ALBUREX 200 g/L SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Alburex 200 g/l solution for infusion

Human Albumin

Read all of this 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.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What is Alburex 200 g/l and what is it used for
2. What you need to know before you use Alburex 200 g/l
3. How to use Alburex 200 g/l
4. Possible side effects
5. Storage of Alburex 200 g/l
6. Contents of the pack and other information

1. What is Alburex 200 g/l and what is it used for

What is Alburex 200 g/l

Alburex 200 g/l is a plasma substitute.

How Alburex 200 g/l works

Albumin stabilizes the volume of circulating blood. It transports hormones, enzymes, medicines, and toxins. The albumin in Alburex 200 g/l is a protein isolated from human plasma. The albumin present in Alburex 200 g/l works exactly like your own protein.

What Alburex 200 g/l is used for

Alburex 200 g/l is indicated for the restoration and maintenance of circulating blood volume. It is usually used in situations requiring intensive care, when your blood volume has decreased dangerously. This can occur, for example:

• due to severe blood loss after an injury or
• due to an extensive superficial burn.

The decision to use Alburex 200 g/l should be made by your doctor. This will depend on your clinical situation.

2. What you need to know before you use Alburex 200 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 200 g/l

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

If this is the case, please inform your doctor or pharmacist before treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alburex 200 g/l.

Your doctor or healthcare professional will be particularly careful if an abnormal increase in blood volume (hypervolemia) or blood dilution (hemodilution) may be hazardous for you. Examples of these situations are:

• heart failure that needs to be treated with medicines (decompensated heart failure),

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

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

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

Consult your doctor or healthcare professional immediately if you notice such reactions during the infusion of Alburex. Your doctor will interrupt the administration completely and start the appropriate treatment.

If the dose and infusion rate are not adjusted to your circulatory situation, an abnormal increase in blood volume (hypervolemia) may occur, which can lead to an overload of the heart and circulatory system (cardiovascular overload). The first signs of such an overload are headache and difficulty breathing or swelling of the neck veins (jugular congestion).

Consult your doctor or healthcare professional immediately if you experience these symptoms. Your doctor will interrupt the treatment and control your circulation if necessary.

Safety information related to infections

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

• The careful selection of blood and plasma donors to ensure that donors at risk of carrying infections are excluded.
• The testing of each individual donation and plasma pools for signs 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 medicines obtained from human blood or plasma are administered, the possibility of transmitting infections cannot be completely excluded. This applies to emerging or unknown viruses and other types of infections. There are no reports of proven viral infections with albumin manufactured according to European Pharmacopoeia specifications and requirements.

It is strongly recommended that each time you are administered a dose of Alburex 200 g/l, a record is kept of the product name and batch number to maintain a record of the batches used.

Interaction of Alburex 200 g/l with other medicines

No specific interactions of Alburex 200 g/l with other medicines are known.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

The use of Alburex 200 g/l has not been studied individually in pregnant or breastfeeding women. However, medicines containing human albumin have been used in pregnant or breastfeeding women. The experiences showed that no harmful effects on pregnancy or on the fetus or newborn are to be expected.

Driving and using machines

No effects of Alburex 200 g/l on the ability to drive and use machines have been observed.

Alburex 200 g/l contains sodium

Patients on low-sodium diets should be aware that this medicine 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 low-sodium diets.

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3. How to use Alburex 200 g/l

• Alburex 200 g/l should be administered by your doctor or healthcare professional. It is intended for intravenous infusion only.

The medicine should be warmed to room or body temperature before administration.

• Your doctor will decide how much Alburex 200 g/l you should be given. The amount and infusion rate depend on your individual needs.

Your doctor or healthcare professional will regularly check important blood flow values such as:

• your blood pressure,
• your pulse, or
• your urine production (diuresis),
• your blood analysis.

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

Alburex 200 g/l should not be mixed with other medicines (except for dilutions such as glucose 5% or sodium chloride 0.9% solution) or with blood products.

