Alburex 20

Package leaflet: Information for the patient

Alburex 20, 200g/l, solution for infusion
Human albumin
Please read the entire leaflet before use, as it contains important information for the patient.

• Keep this leaflet for future reference
• Consult your doctor or healthcare professional if you have any doubts
• If any of the side effects worsens, or if you experience any side effects not listed in this leaflet, including possible side effects, inform your doctor or healthcare professional immediately.

Table of contents:

1. What Alburex 20 is and what it is 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. Contents of the pack and other information

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

What Alburex 20 is
Alburex 20 is a plasma substitute.
How Alburex 20 works
Albumin stabilizes circulating blood volume. It acts as a carrier for hormones, enzymes, drugs, and toxins.
The albumin protein in Alburex 20 is isolated from human blood plasma. Therefore, the action of albumin is identical to that of the body's own protein.
Why Alburex 20 is used
Alburex 20 is used to restore and maintain circulating blood volume. It is usually administered in situations requiring intensive therapy when blood volume has critically decreased, such as:

• severe blood loss following trauma or
• extensive burns.
  The decision to use Alburex 20 will be made by a doctor and will depend on the individual patient's clinical condition.

2. Important information before using Alburex 20

Please read this section carefully, as the information provided here should be taken into account by both the patient and the physician before administering Alburex 20.

When NOT to use Alburex 20

• if the patient is allergic (hypersensitive) to human albumin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Alburex 20, consult your doctor or healthcare professional.

Situations that may increase the risk of adverse reactions

Your doctor or healthcare professional will exercise particular caution if excessive increase in circulating blood volume (hypervolemia) or blood dilution (haemodilution) may pose a high risk for the patient. Examples include:

• heart failure requiring drug therapy (uncompensated heart failure)
• high blood pressure (hypertension)
• oesophageal varices
• excessive accumulation of fluid in the lungs (pulmonary oedema)
• increased tendency to bleed (haemorrhagic diathesis)
• severe deficiency of red blood cells (severe anaemia)
• severe reduction in urine output due to kidney or urinary tract failure (renal and post-renal anuria)

If any of the above conditions are present, inform your doctor or healthcare professional before starting treatment.

When to stop the infusion

• Allergic reactions (hypersensitivity reactions) may occur and, in very rare cases, may be severe enough to cause shock (see also section 4 Possible side effects). If such reactions occur during albumin infusion, inform your doctor or healthcare professional immediately. In such cases, the doctor or healthcare professional will decide to stop the infusion and initiate appropriate treatment.
• Abnormal increase in blood volume (hypervolemia) may occur if the dose and rate of infusion are not appropriately adjusted to the patient's condition. This may lead to overload of the heart and circulatory system (cardiovascular overload). Early signs of such overload include: headache, difficulty in breathing, or distension of the neck veins (jugular vein distension). If any of these symptoms occur, inform your doctor or healthcare professional immediately. In such cases, the doctor or healthcare professional will stop the infusion and, if necessary, initiate circulatory monitoring.

Information regarding safety with respect to infections

For medicinal products derived from human blood or plasma, measures are taken to prevent transmission of infections to patients. These include:

• careful selection of blood and plasma donors to exclude the risk of transmitting infections
• testing of individual donations and plasma pools for markers indicating the presence of viruses/infections
• inclusion of steps in the manufacturing process designed to inactivate or eliminate viruses

Despite these measures, it cannot be completely excluded that infectious agents may be transmitted when administering medicinal products derived from human blood or plasma. This also applies to unknown or newly emerging 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 that the name and batch number of the product be recorded against the patient's name each time Alburex 20 is administered, in order to allow traceability of the batch used to the individual patient.

Other medicines and Alburex 20

Cases of interaction between Alburex 20 and other medicines are not known. Nevertheless, before treatment, always inform your doctor or healthcare professional about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding and fertility

Inform your doctor or healthcare professional if you are pregnant, planning to become pregnant, or breastfeeding. The doctor will decide whether Alburex 20 should be administered during pregnancy or breastfeeding.

Separate studies on the use of Alburex 20 during pregnancy or breastfeeding in women have not been conducted. However, human albumin-containing preparations have been used in pregnant and breastfeeding women. Experience indicates that this preparation has no harmful effect on the course of pregnancy or on the fetus and newborn.

Driving and operating machinery

Alburex 20 has no influence on the ability to drive or operate machinery.

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 consideration in patients on a controlled sodium diet.

3. How to use Alburex 20

Alburex 20 is administered by a doctor or medical personnel. It is intended for intravenous use only (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 the doctor. The amount of the preparation administered and the infusion rate depend on the individual patient's needs.
The doctor or medical personnel will regularly monitor important haemodynamic parameters, such as:

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

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

Accidental administration of a higher than recommended dose of Alburex 20
Alburex 20 is used only under medical supervision. Therefore, overdose is unlikely. However, if too high a dose is administered or the infusion rate is too fast, excessive increase in blood volume (hypervolaemia) may occur. This may lead to cardiac and circulatory overload (cardiovascular overload). Early signs of such overload include:

• headache,
• difficulty in breathing, or
• swelling (distension) of the neck veins. In case any of these symptoms occur, inform the doctor or medical personnel immediately.

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

• elevated blood pressure,
• increased central venous pressure,
• excessive accumulation of fluid in the lungs (pulmonary oedema). In all such cases, the doctor or medical personnel will stop the infusion and, if necessary, will continue monitoring the circulatory system.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Such symptoms may occur even after previous use of Alburex 20 and good tolerance of the product.
General experience with administration of human albumin solutions indicates that the following adverse reactions may be observed.

Allergic reactions (hypersensitivity reactions) may occur, which in very rare cases (less frequently than 1 in 10,000 treated individuals) may be severe enough to cause shock.
Symptoms of an allergic reaction may include one, several, or many of the following:

• Skin reactions, e.g.: redness, itching, swelling, peeling, rash, or hives (itchy lumps).
• Breathing difficulties, e.g.: wheezing, shortness of breath, rapid breathing, or cough.
• Swelling of the face, eyelids, cheeks, tongue, or throat.
• Cold-like symptoms, e.g.: nasal congestion, runny nose, sneezing, redness, burning, swelling, or watering of the eyes.
• Headache, stomach pain, nausea, vomiting, diarrhoea.

If any such reactions occur during infusion of Alburex 20, the doctor or medical staff must be informed immediately. In such a case, the doctor or medical staff will stop the infusion and initiate appropriate treatment.

The following mild adverse reactions occur rarely (between 1 in 1,000 and 1 in 10,000 treated individuals):

• Facial flushing
• Itchy rash (urticaria)
• Fever
• Nausea

These symptoms usually resolve quickly after reducing the infusion rate or after temporarily stopping the infusion.

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The same adverse reactions have been observed following the use of Alburex 20 after the product was placed on the market. However, the exact frequency of these adverse reactions is unknown.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Alburex 20

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer carton and on the label of the vial following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
• The contents of the vial should be used immediately after opening.
• Do not store above 25°C.
• Do not freeze.
• Store the vial in the original outer packaging to protect it from light.
• Do not use this medicine if the solution appears cloudy or contains particulate matter.
• Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
• The batch number is indicated on the label and packaging following the abbreviation "Lot".

6. Contents of the packaging and other information

What Alburex 20 contains

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

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

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

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

Marketing Authorisation Holder and Manufacturer:
CSL Behring GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany

This medicinal product is registered in the EEA Member States under 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, 200 g/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