Albumin intravenously drip. Albumin - instructions for use. Albumin food black

Albumin (Latin name) is a solution of albumin protein isolated from human plasma. Appears as a clear white viscous liquid.

Used for intravenous administration complex treatment shock conditions. Albumin is intended for parenteral nutrition, is a partial substitute for blood plasma.

pharmachologic effect

An anabolic drug that compensates for the deficiency of albumin protein.

When used, Albumin is able to increase arterial pressure, compensate for the deficit in the volume of circulating blood, maintain oncotic blood pressure, promotes the transition of tissue fluid into the bloodstream.

Release form Albumin

Solutions with 5, 10, and 20% Albumin for intravenous administration.

Indications for the use of Albumin

According to the instructions, albumin should be used for the following pathological conditions and diseases:

Traumatic, toxic, hemorrhagic, purulent-septic, operational shock, hypovolemia;
Hypoproteinemia (reduced total protein in the blood);
Hypoalbuminemia (reduced protein content of albumin in the blood);
Severe forms of burns, which are accompanied by large losses of fluid and thickening of the blood;
Nephritis with nephrotic syndrome (kidney disease with massive loss of protein);
Hemolytic disease of the newborn;
Diseases of the liver, with a violation of the function of protein synthesis;
Ascites (fluid in the abdominal cavity);
Digestive disorders with protein malabsorption ( peptic ulcer with decompensated stenosis, impaired patency of anastomoses);
Respiratory distress syndrome in adults;
Prolonged purulent-septic diseases with the development of protein deficiency;
swelling of the brain;
Carrying out hemodialysis, therapeutic plasmapheresis;
Operations with artificial circulation.

Contraindications to the use of the solution

Contraindications to the use of Albumin are: thrombosis, chronic heart failure, ongoing bleeding, arterial hypertension, chronic renal failure, hypersensitivity to albumin protein, pulmonary edema, hypervolemia.

At chronic diseases heart, the drug should be used with caution, as there is a risk of developing acute heart failure.

According to the instructions, Albumin increases blood pressure due to positive oncotic activity. Therefore, after transfusion of the drug after operations and injuries, bleeding from damaged vessels may begin, which earlier due to low pressure didn't bleed. Mandatory control by the doctor during and after the infusion.

Instructions for use Albumin

A solution of 5, 10 and 20% Albumin is injected intravenously at a rate of 50-60 drops (3 ml) per minute.

The daily volume of administration of the albumin solution is 100-500 ml. For each patient, the dose is selected individually, depending on the severity of the condition, clinical picture and age of the patient. Usually a 10% solution of albumin is prescribed, the average dose is calculated based on the formula: 1-2 ml / kg. Intravenous administration carried out daily or every other day, until the effect is achieved.

20% Albumin is used in severe cases, it is important to observe the rate of infusion, as there may be congestion with faster administration of cardio-vascular system.

20% Albumin is contraindicated in elderly patients.

special instructions

Before using the Albumin solution, inspect the vial for sediment, suspension, discoloration. In the presence of such signs, the use of the drug is prohibited.

If the vial has not been completely used, then it cannot be reused. In order to prevent bacterial complications, cracked, damaged or pre-opened vials of Albumin should not be used.

Data from the label of Albumin, the results of the inspection of the vial and the procedure for its introduction are recorded in the medical history.

Side effects

When transfused with 5, 10, and 20% Albumin side effects occur extremely rarely.

emergence side effects as allergic reactions possibly in previously sensitized individuals (those who have already had albumin protein infusions). Also, allergic reactions can occur if the patient has a history of reactions after transfusion of plasma, vaccines and sera. Of the allergic complications, urticaria, Quincke's edema, fever, lowering blood pressure, anaphylactic shock may occur. If an allergic reaction occurs, the infusion of the Albumin solution must be stopped, and, without removing the needle from the venous vessel, the patient should be given antihistamines, cardiotonic agents, according to indications of glucocorticoids and vasopressors.

The use of Albumin in pregnant women

There is no information regarding the effect of Albumin on the fetus in pregnant women..

Experiments on the effect of the drug on the reproductive system have not been conducted. Therefore, the use of Albumin protein in pregnant women is possible according to strict indications.

