País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Sunitinib
Bluefish Pharmaceuticals AB
L01EX01
Sunitinib
Capsule, hard
sunitinib
Not marketed
2023-02-17
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SUNITINIB BLUEFISH 12.5 MG HARD CAPSULES SUNITINIB BLUEFISH 25 MG HARD CAPSULES SUNITINIB BLUEFISH 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 Bluefish is and what it is used for 2. What you need to know before you take Sunitinib Bluefish 3. How to take Sunitinib Bluefish 4. Possible side effects 5. How to store Sunitinib Bluefish 6. Contents of the pack and other information 1. WHAT SUNITINIB BLUEFISH IS AND WHAT IT IS USED FOR Sunitinib Bluefish 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 Bluefish 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 Bluefish works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB BLUEFISH DO NOT TAKE SUNITIN Llegiu el document complet
HealthProductsRegulatoryAuthority 03March2023 CRN00CSQ2 Page1of23 SUMMARYOFPRODUCTCHARACTERISTICS 1NAMEOFTHEMEDICINALPRODUCT SunitinibBluefish12.5mghardcapsules 2QUALITATIVEANDQUANTITATIVECOMPOSITION Eachcapsulecontains12.5mgofsunitinib. Forthefulllistofexcipients,seesection6.1. 3PHARMACEUTICALFORM Hardcapsule Hardcapsulewithorangecapandorangebody,printedwithwhiteink'SB12.5'andwhitelineonthebodyandcontaining yellowtoorangegranules,withanominallengthofapproximately14mm. 4CLINICALPARTICULARS 4.1THERAPEUTICINDICATIONS Gastrointestinal stromal tumour (GIST) SunitinibBluefishisindicatedforthetreatmentofunresectableand/ormetastaticmalignantgastrointestinalstromaltumour (GIST)inadultsafterfailureofimatinibtreatmentduetoresistanceorintolerance. Metastatic renal cell carcinoma (MRCC) SunitinibBluefishisindicatedforthetreatmentofadvanced/metastaticrenalcellcarcinoma(MRCC)inadults. Pancreatic neuroendocrine tumours (pNET) SunitinibBluefishisindicatedforthetreatmentofunresectableormetastatic,well-differentiatedpancreaticneuroendocrine tumours(pNET)withdiseaseprogressioninadults. 4.2POSOLOGYANDMETHODOFADMINISTRATION TherapywithSunitinibBluefishshouldbeinitiatedbyaphysicianexperiencedintheadministrationofanticanceragents. Posology ForGISTandMRCC,therecommendeddoseofSunitinibBluefishis50mgtakenorallyoncedaily,for4consecutiveweeks, followedbya2-weekrestperiod(Schedule4/2)tocompriseacompletecycleof6weeks. ForpNET,therecommendeddoseof Llegiu el document complet