Crealb 40 g/l

Package Leaflet: Information for the User

Crealb 40 g/l, Solution for Infusion

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.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 and what is it used for
• 2. Important information before using Crealb
• 3. How to use Crealb
• 4. Possible side effects
• 5. How to store Crealb
• 6. Contents of the pack and other information

1. What is Crealb and what is it used for

Crealb contains the active substance: human albumin. Human albumin is a normal component of human blood plasma. When used as replacement therapy, human albumin works in the same way as the albumin present in the body. Albumin helps to maintain blood volume and is a carrier for hormones, enzymes, medicinal products, and toxins.
Albumin is used to restore and maintain blood volume in patients who have demonstrated a deficiency in blood volume, and where the doctor considers replacement therapy to be appropriate.

2. Important information before using Crealb

When not to use Crealb:

Warnings and precautions

Before starting treatment with Crealb, discuss it with your doctor or pharmacist.
Particular care should be taken when using Crealb if the patient has one of the following conditions:

• uncontrolled heart failure;
• hypertension;
• esophageal varices;
• pulmonary edema;
• bleeding tendency;
• severe anemia;
• anuria due to renal failure.

Measures are taken to prevent the transmission of infectious agents during the manufacturing process of medicines derived from human blood or plasma. These include careful selection of blood and plasma donors to ensure that the risk of transmission of infectious agents is excluded, as well as testing each donation and plasma pools for signs of viral infections.
Manufacturers of these products also include steps in the production process to inactivate or remove viruses.
Despite this, it cannot be completely excluded that the transmission of infectious agents may occur during the administration of medicines derived 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 viral infections being transmitted with an albumin preparation, such as Crealb, produced using approved processes, in accordance with the specifications set out in the European Pharmacopoeia.
It is recommended to record the name and batch number of the administered product with the patient's name at each administration of Crealb, in order to be able to determine in the future which batch the patient received.

Crealb and other medicines

Tell your doctor or pharmacist about all the 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, 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 has no known effect on the ability to drive or use machines.

Important information about some of the ingredients of Crealb

This medicine contains sodium (a major component of common salt):
One 250 ml vial of Crealb 40 g/l contains 800 mg of sodium. This corresponds to 40% 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.
This should be taken into account in patients on a controlled sodium diet.

3. How to use Crealb

Crealb will be administered as 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 according to the individual patient's requirements. The required dose depends on the patient's growth, body weight, severity of the condition, and ongoing fluid and protein loss.
Crealb 40 g/l is administered directly, intravenously. 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 should not be mixed with other medicinal products, whole blood, and red blood cell concentrates.
During infusion, blood pressure, heart rate, blood morphology, and respiration should be monitored to ensure that the dose is appropriate.

Overdose of Crealb

In case of overdose, hypervolemia may occur. Symptoms include headache, dyspnea, and increased blood pressure. If these symptoms occur, the infusion will be stopped immediately. It may be necessary to apply 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, Crealb 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 will be stopped and appropriate treatment will be initiated.

Reporting of 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, 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
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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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.
Do not use Crealb if 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Crealb contains

Crealb 40 g/l

• The active substance is human albumin at a concentration of 40 g/l; in a vial of 10 g/250 ml.
• The other ingredients are: sodium caprylate, sodium chloride, sodium hydroxide or hydrochloric acid, water for injection.

Crealb 200 g/l

• The active substance is human albumin at a concentration of 200 g/l; in a vial of 20 g/100 ml.
• The other ingredients are: sodium caprylate, sodium chloride, sodium hydroxide or hydrochloric acid, water for injection.

What Crealb looks like and contents of the pack

Crealb 40 g/l:
Crealb 40 g/l is a solution for infusion in a vial (250 ml - pack size: 1 vial) made of type II glass with a stopper (bromobutyl).
The solution is clear, slightly viscous, almost colorless, yellow, amber, or green.
Not all pack sizes may be marketed.
Crealb 200 g/l:
Crealb 200 g/l is a solution for infusion in a vial (100 ml - pack size: 1 vial) made of type II glass with a stopper (bromobutyl).
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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland
Albuman 40 g/l and Albuman 200 g/l
Netherlands
Albuman 40 g/l and Albuman 200 g/l
Iceland
Albuman 40 g/l and Albuman 200 g/l
Cyprus
Albuman 40 g/l and Albuman 200 g/l
Sweden
Crealb 40 g/l and Crealb 200 g/l
Austria
Crealb 40 g/l and Crealb 200 g/l
Germany
Crealb 40 g/l and Crealb 200 g/l
Poland
Crealb 40 g/l and Crealb 200 g/l
Slovakia
Crealb 40 g/l and Crealb 200 g/l

Date of last revision of the package leaflet: 10/2021

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 patient's needs.
Dosage
The required dose depends on the patient's body weight, severity of injury or disease, and ongoing fluid and protein loss. To determine the appropriate dose, the required blood volume should be taken into account, not the albumin level in the plasma.
When administering human albumin, hemodynamic parameters should be regularly monitored, including:

• arterial blood pressure and heart rate;
• central venous pressure;
• pulmonary artery wedge 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 patients when the benefits clearly outweigh the potential risks. The dosage in children and adolescents should be adjusted to the individual patient's requirements.
Administration
Crealb 40 g/l can be administered directly intravenously.
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 indication.
During plasma exchange, the infusion rate should be adjusted to the rate of removal.
More information on the administration 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 6.1.

Special warnings and precautions for use

Identifiability
To improve the traceability 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 special risk for the patient of hypervolemia and its consequences or hemodilution. Examples of such conditions are:

• uncontrolled heart failure;
• hypertension;
• esophageal varices;
• pulmonary edema;
• bleeding tendency;
• severe anemia;
• anuria due to renal failure.

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 overloading of the circulatory system and excessive hydration.
Solutions of human albumin 200 g/l contain relatively few electrolytes compared to solutions of human albumin 40 g/l. When administering albumin, the patient's electrolyte levels should be monitored and appropriate measures taken to restore and maintain electrolyte balance.
In case of large volume replacement, parameters of coagulation and hematocrit should be monitored. Attention should be paid to adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).
Albumin solutions should not be diluted with water for injection, as this may cause hemolysis of the patient's red blood cells.
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, dyspnea, 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.
Crealb 40 g/l contains 140 mmol/l sodium (3.2 g/l):
800 mg sodium per 250 ml vial, corresponding to 40% of the WHO-recommended maximum daily intake of 2 g sodium for adults.
Crealb 200 g/l contains 100 mmol/l sodium (2.3 g/l):
230 mg sodium per 100 ml vial, corresponding to 12% of the WHO-recommended maximum daily intake of 2 g sodium for adults.
This should be taken into account in patients on a controlled sodium diet.
Standard measures to prevent infections with medicinal products derived from human blood or plasma include selection of donors, screening of individual donations and plasma pools for signs of viral infection, and inclusion of steps in the production process to inactivate or remove viruses.
Despite this, it cannot be completely excluded that the transmission of infectious agents may occur during the administration of medicinal products derived 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 viral infections being transmitted with an albumin preparation, such as Crealb, produced using approved processes, in accordance with the specifications set out in the European Pharmacopoeia.

Overdose

If the dose and infusion rate are too high, the patient may experience hypervolemia. After the first clinical signs of circulatory overload (headache, dyspnea, 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

This medicinal product must not be mixed with other medicinal products, whole blood, and red blood cell concentrates. Crealb 200 g/l can only be diluted in an isotonic solution (e.g., 5% glucose solution or 0.9% sodium chloride solution)