Alburex 5

Leaflet attached to the packaging: patient information

Alburex 5, 50g/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 mentioned in the leaflet occur, you should tell your doctor or medical staff.

Table of contents of the leaflet:

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

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

What is Alburex 5

Alburex 5 is a plasma substitute preparation.

How does Alburex 5 work

Albumin stabilizes the circulating blood volume. It is a carrier of 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 patient's own protein.

What is Alburex 5 used for

Alburex 5 is used to supplement and maintain the circulating blood volume. It is usually used in situations where intensive therapy is necessary, when the blood volume has critically decreased, e.g., in the case of:

• severe blood loss after injury or
• burns of a large body surface. The decision to use Alburex 5 will be made by a doctor. It will depend on the patient's clinical condition.

2. Important information before using Alburex 5

You should read this section carefully, as the information provided should be taken into account by the patient and the doctor before administering Alburex 5.

When not to use the medicine Alburex 5

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

Warnings and precautions

Before starting treatment with Alburex 5, 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 circulating blood volume (hyperolemia) or blood dilution (hemodilution) may pose a high risk to the patient.
Examples of such situations are:

• 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 (bleeding disorder)
• 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 the event of any of these 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 can be severe enough to cause shock (see also point 4 Possible side effects). If such reactions occur during the 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 initiate 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 overloading 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.

Safety information 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 applies to all 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 the product with the patient's name at each administration of Alburex 5, to enable the used batch to be linked to a specific patient.

Other medicines and Alburex 5

There are no known cases of interaction between Alburex 5 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 5 during pregnancy or breastfeeding.
No separate studies have been conducted on the use of Alburex 5 in pregnant or breastfeeding women. However, preparations containing human albumin have been used in pregnant or breastfeeding women. Experience indicates that the product has no harmful effect on either the course of pregnancy or the fetus and newborn.

Driving and using machines

Alburex 5 has no effect on the ability to drive and use machines.

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 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 5 to be administered is made by a doctor. The amount of the product 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 5 should not be mixed with other medicinal products and blood products.

Administration of a higher dose of Alburex 5 than recommended

Alburex 5 is used only under medical supervision. Overdose is therefore unlikely. If too high 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 overloading of the heart and circulatory system (cardiovascular overload). The first signs of such overload are:

• headache
• difficulty breathing
• 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 circulation.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The general experience with the administration of human albumin solutions shows that the following side effects may be observed.
Allergic reactions (hypersensitivity reactions) may occur, which in very rare cases (less than 1 in 10,000 treated patients) can 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)
• breathing difficulties, 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 the infusion of Alburex 5, you should immediately inform your doctor or medical staff. In such cases, the doctor or medical staff will stop the infusion and initiate appropriate treatment.

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

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

Such side effects have also been observed after the use of Alburex 5 after the product was introduced onto the market. However, the exact frequency of these side effects is unknown.

Reporting side effects

If you experience any side effects, including those not mentioned in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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.

5. How to store Alburex 5

• 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 needed. 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 5 contains

• Active substanceis human albumin. Alburex 5 is a solution containing 50 g/l of total protein, of which at least 96% is human albumin. 1 vial of 250 ml contains 12.5g of human albumin. 1 vial of 500 ml contains 25g of human albumin.
• Other ingredientsinclude sodium N-acetyltryptophanate, sodium caprylate, sodium chloride, and water for injections.

What Alburex 5 looks like and what the package contains

Alburex 5 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 (12.5g/250 ml; 25g/500 ml).
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 5, 50 g/l, Oplossing voor infusie, Solution pour perfusion, Infusionslösung Bulgaria: Албурекс 5, 50 г/л, инфузионен разтвор Cyprus: Alburex 5, 50 g/l, Διάλυμα για έγχυση Slovakia: Alburex 5, 50 g/l, infuzný 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 Date of last revision of the leaflet:October 2023