Package leaflet: Information for the patient

Alburex 5, 50g/l, solution for infusion
Human albumin
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again
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, inform your doctor or healthcare professional immediately

Table of contents:

What Alburex 5 is and what it is used for
Important information before using Alburex 5
How to use Alburex 5
Possible side effects
How to store Alburex 5
Contents of the packaging and other information

1. What Alburex 5 is and what it is used for

What is Alburex 5
Alburex 5 is a plasma substitute.
How Alburex 5 works
Albumin stabilizes circulating blood volume. It acts as a carrier for hormones, enzymes, drugs, and toxins.
The albumin protein in Alburex 5 is isolated from human blood plasma. Therefore, the action of albumin is identical to that of the body's own protein.
Why Alburex 5 is used
Alburex 5 is used to restore and maintain circulating blood volume. It is usually administered in situations requiring intensive therapy when blood volume has critically decreased, for example:

following severe blood loss due to trauma, or
extensive burns.
The decision to use Alburex 5 will be made by a doctor and will depend on the patient's clinical condition.

2. Information before using Alburex 5

Please read this section carefully, as the information provided here should be
considered by both the patient and the physician before administering Alburex 5.
When NOT to use Alburex 5

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

Warnings and precautions
Before starting treatment with Alburex 5, consult your doctor or healthcare professional.
Which circumstances 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 (hemodilution) may
pose a high risk for the patient.
Examples of such situations include:

heart failure requiring drug therapy (uncompensated heart failure)
high blood pressure (hypertension)
dilated esophageal veins (esophageal varices)
excessive accumulation of fluid in the lungs (pulmonary edema)
increased tendency to bleed (bleeding tendency)
severe deficiency of red blood cells (severe anemia)
significantly reduced 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 should the infusion be stopped?

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, immediately inform your doctor or healthcare professional. 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 breathing, or distension of neck veins (jugular vein distension). If such reactions occur, immediately inform your doctor or healthcare professional. 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, and
testing of individual donations and plasma pools for markers indicating the presence of viruses/infections.
inclusion of steps in the manufacturing process of blood or plasma intended to inactivate or eliminate viruses.
Nevertheless, 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 any unknown or newly emerging viruses and other types of infections. There have been no reports of viral infections associated with albumins manufactured according to the requirements of the European Pharmacopoeia using established technologies.

It is recommended to record the name and batch number of the product next to the patient's name each time Alburex 5 is administered, in order to enable traceability of the batch used to a specific patient.
Other medicines and Alburex 5
Cases of interaction between Alburex 5 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 intends to take.
Pregnancy, breastfeeding and effects on fertility
Inform your doctor or healthcare professional if you are pregnant, planning pregnancy, or breastfeeding. The doctor will decide whether to administer Alburex 5 during pregnancy or breastfeeding.
No separate studies have been conducted on the use of Alburex 5 during pregnancy or breastfeeding in women. However, medicinal products containing human albumin have been used in pregnant or breastfeeding women. Experience indicates that this product has no harmful effect on the course of pregnancy or on the fetus and newborn.
Driving and operating machinery
Alburex 5 has no influence on the ability to drive or operate machinery.
Alburex 5 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 5

Alburex 5 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 5 to be administered is made by the doctor. The amount of product administered and the infusion rate depend on the individual needs of the patient.
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 5 must not be mixed with other medicinal products or blood-derived products.

Accidental administration of a higher than recommended dose of Alburex 5
Alburex 5 is used only under medical supervision. Therefore, overdose is unlikely. However, if too high a dose is administered or if 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,
swelling (distension) of the neck veins.

If any of these symptoms occur, the doctor or medical personnel must be informed 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, continue monitoring of 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 5 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 than 1 in 10,000 treated individuals) may be serious 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 bumps).
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.: stuffy or runny nose, sneezing, redness, burning sensation, swelling, or watery eyes.
Headache, stomach pain, nausea, vomiting, diarrhea.

If any such reactions occur during infusion of Alburex 5, the physician or medical staff must be informed immediately. In such cases, the physician 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 redness
Itchy rash (hives)
Fever
Nausea

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

The same adverse reactions have been observed following the use of Alburex 5 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Alburex 5

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer cardboard packaging 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 outer packaging to protect from light.
Do not use this medicine if the solution appears cloudy or contains a precipitate.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
The batch number is indicated on the label and packaging following the abbreviation "Lot".

6. Contents of the pack and other information

What Alburex 5 contains

Active substance: Human albumin. Alburex 5 is a solution containing 50 g/l of total protein, of which at least 96% is human albumin. One 250 ml vial contains 12.5 g of human albumin. One 500 ml vial contains 25 g of human albumin.
The other components are sodium N-acetyltryptophanate, sodium caprylate, sodium chloride and water for injections.

What Alburex 5 looks like and contents of the pack
Alburex 5 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 in a pack (12.5 g/250 ml; 25 g/500 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 5, 50 g/l, Oplossing voor infusie, Solution pour perfusion, Infusionslösung
Bulgaria: Албурекс 5, 50 g/l, инфузионен разтвор
Cyprus: Alburex 5, 50 g/l, Διάλυμα για έγχυση
Slovakia: Alburex 5, 50 g/l, infuzní roztok / infúzny roztok
Denmark: Alburex 5
France: Alburex 50 g/l, solution pour perfusion
Austria, Germany: Alburex 5, 50 g/l, Infusionslösung
Hungary: Alburex 50g/l oldatos infúzió
Italy: Alburex 5%, 50 g/l, soluzione per infusione
Finland, Norway, Iceland, Sweden: Alburex 50 g/l, infuusioneste, liuos / infusjonsvæske, oppløsning / Eingöngu til notkunar í bláæð / Infusionsvätska, lösning
Poland: Alburex 5, 50 g/l, roztwór do infuzji
Portugal: Alburex 5, 50 g/l, solução para perfusão
Romania: Alburex 50 g/l, soluţie perfuzabilă
Slovenia: Alburex 50 g/l raztopina za infundiranje
Spain: Alburex 50 g/l, solución para perfusión
United Kingdom, Ireland: Alburex 5, 50 g/l, solution for infusion