Alburex 50 g/l solucion para perfusion

PROSPECTO:INFORMATION FOR THE USER

Alburex 50 g/l, solution for infusion

Human albumin

Read this prospectus carefully before starting to use this medication, because

it contains important information for you.

-Keep this prospectus, asperhaps you will need to read it again.

-If you have any doubts, consult your doctor, pharmacist or nurse.

- This medication has been prescribed only to you and should not be given to other people,

although they may have the same symptoms of illness, as it may harm them.

-If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospectus.

1. What isAlburex 50 g/land for what it is used

2. What you need to know before starting to useAlburex 50 g/l

3. How touse Alburex 50 g/l

4. Possible adverse effects

5. Storage ofAlburex 50 g/l

6. Contents of the package and additional information

What isAlburex 50 g/l

Alburex 50 g/l is a plasma substitute.

How Alburex 50 g/l works

The albumin stabilizes the circulating blood volume.Transports hormones, enzymes,

medicines and toxins.The albumin inAlburex 50 g/l is a protein isolated from human plasma. The albumin present in Alburex 50 g/l functions exactly as if it were your own protein.

What is Alburex 50 g/l used for

Alburex 50 g/l is indicated for the restoration and maintenance of circulating blood volume.

It is normally used in intensive care situations, when your

circulating blood volume has decreased dangerously.This can occur, for example:

• due to severe blood loss following an injury or
• due to extensive superficial burns.

The decision to use Alburex 50 g/l should be made by your doctor. Thiswill depend on your clinical situation.

Please read this section carefully. The following information should be taken into account by you and your doctor before Alburex is administered.

DO NOT use Alburex 50 g/l

If you are allergic to human albumin or any of the other components of this

medication (listed in section 6).

Please inform your doctor or pharmacist before treatment if this is the case.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alburex 50 g/l.

Your doctor or healthcare professional will take special care if abnormal blood volume increase (hypervolemia) or blood dilution (hemodilution) may be dangerous for you.Examples of these situations are:

• uncompensated heart failure that needs to be treated with medication (heart failure

descompensated),

• high blood pressure (hypertension),
• esophageal vein expansion (esophageal varices),
• abnormal fluid accumulation in the lung (pulmonary edema),
• predisposition to bleeding (hemorrhagic diathesis),
• severe decrease in red blood cells in the blood (severe anemia),
• severe decrease in urine excretion due to urinary retention or kidney failure (renal anuria and postrenal).

Consult your doctor or healthcare professional before treatment if you experience any of the

mentioned.

Allergic reactions (hypersensitivity reactions) may occur that can be severe and cause shock(see section 4).

Consult your doctor or healthcare professional immediately if you notice such reactions

during Alburex infusion. Your doctor will interrupt your administration completely and

begin appropriate treatment.

If the dose and infusion rate have not been adjusted to your situation, circulatory may

produce an abnormal increase in blood volume (hypervolemia). This may lead to heart and circulatory system overload (cardiovascular overload). The first

signs of this overload are headache and difficulty breathing or jugular vein distension.

Consult your doctor or healthcare professional immediately if you experience these

symptoms. Your doctor will interrupt treatment and monitor your circulation if necessary.

Information on safety in relation to infections

When manufacturing medicines from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients,including:

• The careful selection of blood and plasma donors to ensure that donors at risk of being carriers of infections are excluded, and

The analysis of each individual donation and plasma mixtures to search for signs of viruses and infections.

• Additionally, manufacturers of these products include steps in the processing of blood or plasma that can inactivate or eliminate viruses.

Despite these measures, when administering medicines obtained from human blood or

plasma, it cannot be completely ruled out that infections may be transmitted.This applies to emerging or unknown viruses and other types of infections. There are no reports

of demonstrated viral infections with albumin manufactured in accordance with the requirements

of the European Pharmacopoeia and in accordance with established processes.

It is strongly recommended that each time Alburex 50 g/l is administered, the name and batch number of the product be recorded to maintain a record of the batches used.

Interaction of Alburex 50 g/l with other medications

No specific interactions of Alburex 50 g/l with other medications are known.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Alburex 50 g/l has not been studied individually in pregnant women or breastfeeding women.However, albumin-containing medications have been used in pregnant women or breastfeeding women.

Experiences have shown that no adverse effects should be expected on pregnancy or on the fetus or neonate.

Driving and operating machinery

No effects of Alburex 50 g/l on the ability to drive vehicles or operate machinery have been observed.

Alburex 50 g/l contains sodium

Patients with low-sodium diets should note that this medication contains approximately 3.2 mg of sodium per ml of solution (140 mmol/l). Your doctor will take this into account in the treatment of patients with low-sodium diets.

medication should be warmed to room temperature or body temperature before

administration.

amount and infusion rate depend on your individual needs.

blood flow values such as:

• your blood pressure,
• your pulse,
• your urine production (diuresis),
• your blood test results.

These values are monitored to determine the correct dose and infusion rate.

Do not mix Alburex 50 g/l with other medications or blood-derived products.

Do not mix Alburex 50 g/l with other medications or blood-derived products.

