ALBUMEX 4 albumin (human) 10g/250mL injection vial

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

Albumin, Quantity: 40 g/L

Pieejams no:

CSL Behring Australia Pty Ltd

Zāļu forma:

Injection, solution

Kompozīcija:

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

Ievadīšanas:

Intravenous

Vienības iepakojumā:

1 X 250mL vial

Receptes veids:

Not scheduled. Not considered by committee

Ārstēšanas norādes:

INDICATIONS AS AT 27 JANUARY 2000 : Hypovolaemia/shock: Preservation of an adequate circulating 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, anaemia 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 a 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.

Produktu pārskats:

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

Autorizācija statuss:

Registered

Autorizācija datums:

2000-03-09

Lietošanas instrukcija

Albumex
4 AU CMI 10.00
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
�

Produkta apraksts

Albumex 4 AU PI 10.00
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
ALBUMEX
® 4
(HUMAN ALBUMIN) – SOLUTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Human albumin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin 4% (40 g/L)
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.
Albumex
®
4 is manufactured from human plasma collected by Australian Red Cross
Lifeblood. It is prepared using predominantly chromatographic
techniques.
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
Albumex
®
4 also contains Water for Injections.
3
PHARMACEUTICAL FORM
Solution for intravenous infusion.
Albumex
®
4 is a clear, slightly viscous liquid; it is almost colourless,
yellow, amber or green.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
HYPOVOLAEMIA/SHOCK
Preservation of an adequate circulating 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 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 25 g/L), or if it is
clinically desirable to
avoid the infusion of large volumes of crystalloid solutions.
_ _
Albumex 4 AU PI 10.00
Page 2 of 12
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