البلد: هولندا
اللغة: الهولندية
المصدر: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ABIRATERONACETAAT
ABIRATERONACETAAT
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551)
Oraal gebruik
2021-09-13
Common Technical Document Abiraterone acetate Tablet M1.3.1_03.ATN.tab.003.02.core Page 1 of 7 1.3.1 Package leaflet - Core PACKAGE LEAFLET: INFORMATION FOR THE USER ABIBAM 250 MG, TABLETTEN ABIBAM 500 MG, FILMOMHULDE TABLETTEN abiraterone acetate 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 Abibam is and what it is used for 2. What you need to know before you take Abibam 3. How to take Abibam 4. Possible side effects 5. How to store Abibam 6. Contents of the pack and other information 1. WHAT ABIBAM IS AND WHAT IT IS USED FOR Abibam contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. Abibam stops your body from making testosterone; this can slow the growth of prostate cancer. When Abibam is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy). When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABIBAM _ _ DO NOT TAKE ABIBAM: - if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6). - if you are a woman, especially if pregnant. Abibam is for u اقرأ الوثيقة كاملة
Common Technical Document Abiraterone acetate Tablet M1.3.1_01.ATN.tab.003.04.core Page 1 of 26 1.3.1 Summary of Product Characteristics - Core 1. NAME OF THE MEDICINAL PRODUCT Abibam 250 mg, tabletten Abibam 500 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of abiraterone acetate. Excipients with known effect Each tablet contains 180 mg of lactose. Each tablet contains 500 mg of abiraterone acetate. Excipients with known effect Each tablet contains 241 mg of lactose and 12 mg sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white oval tablet, approximately 16 mm long by 9.5 mm wide, debossed with “ATN” on one side and “250” on the other side. Film-coated tablet Oval-shaped purple film-coated tablet, approximately 19 mm long by 11 mm wide and debossed with “A7TN” on one side and “500” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abibam is indicated with prednisone or prednisolone for: - the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) - the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) - the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. Common Technical Document Abiraterone acetate Tablet M1.3.1_01.ATN.tab.003.04.core Page 2 of 26 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should be prescribed by an appropriate healthcare professional. Posology The recommended dose is 1,000 mg (four 250 mg tablets or two 500 mg tablets) as a single daily dose that must not be taken with food (see “Method of administration” below). Taking the tablets with food increases syst اقرأ الوثيقة كاملة