Interaction with other drugs

The introduction of the drug Albumin is possible in conjunction with the transfusion of blood components (erythrocyte mass, whole blood), electrolyte solutions. Albumin should not be mixed with amino acid solutions, alcohol-containing solutions.

Storage conditions

Albumin solution should be stored in a refrigerator at a temperature of 2-10C.

After the expiration date, the use of the drug is prohibited.

Sincerely,

Albumin is a plasma-substituting substance that maintains oncotic blood pressure, increases blood pressure and BCC, and compensates for the deficiency of plasma albumin. Also, the drug increases the reserves of protein nutrition of tissues and organs.

Release form and composition

Albumin is available as a solution, solution for injection and solution for infusion. Main active substance is human albumin.

Indications for the use of Albumin

According to the instructions for Albumin, this drug is prescribed for the following diseases and conditions:

Shock of toxic, operational, purulent-septic, hemorrhagic, traumatic and hypovolemic nature;
Nephrotic syndrome with nephritis;
Hemolytic disease and hyperbilirubinemia in newborns;
Hypoproteinemia and hypoalbuminemia;
Severe burn, accompanied by dehydration and thickening of the blood;
Liver diseases with a violation of its albumin-synthesizing function;
Therapeutic plasmapheresis, hemodialysis;
Diseases gastrointestinal tract, causing violation digestion;
swelling of the brain;
Ascites;
Acute respiratory distress syndrome in adults.

Albumin is also used in operations involving cardiopulmonary bypass, as well as in the preparation of autologous blood components and preoperative hemodilution.

Contraindications

The drug is contraindicated for:

Hypersensitivity to the active substance;
Thrombosis;
Chronic anemia;
Prolonged internal bleeding;
pulmonary edema;
Chronic heart failure;
arterial hypertension;
Chronic kidney failure;
Hypervolemia.

Albumin is used with caution in the suppression of cardiac function, as there is a risk of developing acute heart failure.

Method of application and dosage of Albumin

Albumin is administered intravenously by jet or drip. The dose of the drug in each case is set individually, it depends on the indications, the clinical picture and the age of the patient. Most often it is 1-2 ml / kg of a ten percent solution. The drug is used daily or every other day until the effect is noticed.

Before using Albumin, remove the film from the bottle cap and immediately treat it with an antiseptic. It is important to carefully inspect the drug: if it looks cloudy, has changed color or contains a precipitate, it should not be used.

Side effects of Albumin

When using Albumin solution, side effects usually do not occur, but allergic reactions of varying severity may occur (urticaria, chills, fever, shortness of breath, anaphylactic shock, tachycardia, decreased blood pressure, pain at the waist). They are prone to patients who are at risk, who have intolerance to intravenous infusions, medicines, plasma substitutes, serums and vaccines.

If an allergic reaction or complication occurs, the infusion of the Albumin solution should be stopped immediately.

special instructions

To date, no experiments have been conducted to investigate the effect this drug on reproductive function, therefore, Albumin is prescribed with caution to pregnant women.

Albumin analogs

Analogues of this drug are Zenalb-20 and Plasmubin 20.

Dosage form: solution for infusion Composition:

1000 ml of the drug contains: 100 g of human plasma proteins, of which at least 97% human albumin; sodium caprylate 3 g; sodium chloride to the content of sodium ions 125 mmol; sodium hydroxide to pH 7.0; water for injection - up to 1000 ml.

Description: clear liquid yellow color, a greenish tint is allowed. Pharmacotherapeutic group:Plasma substitute ATX:

B.05.A.A.01 Albumin

Pharmacodynamics:

Albumin is an integral part of the protein fraction of human blood plasma. The albumin preparation compensates for the deficiency of albumin in the plasma, is a means of restoring colloid-oncotic pressure, disturbed central and peripheral hemodynamics (rapidly increases blood pressure and circulating blood volume, increasing the transition of tissue fluid into the bloodstream and contributing to its retention), water and electrolyte balance; due to the transport function, albumin promotes better absorption of drugs and has detoxification properties.

