Alburex 50 g/L solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Alburex 50 g/l, solution for infusion

Human albumin

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, including any adverse reactions not listed in this leaflet.

Contents of the leaflet

1. What Alburex 50 g/l is and what it is used for
2. What you need to know before using Alburex 50 g/l
3. How to use Alburex 50 g/l
4. Possible side effects
5. How to store Alburex 50 g/l
6. Contents of the pack and other information

1. What Alburex 50 g/l is and what it is used for

What Alburex 50 g/l is

Alburex 50 g/l is a plasma substitute.

How Alburex 50 g/l works

Albumin stabilizes the volume of circulating blood. It transports hormones, enzymes,
medicines, and toxins. The albumin in Alburex 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 Alburex 50 g/l is used for

Alburex 50 g/l is indicated for the restoration and maintenance of circulating blood volume.
It is typically used in situations requiring intensive care when your blood volume has dangerously decreased. This may 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 must be made by your doctor, depending on your clinical condition.

2. What you need to know before using Alburex 50 g/l

Read this section carefully. The following information should be considered by you and your doctor before Alburex is administered.

DO NOT use Alburex 50 g/l

If you are allergic to human albumin or to any of the other components of this
medicinal product (listed in section 6).

If this applies to you, please inform your doctor or pharmacist before treatment.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Alburex 50 g/l.

Your doctor or healthcare professional will exercise special caution if abnormal increase in blood volume (hypervolemia) or blood dilution (haemodilution) could be dangerous for you. Examples of such situations include:

• heart failure requiring treatment with medication (decompensated heart failure),
• high blood pressure (hypertension),
• oesophageal varices (enlarged veins in the oesophagus),
• abnormal accumulation of fluid in the lung (pulmonary oedema),
• predisposition to bleeding (haemorrhagic diathesis),
• severe reduction in red blood cells in the blood (severe anaemia),
• severely reduced urine excretion due to lack of urination or kidney deficiency (renal and post-renal anuria).

Please consult your doctor or healthcare professional before treatment if any of the above apply to you.

Allergic reactions (hypersensitivity reactions) may occur, which can become severe and lead to shock (see section 4).

Contact your doctor or healthcare professional immediately if you notice such reactions during Alburex infusion. Your doctor will stop administration completely and initiate appropriate treatment.

If the dose and infusion rate are not adjusted to your circulatory condition, an abnormal increase in blood volume (hypervolemia) may occur. This may result in overload of the heart and circulatory system (cardiovascular overload). Early signs of such overload include headache, difficulty in breathing, or swelling of the neck veins (jugular venous distension).

Contact your doctor or healthcare professional immediately if you experience any of these symptoms. Your doctor will discontinue treatment and monitor your circulation as necessary.

Information on safety regarding infections

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

• careful selection of blood and plasma donors to ensure exclusion of donors at risk of carrying infections, and

• testing of each individual donation and pooled plasma for evidence of viruses and infections.

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

Despite these measures, when medicinal products derived from human blood or plasma are administered, the possibility of transmitting infections cannot be completely ruled out. This applies to emerging or unknown viruses and other types of infections. There are no reports of proven viral infections associated with albumin manufactured according to the requirements of the European Pharmacopoeia and established processes.

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

Interaction of Alburex 50 g/l with other medicinal products

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicinal products.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicinal product.

The use of Alburex 50 g/l has not been individually studied in pregnant or breastfeeding women. However, medicinal products containing human albumin have been used in pregnant and breastfeeding women. Experience has shown that harmful effects on pregnancy, the foetus or the newborn are not expected.

Driving and use of machines

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 on sodium-restricted diets should be aware that this medicinal product contains approximately 3.2 mg of sodium per ml of solution (140 mmol/l). Your doctor will take this into account when treating patients on sodium-restricted diets.

3. How to use Alburex 50 g/l

• Alburex 50 g/l must be administered by your doctor or healthcare professional. It is intended for intravenous infusion only. The
  medication should be warmed to room or body temperature before
  administration.

• Your doctor will decide how much Alburex 50 g/l you should receive. The dose and infusion rate depend on your individual needs.

• Your doctor or healthcare professional will regularly monitor important blood flow parameters such as:

• your blood pressure,

• your pulse,

• your urine output (diuresis),

• your blood tests.

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

Alburex 50 g/l must not be mixed with other medications or with 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 Toxicology Information Service at 91 562 04 20, indicating the medication and amount used.

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

The first symptoms of such an overload are:

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

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

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

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

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

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Alburex 50 g/l can cause adverse effects, although
not everyone will experience them. These adverse effects could occur even if you have
previously received Alburex 50 g/l and tolerated it well.

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

Allergic reactions (hypersensitivity reactions) may occur, which very rarely
(occur in less than 1 in 10,000 people) can become severe and lead to shock.

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

• Skin reactions, for example, redness, itching, swelling, blisters,
  rash or hives (itchy, raised welts).

• Difficulty breathing, for example, wheezing, chest tightness, shortness of breath, or cough.

• Swelling of the face, eyelids, lips, tongue, or throat.

• Cold-like symptoms, for example, stuffy or runny nose,
  sneezing, red, itchy, swollen, or watery eyes.

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

If you notice these reactions during infusion of Alburex 50 g/l, please inform your
doctor or healthcare professional immediately. In such a case, your doctor or healthcare professional
will stop the infusion and initiate appropriate treatment.

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

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

These usually resolve quickly by reducing the infusion rate or by stopping the infusion.

The same adverse effects have been observed with Human Albumin Behring 5% since
it has been on the market. However, the exact frequency of these effects is unknown.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alburex 50 g/l

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 after "EXP". The expiry date refers to the last day of the month indicated.

• After opening the container, the contents must be used immediately.

• Do not store above 25 °C.

• Do not freeze.

• Keep the vial in its carton to protect it from light.

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

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the container and additional information

Composition of Alburex 50 g/l

• The active substance is: human albumin.

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

The other components are: sodium N-acetyltryptophanate, sodium caprylate, sodium chloride, and water for injections. (see section 2)

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

Alburex 50 g/l is a solution for infusion. The solution is clear and slightly viscous. It may be almost colourless or yellow, amber, or greenish.

Available in the following sizes (1 vial per pack):

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH
Emil-von-Behringstrasse 76
D-35041 Marburg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

CSL Behring, S.A.
Tarragona 157, 18th floor
08014 Barcelona
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

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, Διάλυμα για έγχυση
Denmark: Human Albumin CSL Behring 5%
Slovakia: Alburex 5, 50 g/l, infuzní roztok / infúzny roztok
Slovenia: Alburex 50 g/l raztopina za infundiranje
Spain: Alburex 50 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 50 g/l oldatos infúzió
Italy: Alburex 5%, 50 g/l, soluzione per infusione
Poland: Alburex 5, 50 g/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: Alburex 50 g/l, solutie perfuzabila

Date of the most recent revision of this leaflet: October 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es