Patient leaflet - Albumeon 20 200 g/l solution for infusion
1. What Albumeon is and what it is used for
What is Albumeon
Albumeon is a plasma substitute.
How Albumeon works
Albumin stabilises the circulating blood volume. It is a carrier of hormones, enzymes, medicinal products and toxins. The albumin protein in Albumeon is taken from human blood plasma. Therefore the albumin works exactly as if it was your own protein.
What Albumeon is used for
Albumeon is used to restore and stabilize 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 Albumeon will be made by your doctor. It will depend on your individual clinical situation.
2. What you need to know before you are given Albumeon
Read this section carefully. The information given should be taken into consideration by you and your doctor before you are given Albumeon.
Do not use Albumeon
- if you are allergic (hypersensitive) to human albumin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before you are given Albumeon.
Which circumstances increase the risk of having side effects?
Your doctor or pharmacist 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)
Tell your doctor or pharmacist 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). Tell your doctor or pharmacist immediately if you notice such reactions during the infusion of Albumin. 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 adapted. 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).
Tell your doctor or pharmacist immediately if you notice such signs. He or she will stop the infusion and monitor your circulation as necessary.
Virus safety
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 receive a dose of Albumeon the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Other medicines and Albumeon
No specific interactions of Albumeon with other medicines are known. Harmful effects or interactions are also not expected.
However, always tell your doctor or pharmacist before treatment if you are taking, have recently taken or might take any other medicines.
Albumeon must not be mixed with other medicinal products and blood derived products.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of Albumeon 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 shows 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 Albumeon on the ability to drive and use machines have been observed.
Albumeon contains sodium
50 ml vial
One 50 ml vial of this medicine contains 144 mg sodium (main component of cooking/table salt). This is equivalent to 7.2 % of the recommended maximum daily dietary intake of sodium for an adult.
100 ml vial
One 100 ml vial of this medicine contains 287.5 mg sodium (main component of cooking/table salt). This is equivalent to 14.4 % of the recommended maximum daily dietary intake of sodium for an adult.
3. How to use Albumeon
Albumeon is given to you by your doctor. Albumeon is intended only for the infusion into your veins (intravenous infusion).
Your doctor decides how much Albumeon you will be given. The amount and infusion rate depends on your individual requirements (see also section 2).
Your doctor will regularly monitor important blood flow values like:
- your blood pressure,
- your pulse rate or
- your urine output.
These values are monitored to determine the right dose and infusion rate.
If you are given more Albumeon than you should
Albumeon is usually 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 are
- headache
- breathing difficulty or
- swelling of your neck veins (jugular vein congestion).
Tell your doctor immediately if you notice such symptoms.
Your doctor may also detect signs like
- an increased blood pressure
- a raised central venous pressure or
- 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.
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 Albumeon and had tolerated it well.
The general experience with Human Albumin solutions showed that the following side effects may be observed.
Allergic reactions (hypersensitivity reactions) may occur and may very rarely be severe enough to cause shock.
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, stomachache, nausea, vomiting or diarrhoea.
Tell your doctor or pharmacist if you notice such reactions during the infusion of Albumeon.
In this case, he or she will stop the infusion and start the appropriate treatment.
The following mild side effect may occur rarely (may affect up to 1 in 1,000 people):
- flushing
- itchy rash (urticaria)
- fever
- nausea
They will normally disappear rapidly when the infusion is slowed down or the infusion is stopped.
The following severe side effects may occur very rarely (may affect up to 1 in 10,000 people)
- shock
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the UK Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Albumeon
- 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 label and carton. The expiry date refers to the last day of that month.
- Do not store above +25° C.
- Do not freeze.
- Keep the vial in the outer carton in order to protect from light.
- Once the container has been opened, the contents have to be used immediately.
- 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 Albumeon contains
The active substance is human albumin.
Albumeon is a solution containing 200 g/l of total protein of which at least 96 % is human albumin.
A vial of 100 ml contains at least 19.2 g of human albumin.
A vial of 50 ml contains at least 9.6 g of human albumin.
- The other ingredients are sodium caprylate, sodium N-acetyl-D, L-tryptophan, sodium chloride, sodium hydroxide and hydrochloric acid (in small amounts for pH adjustment) and water for injections.
What Albumeon looks like and contents of the pack
Albumeon is a solution for infusion. The solution is clear and slightly viscous. It may be almost colourless or yellow, amber or green.
Pack sizes:
1 vial per pack (50 ml / 100 ml).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
CSL Behring UK Ltd.
Tel: +44 (0)1444 447405