Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
SUNITINIB
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
L01EX01
SUNITINIB 37.5 mg
HARD CAPSULE
SUNITINIB 37.5 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2019-03-06
mt-pl-sunitinib-remedica-caps-a1 Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER SUNITINIB REMEDICA 12.5 MG HARD CAPSULES SUNITINIB REMEDICA 25 MG HARD CAPSULES SUNITINIB REMEDICA 37.5 MG HARD CAPSULES SUNITINIB REMEDICA 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 Remedica is and what it is used for 2. What you need to know before you take Sunitinib Remedica 3. How to take Sunitinib Remedica 4. Possible side effects 5. How to store Sunitinib Remedica 6. Contents of the pack and other information 1. WHAT SUNITINIB REMEDICA IS AND WHAT IT IS USED FOR Sunitinib Remedica 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 Remedica 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 Remedica works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU Belgenin tamamını okuyun
mt-spc-sunitinib-remedica-caps-v01-r03-a0 Page 1 of 29 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Remedica 12.5 mg hard capsules Sunitinib Remedica 25 mg hard capsules Sunitinib Remedica 37.5 mg hard capsules Sunitinib Remedica 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sunitinib Remedica 12.5 mg hard capsules Each hard capsule contains 12.5 mg of sunitinib. Excipient with known effect: Each hard capsule contains 0.42 mg of sodium. Sunitinib Remedica 25 mg hard capsules Each hard capsule contains 25 mg of sunitinib. Excipient with known effect: Each hard capsule contains 0.84 mg of sodium. Sunitinib Remedica 37.5 mg hard capsules Each hard capsule contains 37.5 mg of sunitinib. Excipient with known effect: Each hard capsule contains 1.26 mg of sodium. Sunitinib Remedica 50 mg hard capsules Each hard capsule contains 50 mg of sunitinib. Excipient with known effect: Each hard capsule contains 1.68 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules. Sunitinib Remedica 12.5 mg hard 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 Remedica 25 mg hard 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. Sunitinib Remedica 37.5 mg hard capsules mt-spc-sunitinib-remedica-caps-v01-r03-a0 Page 2 of 29 Gelatin capsules of size 2 with yellow cap and yellow body, printed with black ink “37.5 mg” on the body and containing yellow to orange granules. Sunitinib Remedica 50 mg hard capsules Gelatin capsules of size 1 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 Remedica is indicated for the treatment of unresectable and/or Belgenin tamamını okuyun