ALBUMIN HUMAN CSL BEHRING 200 g/L SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Human Albumin CSL Behring 200 g/l Solution for Infusion

Active Substance: Human Albumin

Contents of the Package Leaflet

1. What is Human Albumin CSL Behring and what is it used for
2. What you need to know before you use Human Albumin CSL Behring
3. How to use Human Albumin CSL Behring
4. Possible side effects
5. Storage of Human Albumin CSL Behring
6. Contents of the pack and other information

1. What is Human Albumin CSL Behring and what is it used for

What is Human Albumin CSL Behring

Human Albumin CSL Behring is a plasma substitute.

How Human Albumin CSL Behring works

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

What Human Albumin CSL Behring is 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 an extensive superficial burn

The decision to use Human Albumin CSL Behring should be made by your doctor. This will depend on your clinical situation.

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

Read this section carefully. The following information should be considered by you and your doctor before Human Albumin CSL Behring is administered to you.

Do not use Human Albumin CSL Behring

• If you are allergic to human albumin (hypersensitive) or to any of the other components of this medicine (listed 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 from side effects

Your doctor or healthcare professional will be particularly careful if an 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 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 reduction of red blood cells or hematites in the blood (severe anemia),
• severe reduction of urine excretion due to urination deficiency or kidney deficiency (renal and post-renal anuria).

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

When perfusion may need to be interrupted

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

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

• If the dose and perfusion rate have not been adjusted, 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 pharmacist immediately if you experience these symptoms. Your doctor will interrupt the treatment and control your circulation if necessary.

Viral safety

When medicines are manufactured 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 with a risk of being carriers of infections are excluded,
• analysis of each individual donation and plasma pools for signs of viruses and infections,
• inclusion of 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, it cannot be completely excluded that the possibility of transmitting infections. This applies to emerging or unknown viruses and other types of infections.

There are no reports of viral infections with albumin manufactured according to the requirements of the European Pharmacopoeia and according to 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 be recorded to maintain a record of the batches used.

Use of Human Albumin CSL Behring with other medicines

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

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

Human Albumin CSL Behring should not be mixed with other medicines or blood products.

Pregnancy, breastfeeding, and fertility

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

The use of Human Albumin CSL Behring has not been studied individually in pregnant or breastfeeding women. However, medicines containing human albumin have been used in pregnant or breastfeeding women. Experience shows that no harmful effects are expected on gestation or on the fetus or newborn.

Driving and using machines

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

Human Albumin CSL Behring contains sodium

50 ml vial

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

100 ml vial

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

3. How to use Human Albumin CSL Behring

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

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

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

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

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

If you use more Human Albumin CSL Behring 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.

Human Albumin CSL Behring 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, or
• swelling of the neck veins (jugular congestion).

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

Additionally, your doctor may detect symptoms such as

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects may occur even if you have already received Human Albumin CSL Behring and tolerated it well.

General experiencewith human albumin solutions shows that the following effects can be observed.

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

Symptoms of an allergic reaction can include one, some, or several of the following:

• Skin reactions, for example, redness, itching, swelling, blisters, skin rashes, or hives (urticaria).
• 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 Human Albumin CSL Behring, inform your doctor or pharmacist. In this case, your doctor will stop the infusion and start the appropriate treatment.

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

• flushing
• itchy rash (urticaria)
• fever
• nausea

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

The following serious side effect may occur very rarely(affects up to 1 in 10,000 people):

• shock

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Human Albumin CSL Behring

• 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 after EXP. The expiry date is the last day of the month shown.

• Do not store above 25°C.
• Do not freeze.
• Keep the vial in the outer packaging to protect it from light.
• Once the pack is opened, the contents should be used immediately.
• Do not use this medicine if you notice that the solution is cloudy or contains particles.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Human Albumin CSL Behring

• The active substance is 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.

• The other ingredients are sodium caprylate, N-acetyl-DL-tryptophan, sodium chloride, sodium hydroxide, and hydrochloric acid (in small quantities to adjust the pH) and water for injections.

Appearance and packaging

Human Albumin CSL Behring is a solution for infusion. The solution is clear and slightly viscous. It can be almost colorless or yellow, amber, or green.

Package sizes:

• One vial per pack (50 ml/100ml)

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

CSL Behring GmbH

Emil-von-Behring Strasse 76

D-35041 Marburg

Germany

You can obtain further information on this medicine from the 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:

Austria Human Albumin "CSL Behring" 20% Infusionslösung

Belgium Human 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

Bulgaria Human Albumin CSL Behring 200 g/L solution for infusion

Croatia Albumeon 200 g/l otopina za infuziju

Cyprus Albumeon

Czech Republic Human Albumin CSL Behring 200 g/l

Denmark Albumin "Behring"

Estonia Human albumin CSL Behring / 200 g/l / infusioonilahus

Finland Albumin Behring

France Albumine Humaine CSL Behring 200 g/L, solution pour perfusion

Germany Albumeon

Greece Albumeon

Hungary Human Albumin CSL Behring 200 g/l oldatos infuzio

Iceland Albumin Behring / 200 g/l / solution for infusion

Ireland Human Albumin CSL Behring / 200 g/l / solution for infusion

Italy Albumeon, 200 g/l, soluzione per infusione

Latvia Human Albumin CSL Behring 200 g/l solution for infusion

Lithuania Human albumin CSL Behring 200 g/l infuzinis tirpalas

Luxembourg Human Albumin CSL Behring 200 g/l solution pour perfusion

Malta Albumeon 20, 200 g/l, solution for infusion

Netherlands Human Albumin CSL Behring 200 g/l oplossing voor infusie

Norway Albumin Behring

Poland Human Albumin CSL Behring 200 g/l

Portugal Albumina Humana CSL Behring 200 g/l solução para perfusão

Romania ALBUMEON 200 g/l soluție perfuzabilă

Slovakia Human Albumin CSL Behring 200 g/l

Slovenia Humani Albumin CSL Behring 200 g/l raztopina za infundiranje

Spain Albúmina Humana CSL Behring 200 g/l solución para perfusión

United Kingdom Albumeon 20, 200 g/l solution for infusion

Date of last revision of this leaflet:November 2020

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