumours (pNET)Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
Revision: 1
Authorised
2021-02-11
75 B. PACKAGE LEAFLET 76 PACKAGE LEAFLET: INFORMATION FOR THE USER SUNITINIB ACCORD 12.5 MG HARD CAPSULES SUNITINIB ACCORD 25 MG HARD CAPSULES SUNITINIB ACCORD 37.5 MG HARD CAPSULES SUNITINIB ACCORD 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 ,pharmacist or nurse. - 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 pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sunitinib Accord is and what it is used for 2. What you need to know before you take Sunitinib Accord 3. How to take Sunitinib Accord 4. Possible side effects 5. How to store Sunitinib Accord 6. Contents of the pack and other information 1. WHAT SUNITINIB ACCORD IS AND WHAT IT IS USED FOR Sunitinib Accord 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 Accord 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 Accord works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SU קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Accord 12.5 mg hard capsules Sunitinib Accord 25 mg hard capsules Sunitinib Accord 37.5 mg hard capsules Sunitinib Accord 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sunitinib Accord 12.5 mg hard c apsules Each hard capsule contains 12.5 mg of sunitinib. Sunitinib Accord 25 mg hard c apsules Each hard capsule contains 25 mg of sunitinib. Sunitinib Accord 37.5 mg hard c apsules Each hard capsule contains 37.5 mg of sunitinib. Sunitinib Accord 50 mg hard c apsules Each hard capsule contains 50 mg of sunitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule) Sunitinib Accord 12.5 mg hard 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 Accord 25 mg hard 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 Accord 37.5 mg hard 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 Accord 50 mg hard capsules Gelatin capsule 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 Accord 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. 3 Metastatic renal cell carcinoma (MRCC) Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adult קרא את המסמך השלם