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
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

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

Table of contents

1. What Crealb is and what it is 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 Crealb is and what it is used for

Crealb contains the protein: human albumin. Human albumin is a normal component of human plasma. When administered as replacement therapy, human albumin acts in the same way as albumin naturally present in the body. Albumin stabilizes circulating blood volume and serves as a carrier for hormones, enzymes, medicinal products, and toxins.
Albumin is used to restore and maintain circulating blood volume in patients in whom a volume deficit has been demonstrated and when replacement therapy is considered appropriate by the physician.

2. Important information before using Crealb

When not to use Crealb:

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

Warnings and precautions
Before starting treatment with Crealb, discuss this with your doctor or pharmacist.
Exercise particular caution when using Crealb if the patient has any of the following conditions:

• uncompensated heart failure;
• arterial hypertension;
• esophageal varices;
• pulmonary edema;
• tendency to bleeding;
• severe anemia;
• anuria due to, for example, impaired kidney function.

In the manufacturing process of medicines derived from human blood or plasma, measures are taken to prevent transmission of infectious agents to patients. These include careful selection of blood and plasma donors to ensure exclusion of risk of transmission of infectious agents, as well as testing of each individual donation and pooled plasma for signs of viral infection/disease. Manufacturers of these products also include in the production process steps for effective viral inactivation or removal. Despite these measures, however, it cannot be completely excluded that administration of medicines derived from human blood or plasma may transmit infectious agents. This also includes unknown or newly emerging viruses and other types of infections.
There have been no reports of transmission of viral infections associated with albumin preparations such as Crealb manufactured using approved processes in accordance with specifications given in the European Pharmacopoeia.
It is recommended to record the name and batch number of the Crealb preparation for each administration in the patient's medical record to enable identification of the batch administered in the future.

Crealb and other medicines
Inform 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 use.

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.

Driving and operating machinery
Albumin has no known harmful effect on the ability to drive or operate machinery.

Important information about certain ingredients of Crealb
This medicine contains sodium (the main component of common/table salt):
One 250 ml vial of Crealb 40 g/l contains 800 mg of sodium. This corresponds to 40% of the maximum recommended daily dietary sodium intake 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 dietary sodium intake for adults.
This should be taken into account in patients on a sodium-controlled diet.

3. How to use Crealb

Crealb will be administered as a slow intravenous infusion. A 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 needs. The required dose depends on the patient's height and body weight, the severity of the patient's condition, and the ongoing loss of fluids and proteins.

Crealb 40 g/l is administered directly by intravenous route. Crealb 200 g/l may be administered directly or may be diluted in an isotonic solution (e.g. 5% glucose solution or 0.9% sodium chloride solution). However, it must not be diluted with water for injections, as this may cause hemolysis of the patient's red blood cells.

Albumin must not be mixed with other medicinal products, whole blood, or red blood cell concentrates.

During the infusion, blood pressure, heart function, blood morphology, and respiration should be monitored to ensure that the administered dose is appropriate.

Use of a higher than recommended dose of Crealb

In case of overdose, hypervolemia may occur. Symptoms include headache, dyspnea, and elevated blood pressure. If these symptoms occur, the infusion will be stopped immediately. Therapy to remove excess fluid may be necessary.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Uncommon adverse reactions, occurring in 1–10 out of 10,000 treated patients:
Facial flushing, urticaria, fever, and nausea.
These reactions usually resolve quickly when the infusion rate is reduced or the infusion is stopped.
Very rare adverse reactions, occurring 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 initiated.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department for Monitoring Adverse Drug Reactions, 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Crealb 40 g/l

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton after "EXP".
The expiry date refers to the last day of the stated month.
Store below 25°C.
Do not freeze. Store in the original packaging to protect from light.
Crealb 40 g/l must not be used if the solution is cloudy or contains a precipitate. This may
indicate that the protein is unstable or that the solution has become contaminated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures 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 the vial: 10 g/250 ml.
• Other ingredients: sodium caprylate, sodium chloride, sodium hydroxide or hydrochloric acid, water for injections.

Crealb 200 g/l

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

What Crealb looks like and contents of the pack
Crealb 40 g/l:
Crealb 40 g/l is an infusion solution in a vial (250 ml – pack size: 1 vial) made of Type II glass with a bromobutyl rubber stopper.
The solution is clear, slightly viscous, and may be almost colourless, yellow, amber, or green.
Not all pack sizes may be marketed.

