Clinical and pharmacological group: & nbsp

Substitutes for plasma and other blood components

Means for enteral and parenteral nutrition

Included in the formulation
  • Albionin 20%
    solution d / infusion 
    Biotest Pharma GmbH     Germany
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Albumen
    solution d / infusion 
  • Human serum albumin
    solution d / infusion 
    Green Cross Corporation     The Republic of Korea
  • Human albumin
    solution d / infusion 
    Baxter AG     Austria
  • Human albumin
    solution d / infusion 
  • Alburex®
    solution d / infusion 
    CESEL Behring AG     Switzerland
  • Zenalb®-20
    solution d / infusion 
  • Zenalb-4,5
    solution d / infusion 
  • Plazbumin®-20
    solution d / infusion 
  • Uman albumin
    solution d / infusion 
    Kedrion SpA     Italy
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    B.05.A.A.01   Albumen

    Pharmacodynamics:

    The mechanism of action is plasma-replacing; Albumin is an important regulator of circulating blood volume, which accounts for 70-80% of the colloidal oncotic plasma pressure, antihyperbilirubinemic - reversible binding with endogenous and exogenous substances, including bilirubin, fatty acids, hormones, enzymes, drugs, pigments and trace elements.

    Pharmacokinetics:Distribution in the extracellular space, more than 60% goes beyond the vascular bed. The half-life (elimination) period is 15-20 days. Half-life (intravascular) is 24 hours.
    Indications:Shock (traumatic, operating and toxic), burns accompanied by dehydration and thickening of blood, hypoproteinemia and hypoalbuminemia, gastrointestinal disorders with digestive disorders (peptic ulcer, tumors, gastrointestinal obstruction obstruction, acute hemorrhagic pancreatitis or peritonitis with effusion of fluid into the peritoneal cavity and others), purulent-septic conditions, liver diseases with violation of albumin function, kidney disease (nephritis, nephrotic syndrome).

    XI.K20-K31.K26   Duodenal ulcer

    XI.K20-K31.K25   Stomach ulcer

    XI.K70-K77.K74   Fibrosis and cirrhosis of the liver

    IV.E70-E90.E86   Reduction of the volume of the liquid

    IV.E70-E90.E87   Other violations of water-salt metabolism or acid-base balance

    IV.E70-E90.E88.0   Disorders of plasma protein metabolism, not elsewhere classified

    XVIII.R50-R69.R57   Shock, not elsewhere classified

    XVIII.R50-R69.R57.1   Hypovolemic shock

    XIX.T79.T79.4   Traumatic shock

    XIX.T20-T32.T30   Thermal and chemical burns, unspecified

    XIX.T80-T88.T81.1   Shock during or after the procedure, not elsewhere classified

    Contraindications:Thrombosis, severe hypertension, ongoing internal bleeding, severe heart failure.

    Hypersensitivity, severe anemia, hypervolemia, pulmonary edema.

    Carefully:Arterial hypertension, normal albumin concentration (can lead to overload volume and development of arterial hypertension), renal insufficiency (aluminum, present in albumin as an admixture, can accumulate and cause anemia, encephalopathy, hypercalcemia and vitamin D-resistant osteomalacia), chronic heart failure.
    Pregnancy and lactation:

    FDA recommendations in category C. Adequate and well-controlled studies in humans and animals have not been conducted.

    There is no information on the penetration into breast milk, complications in humans are not documented.

    Dosing and Administration:

    Intravenous drip or stream. A single dose of the drug depends on the concentration of the albumin solution, the initial condition and the age of the patient. Solutions of albumin 5-10% are administered in a dose of 200-300 ml, if necessary, a dose of 5% solution can be increased to 500-800 ml.

    A solution of albumin 5% is administered at a rate of not more than 50-60 drops per minute. A single dose of 20% albumin is 100 ml. Solutions of albumin 10-20% are injected at a speed of not more than 40 drops per minute. Correction of the rate of 5-20% albumin is carried out depending on the patient's hemodynamic response. It is possible to inject albumin solutions in a shock of various genesis in order to rapidly increase blood pressure. In elderly patients, the use of concentrated (20%) solutions and rapid administration of 5-10% albumin should be avoided, as this can lead to an overload of the cardiovascular system.

    Hypovolemia - 25 g of albumin (500 ml of 5% albumin or 100 ml of 25% albumin) is intravenously dripped with the maximum tolerated rate.Repeat if no adequate response occurred within 15-30 minutes.

    Hypoproteinemia - 50-75 g of albumin (25% solution) at a rate of 100 ml for 30-40 minutes. For slow infusion, 50 g of albumin in 300 ml of 10% glucose at a rate of 100 ml / h.

    Burns - therapy begins with the introduction of large volumes of crystalloids that support the volume of plasma. After 24 hours, albumin can be added in an initial dose of 25 g, and then the dose is ditched to maintain a concentration of albumin in the plasma of 25 g / l or a protein concentration of 52 g / l.

    Acute nephrotic syndrome - 25 g of albumin in the form of a 25% solution is administered in combination with diuretics 1 time per day for 7-10 days.

