Albumin Octapharma AG human infusion solution 20% vial, 50ml

Composition

Auxiliary substances:

sodium chloride,

acetyltryptophan,

caprylic acid,

hydrochloric acid,

sodium hydroxide,

d/i water.

Pharmacological action

In quantitative terms, human albumin represents more than half of the total plasma protein, accounting for approximately 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 oncotic blood pressure and its transport function. Albumin is a carrier of hormones, enzymes, drugs and toxins, and also normalizes the volume of circulating blood.

Pharmacokinetics

Normally, the total exchange pool of albumin is 4-5 g / kg of body weight, with 40-45% located intravascular, and 55-60% in the tissues. In conditions such as severe burns or septic shock, increased capillary permeability changes the kinetics of albumin and can cause its abnormal distribution. Normally, the average T_1/2 of albumin is about 19 days. The balance between albumin synthesis and degradation is usually achieved through a feedback mechanism. The elimination process is mainly carried out intracellularly under the action of lysosomal proteases.

In healthy subjects, less than 10% of intravenous 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, the blood plasma volume may remain elevated for several hours. However, in patients in critical conditions, albumin can leave the vascular bed in significant quantities and at an unpredictable rate.

Preclinical safety data sheet

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

The study of single-dose toxicity in animals is of little significance and does not allow us to assess the toxic or lethal dose or the relationship between dose and effect.

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

To date, there is no information on the embryonic and fetal toxicity, carcinogenic and mutagenic effects of human albumin. There were also no signs of acute toxicity in animal studies.

Indications

Restoring and maintaining the volume of circulating blood in case of insufficient volume and expediency of using colloids, including human albumin, can be used in the following clinical conditions: :

• shock – when emergency treatment in case of shock, and other conditions that require urgent restoration of circulating blood volume;
• burns – or albumin in saline solution or dextrose solution to prevent severe hemoconcentration and maintain electrolyte balance;
• hypoproteinemia with or without edema edema in clinical situations that are usually associated with a low concentration of protein of blood plasma and leading to a decrease of circulating blood volume;
• hypoalbuminemia – when the lack of albumin was a consequence of insufficient synthesis, excess catabolism, loss due to burns or trauma or as a result of redistribution within the body.

Use 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 should carefully assess the potential risks and benefits of using human Albumin.

Use in children

The safety and efficacy of human albumin solution in paediatric patients has not been established, but no additional risks of using this drug in children, other than the risks that exist when using it in adults, have been identified.

Contraindications

• allergic reactions to albumin or any of the excipients.

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

Human albumin should be used with caution in conditions where 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.

Use in patients with impaired renal function

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

Side effects

Adverse side effects according to clinical studies

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

Adverse side effects reported in the post-marketing period

In the post-marketing period, the following adverse reactions were reported: These reactions are listed by organ system class (SOC) using the preferred terms of the Medical Dictionary for Regulatory Affairs (MedDRA) in descending order of severity:

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

From the central nervous system:  headache.

From the cardiovascular system:  if you need to use the drug during lactation, you should decide whether to stop breastfeeding; tachycardia, decreased blood pressure, hot flashes.

Respiratory system disorders:  shortness of breath.

From the digestive system:  vomiting, nausea, dysgeusia.

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

Local reactions:  fever, chills.

Interaction

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

How to take, course of use and dosage

The dose of the administered solution of human albumin is determined individually. When human Albumin is administered, the patient’s hemodynamic parameters and breathing 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 medicinal products, including whole blood and blood components, but it can be used as a concomitant agent, if it is medically appropriate.

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

Do not add other medications.

If the dose and rate of use are not adjusted for the concentration of the solution and the clinical status of the patient, use of human Albumin may lead to hypervolemia.

In patients receiving human albumin, it is necessary to monitor hemodynamic parameters to prevent the occurrence of hypervolemia and overload of the cardiovascular system.

Overdose

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

Special instructions

Allergic reactions/anaphylactic shock

Any suspected allergic or anaphylactic reaction requires immediate discontinuation of the drug. In case of shock, standard anti-shock therapy should be used.

Since this drug is made from human blood plasma, it can carry the risk of transmitting infectious agents, such as viruses and, theoretically, the causative agent of Creutzfeld-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, and hepatitis C virus, as well as for non-enveloped viruses such as hepatitis A virus and parvovirus B19. It is strongly recommended that each use of human Albumin to a patient should record the name and batch number of the drug 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 where 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. The rate of use should be selected in accordance with the concentration of the solution and the hemodynamic parameters of the patient. Rapid use can lead to circulatory overload and pulmonary edema. At the first clinical signs of cardiovascular overload (headache, shortness of breath, blocked jugular veins) or increased blood pressure, increased pressure in the central vein and pulmonary edema, the drug should be discontinued immediately.

Application in pediatric practice

The safety and efficacy of human albumin solution in paediatric patients has not been established, but no additional risks of using this drug in children, other than the risks that exist when using it in adults, have been identified.

Large volumes

When replacing relatively large volumes, it is necessary to monitor the parameters of the coagulation system and the level of hematocrit. Adequate replacement of other blood components (clotting factors, electrolytes, platelets, and red blood cells) should be provided. Hemodynamic parameters should be strictly monitored.

Electrolyte status

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

Blood pressure

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

Application, handling and disposal

Human albumin solution should not be mixed with other medicinal products, including whole blood and blood components, but it can be used as a concomitant agent, if it is medically appropriate.

Do not use in case of turbidity of the solution or violation of the tightness of the bottle. Preparations for parenteral use should be visually examined for mechanical inclusions and discoloration before use, if the solution and container allow this. If leaks are detected, the product must be discarded.

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

Influence on the ability to drive motor vehicles and manage 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.

Form of production

Solution

Storage conditions

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

Shelf

life is 3 years. Do not use after the expiration date indicated on the package

Active ingredient

Human albumin

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Purpose

Children as prescribed by a doctor, Adults

Indications

Bleed