Human albumin 200 g/l

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HUMAN ALBUMIN 200 g/l (UMANALBUMIN 200 g/l)

Composition:

Active substance: Human Albumin Solution;

in 1000 ml of the preparation contains:

plasma proteins containing not less than 95% albumin 200 g/l;

Excipients:

sodium chloride

sodium caprylate

acetyltryptophan (N-Acetyl-DL-tryptophan)

water for injections

total sodium concentration 123.5–136.5 mmol/l.

Pharmaceutical form. Infusion solution.

Main physico-chemical properties: clear, slightly viscous liquid, practically colorless, yellowish, amber or greenish.

Pharmacotherapeutic group. Plasma expanders and plasma protein fractions. Albumin. ATC code B05A A01.

Pharmacological properties.

Pharmacodynamics.

Human albumin quantitatively accounts for more than half of the total plasma protein and approximately 10% of the protein synthesized by the liver.

HUMAN ALBUMIN 200 g/l exerts a corresponding hyperoncotic effect.

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

Pharmacokinetics.

Under normal conditions, the total exchange volume of albumin is 4–5 g/kg body weight, of which 40–45% is intravascular and 55–60% is in the extravascular space. Increased capillary permeability alters albumin kinetics, and abnormal distribution may occur in conditions such as severe burns or septic shock.

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

In healthy individuals, less than 10% of administered albumin leaves the intravascular space 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, in critically ill patients, albumin may be lost from the vascular compartment in significant amounts and at unpredictable rates.

Clinical characteristics.

Indications.

Used for the restoration and maintenance of circulating blood volume in the presence of volume deficit and when colloid administration is indicated.

The use of albumin or artificial colloids depends on the clinical condition of the specific patient according to official recommendations.

Contraindications.

Hypersensitivity to albumin preparations or to any of the excipients of the medicinal product.

Special safety precautions.

The solution may be administered intravenously either undiluted or after dilution with isotonic solution (e.g., 5% glucose solution or 0.9% sodium chloride solution).

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

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

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

After opening the vial, the contents should be used immediately.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use

Traceability

To improve traceability of biological medicinal products, it is recommended that the name and batch number of the product be recorded whenever the product is administered to a patient.

If an allergic or anaphylactic reaction is suspected, administration of the product must be stopped immediately. In the event of shock, standard anti-shock measures should be implemented.

Albumin should be used with caution in patients at particular risk of developing hypervolemia and its consequences or hemo­dilution. Examples of such conditions include:

• decompensated cardiac insufficiency;
• arterial hypertension;
• esophageal varices;
• pulmonary edema;
• hemorrhagic diathesis;
• severe anemia;
• renal and post-renal anuria.

The colloidal osmotic effect of HUMAN ALBUMIN 200 g/l is approximately four times higher than that of blood plasma. Therefore, when administering concentrated albumin, care must be taken to ensure adequate hydration of the patient. The patient’s condition must be closely monitored to prevent circulatory overload and hyperhydration.

The 200 g/l human albumin solution has a relatively low electrolyte content compared to human albumin solutions with concentrations of 40–50 g/l. Electrolyte balance in patients should be monitored (see section "Dosage and administration") 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 in patients.

When replacing relatively large blood volumes, coagulation and hematocrit must be monitored. Care should be taken to ensure appropriate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).

If hematocrit falls below 30%, erythrocyte concentrate should be administered to maintain blood oxygen-carrying capacity.

If dosage and infusion rate do not correspond to the patient’s circulatory status, hypervolemia may develop. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular vein distension) or increased arterial pressure, elevated venous pressure, or pulmonary edema, administration of the product must be stopped immediately.

Important information on excipients of HUMAN ALBUMIN 200 g/l

This medicinal product contains up to 157 mg of sodium in a 50 ml vial and 314 mg of sodium in a 100 ml vial, corresponding to 7.85% and 15.7% of the WHO recommended maximum daily sodium intake for adults of 2 g, respectively.

Viral safety

Standard measures to prevent transmission of infections with medicinal products derived from human blood or plasma include careful donor selection, screening of individual plasma donations and plasma pools for specific infection markers, and the use of effective methods for virus inactivation/removal during manufacturing. Nevertheless, when administering medicinal products manufactured from human blood or plasma, the possibility of transmitting infectious agents cannot be completely excluded. This also applies to unknown or new viruses and other pathogens.

