Crealb 200 g/l

Package Leaflet: Information for the User

Crealb 200 g/l, Solution for Infusion

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.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Crealb 200 g/l and what is it used for

Crealb 200 g/l contains the active substance: human albumin. Human albumin is a natural component of human blood plasma and, after administration, acts similarly to the albumin present in the body.
Albumin stabilizes the volume of circulating blood and is a carrier of hormones, enzymes, medicinal products, and toxins.
Albumin is used to restore and maintain the volume of circulating blood in patients who have been shown to have a volume deficit, and the doctor will determine if the patient needs this medicine.
The decision depends on the patient's clinical condition.

2. Important information before using Crealb 200 g/l

When not to use Crealb 200 g/l:

Warnings and precautions

Before starting treatment with this medicine, discuss it with your doctor or pharmacist.
Particular caution should be exercised when using Crealb 200 g/l if the patient has one of the following conditions:

• uncompensated heart failure;
• hypertension;
• esophageal varices;
• pulmonary edema;
• bleeding tendency;
• severe anemia;
• anuria due to e.g. kidney dysfunction.

In the manufacturing process of medicines from human blood or plasma, measures are taken to prevent the 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 each donation and plasma pools for signs of virus/infection,
• inclusion in the production process of effective virus inactivation or removal steps.

Despite this, it cannot be completely excluded that infectious agents may be transmitted when administering medicines obtained from human blood or plasma. This also applies to unknown or newly discovered viruses and other types of infections.
There have been no reports of transmission of viral infections with an albumin preparation, such as Crealb, produced using approved processes, in accordance with the requirements of the European Pharmacopoeia.
It is recommended to record the name and batch number of the medicine with the patient's name at each administration of Crealb 200 g/l in order to determine in the future which batch the patient received.

Crealb 200 g/l and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Albumin does not have a harmful effect on the ability to drive and use machines.

Important information about some ingredients of Crealb 200 g/l

This medicine contains sodium (the main component of common salt):
One 50 ml vial of Crealb 200 g/l contains 115 mg of sodium. This corresponds to 6% of the maximum recommended daily intake of sodium in the diet for adults.
One 100 ml vial of Crealb 200 g/l contains 230 mg of sodium. This corresponds to 12% of the maximum recommended daily intake of sodium in the diet for adults.
Patients on a controlled sodium diet should take this into account.

3. How to use Crealb 200 g/l

Crealb 200 g/l will be administered in a slow infusion. The doctor or nurse will administer the solution into a vein through an infusion set. The doctor will adjust the dose and infusion rate to the individual needs of the patient. The required dose depends on the patient's body weight, the severity of the condition, and the ongoing loss of fluids and proteins.
Crealb 200 g/l can be administered directly or can also be diluted in an isotonic solution (e.g. 5% glucose solution or 0.9% sodium chloride solution). However, it should not be diluted with water for injection, as this may cause hemolysis of the patient's red blood cells.
Albumin must not be mixed with other medicinal products, whole blood, and red blood cell concentrate.
During infusion, blood pressure, heart rate, blood morphology, and respiration should be monitored to ensure that the dose is appropriate.

Overdose of Crealb 200 g/l

In case of overdose, hypervolemia may occur. Symptoms include headache, shortness of breath, and increased blood pressure. If these symptoms occur, the infusion should be stopped immediately. It may be necessary to use therapy to remove excess fluid.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare side effects, which occur in 1-10 out of 10,000 treated patients:
Flushing of the face, urticaria, fever, and nausea.
These reactions usually resolve quickly when the infusion rate is reduced or the infusion is stopped.
Very rare side effects, which occur in less than 1 out of 10,000 treated patients:
Anaphylactoid reactions, such as shock.
In such cases, the infusion should be stopped immediately and appropriate treatment started.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to
the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 Crealb 200 g/l

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial label after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Do not freeze.
Store in the original package to protect from light.
After first opening: the product should be used immediately.
Do not use this medicine if you notice that the solution is cloudy or contains sediment. This may indicate that the protein is unstable or that the solution has been contaminated.
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 package and other information

What Crealb 200 g/l contains

• The active substance is human albumin at a concentration of 200 g/l. One liter of solution contains 200 g of total protein, of which at least 95% is human albumin.
• The other ingredients are: sodium caprylate, sodium chloride, sodium hydroxide or hydrochloric acid, water for injection. Total sodium content: 100 mmol/l (see section 2).

