Alburex 20

Leaflet attached to the packaging: patient information

Alburex 20, 200g/l, solution for infusion

Human albumin

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to
• You should consult a doctor or medical staff if you have any doubts
• If any of the side effects worsen or if any side effects not listed in the leaflet occur, you should tell your doctor or medical staff.

Table of contents of the leaflet:

• 1. What is Alburex 20 and what is it used for
• 2. Important information before using Alburex 20
• 3. How to use Alburex 20
• 4. Possible side effects
• 5. How to store Alburex 20
• 6. Package contents and other information

1. What is Alburex 20 and what is it used for

What is Alburex 20

Alburex 20 is a plasma substitute preparation.

How does Alburex 20 work

Albumin stabilizes the volume of circulating blood. It is a carrier of hormones, enzymes, drugs, and toxins.
The albumin protein in Alburex 20 is isolated from human plasma. Therefore, the action of albumin is identical to that of the patient's own protein.

What is Alburex 20 used for

Alburex 20 is used to supplement and maintain the volume of circulating blood. It is usually used in situations where intensive therapy is necessary, when the blood volume has critically decreased, e.g., in cases of:

• severe blood loss after injury or
• burns of a large body surface area. The decision to use Alburex 20 will be made by a doctor. It will depend on the patient's clinical condition.

2. Important information before using Alburex 20

You should read this section carefully, as the information provided should be taken into account by the patient and doctor before administering Alburex 20.

When not to use Alburex 20

Warnings and precautions

Before starting treatment with Alburex 20, you should consult a doctor or medical staff.
What circumstances increase the risk of side effects?
The doctor or medical staff will exercise particular caution if excessive increase in blood volume (hyperolemia) or dilution of blood (hemodilution) may pose a high risk to the patient.
Examples of such situations include:

• heart failure requiring drug therapy (uncompensated heart failure)
• high blood pressure (hypertension)
• esophageal varices (esophageal varices)
• excessive fluid accumulation in the lungs (pulmonary edema)
• increased tendency to bleeding (coagulopathy)
• severe red blood cell deficiency (severe anemia)
• severe reduction in urine excretion due to kidney or urinary tract failure (renal and post-renal anuria) In case of any of the above conditions before starting treatment, you should inform your doctor or medical staff.

When should the infusion be stopped?

• Allergic reactions (hypersensitivity reactions) may occur, and in very rare cases, they may be severe enough to cause shock (see also section 4 Possible side effects). If such reactions occur during infusion of albumin, you should immediately inform your doctor or medical staff. In such cases, the doctor or medical staff will decide to stop the infusion and start appropriate treatment.
• Abnormal increase in blood volume (hyperolemia) may occur if the dose and infusion rate are not properly adjusted to the patient's condition. This can lead to overload of the heart and circulatory system (cardiovascular overload). The first signs of such overload are: headache, difficulty breathing, or swelling of the neck veins (narrowing of the neck veins). If such reactions occur, you should immediately inform your doctor or medical staff. In such cases, the doctor or medical staff will stop the infusion and, if necessary, start monitoring the circulation.

Information on safety regarding infections

In the case of medicinal products derived from human blood or plasma, measures are taken to prevent infections from being transmitted to patients. These include:

• careful selection of blood and plasma donors to exclude the risk of transmitting infections, and
• testing of individual donations and plasma pools for markers of viral infections.
• inclusion in the processing of blood or plasma of steps aimed at inactivating or eliminating viruses. Despite this, it is not possible to completely exclude the possibility of transmitting infectious agents during the administration of medicinal products derived from human blood or plasma. This also applies to any unknown or newly discovered viruses and other types of infections. There have been no reports of viral infections associated with albumins manufactured in accordance with the requirements of the European Pharmacopoeia using established technologies.

It is recommended to record the name and batch number of Alburex 20 with the patient's name each time the preparation is administered, to create the possibility of linking the used batch to a specific patient.

Other medicines and Alburex 20

There are no known cases of interaction between Alburex 20 and other medicines.
However, before treatment, you should always tell your doctor or medical staff about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

You should inform your doctor or medical staff about pregnancy, planned pregnancy, or breastfeeding. The doctor will decide whether to administer Alburex 20 during pregnancy or breastfeeding.
No separate studies have been conducted on the use of Alburex 20 in pregnant or breastfeeding women. However, preparations containing human albumin have been used in pregnant or breastfeeding women. Experience indicates that the preparation has no harmful effect on either the course of pregnancy or the fetus and newborn.

Driving and using machines

Alburex 20 has no effect on the ability to drive vehicles and operate machines.

Alburex 20 contains sodium

This medicine contains approximately 3.2 mg of sodium per 1 ml of solution (140 mmol/l). This amount should be taken into account in patients on a controlled sodium diet.

3. How to use Alburex 20

Alburex 20 is administered by a doctor or medical staff. It is intended exclusively for intravenous administration (intravenous infusion). Before administration, the medicine should be warmed to room temperature or body temperature.
The decision on the dose of Alburex 20 to be administered is made by a doctor. The amount of preparation administered and the infusion rate depend on the individual needs of the patient.
The doctor or medical staff will regularly monitor important blood flow parameters, such as:

• blood pressure,
• heart rate,
• urine output,
• blood tests. These values are monitored to determine the appropriate dose and infusion rate.

