ALBUREX 20 AU Human Albumin 200 g/L (20% w/v) 50 mL solution for intravenous infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Albumin, Quantity: 10 g

Available from:

CSL Behring Australia Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

50 mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient.

Product summary:

Visual Identification: A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-07-07

Patient Information leaflet

Alburex 20 AU CMI 3.00
Page 1 of 4
ALBUREX
® 20 AU
_Human albumin, solution for intravenous infusion. _
CONSUMER MEDICINE INFORMATION
50 ML AUST R 327952
100 ML AUST R 327953
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Alburex
®
20 AU. It does not
contain all the available
information about Alburex
®
20
AU. It does
NOT
take the place of
talking to your doctor.
All medicines have benefits and
risks. Your doctor has weighed
the benefits that Alburex
®
20
AU 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 ALBUREX
® 20
AU IS USED FOR
Alburex
®
20 AU is used to
restore and stabilise the
circulating blood volume. It is
normally used under intensive
care situations, when your blood
volume has decreased critically.
This may be the case, for
example:
•
due to severe loss of blood
after an injury
_or_
•
due to a large surface burn.
The choice of using Alburex
®
20 AU will be made by your
doctor. It will depend on your
individual clinical situation.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
ALBUREX
® 20 AU HAS BEEN
PRESCRIBED FOR YOU.
HOW ALBUREX
® 20 AU
WORKS
Albumin stabilises the
circulating blood volume. It is a
carrier of hormones, enzymes,
medicines and toxins. The
albumin protein in Alburex
®
20
AU is isolated from human
blood plasma. Therefore the
albumin works exactly as if it
was your own protein.
BEFORE YOU ARE GIVEN
ALBUREX
® 20 AU
WHEN YOU MUST NOT
RECEIVE IT
DO NOT RECEIVE ALBUREX
® 20
AU 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 BEFORE
TRE

Summary of Product characteristics

Alburex 20 AU PI 4.00
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
ALBUREX
® 20 AU
(HUMAN ALBUMIN) – SOLUTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Human albumin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin 20% (200 g/L)
Alburex
®
20 AU is a solution containing 200 g/L of total protein of which at
least 96% is
human albumin. Alburex
®
20 AU is hyperoncotic to normal plasma. It has a nominal
osmolality of 258 mOsm/kg, is isotonic and the pH is 6.7–7.3.
Alburex
®
20 AU is manufactured from human plasma collected in Australia by
Australian
Red Cross Lifeblood.
One litre of Alburex
®
20 AU also contains 16 mmol of sodium acetyltryptophanate and
16 mmol of sodium octanoate. Sodium chloride is added to give a sodium
content of
140 mmol/L.
Alburex
®
20 AU also contains Water for Injections.
3
PHARMACEUTICAL FORM
Solution for intravenous infusion.
Alburex
®
20 AU is a clear, slightly viscous liquid; it is almost colourless,
yellow, amber or
green.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Restoration and maintenance of circulating blood volume where volume
deficiency has been
demonstrated and use of a colloid is appropriate.
The choice of albumin rather than artificial colloid will depend on
the clinical situation of the
individual patient.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The concentration of the albumin preparation, dosage and the infusion
rate should be adjusted
to the patient’s individual requirements.
Alburex 20 AU PI 4.00
Page 2 of 9
DOSAGE
The dose required depends on the size of the patient, the severity of
trauma or illness and on
continuing fluid and protein losses. Measures of adequacy of
circulating volume and not
plasma albumin levels should be used to determine the dose required.
Infusion rate and
volume need to be adapted according to clinical conditions, most
notably in the elderly or in
the paediatric population.
_PAEDIATRIC POPULATION _
The dosage in children and adolescents (0–18 years) should be
adjusted to the patient’s
individual requirements.
MON