Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
abiraterone acetate
Mylan Ireland Limited
L02BX03
abiraterone acetate
Endocrine therapy, Other hormone antagonists and related agents
Prostatic Neoplasms
Abiraterone Mylan 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).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.the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.
Revision: 4
Authorised
2021-08-20
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ABIRATERONE MYLAN 500 MG FILM-COATED TABLETS ABIRATERONE MYLAN 1000 MG FILM-COATED TABLETS 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 Abiraterone Mylan is and what it is used for 2. What you need to know before you take Abiraterone Mylan 3. How to take Abiraterone Mylan 4. Possible side effects 5. How to store Abiraterone Mylan 6. Contents of the pack and other information 1. WHAT ABIRATERONE MYLAN IS AND WHAT IT IS USED FOR Abiraterone Mylan 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. Abiraterone Mylan stops your body from making testosterone; this can slow the growth of prostate cancer. When Abiraterone Mylan 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 ABIRATERONE MYLAN DO NOT TAKE ABIRATERONE MYLAN - 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, e Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Abiraterone Mylan 500 mg film-coated tablets Abiraterone Mylan 1000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Abiraterone Mylan 500 mg film-coated tablets Each film-coated tablet contains 500 mg of abiraterone acetate equivalent to 446 mg abiraterone. Abiraterone Mylan 1000 mg film-coated tablets Each film-coated tablet contains 1000 mg of abiraterone acetate equivalent to 893 mg abiraterone. Excipient(s) with known effect Abiraterone Mylan 500 mg film-coated tablets Each 500 mg film-coated tablet contains 68 mg lactose monohydrate (see section 4.4). Abiraterone Mylan 1000 mg film-coated tablets Each 1000 mg film-coated tablet contains 136 mg lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Abiraterone Mylan 500 mg film-coated tablets Brown, oval-shaped film-coated tablet, debossed with “500” on one side, with dimensions 19 mm long x 10 mm wide. Abiraterone Mylan 1000 mg film-coated tablets White to off-white, oval-shaped film-coated tablet, with a break line on one side and plain on the other side, with dimensions 23 mm long x 11 mm wide. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abiraterone Mylan 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 MET Pročitajte cijeli dokument