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ALBUREX 5 50 G/L SOLUTION FOR INFUSION

Active substance(s): HUMAN ALBUMIN

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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
t 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).

Warnings and precautions

t Talk to your doctor or healthcare professional before you are given
Alburex.

Which circumstances increase the risk of having side effects?
Your doctor or healthcare professional will take special care if an abnormal
increase in blood volume (hypervolaemia) or blood dilution (haemodilution)
could be dangerous for you. Examples of such conditions are:
• heart insufficiency which needs to be treated with medicines
(decompensated cardiac insufficiency),
• high blood pressure (hypertension),
• expansion of the gullet vein (oesophageal varices),
• abnormal accumulation of liquid in the lung (pulmonary oedema),
• predisposition for bleeding (haemorrhagic diathesis),
• severe decrease of red blood cells (severe anaemia),
• severe decrease of urine excretion because of renal impairment or outflow
impairment (renal and post-renal anuria),
t Tell your doctor or healthcare professional before treatment if at least
one of these conditions applies to you.
When stopping the infusion may be required?
• Allergic reactions (hypersensitivity reactions) may occur and may very
rarely be severe enough to cause shock (see also section 4 ‘Possible side
effects’).
t Tell your doctor or healthcare professional immediately if you notice
such reactions during the infusion of Alburex. He or she will decide to
stop the infusion completely and start the appropriate treatment.
• An abnormal increase in blood volume (hypervolaemia) may occur if the
dosage and infusion rate are not adequately adjusted to your condition.
This may lead to an overload of the heart and circulatory system
(cardiovascular overload). First signs of such an overload are headache,
breathing difficulty or swelling of your neck veins (jugular vein congestion).
t Tell your doctor or healthcare professional immediately if you notice
such signs. He or she will stop the infusion and monitor your
circulation as necessary.

Information on safety with respect to infections
When medicines are made from human blood or plasma, certain measures
are put in place to prevent infections being passed on to patients. These
include:

• careful selection of blood and plasma donors to make sure those at risk of
carrying infections are excluded,
• the testing of each donation and pools of plasma for signs of
virus/infections,
• the inclusion of steps in the processing of the blood or plasma that can
inactivate or remove viruses.
Despite these measures, when medicines prepared from human blood or
plasma are administered, the possibility of passing on infection cannot be
totally excluded. This also applies to any unknown or emerging viruses and
other types of infections.
There are no reports of virus infections with albumin manufactured to
European Pharmacopoeia requirements by established processes.
It is strongly recommended that every time you are given a dose of Alburex
the name and batch number of the product are recorded, in order to maintain
a record of the batches used.

Other medicines and Alburex
No specific interactions of Alburex with other medicines are known.
t However, always tell your doctor or healthcare professional before
treatment if you are taking, have recently taken or might take any other
medicines.

Pregnancy, breast-feeding and fertility

t Tell your doctor or healthcare professional if you are pregnant, plan to

become pregnant or are breast-feeding. Your doctor will decide whether
you can receive Alburex during your pregnancy or while you are breastfeeding.
The use of Alburex in pregnant or breast-feeding women has not been
studied separately. Nevertheless, medicines containing human albumin have
been used in pregnant or breast-feeding women. The experience showed that
no harmful effects on the course of pregnancy, or on the foetus and the
newborn are to be expected.

Driving and using machines
No effects of Alburex on the ability to drive and use machines have been
observed.

Alburex contains sodium
This medicine contains approximately 3.2 mg sodium per ml of solution
(140 mmol/l). Your doctor or healthcare professional will take that into
consideration if you are on a controlled sodium diet.

3. How to use Alburex
Alburex is given to you by your doctor or healthcare professional. It is
intended only for infusion into your veins (intravenous infusion).
The product should be warmed to room or body temperature before it is
given.

