Albuminorm 25 %

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALBUNORM 20% ALBUNORM 25%

Composition:

Active substance: human albumin;

1000 ml of infusion solution contains 200 g or 250 g of plasma proteins with human albumin content of not less than 96%;

Excipients: sodium, N-acetyl-DL-tryptophan, caprylic acid, water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, slightly viscous liquid; almost colorless, yellow, amber, or green.

Pharmacotherapeutic group. Blood substitutes and plasma protein fractions. Albumin. ATC code B05A A01.

Pharmacological properties.

Pharmacodynamics.

Human albumin constitutes more than half of the total protein in blood plasma in quantitative terms and accounts for approximately 10% of the liver's protein synthesis activity.

Human albumin at a concentration of 200 or 250 g/l has a corresponding hyperoncotic effect.

The most important physiological function of albumin is the maintenance of blood oncotic pressure and transport function. Albumin stabilizes the circulating blood volume and mediates the transport of hormones, enzymes, medicinal products, and toxins.

Pharmacokinetics.

Under normal conditions, the total exchangeable albumin pool is 4–5 g/kg body weight, of which 40–45% is located in the intravascular space and 55–60% in the extravascular space. In pathological conditions such as severe burns or septic shock, the normal distribution of albumin is disrupted due to increased capillary permeability and altered albumin kinetics.

Under normal conditions, the mean half-life of albumin is approximately 19 days. Equilibrium between synthesis and degradation is usually maintained via feedback regulation. Elimination occurs primarily intracellularly with the participation of lysosomal proteases.

In healthy volunteers, less than 10% of intravenously administered albumin is eliminated from the vascular compartment within the first 2 hours after infusion. There are significant individual variations related to the effect on blood plasma volume. In some patients, blood plasma volume may remain increased for several hours. However, critically ill patients may lose substantial amounts of albumin from the vascular compartment at an unpredictable rate.

Human albumin is a normal component of human blood plasma and acts as a physiological albumin. To date, there have been no reports of embryotoxicity or fetotoxicity, oncogenic potential, or mutagenic potential associated with human albumin. No signs of acute toxicity were observed in experimental animal models.

Clinical characteristics.

Indications.

Restoration and maintenance of circulating blood volume in cases of volume deficit, when the use of a colloid is indicated.

The choice of albumin over a synthetic colloid should be made based on official recommendations, depending on the individual patient's clinical condition.

Contraindications.

Hypersensitivity to blood protein preparations or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

Specific interactions of human albumin with other medicinal products are unknown.

When albumin is used concomitantly with ACE inhibitors (angiotensin-converting enzyme inhibitors) in patients undergoing plasmapheresis, the risk of arterial hypotension increases.

Special precautions for use.

Traceability

To improve the traceability of biological medicinal products, it is recommended that for each administration of the medicinal product Albunorm 20% and 25%, the name of the product and the batch number be clearly recorded in order to enable tracking of the effect of the specific batch on the patient.

The medicinal product contains potassium, which is a component of human blood plasma and is not intentionally added as an excipient.

Suspected allergic or anaphylactic reactions require immediate discontinuation of the infusion. In case of shock, standard shock treatment should be initiated.

Albumin should be administered with caution if there is a particular risk of hypervolemia and its consequences or hemodilution for the patient, for example in cases of:

• decompensated cardiac failure;
• hypertension;
• esophageal varices;
• pulmonary edema;
• hemorrhagic diathesis;
• severe anemia;
• renal or post-renal anuria.

In critically ill patients with traumatic brain injury, resuscitation using albumin has been associated with a higher risk of mortality compared to resuscitation using saline solution. It is recommended to exercise caution when administering albumin to patients with severe traumatic brain injury.

The colloid-osmotic effect of human albumin at concentrations of 200 or 250 g/L is approximately four times higher than that of blood plasma. Therefore, when administering concentrated albumin, caution is required, ensuring adequate hydration (replacement of fluid loss) of the patient. Patients must be under close monitoring to prevent circulatory overload and hyperhydration.

Human albumin solutions at 200–250 g/L have a relatively low electrolyte content compared to human albumid solutions at 40–50 g/L. During albumin administration, the patient's electrolyte status should be monitored, and appropriate measures taken to restore or maintain electrolyte balance.

Albumin solutions must not be diluted with water for injection, as this may cause hemolysis in patients.

If large volumes are administered, the product should be warmed to room temperature or body temperature prior to use.

Solutions that have become cloudy or contain a precipitate must not be used. This may indicate protein instability or contamination of the solution.

Once the vial has been opened, its contents should be used immediately.

Any unused solution should be disposed of in accordance with local legislation.

If relatively large volumes need to be replaced, monitoring of coagulation parameters and hematocrit is required. Caution should be exercised to ensure appropriate replacement of other blood components (clotting factors, electrolytes, platelets, and erythrocytes).

Hypervolemia may occur if the dose and infusion rate are not adjusted according to the patient's circulatory status. If early clinical signs of cardiovascular overload (headache, dyspnea, jugular vein distension) or increased blood pressure, elevated venous pressure, or pulmonary edema occur, the infusion must be stopped immediately.

