Albumex 20

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HUMAN ALBUMIN

Available from:

BLOOD SERVICES GROUP, HEALTH SCIENCES AUTHORITY

ATC code:

B05AA01

Dosage:

20.00%

Pharmaceutical form:

INJECTION, SOLUTION, CONCENTRATE

Composition:

HUMAN ALBUMIN 20%

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

CSL Behring (Australia) Pty Ltd

Authorization status:

ACTIVE

Authorization date:

2002-12-02

Patient Information leaflet

Albumex
®
20_SG_PI_6.01
Page 1 of 9
ALBUMEX
®
20
HUMAN ALBUMIN 20 % (200 G/L)
SINGAPORE
NAME OF THE MEDICINE
Human albumin, solution for intravenous infusion.
DESCRIPTION
Albumex
®
20
is manufactured from human plasma donated
by Singapore’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 chromatographic 
techniques. It is a 20 % w/v protein solution, which is
hyperoncotic with human serum and 
supplies the oncotic equivalence of approximately four times its
volume of human plasma. It is 
hypo-osmotic compared to human serum. It has a nominal
osmolality of 130 mOsm/kg, is 
hypotonic and the pH is approximately 7. Albumex
®
20 is heated at 60° C for 10 hours and 
incubated at low pH to inactivate viruses. The composition of
Albumex
®
20 is as follows: 
Human Albumin 200 g/L
Sodium 48 - 100 mmol/L 
Octanoate 32 mmol/L.
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 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.
The beneficial effect of albumin human for fluid
resuscitation is thought to result principally from 
its contribution to colloid osmotic pressure
(i.e. oncotic pressure).
_PHARMACOKINETICS_
There is no specific pharmacokinetic information
on Albume

Summary of Product characteristics

Albumex
®
20 SG PI 7.02
Page 1 of 13
ALBUMEX
® 20
HUMAN ALBUMIN 20% (200 G/L)
SINGAPORE
NAME OF THE MEDICINE
Human albumin, solution for intravenous infusion.
DESCRIPTION
Albumex
®
20 is manufactured from human plasma donated by Singapore’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
chromatographic
techniques. It is a sterile, preservative-free 20% w/v human albumin
solution. It is
hyperoncotic and hypo-osmotic 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 (60°C for 10 hours) and incubation at low pH
to inactivate viruses.
The composition of Albumex
®
20 is as follows:
Human Albumin
200 g/L
Sodium
48–100 mmol/L
Octanoate
32 mmol/L
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 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 has two main functions: maintenance of plasma colloid osmotic
pressure and
carriage of intermediate products in the transport and exchange of
tissue metabolites.
The beneficial effect of human albumin for fluid resuscitation is
thought to result principally
from its contribution to colloid osmotic pressure (i.e. oncotic
pressure).
Albumex
®
20 is hyperoncotic with human serum and supplies the oncotic
equivalence of
approximately four times its volume of human plasma.
Albumex
®
20 SG PI 7.02
Page 2 of 13
PHARMACOKINETICS
There is no specific pharmacokinetic information on Albumex
®
20. The general information
provided is based on published data for albumin.
Under no