Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Abiraterone Acetate
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
Abiraterone Acetate
120 Tablets
Glenmark Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ARABITRO ® 250MG TABLETS Abiraterone Acetate Tablets USP 250mg 1 WHAT IS IN THIS LEAFLET 1. What ARABITRO is used for 2. How ARABITRO works 3. Before you use ARABITRO 4. How to use ARABITRO 5. While you are using it 6. Side effects 7. Storage and Disposal of ARABITRO 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT ARABITRO IS USED FOR ARABITRO is indicated with prednisone or prednisolone for the treatment of prostate cancer that has spread to other parts of the body. HOW ARABITRO WORKS ARABITRO stops your body from making testosterone. Research has shown that testosterone helps to fuel the tumor. Reducing the production of testosterone is important to manage your illness. BEFORE YOU USE ARABITRO _- When you must not use it _ _Pregnancy and lactation _ ARABITRO must not be taken by women who are pregnant or breast- feeding or might be pregnant since ARABITRO may affect the baby. If you are pregnant or might be pregnant, wear gloves if you need to touch or handle ARABITRO. _Women, infants and children _ ARABITRO is not for use in women and children. _ _ _- Before you start to use it _ ARABITRO can make high blood pressure or heart failure or low blood potassium worse. Taking prednisone or prednisolone with ARABITRO helps to avoid worsening of these conditions. If you have these conditions, or other heart or blood vessel problems, discuss them with your doctor. If you are having sex with a pregnant woman you need to use a condom. If you are having sex with a woman who can become pregnant you need to use a condom and another effective birth control method. ARABITRO may affect your liver. Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death. Talk to your doctor if you develop yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems. When you are taking ARABITRO your doc সম্পূর্ণ নথি পড়ুন
Manufactured by: At: Plot NO.-B-25, M.I.D.C., Shendra, Aurangabad - 431154, Maharashtra State, INDIA ® Registered Trade Mark PRODUCT REGISTRATION HOLDER: Glenmark Pharmaceuticals (Malaysia) Sdn Bhd (660397-W) D-31-02, Menara Suezcap 1, No. 2, Jalan Kerinchi, 59200 Kuala Lumpur, Malaysia PE00000 MY SAME SIZE ARTWORK LEAFLET SIZE : 170 mm x 225 mm 25 mm 34 mm _For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory_ PANTONE BLACK PROCESS C SUPERSEDES ARTWORK CODE : PE58020 PANTONE SHADE ICONGRAPHICS CODE: PHARMACODE: ARABITRO 250 MG TABLETS 1. NAME OF THE MEDICINAL PRODUCT Arabitro 250 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Abiraterone acetate 250 mg 3. PHARMACEUTICAL FORM Tablet 4. PRODUCT DESCRIPTION White to off white oval shaped uncoated tablets, debossed with “G” on one side and “135” on other side that should be swallowed whole with water and cannot be subdivided. 5. CLINICAL PARTICULARS 5.1 THERAPEUTIC INDICATION Arabitro is indicated with prednisone or prednisolone for l 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. l the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. Arabitro 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. 5.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 1000 mg (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 presnisolone_ For mCRPC, Arabitro is used with 10 mg prednisone or সম্পূর্ণ নথি পড়ুন