Human albumin, 20% 50 ml

Quantitatively, human albumin represents more than half of the total plasma protein and accounts for about 10% of the protein-synthesizing activity of the liver.

Human albumin has a hyperoncotic effect. The main physiological functions of albumin are related to its contribution to the regulation of blood oncotic pressure and to its transport function. Albumin is a carrier of hormones, enzymes, drugs and toxinova also normalizes the volume of circulating blood.

Pharmacokinetics

In normal conditions, the total metabolic pool of albumin is 4-5 g/kg body weight, with 40-45% being intravascular and 55-60% in the tissues. In body conditions such as severe burns or septic shock, increased capillary permeability alters albumin kinetics and may cause abnormal distribution. Normally, the average T_1/2 albumin is about 19 days. The balance between albumin synthesis and cleavage is usually accomplished through a feedback mechanism. The elimination process is predominantly carried out intracellularly by lysosomal proteases.

In healthy individuals, less than 10% of albumin injected intravenously leaves the intravascular space within the first 2 h. There is considerable individual variability in the effect of albumin infusion on plasma volume. In some patients, plasma volume may remain increased for several hours. However, in patients in critical conditions, albumin may leave the vascular bed in significant amounts and at an unpredictable rate.

Preclinical safety data

Human albumin is a natural component of human plasma and acts similarly to physiological albumin.

The single-dose toxicity study in animals is of little relevance and does not assess toxic or lethal dose or dose-effect relationships.

The study of multiple dose toxicity in animals is not feasible due to the formation of antibodies to the heterogeneous protein.

To date, there are no data regarding embryonic and fetal toxicity, carcinogenic and mutagenic effects of human albumin. Animal studies have also shown no evidence of acute toxicity.

Indications

Restoration and maintenance of circulating blood volume in case of insufficient volume and the advisability of using colloids, incl. Human albumin can be used for the following clinical conditions:

shock – for emergency treatment in case of shock and in other similar conditions when urgent restoration of circulating blood volume is required;
burns – albumin either in an isotonic solution or in a dextrose solution to prevent pronounced hemoconcentration and maintain the required electrolyte balance;
hypoproteinemia with or without edema – in clinical situations usually associated with low plasma protein concentrations and leading to a decrease in circulating blood volume;
hypoalbuminemia – when the lack of albumin is the result of insufficient synthesis, excessive catabolism, loss due to burns or injuries, or as a result of redistribution within the body.

Pharmacological effect

Quantitatively, human albumin represents more than half of the total plasma protein and accounts for approximately 10% of the protein-synthesizing activity of the liver.

Human albumin has a hyperoncotic effect. The main physiological functions of albumin are associated with its contribution to the regulation of blood oncotic pressure and transport function. Albumin is a carrier of hormones, enzymes, drugs and toxins and also normalizes the volume of circulating blood.

Pharmacokinetics

Normally, the total metabolic pool of albumin is 4-5 g/kg body weight, with 40-45% located intravascularly, and 55-60% in the tissues. In conditions such as severe burns or septic shock, increased capillary permeability alters albumin kinetics and may cause abnormal albumin distribution. Normally, the average T1/2 of albumin is about 19 days. The balance between albumin synthesis and breakdown is usually achieved through a feedback mechanism. The elimination process occurs predominantly intracellularly under the action of lysosomal proteases.

In healthy individuals, less than 10% of albumin administered intravenously leaves the intravascular space within the first 2 hours. There is significant interindividual variability in the effect of albumin infusion on plasma volume. In some patients, the blood plasma volume may remain elevated for several hours. However, in critically ill patients, albumin can leave the vascular bed in significant quantities and at an unpredictable rate.

Preclinical safety data

Human albumin is a natural component of human plasma and functions similarly to physiological albumin.

Single-dose toxicity studies in animals are of limited value and do not assess the toxic or lethal dose or dose-effect relationship.

Repeated dose toxicity studies in animals are not feasible due to the formation of antibodies to the heterogeneous protein.

To date, there is no information regarding the embryonic and fetal toxicity, carcinogenic and mutagenic effects of human albumin. Animal studies also showed no evidence of acute toxicity.

Special instructions

Allergic reactions/anaphylactic shock

Any suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the drug. If shock develops, standard antishock therapy should be used.

Because this drug is made from human blood plasma, it may carry a risk of transmitting infectious agents, such as viruses and, theoretically, Creutzfeldt-Jakob disease. This also applies to unknown or new viruses and other pathogens.

The risk of pathogen transmission is reduced by screening plasma donors for possible past exposure to certain viruses, by testing for current infection with certain viral infections, and by inactivating and/or removing certain viruses. The measures taken are considered effective for enveloped viruses such as HIV, hepatitis B virus, hepatitis C virus, as well as for non-enveloped viruses such as hepatitis A virus and parvovirus B19. It is strongly recommended that each time Human Albumin is administered to a patient, the name and batch number of the drug are recorded in order to establish a connection between the patient and the batch of the drug.

