Leaflet: information for the user

Alburex 200 g/l solution for infusion

Human albumin

Read this leaflet carefully before you start using this medicine, because

it contains important information for you.

-Keep this leaflet, aspossibly you will have to read it again.

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

- This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms of illness as you, as it may harm them.

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

1. What isAlburex 200 g/land what it is used for

2. What you need to know before starting to useAlburex 200 g/l

3. How to useAlburex 200 g/l

4. Possible side effects

5. Storage ofAlburex 200 g/l

6. Contents of the pack and additional information

What is Alburex 200 g/l

Alburex 200 g/l is a plasma substitute.

How Alburex 200 g/l works

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

medicines and toxins.The albumin inAlburex 200 g/l is a protein isolated from human plasma. The albumin present in Alburex 200 g/l functions exactly as if it were its

own protein.

What is Alburex 200 g/l used for

Alburex 200 g/l is indicated for the restoration and maintenance of circulating blood volume.

It is normally used in intensive care situations, when your

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 200 g/l should be made by your doctor.This

will 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 200 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.

Warnings and precautions

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

Your doctor or healthcare professional will take special care if you have an abnormal increase in blood volume (hypervolemia) or blood dilution (hemodilution), as these can be hazardous to you.Examples of these situations include:

• uncompensated heart failure that requires medication (heart failure),
• high blood pressure (hypertension),
• esophageal varices (esophageal varices),
• abnormal accumulation of fluid in the lungs (pulmonary edema),
• increased risk of bleeding (diathesis hemorrhagica),
• severe decrease in red blood cells or hemoglobin 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 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 Alburex perfusion. Your doctor will interrupt your administration completely and begin appropriate treatment.

If the dose and perfusion rate have not been adjusted to your circulatory situation, an abnormal increase in blood volume (hypervolemia) may occur. This can lead to heart and circulatory system overload (cardiovascular overload). The first signs of this overload are headache and difficulty breathing or swelling of the neck veins (jugular 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 medications 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 high-risk donors are excluded.
• The analysis of each individual donation and plasma mixtures to detect 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 medications obtained from human blood or plasma, it is not possible to completely rule out the possibility of transmitting infections. This applies to emerging or unknown viruses and other types of infections. There are no reports of demonstrated viral infections with albumin manufactured according to the European Pharmacopoeia specifications and established requirements.

We strongly recommend that each time you receive a dose of Alburex 200 g/l, you record the product name and batch number for record-keeping purposes.

Interaction of Alburex 200 g/l with other medications

No specific interactions of Alburex 200 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 or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Alburex 200 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 during pregnancy or on the fetus or neonate.

Driving vehicles and using machines

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

Alburex 200 g/l contains sodiumsodium

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.

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to be administered, only, by intravenous infusion (intravenous perfusion). The

medication should be warmed to room temperature or body temperature before

administration.

infusion rate will depend on your individual needs.

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

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

Alburex 200 g/l should not be mixed with other medications (except with dilutions such as 5% glucose or 0.9% saline solution) or blood-derived products.

If you use more Alburex 200 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 200 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,
• 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,
• 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 200 g/l may cause side effects, although not everyone will experience them.These side effects may occur even if you have already received Alburex 200 g/l and tolerated it well.

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

Side effects may include allergic reactions (hypersensitivity reactions) thatvery rarely

(affect less than1 in 10,000people) may be severe and cause anaphylaxis.

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

• skin reactions, for example, redness, itching, swelling, blisters,

skin eruptions or urticaria (hives and itching).

• Difficulty breathing, for example, wheezing, chest tightness,

difficulty breathing or coughing.

• Swelling of the face, eyelids, lips, tongue, or throat.
• Symptoms similar to a cold, for example, stuffy nose or nasal discharge,

runny nose, red eyes, itching, swelling, or watery eyes.

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

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

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

• flushing,
• 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 with Behring Human Albumin 20% 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 Medicinal Products for Human Usehttps://www.notificaRAM.es

By 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.

• Do not use this medication after its expiration date that appears on the outer carton box and on the vial label after «CAD».The expiration date is the last day of the month indicated.
• Once the container is opened, the contents must be used immediately.

• Do not store at a temperature above25 °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 cloudy or contains particles.

Do not throw themedicines down the drains or in the trash. Ask your pharmacistwhere to disposeof the medications that you no longeruse. This will help protect the environment.

Composition of Alburex 200 g/l

• Theactive principleis: human albumin.

Alburex 200 g/l is a solution that contains 200 g/l of total plasma proteins

humans.At least 96% is human albumin.

• Theother components are:N-acetyltryptophanate of sodium, caprylate of sodium, chloride of

sodium and water for injectable preparations (see section 2).

Appearance of Alburex 200 g/l and contents of the container

Alburex 200 g/l is a perfusion solution in a vial. The solution is transparent and

slightly viscous.It can be almost colorless or yellow, amber or greenish.

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

• A vial of 50 ml contains10 gof human albumin.
• A vial of 100 ml contains20 gof human albumin.

Not all presentations may be marketed.

Holder of the marketing authorization andresponsible for manufacturing

CSL Behring GmbH

Emil-von-Behringstrasse 76

D-35041 Marburg

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

CSL Behring, S.A.

c/ Tarragona 157, floor 18

08014 Barcelona

Spain

This medication is authorized in the member states of the European Economic

Space under the following denominations:

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

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

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

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

Romania:Alburex 200 g/l, solutie perfuzabila

Last review date of this leaflet:October 2014.

Detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Products (AEMPS)http://www.aemps.gob.es