Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Methoxy polyethylene glycol-epoetin beta
ROCHE (MALAYSIA) SDN. BHD.
Methoxy polyethylene glycol-epoetin beta
1Pieces Pieces
ROCHE DIAGNOSTICS GMBH
Consumer Medication Information Leaflet (RiMUP) MIRCERA ® Methoxy polyethylene glycol-epoetin beta (50μg/0.3mL, 75μg/0.3mL, 100μg/0.3mL, 120μg/0.3mL, 150μg/0.3mL, 200μg/0.3mL) 1 What is in this leaflet 1. What Mircera is used for 2. How Mircera works 3. Before you take Mircera 4. How to take Mircera 5. While you are using Mircera 6. Side effects 7. Storage and disposal of Mircera 8. Product description 9. Manufacturer & Product Registration Holder 1. What Mircera is used for Mircera is used to treat anaemia caused by chronic kidney disease (CKD)/kidney failure. Anaemia is a condition where your blood does not have enough red blood cells, causing a low level of haemoglobin (a protein that transports oxygen in the blood). As a result, your body's tissues might not receive enough oxygen. 2. How Mircera works Mircera belongs to a new class of hormones, known as Continuous Erythropoietin Receptor Activators. Erythropoietin, a natural hormone produced by the kidneys, stimulates the production of red blood cells in the bone marrow and spleen. Mircera works like erythropoietin, thereby increasing the number of red blood cells and the haemoglobin level in your blood. Consequently, this will reduce your need for blood transfusions. Your doctor, however, may have prescribed Mircera for another purpose. 3. Before you take Mircera - When you must not use it Do not take or receive Mircera if: you have or have had an allergic reaction in the past to: Mircera (Methoxy polyethylene glycol-epoetin beta) or any ingredients listed at the end of this leaflet. any other similar medicines (i.e. containing erythropoietin). Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue, or other parts of the body rash, itching or hives on the skin you are diagnosed with Pure Red Cell Aplasia (PRCA) through examination of the bone marrow. you have high blood pressure that is not well controlled. the package is torn Baca dokumen lengkap
PACK INSERT FOR MALAYSIA Mircera ® Methoxy polyethylene glycol-epoetin beta 1. DESCRIPTION 1.1 Therapeutic / Pharmacologic Class of Drug MIRCERA is the first molecule of a new class of Continuous Erythropoietin Receptor Activators called methoxy polyethylene glycol-epoetin beta. ATC Code – B03XA03 1.2 Type of Dosage Form Solution for injection supplied as a sterile, ready to use liquid in: Single dose pre-filled syringes 1.3 Route of Administration Subcutaneous or intravenous. 1.4 Sterile / Radioactive Statement Not applicable. 1.5 Qualitative and Quantitative Composition Single dose pre-filled syringes: containing 50 g, 75 g, 100 g, 120 g, 150 g or 200 g methoxy polyethylene glycol-epoetin beta in 0.3 ml. The active substance, methoxy polyethylene glycol-epoetin beta, is a covalent conjugate of a protein produced by recombinant DNA technology in Chinese Hamster Ovarian cells and a linear methoxy-polyethylene glycol (PEG). This results in an approximate molecular weight of 60 kDa. The dosage strength in g indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation. The solution is clear and colorless to slightly yellowish. Excipients: sodium phosphate monobasic monohydrate, sodium sulphate, mannitol, methionine, poloxamer 188 and water for injections. 2. CLINICAL PARTICULARS 2.1 Therapeutic Indication(s) MIRCERA is indicated for the treatment of anemia associated with chronic kidney disease (CKD) including patients on dialysis and patients not on dialysis. The safety and efficacy of MIRCERA therapy in other indications has not been established. 2.2 Dosage and Administration Standard dosage MIRCERA is administered less frequently than other erythropoiesis stimulating agents (ESAs) due to the longer elimination half-life. Treatment with MIRCERA has to be initiated under the supervision of a healthcare professional. Treatment of anemic patients with chronic kidney disease The solution can be admin Baca dokumen lengkap