Prospecto: information for the user

Human Albumin CSL Behring 200 g/l solution for infusion

Active ingredient: human albumin

1.What is Human Albumin CSL Behring and how it is used

2. What you need to know before starting to use Human Albumin CSL Behring

3.How to use Human Albumin CSL Behring

4. Possible adverse effects

5.Storage of Human Albumin CSL Behring

6. Contents of the package and additional information

What is Human Albumin CSL Behring

Human Albumin CSL Behring is a plasma substitute.

How Human Albumin CSL Behring works

The albumin stabilizes the circulating blood volume. It transports hormones, enzymes, medicines, and toxins. The albumin present in Human Albumin CSL Behring comes from human plasma. Therefore, the albumin functions exactly as if it were your own protein.

What is Human Albumin CSL Behring used for

Human Albumin CSL Behring is indicated for the restoration and maintenance of circulating blood volume. It is usually used in intensive care situations when your blood volume has decreased dangerously. This can occur, for example:

• due to severe blood loss after an injury or

• due to extensive superficial burns

The decision to use Human Albumin CSL Behring 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 you are administered Human Albumin CSL Behring.

Do not use Human Albumin CSL Behring

• If you are allergic to human albumin (hypersensitive) or to any of the other components of this medication (including those in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Human Albumin CSL Behring.

What circumstances increase the risk of suffering adverse effects

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

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

• high blood pressure (hypertension),

• esophageal vein expansion (esophageal varices),

• abnormal accumulation of fluid in the lung (pulmonary edema),

• predisposition to bleeding (hemorrhagic diathesis),

• severe decrease in red blood cells or hemoglobin in the blood (severe anemia),

• severe decrease in urine excretion due to urinary or renal deficiency (renal and postrenal anuria).

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

When the infusion may need to be interrupted

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

Consult your doctor or pharmacist immediately if you notice these reactions during the infusion of Human Albumin CSL Behring. Your doctor will interrupt your administration completely and start the appropriate treatment.

• If the dose and infusion rate have not been adjusted, an abnormal increase in blood volume (hypervolemia) may occur. This can lead to heart and circulatory 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 pharmacist immediately if you experience these symptoms. Your doctor will interrupt the treatment and check your circulation if necessary.

Viral safety

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

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

• analysis of each individual donation and plasma mixtures to search for signs of viruses and infections,

• inclusion of steps in the blood or plasma processing that may 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.

No reports of viral infections have been reported with albumin manufactured in accordance with the European Pharmacopoeia and in accordance with established processes.

It is strongly recommended that each time you are administered a dose of Human Albumin CSL Behring, the name and batch number of the product are recorded to maintain a record of the batches used.

Use of Human Albumin CSL Behring with other medications

No specific interactions of Human Albumin CSL Behring with other medications are known. No harmful effects or interactions are expected.

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

Human Albumin CSL Behring should not be mixed with other medications or blood-derived products.

Pregnancy, breastfeeding, and fertility

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

Human Albumin CSL Behring has not been studied individually in pregnant women or breastfeeding women. However, albumin-containing medications have been used in pregnant women or breastfeeding women. Experience shows that no adverse effects should be expected on pregnancy or on the fetus or neonate.

Driving and operating machinery

No effects of Human Albumin CSL Behring have been observed on the ability to drive or operate machinery.

Human Albumin CSL Behring contains sodium

50 ml vial

This medication contains 144 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 7.2% of the maximum daily sodium intake recommended for an adult.

100 ml vial

This medication contains 287.5 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 14.4% of the maximum daily sodium intake recommended for an adult.

CSL Behring Human Albumin should be administered by your doctor. CSL Behring Human Albumin is intended for administration, only, by intravenous infusion.

Your doctor will decide how much CSL Behring Human Albumin you should receive. The amount and rate of infusion will depend on your individual needs.

Your doctor will regularly monitor important blood flow values such as:

• your blood pressure,

• your pulseor

• your urine production (diuresis),

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

If you use more CSL Behring Human Albumin 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.

CSL Behring Human Albumin is only administered under medical supervision. Therefore, it is highly unlikely that you will receive 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 breathingor

• swelling of the neck veins (jugular vein congestion).

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

Additionally, your doctor may detect symptoms such as

• higher blood pressure,

• elevated central venous pressureor

• abnormal fluid accumulation in the lungs (pulmonary edema).

