Package leaflet: Information for the user

Human Albumin CSL Behring 200 g/l, 200 g/l, solution for infusion
Active substance: human albumin
Please read carefully the entire leaflet before using this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Human Albumin CSL Behring 200 g/l is and what it is used for
Important information before using Human Albumin CSL Behring 200 g/l
How to use Human Albumin CSL Behring 200 g/l
Possible side effects
How to store Human Albumin CSL Behring 200 g/l
Contents of the pack and other information

1. What Human Albumin CSL Behring 200 g/l is and what it is used for
What is Human Albumin CSL Behring 200 g/l
Human Albumin CSL Behring 200 g/l is a plasma substitute.
How Human Albumin CSL Behring 200 g/l works
Albumin stabilizes circulating blood volume. It acts as a carrier for hormones, enzymes, drugs, and toxins.
The albumin protein in Human Albumin CSL Behring 200 g/l is derived from human plasma.
Therefore, the action of albumin is identical to that of the body's own protein.
Why Human Albumin CSL Behring 200 g/l is used
Human Albumin CSL Behring 200 g/l is used to restore and maintain circulating blood volume. It is usually administered in situations requiring intensive therapy when blood volume has critically decreased, for example:

severe blood loss following trauma or
extensive burns of the body surface
The decision to use Human Albumin CSL Behring 200 g/l will be made by a doctor and will depend on the patient's clinical condition.

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

Please read this section carefully, as the information provided should be considered by both the patient and the 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 to 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 your doctor or pharmacist.
Which circumstances increase the risk of adverse reactions?
The doctor or pharmacist will exercise particular caution if excessive increase in circulating blood volume (hypervolemia) or blood dilution (hemodilution) may pose a high risk for the patient. Examples of such situations include:

heart failure requiring drug therapy (uncompensated heart failure)
high blood pressure (hypertension)
esophageal varices (dilated veins in the esophagus)
excessive accumulation of fluid in the lungs (pulmonary edema)
increased tendency to bleed (hemorrhagic diathesis)
severe deficiency of red blood cells (severe anemia)
severe reduction in urine output due to kidney or urinary tract failure (renal and post-renal anuria)
If any of the above conditions are present, inform your doctor or pharmacist before starting treatment.

When to stop the infusion

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

Viral safety
For medicinal products derived from human blood or plasma, measures are taken to prevent transmission of infections to patients. These include:

careful selection of blood and plasma donors to exclude the risk of transmitting infection,
testing of individual donations and plasma pools for markers indicating the presence of viruses/infections,
inclusion of steps in the manufacturing process intended to inactivate or eliminate viruses.
Despite these measures, it cannot be completely excluded that infectious agents may be transmitted during administration of medicinal products derived from human blood or plasma. This also applies to unknown or newly emerging viruses and other types of infections. There have been 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 of the product next to the patient's name with each administration of Human Albumin CSL Behring 200 g/l, to allow traceability of the batch used to the specific patient.
Human Albumin CSL Behring 200 g/l and other medicines
Specific interactions between Human Albumin CSL Behring 200 g/l and other medicines are not known.
Harmful effects or interactions are not expected.
Tell your 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 or blood-derived products.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Separate studies on the use of Human Albumin CSL Behring 200 g/l during pregnancy or breastfeeding in women have not been conducted. However, medicinal products containing human albumin have been used in pregnant or breastfeeding women. Experience indicates that this product has no harmful effect on the course of pregnancy or on the fetus and newborn.
Driving and operating machinery
Human Albumin CSL Behring 200 g/l has no effect on the ability to drive vehicles or operate machinery.
Human Albumin CSL Behring 200 g/l contains sodium.
50 ml vial
The medicine contains 144 mg of sodium (main component of table salt) in each 50 ml vial. This corresponds to 7.2% of the maximum recommended daily dietary intake of sodium for adults.
100 ml vial
The medicine contains 287.5 mg of sodium (main component of table salt) in each 100 ml vial. This corresponds to 14.4% of the maximum recommended daily dietary intake of sodium 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 for intravenous use only (intravenous infusion).
The decision regarding the dose of Human Albumin CSL Behring 200 g/l to be administered is made by the doctor.
The amount administered and the infusion rate depend on the individual patient's needs (see also section 2).
The doctor will regularly monitor important haemodynamic parameters such as:

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

Accidental administration of a higher than recommended dose of Human Albumin CSL Behring 200 g/l
Human Albumin CSL Behring 200 g/l is usually administered only under medical supervision.
Therefore, overdose is highly unlikely. However, if too high a dose is administered or if the infusion rate is too fast, excessive increase in blood volume (hypervolaemia) may occur.
This may lead to cardiac and circulatory overload (cardiovascular overload).
Early signs of such overload include:

headache,
breathing difficulties, or
neck vein distension (venous congestion).
If any of these symptoms occur, the doctor must be informed immediately.

The doctor may also detect symptoms such as:

elevated blood pressure,
increased central venous pressure, or
excessive fluid accumulation in the lungs (pulmonary oedema).
In all such cases, the doctor or pharmacist will stop the infusion and, if necessary, continue monitoring of the circulatory system.

4. Possible adverse reactions

Like all medicines, this one may cause adverse reactions, although not everyone experiences them.
Such symptoms may occur even after previous use of Human Albumin CSL Behring 200 g/l and good tolerance of the product.
General experience with administration of human albumin solutions shows that the following adverse reactions may occur.

Allergic reactions (hypersensitivity reactions) may occur, which in very rare cases may be severe enough to cause shock.
Symptoms of an allergic reaction may include one, several, or many of the following:

Skin reactions, for example: redness, itching, swelling, blistering, rash or hives (itchy lumps).
Breathing difficulties, for example: wheezing, shortness of breath, rapid breathing or cough.
Swelling of the face, eyelids, lips, tongue or throat.
Cold-like symptoms, for example: blocked or runny nose, sneezing, redness, itching, swelling or watering of the eyes.
Headache, stomach pain, nausea, vomiting or diarrhoea.
If such reactions occur during infusion of Human Albumin CSL Behring 200 g/l, the doctor or pharmacist must be informed immediately. In such a case, the doctor or pharmacist will stop the infusion and initiate appropriate treatment.

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

Flushing of the face
Itchy rash (urticaria)
Fever
Nausea
These symptoms usually resolve quickly after reducing the infusion rate or stopping the infusion.

The following serious adverse reactions occur very rarely (in up to 1 in 10,000 people):

Shock

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 specified month.
Do not store above 25°C.
Do not freeze.
Store the vial in the outer packaging to protect it from light.
After opening the packaging, use the contents immediately.
Do not use this medicine if the solution appears cloudy or contains particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Human Albumin CSL Behring 200 g/l contains
The active substance is human albumin.
Human Albumin CSL Behring 200 g/l is a solution containing 200 g/l of total protein,
of which at least 96% is human albumin.
A 100 ml vial contains not less than 19.2 g of human albumin.
A 50 ml vial contains not less than 9.6 g of human albumin.
The other ingredients are caprylate sodium, N-acetylo-D,L-tryptophanate sodium,
sodium chloride, sodium hydroxide (in small amounts for pH adjustment), and water for injections.

What Human Albumin CSL Behring 200 g/l looks like and contents of the pack
Human Albumin CSL Behring 200 g/l is an infusion solution. The solution is clear and slightly viscous.
It may be almost colourless or have a yellow, amber, or green tint.
Pack sizes:
1 vial in a pack (50 ml / 100 ml)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
CSL Behring GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany

This medicinal product is authorised 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