Human albumin 20% solution for infusion 200 mg/ml bottle 50 ml


Albumin

Individual, depending on the indications and clinical situation. Typically, adults are administered albumin at a dose of 2-4 ml (0.2-0.4 g) per kg of body weight daily or every other day until a therapeutic effect is achieved; for children, the usual single dose is no more than 3 ml/kg.

The drug can be used in premature infants.

When treating hypovolemic shock

the volume and rate of albumin infusion used should be tailored to the individual patient's response. It is necessary to monitor hemodynamic parameters and observe the usual precautions to prevent volume overload of the circulatory system. The initial dose can be 25 g (0.3-0.4 g albumin or 3-4 ml of the drug per kg body weight); no more than 250 g are administered over 48 hours. The total dose should not exceed the albumin level of a healthy person, i.e. approximately 2 g per kg body weight in the absence of active bleeding. In children, a single dose can reach 0.5-1 g per kg of body weight.

In the treatment of burn disease

albumin administration begins no earlier than 24 hours after thermal injury, since by this time capillary permeability is usually normalized. The therapy should maintain plasma albumin concentration at 20-30 g/l and oncotic pressure 20 mmHg. (equivalent to a total protein concentration of 52 g/L). The duration of therapy is determined by the dynamics of protein loss from burned areas and in the urine. At all stages of treatment of burn disease, it is necessary to carefully monitor the patient’s hemodynamics and water-electrolyte balance.

For filling heart-lung machines

albumin and crystalloid solutions are used until a hematocrit level of 20% and an albumin concentration of 25 g/l are achieved.

For purulent-septic conditions

depending on the severity of intoxication and the degree of hemodynamic disturbances, the single dose can be increased to 7 ml of the drug (0.7 g of albumin) per kg of body weight.

The use of albumin in the treatment of patients with acute liver failure

aims to maintain oncotic pressure and relieve intoxication caused, among other things, by high levels of bilirubin. Therapy begins with a single dose of 25 g (0.3-0.4 g of albumin or 3-4 ml of the drug per kg of body weight) and continues until serum albumin reaches 25 g/l, taking into account the general condition of the patient.

Method of administration:

intravenously. The rate of administration should not exceed 40 drops per minute. Injection of albumin solution is acceptable for shocks of various origins to quickly increase blood pressure.

Albumin, 1 piece, 100 ml, 10%, solution for infusion

If you suspect an allergic or anaphylactic reaction, you must immediately stop administering the drug. In case of shock, it is necessary to take standard measures of anti-shock therapy, for which the premises where the drug is administered must be provided with means of anti-shock therapy.

Albumin should be used with caution if hypervolemia and its consequences or hemodilution may pose a danger to the patient.

Examples of such conditions are:

  • decompensated heart failure;
  • arterial hypertension;
  • varicose veins of the esophagus;
  • pulmonary edema;
  • hemorrhagic diathesis;
  • severe anemia;
  • renal and postrenal anuria.

In elderly people, the use of concentrated albumin solution 20% and rapid administration of albumin solution 10% should be avoided, as this can lead to overload of the cardiovascular system.

The colloid osmotic effect of human albumin at a dosage of 20% is approximately four times higher than that of plasma. Therefore, when administering concentrated albumin solutions, the patient should be properly hydrated (orally and parenterally). Careful monitoring of the patient's condition is necessary to avoid circulatory overload and overhydration.

The electrolyte content in human albumin solutions with a dosage of 20-25% is relatively lower than in albumin solutions with a dosage of 4-5%. When administering albumin, it is necessary to monitor the patient's electrolyte status (see subsection "Dosage Regimen") and take appropriate measures to restore or maintain electrolyte balance.

Albumin solutions should not be diluted with water for injection, as this may lead to hemolysis in the recipient.

With extensive replacement therapy, monitoring of blood coagulation and hematocrit is necessary. Particular attention should be paid to the proper replacement of other blood components (clotting factors, electrolytes, platelets and red blood cells).

If the dose and rate of administration of the drug do not correspond to the patient’s circulatory condition, hypervolemia may develop. At the first signs of overload of the cardiovascular system (headache, shortness of breath, swelling of the jugular veins) or an increase in arterial and central venous pressure and pulmonary edema, administration of the drug should be stopped immediately.

