Albiomin 20%

Leaflet attached to the packaging: information for the user

Albiomin 20% (200 g/l), solution for infusion

Human albumin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Albiomin 20% (200 g/l) and what is it used for
• 2. Important information before using Albiomin 20% (200 g/l)
• 3. How to use Albiomin 20% (200 g/l)
• 4. Possible side effects
• 5. How to store Albiomin 20% (200 g/l)
• 6. Contents of the packaging and other information

1. What is Albiomin 20% (200 g/l) and what is it used for

Albiomin 20% (200 g/l) is a solution for infusion (intravenous). One liter of solution contains 200 g of human plasma protein, of which at least 96% is human albumin. Albiomin 20% (200 g/l) is used to supplement and maintain blood volume, when its volume is reduced and the use of colloids, such as albumin, is appropriate.

2. Important information before using Albiomin 20% (200 g/l)

When not to use Albiomin 20% (200 g/l):

Warnings and precautions

If there is a suspicion of an allergic reaction or anaphylactic reaction, the infusion should be stopped immediately. In case of shock, follow current guidelines for shock therapy. The infusion should also be stopped if the following symptoms occur, which are signs of circulatory overload (hyperolemia):

• headache
• shortness of breath (difficulty breathing)
• blood congestion in the jugular vein (fluid accumulation in the jugular vein)
• increased blood pressure
• increased venous pressure (increased pressure in the veins)
• pulmonary edema (fluid in the lungs)

Discuss with your doctor if the patient has any of the following conditions:

• heart failure (uncompensated heart failure)
• high blood pressure (hypertension)
• enlarged veins in the esophagus (esophageal varices)
• fluid in the lungs (pulmonary edema)
• tendency to abnormal or spontaneous bleeding (bleeding disorder)
• reduced red blood cell count (severe anemia)
• reduced or absent urine production (renal and post-renal failure) The doctor will take appropriate precautions. The doctor will also monitor the patient's circulation parameters, including electrolyte balance and blood volume.

Information on the transmission of infectious agents

In the case of a medicine produced from human blood or plasma, measures are taken to prevent the passive transmission of infectious agents to patients. These include:

• careful selection of blood and plasma donors to ensure that the risk of transmitting infectious agents is excluded,
• testing of individual donations and plasma pools for the presence of viruses/infections,
• inclusion in the production process of effective virus inactivation or removal steps. Despite this, it is not possible to completely exclude the possibility of transmitting infectious agents when administering medicinal products derived from human blood or plasma. This also applies to unknown and newly discovered viruses and other types of infections.

There have been no reports of virus transmission with albumin preparations produced using a process approved in accordance with the requirements of the European Pharmacopoeia. It is recommended to record the name and batch number with the patient's name each time Albiomin 20% (200 g/l) is administered in order to determine in the future which batch the patient received.

Albiomin 20% (200 g/l) and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine. The doctor will decide whether Albiomin 20% (200 g/l) can be used during pregnancy and breastfeeding.

Driving and using machines

The effect of Albiomin 20% (200 g/l) on the ability to drive and use machines is not known.

Albiomin 20% (200 g/l) contains sodium

The medicine contains approximately 140 mg of sodium (the main component of table salt) in each 50 ml vial. This corresponds to 7.0% of the maximum recommended daily intake of sodium in the diet for adults. The medicine contains approximately 280 mg of sodium (the main component of table salt) in each 100 ml vial. This corresponds to 14.0% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Albiomin 20% (200 g/l)

Albiomin 20% (200 g/l) is usually administered in a hospital by a doctor or nurse. Human albumin can be administered directly into a vein or can be diluted in 0.9% sodium chloride. Dosage and frequency of administration The amount of Albiomin 20% (200 g/l) the patient receives will depend on body weight, type of disease, and amount of fluids or proteins lost. The doctor will determine the appropriate dose of Albiomin 20% (200 g/l) and how often it will be administered to achieve the correct level in the blood.

