Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Abiraterone Acetate
ACCORD HEALTHCARE SDN.BHD.
Abiraterone Acetate
120 Tablets
Aizant Drug Research Solutions Private Limited
ABYTONE TABLETS Abiraterone Acetate Tablet (250 mg) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What ABYTONE is used for 2. How ABYTONE works 3. Before you use ABYTONE 4. How to use ABYTONE 5. While you are using it 6. Side effects 7. Storage and disposal of ABYTONE 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 11. Serial Number WHAT ABYTONE IS USED FOR ABYTONE is indicated with prednisone or prednisolone for the treatment of prostate cancer that has spread to other parts of the body. HOW ABYTONE WORKS ABYTONE stops your body from making testosterone; this can slow the growth of prostate cancer. Research has shown that testosterone helps to fuel the tumor. Reducing the production of testosterone is important to manage your illness. When ABYTONE 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 mineral known as potassium in your blood. BEFORE YOU USE ABYTONE - _When you must not use it _ - Do not take this medicine if you have an allergy to: • abiraterone acetate • any of the other ingredients listed at the end of this leaflet - _Pregnancy and lactation _ Pregnancy and lactation ABYTONE must not be taken by women who are pregnant or breastfeeding or might be pregnant since ABYTONE may affect the baby. If you are pregnant or might be pregnant, wear gloves if you _ _ need to touch or handle ABYTONE. Women, infants and children ABYTONE is not for use in women and children. - Do not take this medicine if you have severe liver damage - Do not take this medicine in combination with Ra-223 (which is used to treat prostate cancer). - _Before you start use it _ Läs hela dokumentet
PACKAGE INSERT (FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL) 1. NAME OF THE MEDICINAL PRODUCT ABYTONE (Abiraterone Acetate Tablets 250 mg) 2. QUALITATIVE AND QUATITATIVE COMPOSITION Each tablet contains Abiraterone acetate 250 mg For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white, oval-shaped tablets debossed with A on one side and 250 on other side. 4. CLINICAL PARTICULARS 4.1 INDICATIONS Abiraterone Acetate 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. • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. Abiraterone Acetate is also indicated in combination with prednisone or pred- nisolone 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 1000 mg (four 250 mg tablets) as a single dai- ly 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 (see sections 4.5 and 5.2). _Dosage of prednisone or presnisolone_ For mCRPC, Abiraterone Acetate is used with 10 mg prednisone or prednis- olone daily. For mHSPC, Abiraterone Acetate is used with 5 mg prednisone or prednisolone daily. Medical castration with 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 weeks for the first three months of treatment and monthly thereafter. Blood pressure, serum potassium and fluid retention should be monito Läs hela dokumentet