Human Albumin Csl Behring 200 g/l

Package Leaflet: Information for the User

Human Albumin CSL Behring 200 g/l, 200 g/l, Solution for Infusion

Active Substance: Human Albumin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What Human Albumin CSL Behring 200 g/l is and what it is used for
• 2. Important information before using Human Albumin CSL Behring 200 g/l
• 3. How to use Human Albumin CSL Behring 200 g/l
• 4. Possible side effects
• 5. How to store Human Albumin CSL Behring 200 g/l
• 6. Package contents and other information

1. What Human Albumin CSL Behring 200 g/l is and what it is used for

What Human Albumin CSL Behring 200 g/l is
Human Albumin CSL Behring 200 g/l is a plasma substitute.
How Human Albumin CSL Behring 200 g/l works
Albumin stabilizes the blood volume. It is a carrier of hormones, enzymes, medicines, and toxins.
The albumin protein in Human Albumin CSL Behring 200 g/l is obtained from human blood plasma.
Therefore, the action of albumin is identical to that of the patient's own protein.
What Human Albumin CSL Behring 200 g/l is used for
Human Albumin CSL Behring 200 g/l is used to supplement and maintain blood volume.
It is usually used in situations where intensive therapy is necessary, when blood volume has critically decreased, e.g., in cases of:

• severe blood loss after injury or
• burns of a large body surface area The decision to use Human Albumin CSL Behring 200 g/l will be made by a doctor. It will depend on the patient's clinical condition.

2. Important information before using Human Albumin CSL Behring 200 g/l

Read this section carefully, as the information provided should be taken into account by the patient and doctor before administering Human Albumin CSL Behring 200 g/l.

When not to use Human Albumin CSL Behring 200 g/l

• if the patient is allergic (hypersensitive) to human albumin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Human Albumin CSL Behring 200 g/l, discuss it with a doctor or pharmacist.
What circumstances increase the risk of side effects?
The doctor or pharmacist will exercise special caution if excessive increase in blood volume (hyperolemia) or blood dilution (hemodilution) may pose a high risk to the patient. Examples of such situations include:

• heart failure requiring drug therapy (uncompensated heart failure)
• high blood pressure (hypertension)
• esophageal varices (esophageal varices)
• excessive fluid accumulation in the lungs (pulmonary edema)
• increased tendency to bleed (bleeding disorder)
• severe red blood cell deficiency (severe anemia)
• severe reduction in urine excretion due to kidney or urinary tract failure (renal and post-renal anuria) If any of these conditions occur before starting treatment, inform the doctor or pharmacist.

When to stop the infusion

• Allergic reactions (hypersensitivity reactions) may occur, and in very rare cases, they can be severe enough to cause shock (see also section 4). If such reactions occur during albumin infusion, immediately inform the doctor. In such cases, the doctor or medical staff will decide to stop the infusion and start appropriate treatment.
• Abnormal increase in blood volume (hyperolemia) may occur if the dose and infusion rate are not properly adjusted to the patient's condition. This can lead to overload of the heart and circulatory system (cardiovascular overload). The first signs of such overload are: headache, difficulty breathing, or swelling of the neck veins (neck vein overload). If such reactions occur, immediately inform the doctor. In such cases, the doctor or medical staff will stop the infusion and, if necessary, start monitoring the circulation.

Viral safety

In the case of medicinal products obtained from human blood or plasma, measures are taken to prevent infections from being transmitted to patients. These include:

• careful selection of blood and plasma donors to exclude the risk of infection transmission,
• testing of individual donations and plasma pools for markers of virus presence/infection.
• inclusion in the blood or plasma processing process of stages aimed at inactivating or eliminating viruses. Despite this, it is not possible to completely exclude the possibility of transmitting infectious agents during the administration of medicinal products obtained from human blood or plasma. This applies to all unknown or newly discovered viruses and other types of infections. There are no reports of viral infections associated with albumins manufactured in accordance with the requirements of the European Pharmacopoeia using established technologies.

It is recommended to record the name and batch number with the patient's name each time the Human Albumin CSL Behring 200 g/l preparation is administered, to create the possibility of linking the used batch to a specific patient.

