Maa: Malesia
Kieli: englanti
Lähde: 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 (30μg/0.3mL, 50μg/0.3mL, 75μg/0.3mL, 100μg/0.3mL, 120μg/0.3mL, 150μg/0.3mL, _ _200μg/0.3mL, 250μg/0.3mL, 360μg/0.6mL, 800μg/0.6mL) _ 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: o Mircera (Methoxy polyethylene glycol-epoetin beta) or any ingredients listed at the end of this leaflet. o any other similar medicines (i.e. containing erythropoietin). Some of the symptoms of an allergic reaction may include: o shortness of breath o wheezing or difficulty breathing o swelling of the face, lips, tongue, or other parts of the body o 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 Lue koko asiakirja
Clinical Study Report: Ro 50-3821 - F. Hoffmann-La Roche Ltd Protocol NH19707 Report Number 1035312 16 6 Lue koko asiakirja