What Crealb 200 g/l looks like and contents of the package

Crealb 200 g/l is a solution for infusion in a vial (50 ml or 100 ml – pack size: 1 vial).
The solution is clear, slightly viscous, almost colorless, yellow, amber, or green.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Prothya Biosolutions Netherlands B.V.
Plesmanlaan 125
NL-1066 CX Amsterdam
Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Finland, Netherlands, Iceland, Cyprus: Albuman 200 g/l
Sweden, Austria, Germany, Poland, Hungary: Crealb 200 g/l

Date of last revision of the package leaflet: 02/2025

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://urpl.gov.pl/pl .
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Information intended for healthcare professionals only:

Dosage and administration

The concentration of the albumin solution, dosage, and infusion rate should be adjusted to the individual needs of the patient.
Dosage
The required dose depends on the patient's body weight, the severity of the injury or disease, and the ongoing loss of fluids and proteins. To determine the appropriate dose, the required volume of circulating fluids should be considered, not the albumin level in the blood.
When administering human albumin, hemodynamic parameters should be regularly monitored, including:

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

Children and adolescents
Data on the use of Crealb 200 g/l in children and adolescents (0-18 years) are limited; therefore, the product should only be administered to these individuals when the benefits clearly outweigh the potential risks. The dosage in children and adolescents should be adjusted to the individual needs of the patient.
Administration route
Crealb 200 g/l can be administered directly intravenously or can also be diluted in an isotonic solution (e.g. 5% glucose solution or 0.9% sodium chloride solution).
The infusion rate should be adjusted to the individual case and indications.
During plasma exchange, the infusion rate should be adjusted to the rate of removal.
More information on the administration route can be found in section 3 of this package leaflet for the patient.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6 of this package leaflet.

Special warnings and precautions for use

Identifiability
To improve the identifiability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Suspicion of an allergic or anaphylactic reaction requires immediate discontinuation of the infusion. In case of shock, follow current guidelines for shock treatment.
Albumin should be used with caution when there is a particular risk to the patient of hypervolemia with its consequences or hemodilution. Examples of such conditions are:

• uncompensated heart failure;
• hypertension;
• esophageal varices;
• pulmonary edema;
• bleeding tendency;
• severe anemia;
• anuria due to e.g. kidney dysfunction.

The colloid-osmotic effect of human albumin 200 g/l is about four times greater than that of blood plasma. Therefore, when administering concentrated albumin, caution should be exercised to ensure adequate hydration of the patient. The patient should be closely monitored to prevent circulatory overload and excessive hydration.
Solutions of human albumin at a concentration of 200-250 g/l contain relatively few electrolytes compared to solutions of human albumin at a concentration of 40-50 g/l. When administering albumin, the patient's electrolyte levels should be monitored and appropriate measures taken to restore and maintain electrolyte balance.
Solutions of albumin must not be diluted with water for injection, as this may cause hemolysis of the patient's red blood cells.
In case of large volume deficits, parameters of the coagulation system and hematocrit should be monitored. Attention should be paid to the proper supplementation of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).
If the dose and infusion rate are not adjusted to the patient's circulatory function, hypervolemia may occur. If the first clinical signs of circulatory overload (headache, shortness of breath, jugular venous distension) or increased blood pressure, increased central venous pressure, and pulmonary edema occur, the infusion should be stopped immediately and the patient's hemodynamic parameters should be closely monitored.

Overdose

If the dose and infusion rate are too high, the patient may experience hypervolemia. After the first clinical signs of circulatory overload (headache, shortness of breath, jugular venous distension) or increased blood pressure, increased central venous pressure, and pulmonary edema, the infusion should be stopped immediately and the patient's hemodynamic parameters should be closely monitored.

Incompatibilities

Do not mix human albumin with other medicinal products, whole blood, and red blood cell concentrate. The only exception is mentioned in the "Dosage and administration" section.