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ALBUNORM 20% 200 G/L SOLUTION FOR INFUSION

Active substance(s): HUMAN ALBUMIN

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6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Albunorm 20% contains
­- The active substance is 200 g/l human albumin derived from human
plasma (bottle of 50, 100 ml).

2015.01.25 / 380 x 135 mm / B.666.000.UK_GTP_02

This medicinal product is authorised in the Member States of the EEA
under the following names:

What Albunorm 20% looks like and contents of the pack:

The product is given to patients to restore and maintain circulating
blood volume where a deficiency in volume has been demonstrated.
2. WHAT YOU NEED TO KNOW BEFORE YOU ALBUNORM 20%

Albunorm 200 g/l: Austria, Estonia, Greece, Finland, France, Hungary,
Latvia, Lithuania, Norway, Romania, Sweden, Slovenia

­- Keep this leaflet. You may need to read it again.

Do not use Albunorm 20%

­- If you have any further questions, ask your doctor or pharmacist.

Manufacturers:

­- This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.

-­ if you are allergic to human albumin preparations or any of the other
ingredients of this medicine (listed in section 6).

Octapharma Pharmazeutika, Produktionsges.m.b.H.,
Oberlaaerstrasse 235, 1100 Vienna, Austria

Not all pack sizes may be marketed in all countries.

Octapharma S.A.S., 72 rue du Maréchal Foch, 67380 Lingolsheim,
France

Marketing Authorisation Holder and Manufacturers:

Octapharma AB, Elersvägen 40, 112 75 Stockholm, Sweden

­- If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Albunorm 20% is and what it is used for
2. What you need to know before you use Albunorm 20%
3. How to use Albunorm 20%

Octapharma Produktionsgesellschaft Deutschland mbH,
Wolfgang-Marguerre-Allee 1, 31832 Springe, Germany

4. Possible side effects
5. How to store Albunorm 20%
6. Contents of the pack and other information

This leaflet was last revised in 08/2014.

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Human albumin
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

The solution is clear, yellow, amber or green.

Octapharma Ltd.
The Zenith Building
26 Spring Gardens
Manchester M2 1AB
United Kingdom

ALBUNORM 20%
200 g/l, Solution for infusion

­- The other ingredients are sodium chloride, N-Acetyl-DL-tryptophan,
caprylic acid and water for injections.

Albunorm 20% is a solution for infusion in a bottle (100 ml - pack size
of 1 and 10)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Albunorm: Denmark, Italy
Albunorm 20%: Belgium, Bulgaria, Cyprus, Czech Republic, Germany,
Ireland, Iceland, Luxemburg, Malta, Netherlands, Poland, Portugal,
Slovak Republic, Spain, United Kingdom

Albunorm 20% is a solution for infusion in a bottle (50 ml - pack size
of 1 and 10)

B.666.000.UK

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Albunorm 20%.
Take special care with Albunorm 20%
-­ if you are at special risk from increased blood volume e.g. in case
of severe heart disorders, high blood pressure, dilated veins of the
oesophagus, fluid in the lung, bleeding disorders, severely lowered
red blood cell count or without urine output.
-­ when there are signs for increased blood volume (headache,
breathing disorder, jugular vein congestion) or increased blood
pressure. The infusion should be stopped immediately.
-­ when there are signs of an allergic reaction. The infusion should be
stopped immediately.
-­ when it is used in patients with severe traumatic brain injury.

1. WHAT ALBUNORM 20% IS AND WHAT IT IS USED FOR

Virus safety

Albunorm 20% belongs to the pharmacotherapeutic group: blood
substitutes and plasma protein fractions.

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:

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• careful selection of blood and plasma donors to make sure those
at risk of carrying infections are excluded
• testing of each donation and pools of plasma for signs of virus/
infections
• steps included by the manufacturers 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 or other types of infections.
There are no reports of virus infections with albumin manufactured to
European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time you receive a dose of
Albunorm 20% the name and batch number of the product are
recorded in order to maintain a record of the batches used.
Other medicines and Albunorm 20%
No interactions of human albumin with other products are known so
far. However, Albunorm 20% solution should not be mixed in the same
infusion with other drugs, whole blood or packed red cells. Tell your
doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Pregnancy and breast-feeding
Human albumin is a normal constituent of human blood. No harmful
effects are known when this product is used during pregnancy or
breast-feeding. Particular care should be taken to adjust blood volume
in pregnant women.

• If you have any further questions on the use of this product, ask
your doctor or pharmacist.
If you use more Albunorm 20% than you should

Reporting of suspected adverse reactions

Driving and using machines

If the dosage and rate of infusion are too high, you may develop
headache, high blood pressure and discomfort breathing. The infusion
should be stopped immediately and your doctor will decide if any other
treatment is necessary.

There are no indications that human albumin impairs the ability to
drive or to operate machines.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the
safety of this medicine.

4. POSSIBLE SIDE EFFECTS

Ask your doctor for advice before taking any medicine.

Important information about some of the ingredients of
Albunorm 20%
This product contains sodium and potassium and may be harmful
to people on a low sodium or potassium diet. Tell your doctor if this
applies to you.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Albunorm 20% is ready for use as an infusion (“drip”) into a vein. The
dosage and infusion rate (how quickly you are given albumin into a
vein) will depend on your particular condition. Your doctor will decide
what treatment is best for you.
Instructions
• The product should be brought to room or body temperature
before use.

Keep this medicine out of the sight and reach of children.

Side effects after infusion of human albumin are rare and they normally
disappear when the infusion-rate is slowed down or stopped.

Do not use this medicine after expiry date which is stated on the label
and the carton. The expiry date refers to the last day of that month.

Rare: affects 1 to 10 users in 10,000:

Do not store above 25°C. Store in the original package in order to
protect from light. Do not freeze.

Flush, urticaria, fever and nausea.

3. HOW TO USE ALBUNORM 20%

5. HOW TO STORE ALBUNORM 20%

Very rare: affects less than 1 user in 10,000:
Shock due to hypersensitivity reaction.
Frequency not known: cannot be estimated from the available data:
Confusional state; headache; increased or decreased heart rate; high
blood pressure or low blood pressure; heat sensation; shortage of
breath; nausea; nettle rash; swelling around eyes, nose, mouth; rash;
increased sweating; fever; chills.

Once the infusion container has been opened, the content should be
used immediately.
The solution should be clear or slightly opalescent. Do not use solutions
which are cloudy or have deposits.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

• The solution should be clear and should not have a deposit.
• Any unused solution should be discarded.

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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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