Albumex 20 Human Albumin 20% (200 g/L)

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

ALBUMIN HUMAN

Tilgjengelig fra:

PUSAT DARAH NEGARA

INN (International Name):

ALBUMIN HUMAN

Enheter i pakken:

1Units Units; 1 Units Units

Produsert av:

CSL Behring Australia Pty Ltd

Preparatomtale

Albumex 20 MY PI 5.01r
Page 1 of 14
PRODUCT INFORMATION
ALBUMEX
® 20
HUMAN ALBUMIN 20% (200 G/L)
MALAYSIA
NAME OF THE MEDICINE
Human albumin, solution for intravenous infusion.
DESCRIPTION
Albumex
®
20 is manufactured from human plasma donated by Malaysia’s voluntary
and
non-remunerated donors. Albumex
®
20 is a clear, slightly viscous liquid; it is almost
colourless, yellow, amber or green. It is prepared using predominantly
by a combination of
the Cohn cold-ethanol fractionation process and chromatographic
techniques. It is a sterile,
preservative-free 20% w/v protein human albumin solution. which It is
hyperoncotic and
hypo-osmotic with compared to human serum. It has a nominal osmolality
of 130 mOsm/kg,
is hypotonic and the pH is 6.7 to 7.3. The manufacturing process for
Albumex
®
20 contains
dedicated steps to reduce the possibility of virus transmission
including pasteurisation
(Albumex
®
20 is heated at 60°C for 10 hours) and incubationed at low pH to
inactivate
viruses. The composition of Albumex
®
20 is as follows:
Human Albumin
200 g/Litre
Sodium
48– to 100 mmol/Litre
Octanoate
32 mmol/Litre
PHARMACOLOGY
Albumin accounts quantitatively for more than half of the total
protein in the plasma and
represents about 10% of the protein synthesis activity of the liver.
The metabolic half-life of
albumin
_in vivo_
is about 20 19 days and the turnover in an adult is approximately 15 g
per
day. There is rapid interchange of albumin between the intra- and
extravascular spaces.
Albumex
®
20 is hyperoncotic with human serum and supplies the oncotic
equivalence of
approximately four times its volume of human plasma. Albumex
®
20 has two main functions:
maintenance of plasma colloid osmotic pressure and carriage of
intermediate products in the
transport and exchange of tissue metabolites.
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Albumex 20 MY PI 5.01r
Page 2 of 14
The beneficial effect of human albumin for fluid resuscitation is
thought to result principally
from its contribution to colloid osmotic pressure (i.e. oncoti