国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ABIRATERONACETAAT 250 mg/stuk
Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)
ABIRATERONACETAAT 250 mg/stuk
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551), 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
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ABIRATERON BETAPHARM 250 MG, TABLETTEN abirateron acetaat 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 Abirateron betapharm is and what it is used for 2. What you need to know before you take Abirateron betapharm 3. How to take Abirateron betapharm 4. Possible side effects 5. How to store Abirateron betapharm 6. Contents of the pack and other information 1. WHAT ABIRATERON BETAPHARM IS AND WHAT IT IS USED FOR Abirateron betapharm 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. Abirateron betapharm stops your body from making testosterone; this can slow the growth of prostate cancer. When Abirateron betapharm 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 ABIRATERON BETAPHARM _ _ DO NOT TAKE ABIRATERON BETAPHARM: - 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. Abirateron betapharm is 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ABIRATERON BETAPHARM 250 MG, 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. 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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abirateron betapharm 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. 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 systemic exposure to abiraterone (see sections 4.5 and 5.2). _Dosage of prednisone or prednisolone_ For mHSPC, Abirateron betapharm is used with 5 mg prednisone or prednisolone daily. For mCRPC, Abirateron betapharm is used with 10 mg prednisone or prednisolone daily. Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated. _Recommended monitoring_ Serum transaminases should be measured prior to starting treatment, every two w 阅读完整的文件