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Albumex
4 AU CMI 8.00
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ALBUMEX
®
4_ _
Human albumin, solution for intravenous infusion
Consumer Medicine Information
50 ML AUST R 59154
250 ML AUST R 72895
500 ML AUST R 59155
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
Albumex
®
4. It does not contain
all the available information about
Albumex
®
4. It does NOT take the
place of talking to your doctor.
All medicines have benefits and
risks. Your doctor has weighed
the benefits that Albumex
®
4 will
have for you against the risks.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR. FOLLOW YOUR DOCTOR'S
ADVICE EVEN IF IT IS DIFFERENT
FROM WHAT THIS LEAFLET SAYS.
PLEASE READ THIS LEAFLET
CAREFULLY AND KEEP IT FOR FUTURE
REFERENCE. The information in this
leaflet is subject to change.
Please check with your doctor
whether there is any new
information about this medicine
that you should know since you
were last treated with this
medicine.
WHAT ALBUMEX
®
4 IS USED
FOR
Albumex
®
4 may be used:
• when the blood volume is
low (hypovolaemia)
• during heart-lung bypass
surgery
• in procedures where the
patient’s plasma is
replaced (plasma
exchange).
Acute loss of blood or plasma
(plasma is the non-cellular part of
the blood) may occur due to
trauma, after heart-lung bypass
surgery, and in patients with
multiple organ failure or leaky
small blood vessels.
The main functions of
Albumex
®
4 are to replace and
retain fluid in the blood vessels,
and to carry other chemicals
through the blood stream.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
ALBUMEX
®
4 HAS BEEN
PRESCRIBED FOR YOU. Your doctor
will have assessed the risks and
benefits for you associated with
the use of this product.
BEFORE YOU A
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제품 특성 요약
Albumex 4 AU PI 8.00
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Product Information
ALBUMEX
®
4
HUMAN ALBUMIN 4% (40 G/L)
AUSTRALIA
NAME OF THE MEDICINE
Human albumin, solution for intravenous infusion.
DESCRIPTION
Albumex
®
4 is manufactured from human plasma collected by the Australian
Red Cross Blood
Service. Albumex
®
4 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
4% w/v human albumin solution which is iso-oncotic with human
serum. It has a nominal osmolality
of 260 mOsm/kg, is approximately isotonic and the pH is 6.7
to 7.3. The manufacturing process for
Albumex
®
4
contains dedicated steps to reduce the possibility of virus transmission including
pasteurisation (heating at 60°C for 10
hours) and incubation at low pH to inactivate viruses. The
nominal composition of Albumex
®
4 is as follows:
Human Albumin
40 g/L
Sodium
140 mmol/L
Chloride
128 mmol/L
Octanoate
6.4 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
®
4 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
®
4 is iso-onc
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