Storage conditions albumin. Albumin: instructions for use

Albumin - what is it? It is a solution of albumin protein, which is isolated from human plasma and is a clear, viscous liquid. white... Use it for intravenous administration in complex therapy shock states. Albumin is intended for parenteral nutrition and is a partial substitute for blood plasma. Let us consider in more detail the composition, release form of Albumin, instructions for the use of this drug.

Composition and form of release

The drug is presented in the form of 5, 10 and 20% solution for infusion, which is produced in glass bottles or ampoules. Solution bottles should be sealed with rubber stoppers. Both ampoules and bottles are placed in cardboard boxes, and the ampoule packaging is supplemented with an ampoule knife.

Albumin contains the main active substance- human protein albumin, which is isolated from blood plasma. In addition, the composition of the Albumin preparation is supplemented with auxiliary substances: sodium caprylic acid,.

pharmachologic effect

The active ingredient helps to transport many substances in the body. The necessary compounds, as well as toxins that are to be utilized, enter into a reversible interaction with these blood proteins, and then are transported to the organ in which they will then be processed.

Albumin protein is necessary to regulate such an important indicator as oncotic blood pressure. In addition, it eliminates the plasma albumin deficiency and leads to a rapid increase in circulating blood volume.

Indications for use

The drug Albumin has the following indications for use:

• liver pathology;
• nephrotic syndrome with nephritis;
• severe burns, accompanied by blood thickening and dehydration;
• hypoproteinemia and hypoalbuminemia;
• hypovolemic, hemorrhagic, operational, purulent-septic, toxic and traumatic shock;
• swelling of the brain;
• therapeutic plasmapheresis, hemodialysis;
• ascites;
• gastrointestinal diseases;
• hemolytic disease and hyperbilirubinemia in newborns.

Moreover, this drug is prescribed for operations, accompanied by artificial circulation, during hemodilution before surgical intervention and preparation of autologous blood components. It is inappropriate to use the product for chronic nephrosis, because Albumin does not have time to exert its effect on kidney damage, since the kidneys immediately eliminate it.

The drug Human Albumin is rarely used for acute nephrosis. The use of infusions as a source of protein for patients suffering from liver cirrhosis, pancreatitis and intestinal malabsorption is not at all justified.

Contraindications

Human albumin cannot be taken with the following diseases:

The drug should be taken with caution when the function of the heart is suppressed, since there is a high probability that acute heart failure will develop. As stated in the instructions, it increases arterial pressure... Therefore, after its infusion after injuries and operations, bleeding often opens from damaged vessels, which, due to low pressure, did not previously bleed.

The drug cannot be used if it looks cloudy and has been frozen. If the solution has not been used up to the end, then it cannot be reused. To prevent possible bacterial contamination, it is forbidden to use vials that are cracked, damaged or were previously opened.

Method of administration and dosage of Albumin

The solution for infusion, namely its concentration and dosage, is selected individually by the doctor. It depends on body weight, injury, severity of illness, and loss of fluid and protein.

According to the instructions for use, the drug must be administered intravenously drip... The recommended single dosage for a 5% solution is 200-300 ml, and the maximum allowable dosage is 500-800 ml.

Usually the doctor prescribes a 10% solution of the drug. The average dose is calculated using the following formula: 1-2 ml / kg. The agent is administered intravenously every day or every other day until a positive result is achieved. A twenty percent solution is used in severe cases. It should not be used by elderly patients.

It is important to control the rate of infusion, because its rapid introduction can disrupt function. of cardio-vascular system.

Albumin can be used during pregnancy only under strict doctor's indications, since there is no reliable information about how the drug affects the fetus.

Side effects

When using the drug side effects usually do not occur.

In previously sensitized individuals side effects can manifest as allergic reactions: shortness of breath, urticaria, chills, tachycardia, lowering blood pressure, fever, pain in the lumbar region, anaphylactic shock. In addition, people who are at risk are prone to complications and allergies. These are patients with a history of information that they cannot tolerate intravenous injections of vaccines, plasma substitutes, medicinal serums and drugs.

If there are reactions or complications, then you must immediately stop the infusion of the solution. The needle should not be removed, but cardiotonic antihistamines, glucocorticoids, vasopressor products, if necessary.

Drug interactions

The simultaneous reception of phenylbutazone, barbituram, penicillin, salicylates and sulfonamide with human albumin reduces the effectiveness of the latter.

Combination of Albumin is allowed with erythrocyte mass, whole blood, carbohydrate and electrolyte solutions. The drug must not be mixed with amino acid solutions, alcohol-containing agents and protein hydrolysates.

