Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SUNITINIBMALAAT SAMENSTELLING overeenkomend met ; SUNITINIB
Holsten Pharma GmbH Hanstrasse 31-35 60528 FRANKFURT AM MAIN (DUITSLAND)
SUNITINIBMALAAT COMPOSITION corresponding to ; SUNITINIB
Capsule, hard
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; WITTE INKT
Oraal gebruik
2021-07-15
M1.3.1_03.SNB.cap.002.05.NL.5079.02 Page 1 of 9 1.3.1 Package leaflet - Core PACKAGE LEAFLET: INFORMATION FOR THE USER Sunitinib Holsten 12,5 mg harde capsules Sunitinib Holsten 25 mg harde capsules Sunitinib Holsten 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 Holsten is and what it is used for 2. What you need to know before you take Sunitinib Holsten 3. How to take Sunitinib Holsten 4. Possible side effects 5. How to store Sunitinib Holsten 6. Contents of the pack and other information 1 WHAT SUNITINIB HOLSTEN IS AND WHAT IT IS USED FOR Sunitinib Holsten 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 Holsten 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 Holsten works or why this medicine has been prescribed for you, ask your doctor. M1.3.1_03.SNB.cap.002.05.NL.5079.02 Page 2 o Baca dokumen lengkapnya
M1.3.1_01.SNB.cap.002.05.NL5079.02 Page 1 of 32 1.3.1 Summary of Product Characteristics - Core 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Holsten 12,5 mg harde capsules Sunitinib Holsten 25 mg harde capsules Sunitinib Holsten 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 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 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 Holsten 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 Holsten is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Holsten is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults. M1.3.1_01.SNB.cap Baca dokumen lengkapnya