Pharmacokinetics:

Normally, the total exchange pool of albumin is 4-5 g/kg of body weight, while 40-45% is intravascular, and 55-60% is in the tissues. For conditions such as severe burns or septic shock, increased capillary permeability changes the kinetics of albumin and can cause itabnormal distribution. The albumin solution introduced into the vascular bed moves into the interstitial space. During the first 3 minutes from the moment of administration, a higher concentration of albumin in the spleen, liver and heart is determined. Complete distribution of albumin occurs after 10-15 minutes. The half-life of albumin averages 19 days, but critically ill patients may lose significant amounts of albumin; the rate of its exit from the vascular bed at the same time varies depending on the individual characteristics and the condition of the patient. Elimination occurs intracellularly with the participation of lysosomal proteases. The breakdown of albumin to amino acids with their subsequent use for the synthesis of the body's own proteins takes 50-60 days, so it is not advisable to use it for parenteral nutrition.

Indications:

hypovolemic shock, burn disease, surgical operations with the use of a heart-lung machine, purulent-septic conditions (including peritonitis, pancreatitis, mediastinitis or severe phlegmon), acute liver failure.

Contraindications:

Hypersensitivity to the components of the drug, severe anemia, chronic heart failure II - IV functional class by NYHA, hypervolemia.

Carefully:

Patients with arterial hypertension, renal failure, thrombosis, ongoing internal bleeding, chronic heart failure, the drug should be used with caution.

Pregnancy and lactation:

Albumin is a normal component of human plasma and is unlikely to adversely affect pregnancy, the fetus or newborn. At the same time, given that experimental studies of the effect of the drug on the reproductive function of animals, as well as clinical studies of the use of the drug in pregnant women and women during lactation, have not been conducted, albumin should be used during pregnancy and during breastfeeding only if the potential benefit to the mother outweighs the potential risk to the fetus or child.

The drug can be used in children.

Dosage and administration:

Individual, depending on the indications and the clinical situation. Usually, albumin is administered to adults 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 not more than 3 ml / kg.

The drug can be used in premature infants.

During therapy hypovolemic shock the applied volume and rate of albumin infusion should be adapted to the response of the individual patient. Hemodynamic parameters should be monitored and the usual precautions taken to avoid volemic overload of the circulatory system. The initial dose may be 25 g, (0.3-0.4 g of albumin or 3-4 ml of the drug per kg of body weight); inject no more than 250 g over 48 hours. The total dose should not exceed the level of albumin healthy person, i.e. approximately 2 g per kg of body weight in the absence of active bleeding. In children, a single dose can reach 0.5-1 g per kg of body weight.

During treatment burn disease the introduction of albumin begins no earlier than 24 hours after the thermal injury, since by this time the capillarypermeability. The ongoing therapy should maintain a plasma albumin concentration of 20-30 g/l and an oncotic pressure of 20 mm Hg. (which is 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 the treatment of burn disease, it is necessary to carefully monitor the state of hemodynamics and the patient's water and electrolyte balance.

For filling heart-lung machines apply albumin and crystalloid solutions to achieve a hematocrit level of 20% and an albumin concentration of 25 g / l.

At purulent-septic conditions depending on the severity of intoxication and the degree of hemodynamic disturbances, a 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, high level 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 a serum albumin of 25 g / l is reached, taking into account the general condition of the patient.

Method of administration: intravenously. The rate of administration should not exceed 40 drops per minute. Jet injection of albumin solution is acceptable for shocks various genesis to rapidly increase blood pressure.

Side effects:In rare cases, allergic reactions may develop, which may include urticaria, chills, fever, shortness of breath, tachycardia, lowering blood pressure, pain in the lumbar region. Overdose:

Symptoms:in cases where the dose and infusion rate of the drug are high or do not correspond to the individual parameters of the patient's blood circulation, hypervolemia and its characteristic symptoms of overload of the cardiovascular system (shortness of breath, swelling of the jugular veins, headache). It is also possible to increase arterial and / or central venous pressure, the development of pulmonary edema.

Relief measures: at the first manifestations of symptoms of overload of the cardiovascular system, the administration of the drug should be immediately stopped and constant monitoring of blood circulation parameters should be established. According to indications - carrying out symptomatic therapy. There are no specific antidotes.

Interaction: With the simultaneous use of albumin with ACE inhibitors, the risk of developing arterial hypotension. Albumin must not be mixed with solutions of amino acids, protein hydrolysates and solutions containing ethyl alcohol. special instructions:

The introduction of the drug should be accompanied by the control of hemodynamic parameters. Rapid administration should be avoided in elderly patients, as this may lead to an overload of the cardiovascular system.