This medicinal product contains 331–368 mg of sodium per 100 mL of albumin solution, equivalent to up to 18.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Caution should be exercised when administering to patients on a sodium-controlled diet.

The medicinal product contains up to 1 mmol of potassium per 100 mL vial of 200 g/L albumin solution and up to 1.25 mmol of potassium per 100 mL vial of 250 g/L albumin solution. Caution should be exercised when administering to patients with impaired renal function or those on a potassium-controlled diet.

Standard measures to prevent infections transmitted by medicinal products derived from human blood or plasma include donor selection, testing of individual blood donations and plasma pools for specific infection markers, and inclusion of effective viral inactivation/removal steps in the manufacturing process. Nevertheless, when using medicinal products derived from human blood or plasma, it is not possible to completely exclude the risk of transmission of infectious agents. This includes unknown or emerging viruses and other pathogenic organisms.

There have been no reports confirming transmission of viruses associated with the use of albumin manufactured in compliance with the requirements of the European Pharmacopoeia.

It is recommended that for each administration of the medicinal product Albunorm, the product name and batch number be recorded to enable tracking of the effect of the specific batch on the patient.

Use during pregnancy or breastfeeding.

The safety of Albunorm use in pregnant women has not been studied in controlled clinical trials. However, clinical experience with albumin use indicates that harmful effects on pregnancy or on the fetus and newborn are not expected.

Studies on the effects of Albunorm on reproductive function in animals have not been conducted, as human albumin is a normal component of human blood plasma.

Ability to influence the speed of reaction when driving vehicles or operating machinery.

No effects on the ability to drive vehicles or operate machinery have been observed.

Administration and Dosage

The albumin concentration, dosage, and rate of administration should be adjusted according to individual patient needs.

Dosage

The required dose depends on the patient's body weight, the severity of trauma or illness, and the degree of fluid and protein loss. To determine the necessary dose, the circulating blood volume should be measured rather than plasma albumin levels.

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

• arterial blood pressure and pulse rate;
• central venous pressure;
• pulmonary artery wedge pressure;
• diuresis;
• electrolyte concentrations;
• hematocrit/hemoglobin;
• clinical signs of cardiac/respiratory insufficiency (e.g., dyspnea);
• clinical signs of increased intracranial pressure (e.g., headache).

Human albumin may be administered directly intravenously or diluted in an isotonic solution (e.g., 5% glucose solution or 0.9% sodium chloride solution).

The infusion rate should be adjusted according to the patient's condition, clinical parameters, and specific indications for use.

When replacing plasma, the infusion rate should be adjusted according to the rate of fluid loss.

When large volumes are administered, the solution should be warmed to room temperature or body temperature prior to administration.

Do not use if the solution is cloudy or contains a precipitate, as this may indicate protein instability or contamination.

Do not use if the packaging is damaged. Destroy the product if leakage is detected.

After opening the vial, the product should be used immediately! Any unused solution should be disposed of according to local regulations.

Children

Data on the use of the drug in children are limited. The medicinal product should be administered only when the benefit clearly outweighs the potential risks.

Overdose

Hypervolemia may occur if the dose or rate of administration is too high. If early clinical signs of cardiovascular overload (headache, dyspnea, jugular vein distension) or increased arterial pressure, elevated central venous pressure, or pulmonary edema occur, administration should be stopped immediately and hemodynamic parameters should be closely monitored.

Adverse reactions.

Rarely, mild allergic reactions may occur, such as facial flushing, urticaria, fever, and nausea. These reactions usually resolve quickly by slowing down the infusion rate or discontinuing the administration of the drug. Very rarely, severe reactions such as shock may occur. In the event of severe reactions, the infusion should be stopped immediately and appropriate therapy initiated.

During the post-marketing period of human albumin solutions, the following adverse reactions have been observed, which may also be expected with the use of this drug.

* Not possible to assess based on available data.

For information on prevention of transmission of infectious agents with the medicinal product, see section "Special precautions for use".

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as patients' legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua/.

Shelf life. 3 years. After opening the vial, the solution should be used immediately.

Storage conditions. Store at a temperature not exceeding 25 °C. Do not freeze.

Store in the original cardboard packaging to protect from light.

Keep out of reach of children.

Incompatibilities.

Human albumin solution must not be mixed with other medicinal products, whole blood, packed red blood cells, or water for injection.

Packaging. 50 or 100 mL of solution in a vial. 1 vial in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

1. Octapharma AB
2. Octapharma
3. Octapharma Pharmazeutika Produktionsges. m.b.H.
4. Octapharma Produktionsgesellschaft Deutschland mbH

Manufacturer's address and place of business.

1. Lars Forssells Gata 23, Stockholm, 11275, Sweden
2. 72 Rue du Maréchal Foch, 67380 Lingolsheim, France
3. Oberlaaer Strasse 235, 1100 Vienna, Austria
4. Wolfgang-Marguerre-Allee 1, Springe, Lower Saxony, 31832, Germany