País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SUNITINIBMALAAT 50,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 37,5 mg/stuk
Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)
SUNITINIBMALAAT 50,12 mg/stuk SAMENSTELLING overeenkomend met ; SUNITINIB 37,5 mg/stuk
Capsule, hard
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT
Oraal gebruik
1900-01-01
M1.3.1_03.SNB.cap.001.05.core Page 1 of 10 1.3.1 Package leaflet - Core PACKAGE LEAFLET: INFORMATION FOR THE USER Sunitinib betapharm 12,5 mg harde capsules Sunitinib betapharm 25 mg harde capsules Sunitinib betapharm 37,5 mg harde capsules Sunitinib betapharm 50 mg harde 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 betapharm is and what it is used for 2. What you need to know before you take Sunitinib betapharm 3. How to take Sunitinib betapharm 4. Possible side effects 5. How to store Sunitinib betapharm 6. Contents of the pack and other information 1 WHAT SUNITINIB BETAPHARM IS AND WHAT IT IS USED FOR Sunitinib betapharm 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 betapharm 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 betapharm works or why this medicine has been prescribed for you, a Leer el documento completo
M1.3.1_01.SNB.cap.001.05.NL.5064.02 Blad 1 van 32 1.3.1 Summary of Product Characteristics - Core 1. NAME OF THE MEDICINAL PRODUCT Sunitinib betapharm 12,5 mg harde capsules Sunitinib betapharm 25 mg harde capsules Sunitinib betapharm 37,5 mg harde capsules Sunitinib betapharm 50 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib. Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib. Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib. Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Sunitinib 12.5 mg capsule Hard gelatine capsule with orange cap and orange body, printed with white imprint “SNB” and “12.5” on the body. The capsule is filled with orange powder. Capsule size: 4 (length of approximately 14 mm). Sunitinib 25 mg 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). Sunitinib 37.5 mg capsule Hard gelatine capsule with yellow cap and yellow body, printed with black imprint “SNB” and “37.5” on the body. The capsule is filled with orange powder. Capsule size: 2 (length of approximately 18 mm). Sunitinib 50 mg capsule Hard gelatine capsule with caramel cap and caramel body (light brown), printed with black imprint “SNB” and “50” on the body. The capsule is filled with orange powder. Capsule size: 1EL (elongated; length of approximately 20 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastrointestinal stromal tumour (GIST) Sunitinib Betapharm 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. M1.3.1_01.SNB.cap.0 Leer el documento completo