If you use more Alburex 50 g/l than you should

In case of overdose, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used.

Alburex 50 g/l is only administered under medical supervision.Therefore, it is highly unlikely that you will be administered an overdose.You may experience an abnormal increase in blood volume (hypervolemia) if the dose and infusion rate are too high,which could lead to heart and circulatory system overload (cardiovascular overload).

The first symptoms of such an overload are::

• headache,
• difficulty breathing or
• swelling of the neck veins (jugular vein congestion).

If you notice these symptoms, please inform your doctor or healthcare professional immediately.

Additionally, your doctor or healthcare professional may detect symptoms such as:

• higher blood pressure,
• higher central venous pressure or
• abnormal fluid accumulation in the lungs (pulmonary edema).

In all these cases, your doctor or healthcare professional will stop the infusion and monitor your circulation if necessary.

If you have any other questions about the use of thismedication, ask your doctor, pharmacistor nurse.

Like all medicines, Alburex 50 g/l may cause side effects, although not everyone will experience them.

These side effects may occur even if you have already received Alburex 50 g/l and tolerated it well.

The general experience with human albumin solutions shows that the following side effects can be observed.

The following side effects may occur.

Allergic reactions (hypersensitivity reactions) that very rarely (affect less than 1 in 10,000 people) can be severe and cause anaphylaxis.

Symptoms of an allergic reaction may include one, some, or all of the following:

• Reactions on the skin, such as redness, itching, swelling, blisters, rashes, or urticaria (hives and itching).

Difficulty breathing, such as wheezing, chest tightness, difficulty breathing, or coughing.

• Swelling of the face, eyelids, lips, tongue, or throat.
• Symptoms similar to a cold, such as a stuffy nose or nasal discharge, sneezing, red eyes, itching, swelling, or watery eyes.

Headache, stomach pain, nausea, vomiting, or diarrhea.

If you notice these reactions during the infusion of Alburex 50 g/l, please inform your doctor or healthcare professional immediately.

In this case, your doctor or healthcare professional will suspend the infusion and initiate the appropriate treatment.

The following mild side effects may occur rarely (affect less than 1 in 1,000 people):

• Confusion,
• Itchy rash (urticaria),
• Fever,
• Nausea.

They usually disappear quickly as the infusion rate is reduced or the infusion is stopped.

The same side effects have been observed in Albúmina Humana Behring 5% since it has been on the market. However, the exact frequency of these side effects is unknown.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

The expiration date is the last day of the month indicated.

Do not use Alburex 50 g/l if you notice that the solution is cloudy or contains particles.

Do not throw the medications down the drain or in the trash. Ask your pharmacist where to dispose of the medications that you no longer use. In this way, you will help protect the environment.

Composition of Alburex 50 g/l

• Theactive principleis:human albumin.

Alburex 50 g/l is a solution that contains 50 g/l of total protein, of which at least 96% is human albumin.

Theother components are:N-acetyltryptophanate of sodium, caprylate of sodium, sodium chloride, and water for injectable preparations. (see section 2)

Appearance of Alburex 50 g/l and contents of the vial

Alburex 50 g/l is a perfusion solution. The solution is transparent and slightly viscous.It may be almost colorless or yellow, amber, or greenish.

It can be obtained in the following sizes (1 vial per package):

• A 250 ml vial contains 12.5 g of human albumin.
• A 500 ml vial contains 25 g of human albumin.

Not all presentations may be marketed.

Holder of the marketing authorization and responsible for manufacturing

CSL Behring GmbH

Emil-von-Behringstrasse 76

D-35041 Marburg

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

CSL Behring, S.A.

c/ Tarragona 157, 18th floor

08014 Barcelona

Spain

This medication is authorized in the member states of the European Economic Area under the following denominations:

Germany, Austria: Alburex 5, 50 g/l, Infusionslösung

Belgium, Luxembourg, Netherlands: Alburex 5, 50 g/l, Oplossing voor infusie, Solution pour perfusion, Infusionslösung

Bulgaria:????????5, 50 g/l,?????????????????

Cyprus: Alburex 5, 50 g/l,Δι?λυμαγια?γχυση

Denmark: Human Albumin CSL Behring 5%

Slovakia:Alburex5, 50g/l,infuzníroztok/infúznyroztok

Slovenia: Alburex 50 g/l raztopina za infundiranje

Spain: Alburex50 g/l, solución para perfusión

Finland, Norway, Sweden:Alburex 50 g/l, infuusioneste, liuos / infusjonsvæske, oppløsning/ Eingöngu til notkunar í bláæð/ Infusionsvätska, lösning

France: Alburex 50 g/l, solution pour perfusion

Hungary: Alburex 50g/l oldatos infúzió

Italy: Alburex 5%, 50 g/l, soluzione per infusione

Poland: Alburex 5, 50g/l, roztwór do infuzji

Portugal: Alburex 5, 50 g/l, solução para perfusão

United Kingdom, Ireland: Alburex 5, 50 g/l, solution for infusion

Romania:Alburex50g/l,solutieperfuzabila

Last revision date of this leaflet:October 2023.

For detailed and updated information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es