Hemodynamics

Do not administer without careful monitoring of hemodynamic parameters, monitor for the 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 in which hypervolemia and its consequences or hemodilution may pose a particular risk to the patient. Examples of such conditions are: decompensated heart failure, hypertension, varicose veins, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and postrenal failure. The rate of administration should be selected in accordance with the concentration of the solution and the hemodynamic parameters of the patient. Rapid administration may result in circulatory overload and pulmonary edema. At the first clinical signs of overload of the cardiovascular system (headache, shortness of breath, blockage of the jugular veins) or increased blood pressure, increased pressure in the central vein and pulmonary edema, administration of the drug should be stopped immediately.

Application in pediatric practice

The safety and effectiveness of human Albumin solution in pediatric patients has not been established, however, no additional risks of using this drug in children, in addition to the risks that exist when using it in adults, have not been identified.

Large volumes

When replacing relatively large volumes, it is necessary to monitor the parameters of the coagulation system and hematocrit level. It is necessary to ensure adequate replacement of other blood components (clotting factors, electrolytes, platelets and red blood cells). It is necessary to strictly monitor hemodynamic parameters.

Electrolyte status

When administering human Albumin, the patient’s electrolyte status should be monitored, and the necessary measures should be taken to restore and maintain electrolyte balance.

Blood pressure

The increase in blood pressure after infusion of human Albumin necessitates careful monitoring of the patient after injury or after surgery in order to identify and treat damaged vessels that might not bleed at lower blood pressure.

Application, handling and disposal

Human Albumin solution should not be mixed with other drugs, incl. with whole blood and blood components, but may be used as a concomitant drug if medically appropriate.

Do not use if the solution becomes cloudy or the seal of the bottle is broken. Before use, preparations for parenteral administration should be visually inspected for the presence of mechanical inclusions and color changes, if the solution and container allow this. If leaks are detected, the drug must be thrown away.

There is a risk of hemolysis, with potentially fatal consequences, as well as a risk of acute renal failure when using sterile water for injection to dilute human albumin at concentrations of 20% or higher. Recommended solvents include 0.9% sodium chloride or 5% dextrose in water.

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 a car and work with other machines and mechanisms.

Active ingredient

Human albumin

Composition

1 ml
human blood plasma proteins
200 mg,
incl. human albumin
no less than 96%

Excipients:

sodium chloride,

acetyltryptophan,

caprylic acid,

hydrochloric acid,

sodium hydroxide,

water d/i.

Pregnancy

There are no data on the use of human albumin in pregnant women and during lactation. Before prescribing the drug in each specific case, doctors should carefully evaluate the potential risks and benefits of using human Albumin.

Use in children

The safety and effectiveness of human Albumin solution in pediatric patients has not been established, however, no additional risks of using this drug in children, in addition to the risks that exist when using it in adults, have not been identified.

Contraindications

allergic reactions to albumin or any of the excipients.

Solutions of human Albumin cannot be diluted with water for injection, because this may cause hemolysis in recipients. There is a risk of hemolysis, with a potentially fatal outcome, as well as a risk of acute renal failure due to the inappropriate use of sterile water for injection for reconstitution of human Albumin.

Human albumin should be used with caution in conditions in which hypervolemia and its consequences or hemodilution may pose a particular risk to the patient. Examples of such conditions are: decompensated heart failure, hypertension, varicose veins, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and postrenal failure.

Use for renal impairment

Human albumin should be used with caution in conditions in which hypervolemia and its consequences or hemodilution may pose a particular risk to the patient. Examples of such conditions are: renal and postrenal failure.

Side Effects

Adverse adverse reactions according to clinical studies

There are no data on adverse reactions in controlled clinical studies of human Albumin.

Post-marketing adverse reactions

The following adverse reactions have been reported post-marketing. These reactions are listed by system organ class (SOC) using the preferred Medical Dictionary for Regulatory Activities (MedDRA) terms in descending order of severity:

From the immune system: anaphylactic shock, anaphylactic reactions, hypersensitivity/allergic reactions.

From the side of the central nervous system: headache.

From the cardiovascular system: if it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided; tachycardia, decreased blood pressure, flushing.

From the respiratory system: shortness of breath.

From the digestive system: vomiting, nausea, dysgeusia.

From the skin: urticaria, rash, itching.

Local reactions: fever, chills.

Interaction

Interaction studies of human Albumin with other drugs have not been conducted (unknown due to the lack of relevant data in clinical studies, medical literature and safety reports).

Overdose

Significantly exceeding the dose and increasing the rate of administration can lead to hypervolemia.

Storage conditions

Store the drug at a temperature of 2° to 25°C. Do not freeze. Keep out of reach of children

Shelf life

3 years. Do not use after the expiration date stated on the package

Manufacturer

Octapharma AG, Austria