Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEFERASIROX
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
DEFERASIROX
28Tablet Tablets; 84Tablet Tablets
NOVARTIS PHARMA STEIN AG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ EXJADE ® DISPERSIBLE TABLETS Deferasirox ( 125 mg, 500 mg) 1 WHAT IS IN THIS LEAFLET 1. What Exjade is used for 2. How Exjade works 3. Before you use Exjade 4. How to use Exjade 5. While you are using Exjade 6. Side effects 7. Storage and Disposal of Exjade 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT EXJADE IS USED FOR Exjade is indicated for the treatment of chronic iron overload due to blood transfusions in adult and pediatric patients (aged 2 years and over). It is also indicated for the treatment of chronic iron overload in patients with non-transfusion- dependant thalassemia syndromes aged 10 years and over. HOW EXJADE WORKS Exjade traps and removes excess iron which is then excreted mainly in the stools. If you have any questions about how Exjade works or why this medicine has been prescribed for you, ask your doctor, pharmacist or healthcare provider. _Monitoring your Exjade treatment _ You will have regular tests (blood, urine, or Magnetic Resonance Imaging (MRI)) before and during treatment. • These will monitor the amount of iron in your body (level of ferritin, liver and/or cardiac iron content) to see how well Exjade is working. • The tests are also done to monitor your kidney function (blood level of creatinine, presence of protein in the urine) and liver function (blood level of transaminases, bilirubin and alkaline phosphatase). • Your doctor will take these tests into consideration when deciding on the dose of Exjade that is the most suitable for you and will also use these tests to decide when you should stop taking Exjade. Your eyesight and hearing will be tested before starting Exjade and each year during treatment as a precautionary measure. If you have any questions about how Exjade works or why this medicine has been prescribed for you, ask your doctor, pharmacist or healthcare provider. BEFORE YOU USE EXJADE Follow all the doctor’s instructions carefully. They may differ from the Đọc toàn bộ tài liệu
Novartis Page 2 Malaysian Package Leaflet 24-Jul-2019 Exjade EXJADE Iron chelating agent. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) Dispersible tablets. ACTIVE SUBSTANCE(S) Each dispersible tablet contains 125 mg / 500 mg deferasirox as active substance. Certain dosage strengths may not be available in all countries. EXCIPIENTS Lactose monohydrate; crospovidone; microcrystalline cellulose; povidone (K30); sodium lauryl sulphate; silicon dioxide; magnesium stearate DESCRIPTION Exjade 125mg: Off white, round, flat, beveled edge and imprint (debossment) “J 125” on one side and “NVR” on the other. Exjade 500mg: White to slightly yellow, round, flat tablet with bevelled edge and imprint (debossment) “J 500” on one side, “NVR” on the other. INDICATIONS Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adult and pediatric patients (aged 2 years and over). Exjade is also indicated for the treatment of chronic iron overload in patients with non- transfusion-dependent thalassemia syndromes aged 10 years and over. DOSAGE REGIMEN AND ADMINISTRATION TRANSFUSIONAL IRON OVERLOAD DOSAGE REGIMEN It is recommended that therapy with Exjade be started after the transfusion of approximately 20 units (about 100 mL/kg) of packed red blood cells or when there is evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin >1,000 microgram/L). Doses (in mg/kg) must be calculated and rounded to the nearest whole tablet size. The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and, as required, to reduce the existing iron burden. The decision to remove Novartis Page 3 Malaysian Package Leaflet 24-Jul-2019 Exjade accumulated iron should be individualized based on anticipated clinical benefit and risks of chelation therapy. For patients who are currently on chelation therapy with Exjade film-coated tablets and switching to Exjade dispersible tablets, the dose of Exj Đọc toàn bộ tài liệu