There are no data indicating transmission of viruses with albumin properly manufactured in accordance with the European Pharmacopoeia specifications.

It is strongly recommended to record the name and batch number of the product each time HUMAN ALBUMIN 200 g/l is administered to a patient, in order to establish a link between the patient and the product batch.

Use during pregnancy or breastfeeding.

The safety of HUMAN ALBUMIN 200 g/l in pregnant women has not been established in controlled clinical trials. However, clinical experience with albumin use has not revealed any harmful effects on pregnancy, the fetus, or the newborn.

Special attention is generally required when replacing circulating blood volume in a pregnant patient.

Studies on the effect of HUMAN ALBUMIN 200 g/l on animal reproductive function have not been conducted.

At the same time, human albumin is a normal component of human blood.

Ability to affect reaction speed when driving or operating machinery.

HUMAN ALBUMIN 200 g/l has no effect or a negligible effect on the ability to drive or operate machinery.

Administration and Dosage

The albumin concentration, dosage, and infusion rate must be adjusted according to the individual patient's needs.

Dosage

The required dose depends on the patient's body weight, the severity of trauma or illness, and the duration of fluid and protein loss. When calculating the required dose, therapy should be guided by the adequacy of circulating blood volume, rather than by plasma albumin concentration.

During administration of 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 concentrations;
• hematocrit/hemoglobin.

HUMAN ALBUMIN 200 g/l may be administered to dialysis patients, as the aluminum content in the finished medicinal product does not exceed 200 μg/l.

Route of Administration

Human albumin may be administered directly intravenously or may be diluted with 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.

When used for plasma replacement, the infusion rate should be adjusted according to the rate of fluid loss.

HUMAN ALBUMIN 200 g/l must be administered intravenously by a physician or a qualified medical nurse.

Children

The safety and efficacy of HUMAN ALBUMIN in children have not been established in controlled clinical trials. The safety of using 20 % HUMAN ALBUMIN in neonates has not been established.

Overdose

If dosage or infusion rate is too high, hypervolemia may occur. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular vein distension) or increased arterial pressure, elevated central venous pressure, or pulmonary edema, administration of the drug must be stopped immediately and hemodynamic parameters should be closely monitored. In addition, diuresis or cardiac output should be increased as appropriate to the severity of the clinical condition.

Adverse Reactions

Summary of safety profile

Minor reactions are rarely observed, such as facial flushing (hot flush), urticaria, increased body temperature (fever), and nausea. These reactions usually resolve quickly by slowing down the rate of infusion or by temporarily stopping the infusion.

Severe reactions, such as shock, may very rarely occur. In such cases, the infusion must be stopped immediately and appropriate treatment initiated.

Table of adverse reactions

The adverse effects that may occur during administration of human albumin solutions are listed in the table below, classified according to MedDRA system organ classes and preferred terms.

The frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data).

Confirmed data on the frequency of adverse reactions from clinical trials are lacking.

The information provided below is based on the safety profile of human albumin and supported by post-marketing experience. Since post-marketing adverse reaction reports are voluntary and derived from a population of unknown size, it is not possible to reliably estimate their frequency.

Safety information regarding transmissible agents is provided in the section "Special precautions for use".

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national reporting system.

Shelf life.

3 years from the date of manufacture, provided the packaging has not been damaged and storage conditions have been fully observed.

Storage conditions.

Store at a temperature not exceeding 30 ºC.

Keep in the original packaging to protect from light.

Do not freeze!

Keep out of the reach and sight of children!

Storage conditions must be strictly observed!

Incompatibilities.

HUMAN ALBUMIN 200 g/l must not be mixed with other medicinal products (except those specified in the section "Method of administration and dosage"), whole blood or packed red blood cells.

Packaging.

50 ml or 100 ml of solution in a vial; 1 vial in a cardboard box with labeling in Ukrainian.

Prescription status.

Prescription only.

Manufacturer.

KEDRION S.P.A.

Manufacturer's address.

Via Provinciale (Loc. Bolgianona) – 55027 Galllicano (LU), Italy

Marketing Authorization Holder.

KEDRION S.P.A.

Address of the Marketing Authorization Holder.

Località Ai Conti, Castelvecchio Pascoli, 55051 Barga, Lucca (LU), Italy