Using a higher dose of Albiomin 20% (200 g/l) than recommended

This is unlikely, but if it happens, the doctor will know how to proceed. If you have any further doubts about using this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following symptoms, tell your doctor immediately:

• rash
• itching
• wheezing
• difficulty breathing
• swelling of the eyelids, face, lips, throat, or tongue
• very low blood pressure with symptoms such as dizziness, confusion, fainting, rapid heartbeat

This may be an allergic reaction or, in rare cases, a severe allergic reaction (anaphylactic shock) or hypersensitivity reaction.

The following side effects have been reported for Albiomin 20% (200 g/l) or are known for other human albumin products:

Frequency not known(frequency cannot be estimated from the available data):

• Hypersensitivity, anaphylactic reaction, anaphylactic shock
• Chest tightness (bronchospasm)
• Increased heart rate (tachycardia)
• Shock
• Nausea
• Skin reactions (flushing, urticaria, itching, erythema, rash)
• Chills
• Fever
• Low blood pressure (hypotension)
• Decreased oxygen saturation
• Leakage at the injection site (extravasation)

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell the doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides Al. Jerozolimskie 181C PL-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 Albiomin 20% (200 g/l)

Store the medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton. Store the vial in the outer packaging to protect from light. Do not store above 25°C.

Do not freeze.

After opening, use the medicine immediately. Check the solution for clarity before administration. Do not use cloudy or precipitated solutions. 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 packaging and other information

What Albiomin 20% (200 g/l) contains:

Each 50 ml vial contains 10 g of human plasma protein, of which at least 96% is human albumin. Each 100 ml vial contains 20 g of human plasma protein, of which at least 96% is human albumin. The other ingredients are: sodium caprylate (16 mmol/l), sodium chloride (63 mmol/l), N-acetyltryptophan (16 mmol/l), water for injections.

What Albiomin 20% (200 g/l) looks like and what the pack contains:

Clear, slightly viscous liquid; it is almost colorless, yellow, amber, or green. 50 ml glass vial 100 ml glass vial

Marketing authorization holder and manufacturer:

Biotest Pharma GmbH Landsteinerstrasse 5 63303 Dreieich Germany tel. +49 6103 801 – 0 fax +49 6103 801- 150 e-mail: [email protected] Date of last revision of the leaflet: 28.03.2025

THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS:

Special warnings and precautions for use

The colloid-osmotic effect of human albumin 200 g/l is about four times higher than that of human plasma. Therefore, when administering concentrated albumin, it is necessary to proceed with caution to ensure proper hydration of the patient. The patient must be closely monitored to protect against circulatory overload and fluid overload. Albumin solutions must not be diluted with water for injections, as this may cause hemolysis in recipients. If there is a need to exchange relatively large volumes of body fluids, coagulation parameters and hematocrit should be monitored. Attention should be paid to proper supplementation of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes). Hyperolemia may occur if the dose and infusion rate are not adjusted to the patient's circulatory status.

Interactions with other medicines and other types of interactions

No specific interactions between human albumin and other medicinal products have been found.

Dosage and administration

Dosage

To determine the appropriate dose, the required volume of circulating fluids should be taken into account, not the albumin level in the serum. When administering human albumin, hemodynamic parameters should be regularly monitored, including:

• arterial blood pressure and heart rate,
• central venous pressure,
• pulmonary artery occlusion pressure,
• diuresis,
• electrolyte levels,
• hematocrit/hemoglobin level.

Administration

Intravenous administration Human albumin can be administered directly into a vein or can be diluted in an isotonic solution (e.g., 0.9% sodium chloride solution). During plasma exchange, the infusion rate should be adjusted to the rate of removal.

Information on preparation of the medicine for use

Albumin solutions must not be diluted with water for injections, as this may cause hemolysis in recipients. When administering large volumes of albumin, the medicine should be warmed to room temperature or body temperature before administration. The solution should be clear or slightly opalescent. Cloudy or precipitated solutions must not be used. This may indicate that the protein is unstable or that the solution has been contaminated. The contents should be used immediately after opening the vial. Any unused product should be disposed of in accordance with local regulations.