The introduction of dehydration is possible only after prior provision of sufficient fluid intake (orally, parenterally).

With the introduction of an albumin solution, the concentration of sodium and potassium in the patient's blood plasma should be monitored and appropriate measures should be taken to restore or maintain the balance of these electrolytes.

With the introduction of relatively large volumes of the drug, it is necessary to monitor the indicators of the coagulation system, electrolyte balance, the level of platelets and erythrocytes, hematocrit, and their adequate correction.

Since the albumin preparation is able to effectively increase the colloid osmotic pressure, during its administration, the patient's condition should be monitored in order to prevent the development of volemic circulatory overload.

The introduction of albumin can affect the blood coagulation system, therefore, in patients with shock, if it is impossible to exclude the hemorrhagic nature of the shock, it is necessary to control the indicators of the hemostasis system.

The rapid increase in blood pressure that may follow drug transfusion may be accompanied by an increase in bleeding from those vessels that did not bleed at lower blood pressure, which requires control of surgical hemostasis.

In conditions accompanied by a pronounced violation of capillary permeability, use with caution.

Albumin solution, if necessary, can be diluted with saline or 5% dextrose (glucose). Water for injection should not be used for this purpose.

Before use, the drug should be warmed to room temperature or body temperature.

The drug is not suitable for use in containers with impaired integrity and labeling, when the solution is cloudy, in the presence of suspension or sediment.

The drug should be administered immediately after opening the vial. The unused residue of the drug must be disposed of.

When using medicinal products derived from human plasma, the risk of transmission cannot be completely excluded. viral infections.

Influence on the ability to drive transport. cf. and fur.:There was no effect of the drug on the ability to drive vehicles and other potentially dangerous mechanisms. Release form / dosage:Solution for infusions 10%. Package: 100 ml in glass bottles for blood, transfusion and infusion preparations with a capacity of 100 ml. Each bottle, along with instructions for use in a cardboard box. Storage conditions:At temperatures from 2 to 10 °C. Best before date: 5 years. Do not use after the expiry date stated on the package. Conditions for dispensing from pharmacies: On prescription Registration number: LS-002362 Date of registration: 08.10.2012 Expiration date: Perpetual Registration certificate holder:Kirov Research Institute of Hematology and Blood Transfusion of Roszdrav, FGU Russia Manufacturer: Information update date: 14.07.2017 Illustrated Instructions

Instructions for use

Active ingredients

Release form

Composition

1 ml solution for infusion contains: Human albumin 200 mg. Excipients: sodium caprylate, sodium chloride, water for injection

Pharmacological effect

Plasma-substituting (hydrating) Albumin is an integral part of the protein fraction of human blood. The drug is produced from donor plasma, tested for the absence of antibodies to human immunodeficiency viruses (HIV-1, HIV-2), hepatitis C virus and hepatitis B surface antigen. Albumin in the body performs the following main functions: hemodynamic (maintaining colloid-oncotic blood pressure), sorption-transport and the function of the body's main protein reserve. A 10% albumin solution is a weak hyperoncotic solution that maintains the oncotic pressure of the circulating blood. When it is used, fluid from the interstitial space is attracted and retained in the vascular bed, which increases and stabilizes blood pressure. Albumin binds and inactivates toxins, transports pigments (bilirubin), fatty acids, some metal ions inside the body, medicinal substances, improves tissue perfusion in diseases accompanied by hypoproteinemia, has a positive effect on the protein-synthesizing function of the liver

Pharmacokinetics

Normally, blood plasma contains 40-50 g / l of albumin, which is 55-60% of the total protein content. After internal administration of albumin, it takes 10-15 minutes for complete intravascular distribution. During the first 3 minutes from the moment of administration, a higher concentration of albumin in the spleen, liver and heart is determined. Albumin solution injected into the bloodstream in large numbers moves into the interstitial space. The biological half-life of serum albumin is 7 to 20 days. From 10 to 16 g of albumin is consumed daily in the body. Albumin is the main reserve protein of the body, its breakdown provides the possibility of synthesis of globulins and structural proteins of tissues and organs. The use of albumin preparations for parenteral nutrition is impractical, since its half-life in the body can reach 60 days.

