Alburex 5, 50g/l, solution for infusion

• 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.

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

Alburex is a plasma substitute.

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.

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.

• If you are allergic (hypersensitive) to human albumin or any of the other ingredients of this medicine (listed in section 6).

• 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)

• 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’).

• 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).

• 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.

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.

No specific interactions of Alburex with other medicines are known.

• However, always tell your doctor or healthcare professional before treatment if you are taking, have recently taken or might take any other medicines.

• 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 breast-feeding.

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.

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

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.

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).

• Tell your doctor or healthcare professional immediately if you notice such symptoms.

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 the UK Yellow Card Scheme at 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.

• 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.
  One vial of 250 ml containing 12.5 g of human albumin.
  One vial of 500 ml containing 25 g of human albumin.
  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.
• The other ingredients are sodium N-acetyltryptophanate, sodium caprylate, sodium chloride, and water for injections.

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 (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.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: