Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Epoetin Beta
ROCHE (MALAYSIA) SDN. BHD.
Epoetin Beta
6Units Units
VETTER PHARMA-FERTIGUNG GMBH & CO KG
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. you have high b সম্পূর্ণ নথি পড়ুন
PACK INSERT FOR MALAYSIA RECORMON® PRE-FILLED SYRINGES Epoetin beta Information as set forth in this label only applies to Recormon 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Antianaemic agent ATC code: B03XA 1.2 TYPE OF DOSAGE FORM Solution for injection (pre-filled syringes) (s.c. or i.v.). 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 (recombinant human erythropoietin: produced by recombinant DNA technology in CHO cell line). Recormon is provided as solution for injection in pre-filled syringes. The solution is a colourless, clear to slightly opalescent. _Solution for injection in pre-filled syringe:_ 2000 IU = 16.6 micrograms epoetin beta with 0.3 ml solution for injection 4000 IU = 33.2 micrograms epoetin beta with 0.3 ml solution for injection. 5000 IU = 41.5 micrograms epoetin beta with 0.3 ml solution for injection. _LIST OF EXCIPIENTS:_ All presentations contain up to 0.3 mg phenylalanine per pre-filled syringe (see section 2.4.1, Warnings and Precautions, General). All other excipients include: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, sodium monohydrogen phosphate, calcium chloride, glycine, leucine, isoleucine, threonine, and glutamic acid. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Recormon is indicated for: Treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. Treatment of symptomatic renal anemia in patients not yet undergoing dialysis. Prevention of anemia of prematurity in infants with a birth weight of 750g to 1500 g and a gestational age of less than 34 weeks. Treatment of anemia in adult patients with solid tumours and treated with platinum-based chemotherapy prone to induce anemia (cisplatin: 75 mg/m2/cycle; carboplatin: 350 mg/m2/cycle). Treatment of symptomatic anemia in adult patients with multipl সম্পূর্ণ নথি পড়ুন