Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EPOETIN ALFA
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
EPOETIN ALFA
6Units Units
SANDOZ GMBH
1 _Consumer Medication Information Leaflet (RiMUP) _ BINOCRIT ® PRE-FILLED SYRINGE Epoetin alfa (2000IU/ml, 4000IU/0.4ml, 10 000IU/ml, 40 000IU/ml) WHAT IS IN THIS LEAFLET 1. What BINOCRIT ® is used for 2. How BINOCRIT ® works 3. Before you use BINOCRIT ® 4. How to use BINOCRIT ® 5. While you are using BINOCRIT ® 6. Side effects 7. Storage and disposal of BINOCRIT ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT BINOCRIT ® IS USED FOR BINOCRIT ® is used to treat symptomatic anemia caused by kidney disease - in children on hemodialysis - in adults on hemodialysis, peritoneal dialysis or not yet undergoing dialysis. If you have kidney disease, you may be short of red blood cells if your kidney does not produce enough erythropoietin (necessary for red cell production). BINOCRIT ® is prescribed to stimulate your bone marrow to produce more red blood cells. BINOCRIT ® is used to treat anemia if you are receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma (bone marrow cancer) and your doctor decides you may have a need for a blood transfusion. BINOCRIT ® can reduce the need for a blood transfusion. BINOCRIT ® is used in moderately anemic people who donate some of their blood before surgery, so that it can be given back to them during or after the operation. Because BINOCRIT ® stimulates the production of red blood cells, doctors can take more blood from these people. BINOCRIT ® is used in moderately anemic adults about to have major orthopedic surgery (for example hip or knee replacement operations), to reduce the potential need for blood transfusions. BINOCRIT ® is used to treat anemia in adults with low- or intermediate-1-risk myelodysplastic syndromes. BINOCRIT ® can reduce the need for a blood transfusion. HOW BINOCRIT ® WORKS BINOCRIT ® contains the active substance epoetin alfa - a protein that stimulates the bone marrow to produce more red blood cells which carry hemoglobin (a substance that transports oxygen). Epoeti Soma hati kamili
Page 1 of 28 BINOCRIT ® EPOETIN ALFA 1. NAME OF THE MEDICINAL PRODUCT Binocrit solution for injection in a pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION a) Binocrit 2,000 IU/1 ml solution for injection in a pre-filled syringe: Each ml of solution contains 2,000 IU of epoetin alfa* corresponding to 16.8 micrograms per ml 1 pre-filled syringe of 1 ml contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa b) Binocrit 4,000 IU/0.4 ml solution for injection in a pre-filled syringe: Each ml of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.4 ml contains 4,000 international units (IU) corresponding to 33.6 micrograms epoetin alfa c) Binocrit 10,000 IU/1 ml solution for injection in a pre-filled syringe: Each ml of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 1 ml contains 10,000 international units (IU) corresponding to 84.0 micrograms epoetin alfa d) Binocrit 40,000 IU/1 ml solution for injection in a pre-filled syringe: Each ml of solution contains 40,000 IU of epoetin alfa* corresponding to 336.0 micrograms per ml 1 pre-filled syringe of 1 ml contains 40,000 international units (IU) corresponding to 336.0 micrograms epoetin alfa * Produced in CHO cell line by recombinant DNA technology For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled syringe (injection). Clear colourless solution. Page 2 of 28 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of anemia associated with chronic renal failure in adult hemodialysis, peritoneal dialysis and predialysis patients and pediatric patients on hemodialysis. • Treatment of anemia and reduction of transfusion in adult cancer patients with non-myeloid malignancies receiving chemotherapy. • To facilitate autologous blood collection within a predeposit program and decrease the risk of receiving allogeneic blood transfusions in pat Soma hati kamili