Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Epoetin Beta
ROCHE (MALAYSIA) SDN. BHD.
Epoetin Beta
6Units Units
ROCHE DIAGNOSTICS GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ RECORMON ® _Epoetin beta (2000 iu/0.3 mL, 4000 iu/0.3 mL, 5000 iu/0.3 mL) _ _ _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What Recormon is used for 2. How Recormon works 3. Before you use Recormon 4. How to use Recormon 5. While you are using Recormon 6. Side effects 7. Storage and Disposal of Recormon 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT RECORMON IS USED FOR Recormon is used to treat anaemia. Anaemia is a condition where your blood does not have enough red blood cells and your haemoglobin (a protein which transports oxygen in the blood) level is too low. Therefore, your body's tissues might not receive enough oxygen. Anaemia may occur if a person has kidney disease. There are also other circumstances where a person has normal functioning kidneys but still has anaemia (such as patients receiving chemotherapy). Recormon may also be useful in these circumstances. Recormon is also used when a patient's own blood is donated and stored for transfusion prior to major surgery. This means that the patient will not need to receive a transfusion from a blood bank. Recormon is also used to treat anaemia in premature babies. Your doctor, however, may have prescribed Recormon for another reason. HOW RECORMON WORKS Recormon contains the active ingredient epoetin beta (pronounced ee- poe-tin bee-ta). Epoetin beta is also known as recombinant human erythropoietin (pronounced ee-rith-roe- poy-tin). Erythropoietin is a natural hormone produced by the kidneys which stimulates the production of red blood cells in the bone marrow and spleen. Like erythropoietin, Recormon works by increasing the number of red blood cells and haemoglobin level in your blood. BEFORE YOU USE RECORMON - _When you must not use it _ Do not take Recormon if: you have had an allergic reaction to epoetin beta or any ingredients listed at the end of this leaflet. Symptoms of an allergic reaction include swelling, itching, rash or breathing difficulties. Lue koko asiakirja
PACK INSERT FOR MALAYSIA Recormon ® pre -filled syringes Epoetin beta Information as set forth in this label only applies to Recormon 1. DESCRIPTION Composition 1.1 Therapeutic / Pharmacologic Class of Drug aAntianemic, ATC code: B03XA 1.2 Type of Dosage Form Solution for injection (pre -filled syringes) . 1.3 Route of administration Solution for intravenous (i.v.) or subcutaneous (s.c.) injection . 1.4 Sterile / Radioactive Statement Sterile product . 1.5 Qualitative and Quantitative Composition Active ingredient: epoetin beta (synonyms: rhEPO, recombinant human erythropoietin : produced by recombinant DNA technology in CHO cell line ). Recormon is supplied as a colourless, clear to slightly opalescent, solution for injection in glass syringes. Recormon 2000 1 pre -filled syringe contains 2000 international units (IU) (corresponding to 16.6 µg ) epoetin beta in 0.3 ml water solution for injection s. Recormon 4000 1 pre -filled syringe contains 4000 international units (IU) (corresponding to 33.2 µg ) epoetin beta in 0.3 ml water solution for injection s. Recormon 5000 1 pre -filled syringe contains 5000 international units (IU) (corresponding to 41.5 µg ) epoetin beta in 0.3 ml water solution for injection s. List of Eexcipients: It contains phenylalanine (up to 0.3mg per pre -filled syringe) (see section 2.4.1 General, Warnings and Precautions). All other excipients include: u Urea, sodium chloride, polysorbate 20, sodium dihydrogen ph osphate, sodium monohydrogen phosphate, calcium chloride, glycine, leucine, isoleucine, threonine , and glutamic acid and phenylalanine Recormon is supplied as a clear colourless solution for injection in glass syringes. 2. CLINICAL PARTICULARS 2.1 Therapeutic Indication(s) Indications Recormon is indicated for: Treatment of anemia associated with chronic renal failure ( renal anemia ) in patients on dialysis. Treat ment of symptomatic renal anemia in patients not yet undergoing dialysis. Prevention of anemia of prematurity in infants with a birth weig Lue koko asiakirja