EPREX 4000

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

EPOETIN ALFA

Tilgængelig fra:

INTEGRATED HEALTHCARE INDONESIA - Indonesia

INN (International Name):

EPOETIN ALFA

Dosering:

4000 IU

Lægemiddelform:

INJEKSI

Enheder i pakken:

DUS, 6 PREFILLED SYRINGE @ 0,4 ML

Fremstillet af:

CILAG AG SWITZERLAND - Switzerland

Autorisation dato:

2021-10-25

Produktets egenskaber

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