Alburex 20 Solution for Infusion 200g/l (50ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HUMAN ALBUMIN, SOLUTION

Available from:

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

ATC code:

B05AA01

INN (International Name):

HUMAN ALBUMIN SOLUTION 200 g/l

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

HUMAN ALBUMIN SOLUTION 200 g/l

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2019-02-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUREX 5, 50 G/L, SOLUTION FOR INFUSION &
ALBUREX 20, 200 G/L, SOLUTION FOR INFUSION
Human albumin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or healthcare
professional.
•
If you get any side effects, talk to your doctor or healthcare
professional. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Alburex is and what it is used for
2.
What you need to know before you are given Alburex
3.
How to use Alburex
4.
Possible side effects
5.
How to store Alburex
6.
Contents of the pack and other information
1.
WHAT ALBUREX IS AND WHAT IT IS USED FOR
WHAT ALBUREX IS
Alburex is a plasma substitute.
HOW ALBUREX WORKS
Albumin stabilises the circulating blood volume. It is a carrier of
hormones, enzymes, medicines
and toxins. The albumin protein in Alburex is isolated from human
blood plasma. Therefore the
albumin works exactly as if it was your own protein.
WHAT ALBUREX IS USED FOR
Alburex 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
e.g.:
•
due to severe loss of blood after an injury,
_or_
•
due to a large surface burn
The choice of using Alburex will be made by your doctor. It will
depend on your individual clinical
situation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALBUREX
➔
Read this section carefully. The information given should be taken
into consideration by you
and your doctor before you are given Alburex.
DO NOT USE ALBUREX
•
If you are allergic (hypersensitive) to human albumin or any of the
other ingredients of this
medicine (listed in section 6).
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WARNINGS AND PRECAUTIONS
➔
Talk to your doctor or healthcare professional before you are given
Alburex.
Which cir

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Alburex 20, 200 g/l, solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alburex 20 is a solution containing 200 g/l of total protein of which
at least 96% is human albumin.
One vial of 50 ml contains 10 g of human albumin.
One vial of 100 ml contains 20 g of human albumin.
Alburex 20 is hyperoncotic to normal plasma.
Excipient with known effect:
Alburex 20 contains approximately 3.2 mg sodium per ml of solution
(140 mmol/l).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
A clear, slightly viscous liquid; it is almost colourless, yellow,
amber or green.
4.
CLINICAL PARTICULARS
4.1
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, based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The concentration of the albumin preparation, dosage and the infusion
rate should be adjusted to the
patient’s individual requirements.
Posology
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.
If human albumin is to be administered, haemodynamic performance
should be monitored
regularly; this may include:
•
arterial blood pressure and pulse rate
•
central venous pressure
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•
pulmonary artery wedge pressure
•
urine output
•
electrolyte
•
haematocrit / haemoglobin
_Paediatric population _
The posology in children and adolescents (0-18 years) should be
adjusted to the patient’s individual
requirements.
Method of administration
Human albumin can be directly administered by the intravenous route,
or it can also b