Human albumin CSL Behring 200 g/L solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Human Albumin CSL Behring 200 g/l solution for infusion

Active substance: human albumin

Package leaflet contents

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

1. What Albúmina Humana CSL Behring is and what it is used for

What Albúmina Humana CSL Behring is

Albúmina Humana CSL Behring is a plasma substitute.

How Albúmina Humana CSL Behring works

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

What Albúmina Humana CSL Behring is used for

Albúmina Humana CSL Behring 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 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 Albúmina Humana CSL Behring must be made by your doctor, depending on your clinical condition.

2. What you need to know before using Albúmina Humana CSL Behring

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

Do not use Albúmina Humana 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

Talk to your doctor or pharmacist before starting treatment with Albúmina Humana CSL Behring.

Conditions that increase the risk of experiencing adverse effects

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

• heart failure requiring treatment with medication (decompensated heart failure),
• high blood pressure (hypertension),
• esophageal vein enlargement (esophageal varices),
• abnormal accumulation of fluid in the lungs (pulmonary edema),
• tendency to bleed (hemorrhagic diathesis),
• severe reduction in red blood cells or erythrocytes in the blood (severe anemia),
• severely reduced urine excretion due to lack of urination or kidney deficiency (renal and postrenal anuria).

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

When perfusion may need to be interrupted

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

Contact your doctor or pharmacist immediately if you notice such reactions during infusion of Albúmina Humana CSL Behring. Your doctor will stop administration completely and initiate appropriate treatment.

• If the dose and infusion rate have not been properly adjusted, an abnormal increase in blood volume (hypervolemia) may occur. This may lead to overload of the heart and circulatory system (cardiovascular overload). Early signs of such overload include headache, difficulty breathing, or swelling of the neck veins (jugular venous distention).

Contact your doctor or pharmacist immediately if you experience these symptoms. Your doctor will stop treatment and monitor your circulation as necessary.

Viral safety

When medicines 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,
• testing of each individual donation and plasma pools for signs of viruses and infections,
• inclusion of steps in the manufacturing process that can inactivate or remove viruses.

Despite these measures, when medicines 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 viral infections associated with albumin manufactured according to the requirements of the European Pharmacopoeia and established manufacturing processes.

It is strongly recommended that each time a dose of Albúmina Humana CSL Behring is administered, the product name and batch number be recorded to maintain a record of batches used.

Use of Albúmina Humana CSL Behring with other medicines

No specific interactions between Albúmina Humana CSL Behring and other medicines are known. No harmful effects or interactions are expected.

However, always inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Albúmina Humana CSL Behring must not be mixed with other medicines or blood-derived products.

Pregnancy, breastfeeding, and fertility

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

The use of Albúmina Humana CSL Behring has not been individually studied in pregnant or breastfeeding women. However, medicines containing human albumin have been used in pregnant and breastfeeding women. Experience shows that harmful effects on pregnancy, the fetus, or the newborn should not be expected.

Driving and using machines

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

Albúmina Humana CSL Behring contains sodium

50 ml vial

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

100 ml vial

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

3. How to use Human Albumin CSL Behring

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

Your doctor will determine the amount of Human Albumin CSL Behring to be administered. The dose and infusion rate depend on your individual needs.

Your doctor will regularly monitor important circulatory parameters such as:

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

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

If you are given more Human Albumin CSL Behring than you should

In case of overdose, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount used.

Human Albumin CSL Behring is only administered 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 overload are:

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

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

In addition, your doctor may detect symptoms such as:

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

In any of these cases, your doctor will stop the infusion and monitor your circulation as necessary.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. These adverse effects could occur even if you have previously received Human Albumin CSL Behring and tolerated it well.

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

Allergic reactions (hypersensitivity reactions) may occur, which very rarely may become severe and lead to shock.

Symptoms of an allergic reaction may include one or more of the following:

• Skin reactions, for example, redness, itching, swelling, blisters, rashes, or hives (rash and itching).
• 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, nasal congestion, runny nose, sneezing, red, itchy, swollen, or watery eyes.
• Headache, stomach pain, nausea, vomiting, or diarrhea.

If you notice any of these reactions during the infusion of Human Albumin CSL Behring, inform your doctor or pharmacist immediately. In such a case, your doctor will stop the infusion and initiate appropriate treatment.

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

• Shock

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 through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 outer carton and label after EXP. The expiry date refers to the last day of the month indicated.

• Do not store above +25 °C.

• Do not freeze.

• Keep the vial in the outer packaging to protect it from light.

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

• Do not use this medicine if you notice that the solution is cloudy or contains particles.

• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Human Albumin CSL Behring

• The active substance is human albumin.

Human Albumin CSL Behring is a solution containing 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 components are sodium caprylate, N-acetyl-DL-tryptophan, sodium chloride, sodium hydroxide, and hydrochloric acid (in small amounts to adjust pH), and water for injections.

Appearance of the product and contents of the container

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

Pack sizes:

• One vial per pack (50 ml/100 ml)

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

For further information on 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:

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 the most recent review of this leaflet: November 2020

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