The production of drugs from human blood or plasma includes a set of measures to prevent the transmission of infections to patients. These measures include careful selection of blood and plasma donors to ensure that individuals at risk are not donated, and testing of each unit of blood or plasma and plasma pool for viruses/infections. Manufacturers of these drugs also take steps to treat blood or plasma to inactivate or remove viruses. Despite these precautions, when preparing medicinal products from human blood or administering plasma, the risk of transmission of infection, including unknown or recently discovered viruses or other types of infection, cannot be completely eliminated.

When administering each dose of an albumin drug, it is strongly recommended that the name and batch be recorded to maintain records of the drug.

Impact on the ability to drive vehicles and machinery.

Does not affect the ability to drive vehicles and machinery.

Albumin solution d/inf 20% 50ml

Compound

Active substance: 1 ml human blood plasma proteins 200 mg, incl. human albumin is not less than 96%. Excipients: sodium chloride, acetyltryptophan, caprylic acid, hydrochloric acid, sodium hydroxide, water for injection.

Pharmacokinetics

Under normal conditions, the average half-life is 19 days. The balance between synthesis and elimination is usually achieved by regulating the response.

If albumin is replenished externally, equilibrium is established within approximately 48 hours of drug administration. After 1-3 hours of infusion, an increase in circulating blood volume is established due to the diffusion of fluid from the interstitial space.

Indications for use

  • Hypovolemic shock;
  • burns;
  • hypoproteinemia with or without concomitant tissue edema (after major surgery, in sepsis);
  • acute respiratory distress syndrome in adults (with volume overload combined with the use of diuretics);
  • acute liver failure (to maintain oncotic pressure and bind excess plasma bilirubin);
  • hemolytic disease of newborns (in order to bind free bilirubin);
  • when removing biological fluids rich in protein (ascites, peritonitis, mediastinitis);
  • resuspension of red blood cells;
  • acute nephrosis (together with diuretics in the absence of effect from steroid therapy);
  • hemodialysis (with the development of hypovolemic shock and hypotension during the session).

Contraindications

  • Chronic heart failure degree II-III;
  • severe anemia;
  • hypervolemia;
  • pulmonary edema;
  • hypersensitivity to albumin or any components of the drug.

Directions for use and doses

Individual, depending on the indications and clinical situation.

Storage conditions

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

Best before date

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

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.

Conditions for dispensing from pharmacies

On prescription.

Dosage form

Solution for infusion.

Use in children

Possible use depending on the clinical situation.

Pharmacodynamics

A plasma replacement agent obtained by fractionating plasma and serum from healthy donors. Replenishes the deficiency of blood plasma albumin, maintains colloid-osmotic (oncotic) blood pressure, quickly increases blood pressure and blood volume, promotes the transition of fluid from tissues to the bloodstream, and has detoxification properties. Albumin is a natural protein that is an integral part of the protein fraction of human blood, with a molecular weight of 69,000 daltons. Normally, albumin makes up approximately 60% of human blood plasma. The protein molecule albumin contains all 20 amino acids. Albumin synthesis occurs in the liver. Albumin performs a number of functions in the body. Its main function is to maintain colloid-oncotic blood pressure. Albumin solution 100 mg/ml is an effective means of correcting hypoalbuminemia of various origins, impaired central and peripheral hemodynamics, water-electrolyte balance, and has detoxification properties. Albumin binds and transports pigments (bilirubin), fatty acids, certain metal ions, and medicinal substances into the body. In addition, albumin binds toxins and inactivates them.

Side effects

From the digestive system: nausea, vomiting, hypersalivation are possible.

From the cardiovascular system: arterial hypotension, tachycardia.

Allergic reactions: possible urticaria; rarely - anaphylactic shock.

Other: possible increase in body temperature, pain in the lumbar region.

Use during pregnancy and breastfeeding

During pregnancy, the use of human albumin is possible only in cases of extreme necessity. There are no data on the safety of human albumin during lactation.

Interaction

With simultaneous use of human albumin with ACE inhibitors, the risk of developing arterial hypotension increases.

Overdose

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

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.

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