In this way, Human albumin, a photo of which is presented in the article, in some cases can save a person's life. But it should be remembered that this drug has contraindications and side effects, in addition, it is very expensive. Its analogues are able to partially solve this problem, since they are not much cheaper.

Albumin preparation

Dosage form"type =" checkbox ">

Dosage form

Solution for infusion 5%, 10%, 20%, 20 ml, 50 ml, 100 ml, 200 ml

Structure

1 liter of solution contains, in grams

active substance:

human albumin 50.0 100.0 or 200.0

Excipients:

caprylate 1.5 3.0 6.0

sodium chloride 9.0 - -

water for injection up to 1.0 l 1.0 l 1.0 l

Description

Transparent liquid of yellow, amber or greenish tint, odorless.

Pharmacotherapeutic group

Plasma substitution and perfusion solutions. Blood plasma preparations Plasma-substituting drugs Albumin

ATX code B05AA01

Pharmacological properties"type =" checkbox ">

Pharmacological properties

Pharmacokinetics

Albumin is a natural protein that is an integral part of the protein fraction of human blood. The molecular weight of albumin is 69,000 daltons. The albumin protein fraction contains all 20 amino acids. Normally, blood plasma contains 40-50 g / l of albumin, which is 55-60% of the total protein content. The total amount of albumin in the vascular bed is about 120 g, and in the extravascular space - 180 g. Albumin is synthesized mainly by the liver, where other important blood proteins are produced - globulins, fibrinogen, prothrombin and others. The liver daily synthesizes 10-16 g of albumin, and in newborns 180-300 mg / l of body weight with a gradual decrease to normal values. It is believed that from 10 to 16 g of albumin is consumed daily in the body, that is, an amount equal to its synthesis. The cleavage of the albumin molecule to amino acids with their subsequent use by the body for the synthesis of its own proteins takes 50-60 days, therefore it is inappropriate to use it for parenteral nutrition.

Under normal conditions, the average half-life of albumin is 19 days. Excretion occurs mainly intracellularly due to the activity of lysosomal proteases. Complete distribution of albumin after intravenous administration occurs in 10-15 minutes, 50% of it is excreted from the body in 24 hours, within 2-4 days the albumin content remains at the same level, rapidly decreasing by the end of the fifth day.

Pharmacodynamics

Albumin is a plasma-substituting agent, a blood product that performs a number of functions in the body. Its main function is to maintain the colloid-osmotic (oncotic) blood pressure. Albumin solution is effective remedy correction of hypoalbuminemia of various origins (replenishes the deficiency of plasma albumin), restoration of colloid-oncotic pressure, disturbed central and peripheral hemodynamics (rapidly increases blood pressure (BP) and circulating plasma volume (BCC) by increasing the transition of tissue fluid in the bloodstream), water electrolyte balance, promotes better absorption medicines, has detoxification properties. Albumin binds and transports pigments (bilirubin), fatty acids, ions of certain metals inside the body, medicinal substances... In addition, albumin binds and inactivates toxins like bacterial origin, and formed in the process of metabolism. Binds and removes from the body magnesium, zinc, nickel, lead, mercury, acetates, bicarbonates, nitrates, citrates.

Albumin solution 5% is isoonotic to normal plasma. The introduction of this drug at a normal level of albumin in plasma reduces the viscosity of circulating blood, improves microcirculation. With hypoalbuminemia, it increases its plasma level.

Albumin solution 10% has a hyperoncotic effect, increasing the oncotic pressure of the circulating blood and increasing the reabsorption of interstitial water into the vascular bed. Increases and stabilizes blood pressure by increasing the volume of fluid reabsorbed from the interstitium, reduces edema.

Albumin solution 20% is a hyperoncotic solution that actively attracts fluid from the interstitial space by increasing reabsorption. Increases and stabilizes blood pressure by increasing the volume of circulating blood (BCC), reduces edema.

