Albunorm 20% solution for infusions 20% bottle 100 ml No. 1

Instructions for Albunorm 20% solution for infusions 20% bottle 100 ml No. 1

Composition

active ingredient: human albumin;

1000 ml of infusion solution contains 200 g or 250 g of plasma proteins with a human albumin content of at least 96%;

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

Dosage form

Solution for infusion.

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

Pharmacotherapeutic group

Blood products. 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 and accounts for approximately 10% of the liver's protein synthesis activity.

Human albumin 200 or 250 g/L has a corresponding hyperoncotic effect.

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

Pharmacokinetics.

Normally, the total metabolic pool of albumin is 4–5 g/kg of body weight, 40–45% of which is 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, which is associated with increased capillary permeability and changes in albumin kinetics.

Normally, the average half-life of albumin is approximately 19 days. The balance between synthesis and degradation is usually achieved by feedback regulation. Elimination occurs primarily intracellularly, involving lysosomal proteases.

In healthy volunteers, less than 10% of intravenously administered albumin is removed from the vascular bed within the first 2 hours after infusion. There is considerable individual variation in the effect on plasma volume. In some patients, plasma volume may remain elevated for several hours. However, critically ill patients may lose significant amounts of albumin from the vascular bed 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 an association between human albumin and embryo-fetal toxicity, oncogenic or mutagenic potential. No signs of acute toxicity have been observed in animal models.

Indication

Restoration and maintenance of circulating blood volume in case of volume deficiency, if the use of colloid is indicated.

The choice of albumin over synthetic colloid should be based on official recommendations and the clinical condition of the individual patient.

Contraindication

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

Interaction with other medicinal products and other types of interactions

Specific interactions of human albumin with other drugs are unknown.

The risk of arterial hypotension increases when albumin is used concomitantly with ACE inhibitors (angiotensin-converting enzyme) in patients receiving plasmapheresis.

Application features

Traceability

In order to improve the traceability of biological medicinal products, it is recommended that every time Albunorm 20% and 25% is administered, the name and batch number of the product are clearly recorded in order to maintain a record of the effects of the particular 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 drug. In case of shock, standard medical treatment for shock should be administered.

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

decompensated heart failure;

hypertension;

esophageal varices;

pulmonary edema;

hemorrhagic diathesis;

severe anemia;

renal or postrenal anuria.

In critically ill patients with traumatic brain injury, rehydration with albumin is associated with a higher risk of death than rehydration with saline. Caution is recommended when using albumin in patients with severe traumatic brain injury.

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

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

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

Solutions that are cloudy or have a precipitate should not be used. This may indicate that the protein is unstable or that the solution has become contaminated.

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

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

If relatively large volumes are required, coagulation and haematocrit monitoring is required. Care should be taken to ensure adequate replacement of other blood components (clotting factors, electrolytes, platelets and red blood cells).

Hypervolemia may occur if the dose and rate of infusion are not adjusted according to the patient's circulatory status. At the first clinical signs of cardiovascular overload (headache, shortness of breath, jugular venous congestion) or in the event of increased blood pressure, increased venous pressure and pulmonary edema, the infusion should be stopped immediately.

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

The medicinal product contains a maximum of 1 mmol potassium per 100 ml vial of 200 g/l albumin solution and a maximum of 1.25 mmol potassium per 100 ml vial of 250 g/l albumin. Caution should be exercised when used in patients with reduced renal function or those on a controlled potassium diet.

Standard measures to prevent infections when medicinal products prepared from human blood or plasma include selection of donors, screening of individual blood donations and plasma pools for specific markers of infection and the inclusion of effective steps for the inactivation/removal of viruses in the manufacturing process. However, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded. This includes unknown or emerging viruses as well as other pathogens.

There are no reports confirming the transmission of viruses when using albumin manufactured in accordance with the requirements of the European Pharmacopoeia.

It is recommended that each time Albunorm is administered, the name of the drug and the batch number be recorded in order to track the effect of the drug of a particular batch on the patient.

Use during pregnancy or breastfeeding

The safety of Albunorm for pregnant women has not been studied in controlled clinical trials. However, experience with clinical use of albumin indicates that no harmful effects on the course of pregnancy or on the fetus and newborn should be expected.

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

The ability to influence the reaction speed when driving or working with other mechanisms

No effect on the ability to drive or use machines was observed.

Method of administration and doses

Albumin concentration, doses, and rate of administration should be adjusted according to the individual patient's needs.

Dosage

The required dose depends on the patient's weight, the severity of the injury or illness, and the degree of fluid and protein loss. Circulating blood volume, not plasma albumin levels, should be measured to determine the required dose.

If human albumin is prescribed, geodynamic parameters should be monitored regularly, including:

arterial blood pressure and pulse rate;

central venous pressure;

pulmonary artery wedge pressure;

diuresis;

electrolyte concentration;

hematocrit/hemoglobin;

clinical manifestations of cardiac/respiratory failure (e.g., shortness of breath);

clinical manifestations of increased intracranial pressure (e.g., headache).

Human albumin can be administered directly intravenously or dissolved 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, indicators and indications for use for the specific patient.

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

When administering large volumes, the drug should be warmed to room temperature or body temperature before use.

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

After opening the vial, the product should be used immediately! Any unused solution should be disposed of in accordance with local requirements.

Children

Data on the use of the drug in children are limited. The drug should be prescribed only when the benefits clearly outweigh the potential risks.

Overdose

Hypervolemia may occur if the dose and rate of administration are too high. At the first clinical signs of cardiovascular overload (headache, shortness of breath, swelling of the jugular veins) or increased blood pressure, with increased central venous pressure and pulmonary edema, the drug should be immediately discontinued and hemodynamic parameters should be carefully monitored.

Side effects

Minor allergic reactions such as facial flushing (flushing), hives, fever and nausea occur rarely. These reactions usually resolve quickly when the infusion rate is slowed or the drug is stopped. Severe reactions such as shock may occur very rarely. In the event of severe reactions, the infusion should be stopped immediately and appropriate therapy should be initiated.

The following undesirable side effects have been observed during the post-marketing period with human albumin solutions, the occurrence of which can also be expected when using the drug.

* Cannot be estimated based on available data.

For information on preventing the transmission of infectious agents through the drug, see the section "Special instructions for use".

Reporting of suspected adverse reactions

Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua/.

Expiration date

3 years. After opening the bottle, use the solution immediately.

Storage conditions

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

Store in the cardboard box to protect from light.

Keep out of reach of children.

Incompatibility

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

Packaging

50 or 100 ml of solution in a bottle. 1 bottle in a cardboard box.

Vacation category

According to the recipe.

Producer

1. Octapharma AB.

2. Octapharma.

3. Oktapharma Pharmaceutika Produktionsges. m.b.H..

4. Oktapharma Produktionsgesellschaft Deutschland mbH.

Location of the manufacturer and address of its place of business.

1. Lars Forssellsgata 23, Stockholm, 11275, Sweden.

2. 72 rue du Marshal Foch, 67380 Lingolsheim, France.

3. Oberlaaer Strasse 235, 1100 Vienna, Austria.

4. Wolfgang-Marguerre-Allee 1, Springe, Lower Saxony, 31832, Germany.