    Extracorporeal circulation - 5% or 25% albumin in combination with crystalloids (priming the device before use) to achieve albumin concentration in plasma 25 g / l or hematocrit 20%.

    Ascites - to maintain cardiovascular function after laparocentesis and remove large volumes of fluid: 4-8 g of albumin per 1 liter of removed ascites fluid.

    Hemodialysis (with long-term hemodialysis and a tendency to shock and hypotension or to treat shock or hypotension in hypervolemic patients who do not tolerate large amounts of crystalloids) - intravenously 25 g of albumin as a 25% solution.

    Dilution after transfusion of erythrocyte mass - 20-25 g of albumin in the form of 25% solution per 1 liter of erythrocyte mass.

    Treatment plasmapheresis - 5% albumin with a plasma loss of more than 20 ml / kg during one procedure or more than 20 ml / kg per week with multiple plasmapheresis.

    Use in children

    5% albumin - acute or subacute plasma loss, for example, with burns, pancreatitis, trauma or complications of operations, plasma exchange. Hypovolemia - 2.5-12.5 g or 0.5-1.0 g / kg intravenously drip with the maximum tolerated patient rate. Repeat if there is no adequate response in 15-30 minutes. Burns - begin with the introduction of crystalloids to maintain the volume of plasma. After 24 hours, albumin may be added at an initial dose of 25 g, and then the dose is dispensed to maintain a concentration of albumin of 25 g / l or a protein concentration of 52 g / l.

    20% albumin - severe hypoalbuminemia, accompanied by a reduced volume of plasma, generalized edema, when it is necessary to limit the intake of salt and water in the composition of plasma-substituting solutions; as an addition to blood transfusion in the treatment of hyperbilirubinemia in newborns (1 g / kg 1-2 hours before or during an exchange blood transfusion to bind and remove bilirubin).

    Side effects:

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

    From the cardiovascular system: arterial hypotension, tachycardia. Heart failure, especially in people with impaired cardiovascular function. Decreased myocardial contractility, pulmonary edema, salt and water retention. More often in patients who received large volumes of crystalloids before the introduction of albumin.

    Allergic reactions: possible hives, skin rashes; rarely anaphylactic shock.

    Other: possible increase in body temperature, chills, pain in the lumbar region, breathing disorders. The transmission of infection - suggest that albumin preparations carry the potential risk of transmission of viral and subviral particles, especially Creutzfeldt-Jakob disease.

    Overdose:

    With a high dose or speed of administration, hypervolemia may develop.

    Treatment is symptomatic.

    Interaction:

    Water: human albumin can not be diluted with water for injections as this may lead to acute hemolysis and acute renal failure.

    Protein hydrolyzates for parenteral nutrition: incompatibility.

    Verapamil hydrochloride: incompatibility.

    Ethanol-containing solutions: incompatibility.

    Amino acid solutions: incompatibility.

    Fatty emulsions: incompatibility.

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

    Special instructions:

    Patients with severe dehydration require additional fluid when 25% albumin is administered. Transfusion of whole blood or erythrocyte mass is necessary after infusion of large volumes of albumin in order to restore hemoglobin concentration and prevent anemia.

    Albumin was not effective in the treatment of chronic cirrhosis or nephrosis. Albumin does not contain the necessary amino acids, so it is not recommended for parenteral nutrition. When used in large quantities can increase the catabolism of endogenous albumin.

    Prepare 5% albumin from 25% albumin, diluting one volume of 25% albumin in 4 volumes of 0.9% sodium chloride or 5% glucose. When diluting concentrated albumin before infusion, only 0.9% sodium chloride or 5% glucose. Cases of severe hemolysis and renal insufficiency were registered in the background of plasmapheresisintroduction of 25% albumin, diluted to 5% albumin with distilled water, in one case the outcome was lethal. Although 5% of glucose is considered an acceptable solvent, when diluting 25% of albumin and using the resulting solution to compensate for fluid loss after plasmapheresis, or when co-administered with erythrocyte mass, hemolysis may develop. The introduction of large volumes of such a solution can lead to hyponatremia. Therefore, some clinicians recommend using only 0.9% sodium chloride, except for patients at risk of sodium overdose, or when it is necessary to maintain a concentration of glucose in the blood.

    The use of albumin in critically ill patients is currently controversial.

    5% albumin creates an equivalent oncotic pressure and increases the volume of circulating blood in the volume of albumin, 25% albumin creates a pressure 5 times greater than the oncotic plasma pressure and increases the blood volume by approximately 3.5 times compared to the volume of albumin administered. Albumin causes a temporary increase in blood volume, accompanied by hemodilution and a decrease in blood viscosity.

    Store at a temperature of 15-30 ° C (unless otherwise specified by the manufacturer). Do not freeze! Do not use turbid solutions or solutions containing precipitate. Albumin does not contain preservatives and should be used within 4 hours after the depressurization of the vial. Unused residues of the albumin solution must be destroyed.

    Impact on the ability to drive vehicles and manage mechanisms

    Does not affect the ability to manage vehicles and mechanisms.

    Instructions
    Up