Indications for use

Laboratory confirmed hypoproteinemia or hypoalbuminemia of any genesis (a decrease in the content of albumin in plasma below 30 g / l, or the level of colloid-oncotic pressure below 15 mm Hg, or a decrease in the content total protein below 50 g / l)

Shock (hypovolemic, hemorrhagic, traumatic, operational, toxic, purulent-septic) in order to increase the BCC during dehydration and "thickening" of the blood

With severe cerebral edema of traumatic and non-traumatic genesis (even with normal laboratory parameters)

Long-term purulent-septic conditions with the development of protein deficiency

Nephrotic syndrome with nephritis

Severe burns

Hemolytic disease of the newborn; hyperbilirubinemia in newborns - during exchange transfusion (in order to reduce the level of free bilirubin in the blood)

Sharp liver failure; acute liver necrosis (both for the purpose of maintaining the oncotic pressure of the plasma, and for the purpose of binding an excess amount of free bilirubin in the blood plasma)

Ascites (to maintain blood volume)

Cardiopulmonary bypass surgery

Therapeutic plasmapheresis when replacing large volumes of removed plasma (more than 50%), hemodialysis

Acute respiratory distress syndrome in adults (with volume overload in conjunction with diuretics)

Preoperative hemodilution and preparation of autologous blood components

Method of administration and dosage

The concentration of the drug, dosage and infusion rate are selected in accordance with the individual characteristics of the patient.

Albumin solution is injected intravenously or by stream for adults and children. It is recommended to monitor the concentration of albumin in the blood plasma, to monitor the hemodynamic parameters. The rate of infusion should be adjusted according to the patient's condition and indication. With exchange transfusion of plasma, the infusion rate may be higher and should be consistent with the removal rate.

Albumin is injected intravenously at a rate of 5 ml / minute or not more than 50-60 drops per minute for a 5% solution and up to 1-2 ml / minute or not more than 40 drops per minute for a 20% solution. The maximum administration time is 3 hours.

The maximum single dose of the drug depends on the concentration of the albumin solution, the initial state and the patient's age. Albumin 5% solutions are administered at a dose of 200-300 ml, if necessary, the dose of a 5% solution can be increased to 500-800 ml. The maximum single dose of 20% albumin solution may be limited to 100 ml. Jet injection of albumin solutions is permissible for shocks of various origins for a rapid increase in blood pressure. In old age, the use of concentrated (20%) solutions and the rapid administration of 5% albumin solutions should be avoided, as this can overload the cardiovascular system.

Hypovolemia

For the treatment of hypovolemic shock, the volume applied and the infusion rate must be adapted to the response of the individual patient. It is necessary to monitor the hemodynamic parameters of the patient, to observe the usual precautions in order to prevent volemic overload of the circulatory system.

Adults: the average initial dose is 25 g, no more than 250 g is administered within 48 hours. The total dose should not exceed the level of albumin observed normally (about 2 g / kg of body weight) in the absence of active bleeding. Children: in emergency cases, the initial dose is 25 g, in other cases the dose is 2-4 times less than the dose for adults and, taking into account the concentration of albumin solutions, the dosage should be calculated in milliliters per kilogram of body weight (no more than 3 ml / kg of the child's body weight). If extracellular dehydration occurs, then a saline solution should be infused after albumin. If a 5% albumin solution is preferable with a small deficit in circulating blood volume (10 - 15%), then a 20% albumin solution, transfused with subsequent saline administration, has significant therapeutic advantages with a pronounced decrease in BCC (more than 20%), circulating protein deficiency, torpid shock and in situations where transfusion therapy is forced to start with a delay. Removal of ascitic fluid in a patient with liver cirrhosis may be accompanied by changes in the activity of the cardiovascular system and even the development of hypovolemic shock. In these circumstances, albumin transfusion is necessary to maintain blood volume.

Burn therapy

After a burn injury (usually more than 24 hours later) there is an exact correspondence between the amount of albumin infused and the resulting increase in the osmotic colloidal pressure of the plasma. The goal should be the ability to maintain a plasma albumin concentration of 2.5 ± 0.5 g / L with a plasma oncotic pressure of 20 mm Hg (equivalent to a total protein concentration of 5.2 g / L). The duration of therapy is determined by the loss of protein from the burned areas and in the urine. In addition, it is necessary to start a probe or parenteral nutrition amino acids, since long-term use of albumin should not be considered a food source. The optimal regimen of transfusion therapy for extensive burns (prescription of colloids and saline solutions) not installed. Typically, in the first 24 hours after thermal injury, large volumes of saline are poured to restore the reduced volume of interstitial (extracellular) fluid. After 24 hours, albumin solutions can be used to maintain the colloidal oncotic pressure of the plasma.

Hypoproteinemia with or without tissue edema

If the underlying pathology leading to hypoproteinemia can be corrected, the use of albumin should be considered purely symptomatic or supportive. Regular daily dose albumin for adults is 50 to 75 g (0.5-1 g / kg) and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require large amounts. Since patients with hypoproteinemia usually have an approximately normal blood volume, the albumin infusion rate should not exceed 2 ml / min as faster infusion may cause circulatory disturbances and pulmonary edema.

