Human albumin, 20% 50 ml

The drug Albumin human is recommended for restoration and maintenance of circulating blood volume when the volume and appropriateness of colloidal solutions are insufficient.

The choice of the drug Albumin human instead of synthetic colloidal solutions is determined by the clinical condition of the patient, as well as the standards of medical care.

The drug Albumin human may be used for the following clinical conditions:

• shock – in emergency therapy in case of shock and other similar conditions when urgent restoration of circulating blood volume is required;
• Burns – to prevent severe hemoconcentration and maintain the necessary electrolyte balance (drug Albumin human in an isotonic solution (5% solution of dextrose or 0.9% sodium chloride solution);hypoproteinemia with or without edema – in clinical situations usually associated with low plasma protein concentrations and resulting in reduced circulating blood volume;
• hypoalbuminemia – when albumin deficiency has resulted from insufficient synthesis, excessive catabolism, loss due to burns, trauma or due to redistribution within the body.

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Active ingredient

Composition

Active ingredient:

Human albumin – the solution contains 200 g/l total protein (at least 95% albumin) produced from human plasma.

Auxiliary substances:

Caprylic acid 16 mmol/L

N-acetyltryptophan 16 mmol/L

Water for injection up to 1 L

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The total sodium ion content is 100 – 130 mmol/L

The solution is hyperoncotic.

How to take, the dosage

The drug Albumin human is administered intravenously undiluted or pre-diluted in isotonic solution (5% dextrose solution or 0.9% sodium chloride solution).

The dose of Human Albumin and the rate of administration are chosen individually according to the indication and the patient’s condition

The dose required for administration depends on the patient’s weight, the severity of the injury or disease and the ongoing loss of fluid and protein. The dose required for administration is based on measures of circulating blood volume adequacy, not on plasma albumin concentration.

When administering Human Albumin, hemodynamic parameters, respiratory function should be monitored to prevent pulmonary edema, as well as the neurological status of the patient to prevent increase in intracranial pressure:

He blood pressure and pulse rate,

central venous pressure,

pulmonary artery occlusion pressure,

diuresis,

electrolyte concentration,

p>hematocrit/hemoglobin,

clinical signs of heart/pulmonary failure (e.g., dyspnea),

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

If the dose and rate of administration of human albumin solution is selected without regard to the concentration and condition of the patient, administration of human albumin solution can lead to hypervolemia. In patients receiving human albumin therapy, hemodynamic parameters should be monitored to prevent the development of hypervolemia and cardiovascular overload. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular vein swelling), as well as at high blood pressure, increased central venous pressure and at the development of pulmonary edema, the infusion should be stopped immediately. (See section “Special Precautions and Precautions for Use”). When performing therapeutic plasma exchange, the rate of administration of albumin solution should be correlated with the rate of plasma removal.

Application in children

The safety and effectiveness of Human Albumin in children has not been studied in controlled, company-sponsored clinical trials. However, the use of albumin solutions in children has been described in the medical literature.

Human Albumin should not be mixed with other medications or with whole blood and blood components; however, it may be used consistently if medically advisable.

Human Albumin must not be diluted with water for injection as this may cause hemolysis in patients. Human Albumin must not be mixed with protein hydrolysates or solutions containing alcohol because this may cause precipitation of proteins.

No other medicinal products should be added to Human Albumin.

Interaction

Special Instructions

Impact on the ability to drive vehicles and operate machinery

There are no data on the effect of human albumin on the ability to drive and on the ability to work with other machines and mechanisms that require extra attention.

DIRECTIONS AND WARNINGS FOR USE

Allergic reactions / anaphylactic shock

Allergic reactions / anaphylactic shock.

In case of suspected allergic or anaphylactic reactions, the drug administration should be stopped immediately and appropriate treatment should be started. In case of shock, antishock therapy should be initiated in accordance with current treatment standards.

Hemodynamics

Human Albumin should be administered with close monitoring of hemodynamic parameters for development of symptoms of cardiac or respiratory failure, renal failure or increased intracranial pressure.

Hypervolemia/hemodilution

Human Albumin should be used with caution in conditions where hypervolemia and its consequences or hemodilution may pose a particular risk to the patient, particularly in decompensated heart failure, arterial hypertension, esophageal varices, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and postrenal anuria.

The colloid-osmotic effect of human albumin solution at a concentration of 200 g/l is approximately four times greater than that of blood plasma. Therefore, when administering concentrated albumin solution, adequate hydration of the patient should be ensured. Careful monitoring is necessary to prevent cardiovascular overload and hyperhydration.