Alburex 20 should not be mixed with other medicinal products (except for solvents such as 5% glucose solution or 0.9% sodium chloride solution) and blood products.

Overdose of Alburex 20

Alburex 20 is used only under medical supervision. Overdose is therefore unlikely. If too large a dose of the product is administered or if the infusion rate is too high, excessive increase in blood volume (hyperolemia) may occur. This can lead to overload of the heart and circulatory system (cardiovascular overload). The first signs of such overload are:

• headache
• difficulty breathing or
• swelling (overload) of the neck veins. If such symptoms occur, you should immediately inform your doctor or medical staff.

The doctor or medical staff may also detect symptoms such as:

• increased blood pressure
• increased central venous pressure
• excessive fluid accumulation in the lungs (pulmonary edema) In all these cases, the doctor or medical staff will stop the infusion and, if necessary, start monitoring the circulatory system.

4. Possible side effects

Like all medicines, Alburex 20 can cause side effects, although they may not occur in everyone.
Such symptoms may occur even after previous use of Alburex 20 and good tolerance of the preparation.
General experiencewith the administration of human albumin solutions shows that the following side effects may be observed.
Allergic reactions (hypersensitivity reactions) may occur, which in very rarecases (less than 1 in 10,000 treated patients) may be severe enough to cause shock.
Symptoms of an allergic reaction may occur in the form of one, several, or many of the following:

• skin reactions, e.g., redness, itching, swelling, peeling, rash, or hives (itching bumps)
• difficulty breathing, e.g., wheezing, shortness of breath, or cough
• swelling of the face, eyelids, cheeks, tongue, or throat
• symptoms similar to a cold, e.g., stuffy or runny nose, sneezing, redness, burning, swelling, or tearing of the eyes
• headache, stomach pain, nausea, vomiting, diarrhea. If such reactions occur during infusion of Alburex 20, you should immediately inform your doctor or medical staff. In such cases, the doctor or medical staff will stop the infusion and start appropriate treatment.

The following mild side effects occur rarely(between 1 in 1000and 1 in 10,000treated patients):

• redness of the face
• itching rash (hives)
• fever
• nausea These symptoms usually resolve quickly after reducing the infusion rate or interrupting it.

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Such side effects have also been observed after the use of Alburex 20 after its introduction to the market. However, the exact frequency of these side effects is unknown.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Alburex 20

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer carton packaging and on the vial label after the abbreviation "EXP". The expiry date refers to the last day of the specified month.
• The contents of the vial should be used immediately after opening.
• Do not store above 25°C.
• Do not freeze.
• The vial should be stored in the outer packaging to protect it from light
• Do not use this medicine if you notice that the solution is cloudy or contains sediment.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.
• The batch number is stated on the label and packaging after the abbreviation "Lot".

6. Package contents and other information

What Alburex 20 contains

• The active substanceis human albumin. Alburex 20 is a solution containing 200 g/l of total protein, of which at least 96% is human albumin.

1 vial of 50 ml contains 10 g of human albumin.
1 vial of 100 ml contains 20 g of human albumin.

• The other ingredientsare sodium N-acetyltryptophanate, sodium caprylate, sodium chloride, and water for injections.

What Alburex 20 looks like and what the package contains

Alburex 20 is a solution for infusion. The solution is clear and slightly viscous. It may have a colorless or slightly yellow, amber, or green color.
Package sizes:
1 vial in a package (10g/50ml, 20g/100ml)
Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

CSL Behring GmbH

Emil-von-Behring-Str. 76
35041 Marburg
Germany

This medicinal product is registered in the EEA Member States with the following names:

Belgium, Luxembourg, Netherlands: Alburex 20, 200 g/l, Oplossing voor infusie, Solution pour perfusion, Infusionslösung
Bulgaria: Албурекс 20, 200 g/l, инфузионен разтвор
Cyprus, Greece: Alburex 20, 200 g/l, Διάλυμα για έγχυση
Czech Republic, Slovakia: Alburex 20, 200 g/l, infuzní roztok / infúzny roztok
Denmark: Human Albumin CSL Behring 20%
France: Alburex 200 g/l, solution pour perfusion
Austria, Germany: Alburex 20, 200 g/l, Infusionslösung
Hungary: Alburex 200g/l oldatos infúzió
Italy: Alburex 20%, 200 g/l, soluzione per infusione
Finland, Norway, Iceland, Sweden: Alburex 200 g/l, infuusioneste, liuos/infusjonsvæske, oppløsning/ Eingöngu til notkunar í bláæð/ Infusionsvätska, lösning
Poland: Alburex 20, 200g/l, roztwór do infuzji
Portugal: Alburex 20, 200 g/l, solução para perfusão
Romania: Alburex 200 g/l, soluţie perfuzabilă
Slovenia: Alburex 200 g/l raztopina za infundiranje
Spain: Alburex 200 g/l, solución para perfusión
United Kingdom, Ireland: Alburex 20, 200 g/l, solution for infusion
Date of last revision of the leaflet:August 2021