Krajina: Malta
Jazyk: angličtina
Zdroj: Malta Medicines Authority
SUNITINIB
Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
L01EX01
SUNITINIB 12.5 mg
HARD CAPSULE
SUNITINIB 12.5 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2019-06-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SUNITINIB MYLAN 12.5 MG HARD CAPSULES SUNITINIB MYLAN 25 MG HARD CAPSULES SUNITINIB MYLAN 37.5 MG HARD CAPSULES SUNITINIB MYLAN 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 Mylan is and what it is used for 2. What you need to know before you take Sunitinib Mylan 3. How to take Sunitinib Mylan 4. Possible side effects 5. How to store Sunitinib Mylan 6. Contents of the pack and other information 1. WHAT SUNITINIB MYLAN IS AND WHAT IT IS USED FOR Sunitinib Mylan 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 Mylan 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 Mylan works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB MYLAN DO NOT TAKE SUNITINIB MYLAN: - if Prečítajte si celý dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Mylan 12.5 mg hard capsules Sunitinib Mylan 25 mg hard capsules Sunitinib Mylan 37.5 mg hard capsules Sunitinib Mylan 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sunitinib Mylan 12.5 mg hard capsules Each capsule contains 12.5 mg of sunitinib. Excipient with known effect: Each capsule contains 0.4 mg of sodium. Sunitinib Mylan 25 mg hard capsules Each capsule contains 25 mg of sunitinib. Excipient with known effect: Each capsule contains 0.8 mg of sodium. Sunitinib Mylan 37.5 mg hard capsules Each capsule contains 37.5 mg of sunitinib. Excipient with known effect: Each capsule contains 1.3 mg of sodium. Sunitinib Mylan 50 mg hard capsules Each capsule contains 50 mg of sunitinib. Excipient with known effect: Each capsule contains 1.7 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Sunitinib Mylan 12.5 mg hard capsules (capsules) Gelatin capsules of of 14.2 mm ± 0.5 mm size with orange cap and orange body, printed with white ink “12.5 mg” on the body and containing yellow to orange granules. Sunitinib Mylan 25 mg hard capsules (capsules) Gelatin capsules of of 15.9 mm ± 0.5 mm size with caramel cap and orange body, printed with white ink “25 mg” on the body and containing yellow to orange granules. Sunitinib Mylan 37.5 mg hard capsules (capsules) Gelatin capsules of of 17.9 mm ± 0.5 mm size with yellow cap and yellow body, printed with black ink “37.5 mg” on the body and containing yellow to orange granules. 2 Sunitinib Mylan 50 mg hard capsules (capsules) Gelatin capsules of 19.3 mm ± 0.5 mm size 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 Mylan is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in Prečítajte si celý dokument