البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Abiraterone Acetate
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
Abiraterone Acetate
120 Tablets
DR. REDDY`S LABORATORIES LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ABIRATRED Abiraterone Acetate Tablets 250 mg 1 WHAT IS IN THIS LEAFLET 1. What _ABIRATRED _ is used for 2. How _ABIRATRED _ works _3._ _ _ Before you use _ABIRATRED _ _4._ _ _ How to use _ABIRATRED _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _ABIRATRED _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1. WHAT _ABIRATRED _IS USED FOR It is used to treat prostate cancer that has spread to other parts of the body. Prostate cancer is a disease which only affects men. Cancer begins to grow in the prostate - a gland in the male reproductive system. 2. HOW _ABIRATRED _WORKS _ABIRATRED _ stops your body from making testosterone; this can slow the growth of prostate cancer. 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 mineral known as potassium in your blood. _3._ _ _ BEFORE YOU USE _ABIRATRED _ When you must not use it - if you are allergic to _ABIRATRED _ or any of the other ingredients of this medicine. - if you are a woman, especially if pregnant. _ABIRATRED _ is for use in male patients only. - if you have severe liver damage. Before you start _ABIRATRED _ Talk to your doctor or pharmacist before taking _ABIRATRED_ : - if you have been told you have high blood pressure or heart failure or low blood potassium (low blood potassium may increase the risk of heart rhythm problems) - if you have liver problems - about the need to take this medicine with prednisone or prednisolone - about possible effects on your bones - if you have taken a medicine known as ketoconazole in the past for prostate cancer - if you have high blood sugar. Decrease in red blood cells, sexual dysfunction, muscle weakness and/or muscle pain may occur. If you are not sure if any of the above apply to you, talk to your do اقرأ الوثيقة كاملة
Page 1 of 11 PRESCRIBING INFORMATION ABIRATRED ABIRATERONE ACETATE TABLETS 250 MG COMPOSITION Each film coated tablet contains: Abiraterone Acetate 250 mg Excipients: Lactose Monohydrate, Microcrystalline Cellulose, Croscarmellose sodium, Povidone, Sodium Lauryl Sulfate, Colloidal Silicon Dioxide, Magnesium Stearate, Opadry White OY-58900 and Purified Water. Colour: Titanium Dioxide Description: White to off white, oval shaped, film coated tablets, debossed with “ “(logo) on one side and “358” on other side. CLINICAL INFORMATION THERAPEUTIC INDICATION ABIRATRED is indicated with prednisone or prednisolone for • 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 Pharmacodynamic Properties). • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. ABIRATRED is also indicated in combination with prednisone or prednisolone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) who may have received up to 3 months of prior ADT. POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 1000 mg (two 500 mg tablets or four 250 mg tablets) as a single daily dose that must not be taken with food (see information on the method of administration). Taking the tablets with food increases systemic exposure to abiraterone. _Dosage of prednisone or prednisolone _ For mCRPC, ABIRATRED is used with 10 mg prednisone or prednisolone daily. For mHSPC, ABIRATRED is used with 5 mg prednisone or prednisolone daily. Medical castration with LHRH analogue should be continued during treatment in patients not surgically castrated. Page 2 of 11 _Recommended monitoring _ Serum transaminases should be measured prior to starting treatment, every two weeks for the first three mon اقرأ الوثيقة كاملة