Albumin solution for infusion 20%, 50ml

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

• shock - in emergency treatment in case of shock and in other similar conditions, when an urgent restoration of the circulating blood volume is required;

• burns - albumin either in isotonic solution or in dextrose solution to prevent severe hemoconcentration and maintain the required electrolyte balance;

• hypoproteinemia with or without edema - in clinical situations, usually associated with a low concentration of plasma protein and leading to a decrease in circulating blood volume;

• hypoalbuminemia - when the lack of albumin was the result of insufficient synthesis, excessive catabolism, loss due to burns or injuries, or as a result of redistribution within the body.

The dose of the administered solution of human albumin is determined individually. With the introduction of human albumin, the patient's hemodynamic parameters and respiration should be monitored to prevent pulmonary edema. In addition, the patient's neurological status should be monitored to prevent an increase in intracranial pressure.

Human albumin solution should be administered intravenously. Human albumin solution should not be mixed with other drugs, incl. whole blood and blood components, but it can be used as an adjunct if medically appropriate.

Human albumin solution should not be diluted with water for injection, because this can cause hemolysis in patients. Human albumin solution should not be mixed with protein hydrolysates or solutions containing alcohol, because such combinations can result in protein precipitation.

Do not add other medicines.

If the dose and rate of administration are not selected taking into account the concentration of the solution and the clinical status of the patient, the administration of human albumin can lead to hypervolemia.

In patients receiving human albumin, hemodynamic parameters must be monitored to prevent the occurrence of hypervolemia and overload of the cardiovascular system.

The solution for infusion is transparent, slightly viscous, almost colorless, with a yellowish, brownish or greenish tint.

1 l

human blood plasma proteins 200 g,?

incl. human albumin at least 96%

Excipients: sodium caprylate - 2.7 g (16 mmol / l), sodium acetyltryptophan - 2.7 g (16 mmol / l), sodium chloride - 3 g, water d / i - up to 1 l.

• Allergic reactions to albumin or any of the excipients.

Human albumin solutions should not be diluted with water for injection, because this can cause hemolysis in recipients. There is a risk of potentially fatal hemolysis, as well as a risk of acute renal failure due to the inappropriate use of sterile water for injection to dilute human albumin.

With caution, Human Albumin should be used 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 insufficiency.

pharmachologic effect

In quantitative terms, human albumin represents more than half of the total plasma protein, it accounts for approximately 10% of the protein-synthesizing activity of the liver.

Human albumin has a corresponding hyperoncotic effect. The most important physiological functions of albumin are related to its contribution to the regulation of oncotic blood pressure, as well as its transport function. Albumin stabilizes the circulating blood volume and is a carrier of hormones, enzymes, drugs and toxins.

Pharmacokinetics

Normally, the total exchange pool of albumin is 4-5 g / kg of body weight, with 40-45% being intravascular, and 55-60% in tissues. In conditions of the body such as severe burns or septic shock, increased capillary permeability alters the kinetics of albumin and can cause its abnormal distribution. Normally, the average T1 / 2 of albumin is about 19 days. The balance between synthesis and degradation of albumin is usually accomplished through a feedback mechanism. The elimination process is carried out mainly intracellularly under the action of lysosomal proteases.

In healthy people, less than 10% of injected iv albumin leaves the intravascular space within the first 2 hours. There is significant individual variability in the effect of albumin infusion on plasma volume. In some patients, plasma volume may remain increased 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 naturally occurring component of human plasma and acts in a similar manner to physiological albumin.

The study of toxicity of a single dose in animals is of little value and does not allow assessing the toxic or lethal dose or the relationship between dose and effect.

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

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

Side effect

Adverse Adverse Reactions According to Clinical Trials

There are no data on adverse reactions in controlled clinical trials of human albumin.

Post-marketing Adverse Reactions

In the post-marketing period, the following adverse reactions have been reported. These reactions are listed by System Organ Class (SOC) using preferred Medical Dictionary for Regulatory Action (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 side of the cardiovascular system: if it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be resolved; tachycardia, lowering blood pressure, flushing.

From the respiratory system: shortness of breath.

From the digestive system: vomiting, nausea, dysgeusia.

From the side of the skin: urticaria, rash, itching.

Local reactions: fever, chills.

Application during pregnancy and lactation

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 must carefully assess the potential risks and benefits of using Human Albumin.

Application for impaired renal function

With caution, Albumin human should be used 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 post-renal failure.

Application in children

The safety and efficacy of human albumin solution in pediatric patients has not been established, however, no additional risks of using this drug in children, except for the risks that exist when using it in adults, have not been identified.

special instructions

Allergic reactions / anaphylactic shock

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

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

The risk of transmission of infectious agents is reduced by screening plasma donors for possible infection with certain viruses in the past, by testing for the current presence of 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 non-enveloped viruses such as hepatitis A virus and parvovirus B19. It is strongly recommended that each time Albumin is administered to a patient, the name and batch number of the drug should be recorded in order to establish a link between the patient and the batch of the drug.

Hemodynamics

Do not administer without careful monitoring of hemodynamic parameters, monitor the development of symptoms of heart 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 infusion rate should be selected in accordance with the concentration of the solution and the hemodynamic parameters of the patient. Rapid administration can lead to circulatory overload and pulmonary edema. At the first clinical signs of an 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 efficacy of human albumin solution in pediatric patients has not been established, however, no additional risks of using this drug in children, except for 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 indicators of the coagulation system and the level of hematocrit. It is necessary to ensure adequate replacement of other blood components (coagulation factors, electrolytes, platelets and erythrocytes). It is necessary to strictly monitor hemodynamic parameters.

Electrolyte status

With the introduction of human albumin, the electrolyte status of the patient should be monitored, and the necessary measures should be taken to restore and maintain the balance of electrolytes.

Blood pressure

The increase in blood pressure after the infusion of Human Albumin necessitates careful monitoring of the patient after trauma or after surgery in order to detect and treat damaged vessels that may 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 it can be used as an adjunct if medically appropriate.

Do not use if the solution is cloudy or the bottle is not tight. Preparations for parenteral administration before use should be visually inspected for the presence of mechanical impurities and discoloration, if the solution and container allow this. If leaks are found, discard the product.

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 a concentration of 20% or higher. Recommended solvents include 0.9% sodium chloride solution or 5% dextrose in water.

Influence on the ability to drive vehicles and use mechanisms

There are no data on the effect of human albumin on the ability to drive a car and work with other machines and mechanisms.

Overdose

A significant excess of the dose and an increase in the rate of administration can lead to hypervolemia.

Drug interactions

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).