Crealb 200 g/l:
Crealb 200 g/l is an infusion solution in a vial (100 ml – pack size: 1 vial) made of Type II glass with a bromobutyl rubber stopper.
The solution is clear, slightly viscous, and may be almost colourless, yellow, amber, or green.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Prothya Biosolutions Netherlands B.V.
Plesmanlaan 125
NL-1066 CX Amsterdam
The Netherlands

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Finland Albuman 40 g/l and Albuman 200 g/l
The 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

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://urpl.gov.pl/pl .

Information intended exclusively for medical professionals:

Dosage and method of administration
The albumin concentration, dosage, and infusion rate should be adjusted according to the individual patient's needs.

Dosage
The required dose depends on the patient's body weight, the severity of injury or illness, and ongoing fluid and protein losses. To determine the appropriate dose, the required circulating fluid volume should be considered, not the plasma albumin level.

When administering human albumin, hemodynamic parameters should be monitored regularly, including:

• arterial blood pressure and pulse rate;
• central venous pressure;
• pulmonary artery wedge pressure;
• urine output (diuresis);
• electrolyte levels;
• hematocrit/hemoglobin levels.

Children and adolescents
Data on the use of Crealb 200 g/l in children and adolescents (aged 0–18 years) are limited; therefore, this product should be administered to these patients only when benefits clearly outweigh potential risks. Dosing in children and adolescents should be adjusted according to individual patient requirements.

Method of administration
Crealb 40 g/l may be administered directly intravenously.
Crealb 200 g/l may be administered directly intravenously or may also be diluted in an isotonic solution (e.g., 5% glucose solution or 0.9% sodium chloride solution).
The infusion rate should be adjusted according to individual circumstances and indications.
During plasma exchange, the infusion rate should be matched to the plasma removal rate.
Further information on the method of administration is provided in section 3 of the patient leaflet.

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use
Traceability
To improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Suspected allergic or anaphylactic reactions require immediate discontinuation of the infusion. In case of shock, current guidelines for shock management should be followed.

Human albumin should be used with caution in situations where hypervolemia and its consequences or hemodilution pose a particular risk to the patient. Examples include:

• uncompensated cardiac insufficiency;
• arterial hypertension;
• esophageal varices;
• pulmonary edema;
• hemorrhagic diathesis;
• severe anemia;
• renal and extrarenal anuria.

The colloid osmotic effect of human albumin 200 g/l is approximately four times greater than that of plasma. Therefore, when administering concentrated albumin, care must be taken to ensure adequate hydration of the patient. The patient must be closely monitored to prevent circulatory overload and excessive hydration.

Human albumin solutions at a concentration of 200 g/l contain relatively low amounts of electrolytes compared to human albumin solutions at 40 g/l. During albumin administration, the patient's electrolyte levels should be monitored, and appropriate measures taken to restore and maintain electrolyte balance.

When large volume deficits are being corrected, coagulation parameters and hematocrit should be monitored. Attention should be paid to adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).

Albumin solutions must not be diluted with water for injections, 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 capacity, hypervolemia may occur. If early clinical signs of cardiovascular overload appear (headache, dyspnea, jugular vein distension) or if increased blood pressure, elevated venous pressure, or pulmonary edema occur, the infusion must be stopped immediately.

Crealb 40 g/l contains 140 mmol/l of sodium (3.2 g/l):
800 mg of sodium per 250 ml vial, corresponding to 40% of the maximum 2 g daily sodium intake recommended by WHO for adults.

Crealb 200 g/l contains 100 mmol/l of sodium (2.3 g/l):
230 mg of sodium per 100 ml vial, corresponding to 12% of the maximum 2 g daily sodium intake recommended by WHO for adults.

This should be taken into account in patients on a sodium-controlled diet.

Standard measures to prevent infections associated with medicinal products derived from human blood or plasma include donor selection, screening tests for specific infection markers on individual donations and pooled plasma, and inclusion of effective viral inactivation/removal steps during manufacturing.

Despite these measures, the possibility of transmitting infectious agents through medicinal products derived from human blood or plasma cannot be completely excluded. This includes unknown or newly emerging viruses and other pathogens.

There have been no reports of viral infections transmitted by albumin preparations such as Crealb manufactured using approved processes in compliance with specifications provided in the European Pharmacopoeia.

Overdose
If the dose and infusion rate are too high, hypervolemia may occur. Upon the first clinical signs of cardiovascular overload (headache, dyspnea, jugular vein distension) or increased blood pressure, elevated central venous pressure, or pulmonary edema, the infusion must be stopped immediately and hemodynamic parameters must be closely monitored.

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