The infusion rate of human Albumin should be adjusted to the concentration of the infusion solution and hemodynamic parameters. If the infusion rate does not correspond to the patient’s condition, hypervolemia and pulmonary edema may develop. If the first clinical signs of cardiovascular overload appear (headache, dyspnea, jugular vein swelling), if blood pressure rises, central venous pressure rises or if pulmonary edema develops, the infusion should be stopped immediately.

Higher volumes

If relatively large volumes of fluid need to be reimbursed, coagulation parameters and hematocrit should be monitored. Adequate replacement of other blood components (clotting factors, electrolytes, platelets and erythrocytes) should be ensured and hemodynamic parameters should be closely monitored.

The drug should be warmed to room temperature or body temperature before administering large amounts.

Electrolyte status

When administering Human Albumin, the patient’s electrolyte status should be monitored (see section “Dosage and administration”) and appropriate measures should be taken to restore and maintain electrolyte balance. Human Albumin contains 100-130 mmol/l of sodium, which must be taken into account when using in patients on a low-salt diet.

Arterial Blood Pressure

Human Albumin infusion requires close monitoring of the patient who has had trauma or surgery to look for damaged blood vessels that may not have bled at lower blood pressures, and to take appropriate action.

Infection prevention

. Standard measures to prevent infections arising from the use of drugs produced from human plasma or blood include donor selection, screening individual donor portions and plasma pools for specific markers of infection, and the use of effective virus inactivation/removal measures during production. Despite this, the possibility of transmission of an infectious agent cannot be completely ruled out when administering drugs produced from human blood or plasma. This also applies to unknown or new viruses and other pathogens.

There have been no reports of virus transmission with human Albumin produced according to European Pharmacopoeia specifications using standard processes.

Whenever Human Albumin is administered, it is highly recommended that the trade name and series number of the product be recorded to understand the relationship between the patient and the specific product series.

Pharmaceutical Incompatibilities

Human Albumin must not be mixed with other medications (except the recommended solvents listed under “Dosage and Administration”), whole blood and red blood cell mass. Human albumin should also not be mixed with protein hydrolysates, particularly parenteral nutrition solutions or solutions containing alcohol, as this may lead to precipitation of proteins.

Application and disposal

The drug should not be used if the solution is cloudy, the vial is not sealed or leaks are detected. Preparations for parenteral administration should be visually checked for mechanical inclusions and discoloration before use, if the color of the solution and the material of the container allow to do so Human Albumin does not contain preservatives, so the contents of the bottle should be used immediately after opening. Unused residue of the drug should be disposed of in accordance with local requirements.

If sterile water for injection is used to dilute Human Albumin at a concentration of 20% or higher, there is a potential risk of fatal hemolysis and acute renal failure. Suitable diluents are 5% dextrose solution or 0.9% sodium chloride solution.

Synopsis

Contraindications

Hypersensitivity to human albumin or any other component of the drug.

WARNING

. Human Albumin should be used with caution in conditions where hypervolemia and its consequences or hemodilution may pose a particular risk to the patient, particularly in decompensated heart failure, arterial hypertension, esophageal varices, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and postrenal anuria.

Side effects

Unwanted effects observed in clinical studies

Human Albumin has not been reported as an adverse adverse reaction in controlled clinical studies sponsored by the company.

adverse effects observed during post-marketing use

. During post-marketing use of Human Albumin, the following adverse reactions were noted, listed according to the Organ System Classification (SOC) using the preferred terms of the Medical Dictionary of Regulatory Affairs (MedDRA), in descending order of severity of occurrence.

Disorders of the immune system: anaphylactic shock, anaphylactic reactions, hypersensitivity/allergic reactions

Nervous system disorders: headache, dysgeusia

Cardiovascular system disorders: myocardial infarction, atrial fibrillation, tachycardia, hypotension, hyperemia

Respiratory system, chest and mediastinum disorders: pulmonary edema, dyspnea

Disorders withthe gastrointestinal tract: vomiting, nausea

Skin and subcutaneous tissue disorders: rash, rash, itching

General disorders and reactions at the injection site: hyperthermia, chills

For safety information regarding transmissible agents, see “Special Precautions and Precautions for Use.”

Overdose

Pregnancy use

The safety of human albumin in pregnant and breastfeeding women has not been studied in controlled clinical trials. However, clinical experience with human albumin, a natural component of human blood, suggests that there are no adverse effects on pregnancy, the fetus or the newborn.

The effect of human albumin on fertility has not been studied in controlled clinical trials.

Human albumin has not been used in animal fertility studies.

The results of experimental animal studies are insufficient to evaluate the safety of human albumin in relation to reproduction, embryonic or fetal development, the course of pregnancy, and peri- and postnatal development. The physician must carefully evaluate the possible risks and benefits of human albumin product before prescribing in each individual case.