Indications

Shock (traumatic, operative and toxic), burns accompanied by dehydration and thickening of the blood, hypoproteinemia and hypoalbuminemia, gastrointestinal lesions with indigestion (peptic ulcer, tumors, obstruction of the gastrointestinal anastomosis, etc.)

Contraindications

Hypersensitivity to human albumin. Severe forms of heart failure (due to the possible occurrence of acute heart failure). Thrombosis. Severe form of arterial hypertension. Ongoing internal bleeding. Hypervolemia. Pulmonary edema. Severe anemia. Edema of the brain. Pregnancy. Lactation. Precautions prescribed for: Renal failure. Bronchial asthma. allergic rhinitis. Quincke's edema

Precautionary measures

Before using the drug, the doctor registers the label data (name of the drug, manufacturer, batch number) in the patient's medical history. In the elderly, the rapid administration of a 10% solution of albumin should be avoided, as this can lead to an overload of the cardiovascular system. Before infusion, albumin solutions should be warmed to room temperature. The drug is not suitable for use in containers with impaired integrity or labeling, when changing physical properties(discoloration, turbidity of the solution, the presence of suspension, sediment), with expired suitability, improper storage

Use during pregnancy and lactation

During pregnancy, the use of human albumin is possible only in cases of emergency. Data on the safety of the use of human albumin during lactation are not available.

Dosage and administration

Dosing regimen Individual, depending on the indications and the clinical situation. A 10% albumin solution is administered intravenously by drip or jet. A single dose of the drug depends on the concentration of the albumin solution, the initial state and age of the patient. A 10% albumin solution is administered at a dose of 200-300 ml. The rate of administration of 10% albumin solution is not more than 40 drops per minute. Jet administration of albumin solutions is acceptable for shocks of various origins for a rapid increase in blood pressure. IN pediatric practice the dosage of albumin solutions is calculated taking into account the concentration in milliliters per kilogram of body weight (no more than 3 ml / kg of body weight of the child)

Side effects

From the side digestive system: possible nausea, vomiting, hypersalivation. From the side of the cardiovascular system: arterial hypotension, tachycardia. Allergic reactions: possible urticaria. Rarely - anaphylactic shock. Other: possible fever, pain in the lumbar region

Overdose

Symptoms: in cases where the dose and infusion rate are excessively high or do not correspond to the patient's blood circulation parameters, hypervolemia and its characteristic symptoms of overload of the cardiovascular system (shortness of breath, swelling of the jugular veins, headache) may develop. It is also possible to increase arterial and / or central venous pressure, the development of pulmonary edema. Treatment: at the first manifestations of symptoms of overload of the cardiovascular system, the administration of the drug should be immediately stopped and constant monitoring of blood circulation parameters should be established. According to the indications - symptomatic therapy. There are no specific antidotes

Interaction with other drugs

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

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 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 emerging viruses and other pathogens. The risk of transmission of infectious agents is reduced by screening plasma donors for possible infection certain viruses in the past, by currently testing for the 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 human patient, the name and lot number of the drug should be recorded in order to establish a link between the patient and the lot. Hemodynamics Do not administer without close hemodynamic monitoring, monitor for signs 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 insufficiency. The rate of administration should be adjusted according to 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 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, the drug should be stopped immediately. Pediatric Use Safety and Efficacy of Human Albumin Solution in Patients childhood has not been established, however, no additional risks have been identified from the use of this drug in children, in addition to the risks that exist when it is used in adults. Large volumes When replacing relatively large volumes, it is necessary to monitor the parameters of the coagulation system and the hematocrit level. Adequate replacement of other blood components (coagulation factors, electrolytes, platelets and red blood cells) must be ensured. It is necessary to strictly monitor hemodynamic parameters. Electrolyte status When administering Human Albumin, the patient's electrolyte status should be monitored and appropriate measures taken to restore and maintain electrolyte balance. Blood pressure An increase in blood pressure after infusion of Human Albumin necessitates careful monitoring of the patient after injury or after surgical intervention in order to detect 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 medicinal products, incl. with whole blood and blood components, however, it may be used as a concomitant agent if medically appropriate. Do not use if the solution becomes cloudy or the vial is not sealed. Preparations for parenteral administration should be visually inspected for the presence of particulate matter and discoloration before use, if the solution and container allow this. If leaks are found, the drug must be discarded. 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 with a concentration of 20% or more. Recommended solvents include 0.9% sodium chloride or 5% dextrose in water. Influence on the ability to drive vehicles and control 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.

