Albumonorm 5 %

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALBUNORM 5%

Composition:

Active substance: human albumin;

1000 ml of infusion solution contains 50 g of plasma proteins with a 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 characteristics: clear, slightly viscous liquid; almost colorless, yellow, amber, or green.

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

Pharmacological properties.

Pharmacodynamics.

Human albumin accounts for more than half of the total protein in blood plasma by quantity and represents approximately 10% of liver protein synthesis activity.

Human albumin at 40 or 50 g/l provides a corresponding oncotic effect.

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

Pharmacokinetics.

Under normal conditions, the total exchangeable albumin pool is 4–5 g/kg body weight, with 40–45% 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. The balance 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 lost from the vascular compartment within the first 2 hours after infusion. There are significant individual variations related to effects 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 embryotoxic or fetotoxic effects associated with human albumin, or of oncogenic or mutagenic potential. No signs of acute toxicity have been observed in experimental animal studies.

Clinical characteristics.

Indications.

Restoration and maintenance of circulating blood volume in case of its deficiency, when administration of a colloid is indicated.

The choice of albumin over a synthetic colloid should be 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 every time the medicinal product Albunorm 5% is administered, the name of the product and the batch number are clearly documented, so that the use of the specific batch in a given patient can be traced.

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

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

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

• decompensated cardiac insufficiency;
• hypertension;
• oesophageal varices;
• pulmonary oedema;
• haemorrhagic diathesis;
• severe anaemia;
• renal or post-renal anuria.

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

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

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

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

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

Hypervolaemia may occur if the dose and infusion rate are not adjusted according to the patient's circulatory status. If the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein distension) or increased blood pressure, elevated venous pressure, or pulmonary oedema 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 1.25 mmol of potassium per 500 ml vial of albumin solution. Caution should be exercised when administering to patients with impaired renal function or those on a potassium-controlled diet.

Standard precautions 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 eliminate 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.

Use during pregnancy or breastfeeding.

The safety of using Albunorm 5% in pregnant women has not been studied in controlled clinical trials. However, clinical experience with albumin use suggests that no harmful effects on the course of pregnancy or on the foetus and newborn are expected.

Studies on the effect of Albunorm 5% on reproductive function in animals have not been performed, as human albumin is a normal component of human blood plasma.

Ability to affect reaction speed when driving or operating machinery.

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

Method of 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 injury or illness, and the degree of fluid and protein loss. To determine the necessary dose, measurement of circulating blood volume should be performed 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 failure (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 used for plasma replacement, the infusion rate should be adjusted according to the rate of blood loss.

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

Do not use if the solution is turbid or contains a precipitate. This may indicate protein instability or contamination of the solution.

Do not use if the packaging is damaged. Destroy if leakage is observed.

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

Children

Data on the use of the drug in children are limited. The medicinal product should be prescribed 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 of the drug should be stopped immediately and hemodynamic parameters should be closely monitored.

Adverse reactions.

Rarely, mild allergic reactions occur, such as facial flushing (hot flushes), urticaria, fever, and nausea. Such reactions usually resolve quickly upon slowing the infusion rate or discontinuing administration of the drug. Very rarely, severe reactions such as shock may occur. In the event of severe reactions, the infusion should be immediately discontinued and appropriate therapy initiated.

During the post-marketing period, the following adverse reactions have been observed with human albumin solutions, and their occurrence may also be expected with the use of this medicinal product.

* Not possible to assess based on available data.

For information on preventing transmission of infectious agents via this 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 ongoing monitoring of the benefit-risk balance of this medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life. 3 years. After opening the vial, use the solution immediately.

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

Store in the original cardboard package to protect from light.

Keep out of reach and sight 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. 100 ml, 250 ml or 500 ml of solution in a vial. 1 vial per cardboard box.

Prescription status. Prescription only.

Manufacturer.

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