Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Sunitinib
KRKA, d.d., Novo mesto
L01XE04
Sunitinib
25 milligram(s)
Capsule, hard
sunitinib
Not marketed
2021-07-09
1.3.1 Sunitinib SPC, Labeling and Package Leaflet IE-Ireland PI_Text006560_1 - Updated: Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER SUNITINIB KRKA 12.5 MG HARD CAPSULES SUNITINIB KRKA 25 MG HARD CAPSULES SUNITINIB KRKA 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 Krka is and what it is used for 2. What you need to know before you take Sunitinib Krka 3. How to take Sunitinib Krka 4. Possible side effects 5. How to store Sunitinib Krka 6. Contents of the pack and other information 1. WHAT SUNITINIB KRKA IS AND WHAT IT IS USED FOR Sunitinib Krka 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 Krka 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 Krka works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB KRKA Læs hele dokumentet
Health Products Regulatory Authority 12 July 2021 CRN009PVN Page 1 of 25 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sunitinib Krka 25 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains sunitinib malate, equivalent to 25 mg of sunitinib. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule (capsule). Hard gelatine capsule with caramel (light brown) cap and orange body, printed with white imprint "SNB" and "25" on the body. The capsule is filled with orange powder. Capsule size: 3 (length of approximately 16 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastrointestinal stromal tumour (GIST) Sunitinib Krka 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 Krka is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Krka 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 Krka should be initiated by a physician experienced in the administration of anticancer agents. Posology For GIST and MRCC, the recommended dose of Sunitinib Krka is 50 mg taken orally once daily, for 4 consecutive weeks, followed by a 2-week rest period (Schedule 4/2) to comprise a complete cycle of 6 weeks. For pNET, the recommended dose of Sunitinib Krka is 37.5 mg taken orally once daily without a scheduled rest period. _Dose adjustments_ _Safety and tolerability_ For GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability. Daily dose should not exceed 75 mg nor be decreased below 25 mg. For pNET, dose modification in 12.5 mg steps may be applied Læs hele dokumentet