Human Albumin CSL Behring 200 g/l and other medicines

There are no known specific interactions between Human Albumin CSL Behring 200 g/l and other medicines.
No harmful effects or interactions are expected.
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Human Albumin CSL Behring 200 g/l must not be mixed with other medicines and blood products.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
No separate studies have been conducted on the use of Human Albumin CSL Behring 200 g/l during pregnancy or breastfeeding in women. However, preparations containing human albumin have been used in pregnant or breastfeeding women. Experience indicates that the preparation has no harmful effect on either the course of pregnancy or the fetus and newborn.

Driving and using machines

Human Albumin CSL Behring 200 g/l has no effect on the ability to drive and use machines.

Human Albumin CSL Behring 200 g/l contains sodium.

Vial 50 ml
The medicine contains 144 mg of sodium (the main component of common salt) in each 50 ml vial. This corresponds to 7.2% of the maximum recommended daily sodium intake in the diet for adults.
Vial 100 ml
The medicine contains 287.5 mg of sodium (the main component of common salt) in each 50 ml vial. This corresponds to 14.4% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Human Albumin CSL Behring 200 g/l

Human Albumin CSL Behring 200 g/l is administered by a doctor. It is intended exclusively for intravenous administration (intravenous infusion).
The decision on the dose of Human Albumin CSL Behring 200 g/l is made by a doctor.
The amount of the preparation and the infusion rate depend on the individual requirements of the patient (see also section 2).
The doctor will monitor important blood flow parameters, such as:

• blood pressure,
• heart rate or
• urine output. These values are monitored to determine the appropriate dose and infusion rate.

Overdose of Human Albumin CSL Behring 200 g/l

Human Albumin CSL Behring 200 g/l is usually used only under medical supervision.
Overdose is therefore very unlikely. If too much of the product is administered or at too high an infusion rate, excessive increase in blood volume (hyperolemia) may occur. This can lead to overload of the heart and circulatory system (cardiovascular overload).
The first symptoms of such overload are:

• headache
• difficulty breathing or
• swelling (overload) of the neck veins. If such symptoms occur, immediately inform the doctor.

The doctor may also detect symptoms such as:

• increased blood pressure
• increased central venous pressure or
• excessive fluid accumulation in the lungs (pulmonary edema). In all these cases, the doctor or pharmacist will stop the infusion and, if necessary, monitor the circulatory system.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Such symptoms may occur even after previous use of Human Albumin CSL Behring 200 g/l and good tolerance of the preparation.
General experiencewith the administration of human albumin solutions shows that the following side effects may occur.
Allergic reactions (hypersensitivity reactions) may occur, which in very rare cases can be severe enough to cause shock.
Symptoms of an allergic reaction may occur in the form of one, several, or many of the following:

• skin reactions, e.g., redness, itching, swelling, blistering, rash, or hives (itching bumps).
• breathing difficulties, e.g., wheezing, shortness of breath, or cough
• swelling of the face, eyelids, lips, tongue, or throat
• symptoms similar to a cold, e.g., stuffy or runny nose, sneezing, redness, itching, swelling, or tearing of the eyes.
• headache, stomach pain, nausea, vomiting, or diarrhea. If such reactions occur during the infusion of Human Albumin CSL Behring 200 g/l, immediately inform the doctor or pharmacist. In such cases, the doctor or pharmacist will stop the infusion and start appropriate treatment.

The following mild side effects occur rarely(in up to 1 in 1000 people)

• redness of the face
• itching rash (hives)
• fever
• nausea These symptoms usually resolve quickly after reducing the infusion rate or interrupting it.

The following severe side effects occur very rarely(in up to 1 in 10,000 people)

• shock

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Human Albumin CSL Behring 200 g/l

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
• Do not store above 25°C.
• Do not freeze.
• Store the vial in the outer packaging to protect it from light.
• Use the contents of the packaging immediately after opening.
• 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. Package contents and other information

What Human Albumin CSL Behring 200 g/l containsThe active substance is human albumin.
Human Albumin CSL Behring 200 g/l is a solution containing 200 g/l of total protein, including at least 96% 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
Other ingredientsinclude sodium caprylate, sodium N-acetyl-D,L-tryptophan, sodium chloride, sodium hydroxide (in small amounts to adjust the pH), and water for injections.

What Human Albumin CSL Behring 200 g/l looks like and what the package contains

Human Albumin CSL Behring 200 g/l is a solution for infusion. The solution is clear and slightly viscous. It may be almost colorless or have a yellow, amber, or green color.
Package sizes:
1 vial in a package (50ml/100ml)
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

CSL Behring GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany

This medicinal product 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 infusion
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 the package leaflet:September 2021