**** Alteks, OOO Bayer Healthcare AG BAKSTER AG BELGORODSKAYA OSPK BIYSKAYA GSPK BIOMED Biomed named after I.I. Mechnikova, OJSC VOLOGODSKAYA OSPK GUZ VORONEZHSKAYA SPK GUZ GUZ Nizhny Novgorod region.st. blood transfusion YEKATERINBURG ENTERPRISE FOR THE PRODUCTION OF BAKPR Ivanovskaya Regional blood transfusion station ST. OVERFLOW BLOOD MICROGEN NPO FSUE Microgen NPO FSUE Ministry of Health and Social Development of Omsk Microgen NPO FSUE (Ekaterinburskoye Prospekt for PBP) Microgen NPO FSUE Ministry of Health and Social Development Russia/PharmV MICROGEN NPO FSUE (KHABAROVSKOE PPPBP) Microgen NPO, FSUE Ministry of Health of Russia Tomsk Microgen NPO, FSUE Ministry of Health PERM MICROGEN NPO, Federal State Unitary Enterprise of the Ministry of Health of Russia Ufa MICROGEN NPO, Federal State Unitary Enterprise of the Ministry of Health of Russia Nizhny Novgorod PASTERA Octapharma Pharmaceuticals Productionsges m.b.H. PKF "InterGRIM", CJSC Samara Regional Clinical Transfusion Station Sanofi-Aventis S.A. Talekris Biotherapy Inc. F.Hoffmann-La Roche Ltd/Pharmstandard-Leksredstva, OAO CHELYABINSK OBL.ST. BLOOD TRANSFUSIONS

Country of origin

Austria Russia UNITED STATES

Product group

Blood and circulation

Means for parenteral nutrition

Release form

100 ml - bottles (1) - packs of cardboard. 100 ml - bottles for blood substitutes (1) - packs of cardboard. 100 ml - bottles for blood substitutes (1) - packs of cardboard. 100 ml - bottles for blood and blood substitutes (1) - packs of cardboard. Solution for infusion 20%, 50 ml in a glass bottle) for blood, transfusion and infusion preparations. 1 bottle in a cardboard box along with instructions for use.

Description of the dosage form

Transparent solution of yellow, amber or greenish color. Clear yellow liquid. A greenish tint is allowed. Solution for infusions 10%

pharmachologic effect

Plasma-substituting agent obtained by fractionation of plasma, serum from healthy donors. Compensates for the deficiency of blood plasma albumin, maintains colloid-osmotic (oncotic) blood pressure, quickly increases blood pressure and BCC, promotes the transfer of fluid from tissues into the bloodstream, and has detoxification properties. Albumin is a natural protein, which is an integral part of the protein fraction of human blood, with a molecular weight of 69,000 daltons. Normally, albumin in human plasma is approximately 60%. The albumin protein molecule 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 effective tool correction of hypoalbuminemia of various origins, disturbed central and peripheral hemodynamics, water and electrolyte balance, 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.

Pharmacokinetics

The total exchange fraction of albumin is normally 4-5 g/kg of body weight; of which 40-45% are in the vascular bed, and 55-60% in the extravascular space. In pathological conditions such as severe burns or septic shock, a significant increase in capillary permeability disrupts the kinetics of albumin and can lead to its pathological distribution. The mean half-life of albumin is normally 19 days. The balance between synthesis and degradation is usually achieved through the mechanism feedback. Elimination occurs predominantly intracellularly with the participation of lysosomal proteases. In healthy individuals, less than 10% of intravenously administered albumin is excreted from the vascular bed during the first 2 hours after infusion. The effect on plasma volume is subject to significant individual variation. In some patients, plasma volume may remain elevated for several hours. However, critically ill patients may lose significant amounts of albumin, and the rate of its release from the vascular bed is unpredictable.

