Crealb 200 g/l

Package leaflet: Information for the user

Crealb 200 g/l, solution for infusion
Human albumin
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Crealb 200 g/l is and what it is used for
2. Important information before receiving 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 pack and other information

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

Crealb 200 g/l contains a protein: human albumin. Human albumin is a natural component of human plasma and, after administration, acts similarly to the 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 who have been shown to have volume deficiency, and the decision whether the patient needs this medicine is made by the physician. The decision depends on the individual patient's clinical condition.

2. Important information before using Crealb 200 g/l

When not to use Crealb 200 g/l:

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

Warnings and precautions
Before starting treatment with this medicine, discuss it with your doctor or pharmacist.
Special caution is required when administering Crealb 200 g/l if the patient has any of the following conditions:

• uncontrolled 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;
• testing of each donation and pooled plasma batches for markers of viral/infectious presence;
• inclusion of effective viral inactivation or removal steps during the production process.

Despite these measures, it cannot be completely excluded that infectious agents may be transmitted during administration of medicines 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 transmission of viral infections with albumin preparations such as Crealb manufactured 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 against the patient's name each time Crealb 200 g/l is administered, to allow identification of which batch the patient received in the future.

Crealb 200 g/l 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 take.

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 components of Crealb 200 g/l
This medicine contains sodium (the main component of table salt):
One 50 ml vial of Crealb 200 g/l contains 115 mg of sodium. This corresponds to 6% of the maximum recommended daily dietary intake of sodium 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 intake of sodium for adults.
Patients on a sodium-restricted diet should take this into account.

3. How to use Crealb 200 g/l

Crealb 200 g/l will be administered by slow infusion. The doctor or nurse will give the solution
into a vein through an infusion set. The doctor will adjust the dose and infusion rate according to the individual
needs of the patient. The required dose depends on height and body weight, severity of the patient's condition,
and ongoing losses of fluids and proteins.
Crealb 200 g/l may be given directly or may also 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 haemolysis of the patient's red blood cells.
Albumin must not be mixed with other medicinal products, whole blood, or red blood cell concentrates.
During infusion, blood pressure, heart function, blood count, and respiration should be monitored to ensure that the dose is appropriate.
Use of a higher than recommended dose of Crealb 200 g/l
In case of overdose, hypervolemia may occur. Symptoms include headache, shortness of breath,
and elevated blood pressure. If these symptoms occur, the infusion must be stopped immediately.
Therapy aimed at removing excess fluid may be necessary.
If you have any further questions concerning 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 fewer than 1 out of 10,000 treated patients:
Anaphylactoid reactions such as shock.
In such cases, the infusion must be stopped immediately and appropriate treatment initiated.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform
your doctor or pharmacist. Adverse reactions can be reported directly to the
Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 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.
By reporting adverse reactions, additional information on the safety of this medicine can be
collected.

5. How to store the medicine Crealb 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 outer carton and on the label of the
vial following the abbreviation "EXP". The expiry date refers to the last day of the specified month.
Store below 25°C.
Do not freeze.
Keep in the original packaging to protect from light.
After first opening: the product should be used immediately.
Do not use this medicine if the solution appears 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 the sewage system or in 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 200 g/l contains

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

What Crealb 200 g/l looks like and contents of the pack
Crealb 200 g/l is an infusion solution in a vial (50 ml or 100 ml – pack size: 1 vial).
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 in the European Economic Area countries under the following names:
Finland, The Netherlands, Iceland, Cyprus: Albuman 200 g/l
Sweden, Austria, Germany, Poland, Hungary: 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 administration
The concentration of albumin solution, 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, severity of injury or illness, and ongoing fluid and protein losses. The appropriate dose should be determined based on the required circulating fluid volume, not on serum albumin levels.

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;
• 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, the 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 200 g/l may be administered directly intravenously or may 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 adapted to the plasma removal rate.

Further information on the method of administration can be found in section 3 of the patient leaflet enclosed with the package.

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

Traceability
To improve traceability of biological medicinal products, the name and batch number of the administered product should be clearly documented.

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

Albumin should be used with caution when 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. The patient must be closely monitored to prevent circulatory overload and excessive fluid administration.

Human albumin solutions at concentrations of 200–250 g/l contain relatively low amounts of electrolytes compared to human albumin solutions at concentrations of 40–50 g/l. During albumin administration, the patient's electrolyte levels should be monitored, and appropriate measures taken to restore and maintain electrolyte balance.

Albumin solutions must not be diluted with water for injections, as this may cause hemolysis of the patient's red blood cells.

When large volume deficits are being corrected, coagulation parameters and hematocrit should be monitored. Adequate replacement of other blood components (clotting factors, electrolytes, platelets, and erythrocytes) should be ensured.

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 (headache, dyspnea, jugular vein distension) or elevated blood pressure, increased venous pressure, and pulmonary edema occur, the infusion must be stopped immediately.

Special warning regarding excipients
This medicinal product contains 100 mmol/l of sodium (2.3 g/l):
115 mg of sodium per 50 ml vial, equivalent to 6% of the WHO-recommended maximum daily dietary sodium intake of 2 g for adults.
230 mg of sodium per 100 ml vial, equivalent to 12% of the WHO-recommended maximum daily dietary sodium intake of 2 g for adults.

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

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

Nevertheless, it cannot be completely excluded that medicinal products derived from human blood or plasma may transmit infectious agents, including unknown or newly emerging viruses and other pathogens.

There have been no reports of virus transmission associated with albumin preparations manufactured using a process compliant with European Pharmacopoeia specifications.

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, and pulmonary edema, the infusion must be stopped immediately and hemodynamic parameters closely monitored.

Pharmaceutical incompatibilities
Human albumin must not be mixed with other medicinal products, whole blood, or red blood cell concentrates. The only exception is mentioned in the section "Dosage and administration".