Country: Indonesia
Bahasa: Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
EPOETIN ALFA
INTEGRATED HEALTHCARE INDONESIA - Indonesia
EPOETIN ALFA
10000 IU
INJEKSI
DUS, 6 PRE-FILLED SYRINGE @ 1 ML
CILAG AG SWITZERLAND - Switzerland
2021-10-21
Page 1 of 20 PI EPREX PRODUCT NAME EPREX® _EPOETIN ALFA _ COMPOSITION Epoetin alfa 2,000 IU or 16.8 micrograms per 0.5ml Epoetin alfa 4,000 IU or 33.6 micrograms per 0.4ml Epoetin alfa 10,000 IU or 84.0 micrograms per ml Epoetin alfa 40,000 IU or 336 micrograms per ml PHARMACEUTICAL FORM Eprex is a sterile, clear, colourless, buffered parenteral solution for intravenous or subcutaneous injection PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: anti-anaemia, ATC code: B03XA01. Mechanism of action Erythropoietin (EPO) is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production. EPO is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors. After EPO binds to its cell surface receptor, it activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation. Recombinant human EPO (Epoetinu alfa), expressed in Chinese hamster ovary cells, has a 165 amino acid sequence identical to that of human urinary EPO; the 2 are indistinguishable on the basis of functional assays. The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton. Pharmacodynamic responses to HSA-free Epoetin alfa, change in percent reticulocytes, hemoglobin, and total red blood cell counts as well as the area under the curve (AUCs) of these pharmacodynamic parameters, were similar between two dosing regimens (150 IU/kg SC three times per week to 40000 IU/mL SC once weekly). ESAs are growth factors that primarily stimulates red cell production. Erythropoietin receptors may be expressed on the surface of a variety of tumor cells. CHRONIC RENAL FAILURE Epoetin alfa has been studied in clinical trials in adult anaemic CRF patients, including patients on dialysis and patients not yet on dialysis, to treat anaemia and maintain haematocrit within a concentration range of 30-36%. In clinical trials at starting doses of 50-150 IU/k Baca dokumen lengkap