Your doctor decides how much Alburex you will receive. The amount and
infusion rate depends on your individual requirements.
Your doctor or healthcare professional will regularly monitor important blood
flow values like:
• your blood pressure,
• your pulse rate,
• your urine output,
• your blood tests.
These values are monitored to determine the right dose and infusion rate.
Alburex 5 must not be mixed with other medicinal products or blood-derived
products.
Alburex 20 must not be mixed with other medicinal products (except dilution
solvents such as 5% glucose and 0.9% sodium chloride) and blood-derived
products.

If you are given more Alburex than you should
Alburex is administered under medical supervision only. An overdosage is
therefore very unlikely to occur. An abnormal increase in blood volume
(hypervolaemia) may occur if the dosage and infusion rate are too high. This
may lead to an overload of the heart and circulatory system (cardiovascular
overload).
First signs of such an overload include:
• headache,
• breathing difficulty,
• swelling of your neck veins (jugular vein congestion).
t Tell your doctor or healthcare professional immediately if you notice
such symptoms.

Symptoms of an allergic reaction may include any, some or many of the
following:
• skin reactions, e.g. redness, itching, swelling, blistering, rash or hives (itchy
bumps),
• difficulty breathing, e.g. wheezing, chest tightness, shortness of breath or
cough,
• swelling of the face, eyelids, lips, tongue or throat,
• cold-like symptoms, e.g. stuffy or runny nose, sneezing, red, itchy, swollen
or watery eyes,
• headache, stomach ache, nausea, vomiting or diarrhoea.
t Tell your doctor or healthcare professional immediately if you notice
such reactions during the infusion of Alburex. In this case, he or she
will stop the infusion and start the appropriate treatment.
The following mild side effects may occur rarely (between 1 in 1,000 and
1 in 10,000 persons treated):
• flushing,
• itchy rash (urticaria),
• fever,
• nausea.
They will normally disappear rapidly when the infusion is slowed down or the
infusion is stopped.
The same side effects have been observed with Alburex since the product is
on the market. However, the exact frequency of these side effects is not
known.
t Talk to your doctor or healthcare professional if you get any of the side
effects. This includes any possible side effects not listed in this leaflet.

Reporting of side effects
Your doctor or healthcare professional may also detect signs like:
• an increased blood pressure,
• a raised central venous pressure,
• an abnormal accumulation of liquid in the lung (pulmonary oedema).
In all these cases, he or she will stop the infusion and monitor your circulation
as necessary.

If you get any side effects, talk to your doctor or healthcare professional. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Alburex
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the outer
carton and the vial label after the abbreviation «EXP». The expiry date
refers to the last day of that month.
• Once the vial has been opened, the contents should be used immediately.
• Do not store above +25 °C.
• Do not freeze.
• Keep the vial in the outer carton in order to protect from light.
• Do not use this medicine if you notice that the solution is cloudy or has
particles.
• Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What Alburex contains
• The active substance is human albumin.
Alburex 5 is a solution containing 50 g/l of total protein, of which at least
96% is human albumin.
Alburex 20 is a solution containing 200 g/l of total protein, of which at
least 96% is human albumin.
• The other ingredients are sodium N-acetyltryptophanate, sodium
caprylate, sodium chloride, and water for injections.

What Alburex looks like and contents of the pack
Alburex is a solution for infusion. The solution is clear and slightly viscous. It
may be almost colourless or yellow, amber or green.
Pack sizes:
Alburex 5: 1 vial per pack (5 g/100 ml, 12.5 g/250 ml, 25 g/500 ml)
Alburex 20: 1 vial per pack (10 g/50 ml, 20 g/100 ml)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

General experience with human albumin solutions showed that the
following side effects may be observed.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
Email: medsafety@hpra.ie

Allergic reactions (hypersensitivity reactions) may occur and may very rarely
(less than 1 in 10,000 persons treated) be severe enough to cause shock.

By reporting side effects, you can help provide more information on the safety
of this medicine.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them. Such side effects may occur even when you have
previously received Alburex and had tolerated it well.

CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg
Germany
This leaflet was last revised in 11/2014

C1307/000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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