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them. These adverse effects may occur even if you have already received CSL Behring Human Albumin and tolerated it well.

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

Allergic reactions (hypersensitivity reactions) may occur, which very rarely can be severe and cause shock.

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, sneezing, red eyes, itching, swelling, or watery eyes.

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

If you notice these reactions during the infusion of CSL Behring Human Albumin, inform your doctor or pharmacist. In this case, your doctor will suspend the infusion and initiate the appropriate treatment.

The following mild adverse effects may occur rarely (may affect up to 1 in 1,000 people):

• Dizziness

• Itchy rash (urticaria)

• Fever

• Nausea

They will usually disappear quickly by reducing the infusion rate or stopping the infusion.

The following severe adverse effect may occur very rarely (affect up to 1 in 10,000 people):

• Shock

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the outer carton box and on the label after EXP. The expiration date is the last day of the month indicated.

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

• Do not store at a temperature above +25 °C.
• Do not freeze.
• Store the vial in the outer packaging to protect it from light.
• Once the container is opened, the contents must be used immediately.
• Do not use this medication if you observe that the solution is cloudy or contains particles.

• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Human Albumin CSL Behring

•Theactive principleis human albumin.

Human Albumin CSL Behring is a solution that contains 200 g/l of total protein, of which at least 96% is human albumin.

A 100 ml vial contains at least 19.2 g of human albumin.

A 50 ml vial contains at least 9.6 g of human albumin.

•Theother componentsare sodium caprylate, N-acetyl-DL-tryptophan, sodium chloride, sodium hydroxide, and hydrochloric acid (in small quantities to adjust the pH) and water for injection.

Appearance of the product and contents of the package

Human Albumin CSL Behring is a perfusion solution. The solution is transparent and slightly viscous. It may be almost colorless or yellow, amber, or green.

Package sizes:

- A vial per package (50 ml/100ml)

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

CSL Behring GmbH

Emil-von-Behring Strasse 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.

c/ Tarragona 157, 18th floor

08014 Barcelona

Spain

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

AustriaHuman Albumin „CSL Behring“ 20% Infusionslösung

BélgicaHuman Albumin CSL Behring 200 g/l oplossing voor infusie

Human Albumin CSL Behring 200 g/l solution pour perfusion

Human Albumin CSL Behring 200 g/l Infusionslösung

BulgariaHuman Albumin CSL Behring 200 g/L solution for infusion

CroaciaAlbumeon 200 g/l otopina za infuziju

ChipreAlbumeon

República ChecaHuman Albumin CSL Behring 200 g/l

DinamarcaAlbumin “Behring”

EstoniaHuman albumin CSL Behring / 200 g/l / infusioonilahus

FinlandiaAlbumin Behring

FranciaAlbumine Humaine CSL Behring 200 g/L, solution pour perfusion

AlemaniaAlbumeon

GreciaAlbumeon

HungríaHuman Albumin CSL Behring 200 g/l oldatos infuzio

IslandiaAlbumin Behring® / 200 g/l / solution for infusion

IrlandaHuman Albumin CSL Behring / 200 g/l / solution for infusion

ItaliaAlbumeon, 200 g/l, soluzione per infusione

LetoniaHuman Albumin CSL Behring 200 g/l solution for infusion

LituaniaHuman albumin CSL Behring 200 g/l infuzinis tirpalas

LuxemburgoHuman Albumin CSL Behring 200 g/l solution pour perfusion

MaltaAlbumeon®20, 200 g/l, solution for infusion

Países BajosHuman Albumin CSL Behring 200 g/l oplossing voor infusie

NoruegaAlbumin Behring

PoloniaHuman Albumin CSL Behring 200 g/l

PortugalAlbumina Humana CSL Behring 200 g/l solução para perfusão

RumaníaALBUMEON 200 g/lsolu?ie perfuzabila

EslovaquiaHuman Albumin CSL Behring 200 g/l

EsloveniaHumaniAlbumin CSL Behring 200 g/l raztopina za infundiranje

EspañaAlbúmina Humana CSL Behring 200 g/l solución para perfusión

Reino UnidoAlbumeon 20®, 200 g/l solution for infusion

Last update of the summary of product characteristics:November 2020

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es