If you use more Alburex 200 g/l than you should

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

Alburex 200 g/l is only administered under medical supervision. Therefore, it is very unlikely that you will be given an overdose. You may experience an abnormal increase in blood volume (hypervolemia) if the dose and infusion rate are too high, which can lead to an overload of the heart and circulatory system (cardiovascular overload).

The first symptoms of such an overload are:

• headache,
• difficulty breathing,
• swelling of the neck veins (jugular 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,
• increased central venous pressure,
• abnormal accumulation of fluid in the lung (pulmonary edema).

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

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

4. Possible side effects

Like all medicines, Alburex 200 g/l can cause side effects, although not everybody gets them. These side effects may occur even if you have previously received Alburex 200 g/l and tolerated it well.

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

Allergic reactions (hypersensitivity reactions) may occur, which can very rarely (affect less than 1 in 10,000 people) be severe and cause shock.

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

• Skin reactions, such as redness, itching, swelling, blisters, skin rash, or hives (urticaria),

• difficulty breathing, such as wheezing, chest tightness, difficulty breathing, or coughing,

• swelling of the face, eyelids, lips, tongue, or throat,
• cold-like symptoms, such as a stuffy nose or nasal discharge, sneezing, red, itchy, puffy, or watery eyes,

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

If you notice these reactionsduring the infusion of Alburex 200 g/l, please inform your doctor immediately. In this case, your doctor or healthcare professional will stop the infusion and start the appropriate treatment.

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

• flushing,
• hives (urticaria),
• fever,
• nausea.

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

The same side effects have been observed with Human Albumin Behring 20% since it has been on the market. However, the exact frequency of these effects is unknown.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency https://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alburex 200 g/l

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

• Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after ‘EXP’. The expiry date is the last day of the month stated.
• Once the pack is opened, the contents should be used immediately.

• Do not store above 25 °C.
• • Do not freeze.
  • Keep the vial in its outer packaging to protect it from light.

Do not use Alburex 200 g/l if you notice that the solution is turbid or contains particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Alburex 200 g/l

• The active substanceis: human albumin.

Alburex 200 g/l is a solution that contains 200 g/l of total human plasma proteins. 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 200 g/l and pack contents

Alburex 200 g/l is a solution for infusion in a vial. The solution is clear and slightly viscous. It may be almost colorless or yellow, amber, or greenish.

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

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

You can request more information about this medicine from the local representative of the marketing authorization holder:

CSL Behring, S.A.

c/ Tarragona 157, planta 18

08014 Barcelona

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany, Austria: Alburex 20, 200 g/l, Infusionslösung

Belgium, Luxembourg, Netherlands: Alburex 20, 200 g/l, Oplossing voor infusie, Solution pour perfusion, Infusionslösung

Bulgaria: ???????? 20, 200 g/l, ?????????? ???????

Cyprus, Greece: Alburex 20, 200g/l, Δι?λυμα για ?γχυση

Denmark: Human Albumin CSL Behring 20%

Slovenia: Alburex 200 g/l raztopina za infundiranje

Spain: Alburex 200 g/l, solución para perfusión

Finland, Norway, Iceland, Sweden: Alburex 200 g/l, infuusioneste, liuos/ infusjonsvæske, oppløsning/ Eingöngu til notkunar í bláæð/ Infusionsvätska, lösning

France: Alburex 200 g/l, solution pour perfusion

Hungary: Alburex 200g/l oldatos infúzió

Italy: Alburex 20%, 200 g/l, soluzione per infusione

Poland: Alburex 20, 200g/l, roztwór do infuzji

Portugal: Alburex 20, 200 g/l, solução para perfusão

UK, Ireland: Alburex 20, 200 g/l, solution for infusion

Czech Republic, Slovakia: Alburex 20, 200 g/l, infuzní roztok / infúzny roztok

Romania: Alburex 200 g/l, solutie perfuzabila

Date of last revision of this leaflet:October 2014.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es