ALBUMEX 4 albumin (human) 2g/50mL injection vial

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Albumin, Quantity: 40 g/L

Disponible depuis:

CSL Behring Australia Pty Ltd

forme pharmaceutique:

Injection, solution

Composition:

Excipient Ingredients: chloride; octanoate; water for injections; sodium

Mode d'administration:

Intravenous

Unités en paquet:

50mL x 1

Type d'ordonnance:

Not scheduled. Not considered by committee

indications thérapeutiques:

INDICATIONS AS AT 27 JANUARY 2000 :Hypovolaemia/shock: Preservation of an adequate cirulating blood volume should be the primary aim of therapy. The initial resuscitating fluid should not be a human blood product, but rather an alternative plasma volume expander should be used as a first-line replacement. Albumex 4 may, however, be the initial plasma expander of choice if shock is associated with significant hypoalbuminaemia (albumin concentration less than 25g/Litre) or if it is clinically desirable to avoid the infusion of large volumes of crystalloid solutions. Albumex 4 may also be useful following initial resuscitation with crystalloid or synthetic colloid solutions in patients in whom extended support of the intravascular volume is required, such as seriously ill patients with multiple organ failure or the systemic capillary leak syndrome. Cardiopulmonary bypass: Albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery for patients with poor left ventricular function, and other complicating factors such as long bypass time, aneamia or repeat surgery. For post-operative hypovolaemia Albumex 4 may be used if further colloid is required after a moderate amount of synthetic colloid (1-2L) has been given, or there is ongoing bleeding or anaemia, until cross-matched blood is available. Plasma exchange: Albumex 4 is indicated as a replacement solution in plasma exchange procedures, particularly when the volume exchanged exceeds 20mL/Kg body weight. In patients with thrombotic thrombocytopenic purpura, fresh frozen plasma may be preferred replacement.,Albumex 4 is a plasma volume expander for restoration and maintenance of circulating blood volume. Albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery. Albumex 4 is indicated as a replacement solution in plasma exchange procedures.

Descriptif du produit:

Visual Identification: A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.; Container Type: Vial; Container Material: Glass; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Statut de autorisation:

Licence status A

Date de l'autorisation:

1997-05-19

Notice patient

Albumex
4 AU CMI 9.00
Page 1 of 3
ALBUMEX
® 4
Human albumin, solution for intravenous infusion.
CONSUMER MEDICINE INFORMATION
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.
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.
BEFORE YOU ARE GIVEN
ALBUMEX
® 4
WHEN YOU MUST NOT
TAKE IT
DO NOT TAKE ALBUMEX
® 4 IF YOU
ARE ALLERGIC TO:
•
human albumin
•
any of the ingredients listed
at the end of this leaflet.
BEFORE YOU ARE GIVEN
IT
TELL YOUR DOCTOR IF YOU:
•
are allergic to any other
food or medicine
•
have any other medical
conditions such as a history
of heart or kidney disease,
low blood pressure,
breathing difficulties,
decreased number of red
blood cells (anaemia) or a
tendency to bleed or bruise
easily
�

Résumé des caractéristiques du produit

Albumex 4 AU PI 9.00
Page 1 of 12
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.
Albumex 4 AU PI 9.00
Page 2 of 12
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-oncotic with human serum. When infused into adequately
hydrated
patients its effect is to expand the circulating blood volume by an
amount approximately
equal to the volume of Albumex
®
4 infused.
PHARMACOKINETICS
There is no specific pharmacokinetic information on