Special conditions

Use during pregnancy and during breastfeeding. The safety of albumin use during pregnancy has not been established in controlled clinical trials. but clinical experience the use of albumin does not give reason to expect any harmful effects on the course of pregnancy, fetus or newborn. Animal reproductive toxicity studies of albumin have not been conducted. Experimental data on animals are insufficient to assess safety in relation to reproduction, embryofetal development, the course of pregnancy, peri- and postnatal development. Albumin is a normal protein constituent of human blood. If an allergic or anaphylactic reaction is suspected, the administration of the drug should be stopped immediately. 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 anti-shock therapy. Albumin should be used with caution if hypervolemia and its consequences or hemodilution may pose a risk 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 the elderly, the use of concentrated 20% albumin solution and rapid administration of 10% albumin solution should be avoided, as this can lead to an overload of the cardiovascular system. The colloid osmotic effect of human albumin at a dosage of 20% is approximately four times greater than that of plasma. Therefore, when administering concentrated albumin solutions, proper hydration of the patient (by mouth and parenterally) should be ensured. Careful monitoring of the patient's condition is necessary to avoid circulatory overload and overhydration. The content of electrolytes in solutions of human albumin with a dosage of 20-25% is relatively lower than in solutions of albumin with a dosage of 4-5%. With the introduction of albumin, it is necessary to monitor the electrolyte status of the patient (see subsection "Dosing 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 control of blood coagulation and hematocrit is necessary. Special attention should be given 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 circulatory state of the patient, hypervolemia may develop. At the first signs of an 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, the administration of the drug should be stopped immediately. The production of products from human blood or plasma includes a set of measures to prevent the transmission of infections to patients. Such measures include careful selection of blood and plasma donors to ensure that donations are not made from individuals at risk, testing of each unit of blood or plasma and plasma pool for viruses/infections. Manufacturers of these drugs also take steps to process blood or plasma to inactivate or remove viruses. Despite compliance with these precautions, the risk of transmission of infection, including unknown or newly discovered viruses or other types of infection, cannot be completely eliminated when medicinal products are made from human blood or plasma is administered. For each dose of albumin medicinal product, it is strongly recommended to record its name and batch in order to preserve its identity. Influence on the ability to drive vehicles and mechanisms. Does not affect the ability to drive vehicles and mechanisms.

Composition

1 ml 1 vial human albumin 100 mg 10 g 1 ml 1 vial human albumin 100 mg 10 g human albumin 20 g Albumin obtained from plasma for fractionation with the addition of sodium caprylate, sodium chloride, water for injection. Human albumin - in 1 ml - 200 mg (in 1 vial - 20 g)

Albumin indications for use

Shock (traumatic, operational, toxic); burns, accompanied by dehydration and "thickening" of the blood; acute blood loss; purulent-septic conditions; liver disease (with impaired albumin-synthesizing function); kidney damage (nephritis, nephrotic syndrome). Hypoproteinemia, hypoalbuminemia of various origins, developing with alimentary dystrophy, a decrease in plasma albumin below 30 g / l, or a level of colloid-oncotic pressure below 15 mm Hg. Art., or with a decrease in total protein below 50 g / l; damage to the gastrointestinal tract with impaired absorption or patency. During operations using cardiopulmonary bypass; therapeutic plasmapheresis; hemolytic disease newborns during exchange transfusion. During preoperative hemodilution and harvesting of autologous blood components; with cerebral edema.

Albumin contraindications

thrombosis, arterial hypertension, ongoing internal bleeding, severe anemia, severe forms heart failure hypersensitivity to human albumin.

Albumin dosage

10 % 20% 5%, 10%, 20%

Albumin side effects

The introduction of an albumin solution, as a rule, is not accompanied by adverse reactions and complications. In some previously sensitized patients, allergic reactions may occur. varying degrees gravity. Possibility (very rare) adverse reactions and complications are not excluded in patients at risk, i.e. having a history of intolerance to intravenous infusions of protein preparations and other plasma substitutes, drugs, sera, vaccines. In case of reactions or complications, the transfusion of the albumin solution should be immediately stopped and, without removing the needle from the vein, antihistamines, cardiotonic drugs, glucocorticosteroids, vasopressors should be administered (if indicated).

drug interaction

Interaction of human albumin with others medicines not installed. Albumin should not be mixed with other medicinal products (with the exception of isotonic solutions, for example, 5% dextrose solution or 0.9% sodium chloride solution), blood or red blood cells.

Overdose

At high dose or the rate of administration of the drug, hypervolemia may develop. At the first signs of an 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, the administration of the drug should be immediately stopped and constant monitoring of blood circulation parameters should be established.

Storage conditions

keep away from children
store in a place protected from light

Information provided