During the extensive surgery patients can lose more than half of the albumin circulating in the bloodstream, which is accompanied by a decrease in oncotic pressure with or without the development of edema syndrome. A similar situation can also be observed with sepsis in patients in intensive care units. In such cases, the use of albumin is directly indicated.

Acute Respiratory Distress Syndrome in Adults (ARDS) ARDS is characterized by insufficient oxygen delivery due to interstitial pulmonary edema and is a complication of shock and acute massive blood loss, as well as traumatic brain injury. If at the same time there are clinical signs indicating both hypoproteinemia and volemic overload, then the appointment of albumin together with a diuretic is the most important link in intensive infusion therapy.

Coronary artery bypass grafting

Modern heart-lung machines (AIC) require relatively small volumes to fill. It has been shown that preoperative hemodilution in patients, achieved using albumin and crystalloids, is safe and well tolerated. The limit to which plasma hematocrit and plasma albumin can be safely reduced has not been established, but it is common practice to use albumin and crystalloids to fill the AIC until a hematocrit of 20% and a plasma albumin concentration of 2.5 g / L is reached.

Hemolytic disease of the newborn

Albumin can be prescribed when using plasma exchange in therapy hemolytic disease newborns to bind free bilirubin to reduce the risk of complications due to jaundice and hemolysis. A dose of 1 g / kg of body weight is given approximately one hour before the start of the exchange transfusion procedure. Caution must be exercised in the presence of underlying hypervolemia in children.

Acute nephrosis

In the absence of a response to therapy with cyclophosphamide or steroids or with a worsening of edematous syndrome during steroid therapy, it is possible to use a combined appointment daily of 100 ml of 20% albumin and diuretics for 7-10 days under the control of urine output and potassium concentration in the blood plasma. Reapplying steroids thereafter may be effective.

Hemodialysis

Albumin is not a mandatory part of the standard hemodialysis protocol for chronic renal failure, but it can be indicated when shock or hypotension develops in these patients. Usually, in such situations, 100 ml of 20% albumin is transfused. It is necessary to avoid volemic overload, which is often observed in such patients (which is why they cannot tolerate the infusion of large volumes of saline solutions).

Cerebral edema

For the treatment of cerebral edema, a hyperoncotic 20% albumin solution is used.

Side effects

Seldom

Redness of the face

Hives

Fever

Nausea

They usually go away on their own when the rate decreases or the drug is stopped.

Rarely

Anaphylactic reaction, hypersensitivity reactions: urticaria, angioedema, erythematous rash

Confusional state headache

Tachycardia, bradycardia

Hypotension, hypertension

Nausea

Excessive sweating

Back pain

Contraindications

Individual intolerance (including a history of hypersensitivity) to albumin

Severe anemia

Hypervolemia

Chronic heart failure II-III degree

Pulmonary edema

Thrombosis

Arterial hypertension

The ongoing internal bleeding

Hemorrhagic diathesis

Renal and postrenal anuria

Varicose veins of the esophagus

Drug interactions"type =" checkbox ">

Drug interactions

The binding of albumin with salicylates, barbiturates, phenylbutazone leads to the fact that only a part of the administered dose of these drugs gives an immediate effect, sulfonamides, penicillins largely lose their antibacterial effect. It is not recommended to mix the drug with amino acid solutions, hydrolysates, alcohol-containing mixtures, whole blood, erythrocyte mass and water for injection. It is not recommended to dilute the albumin solution with water for injection, because the patient may have hemolysis.

Albumin solution 20%, if necessary, can be diluted with saline or 5% dextrose solution.

special instructions"type =" checkbox ">

special instructions

If allergic or anaphylactic reactions are suspected, the drug should be discontinued immediately and appropriate treatment initiated. In case of shock, anti-shock treatment should be initiated in accordance with current treatment standards.

During the infusion of the drug, it is necessary to ensure thorough and regular monitoring of blood circulation parameters, incl. BP, heart rate, central venous pressure, diuresis, plasma electrolyte concentration, hematocrit / hemoglobin.

When administering 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.

If it is necessary to replace relatively large volumes, monitoring of blood coagulation and hematocrit indicators is required. Adequate replacement of other blood components (clotting factors, electrolytes, platelets and erythrocytes) should be ensured.

If the dosage and rate of infusion do not correspond to the characteristics of the patient's blood circulation, then hypervolemia may occur. At the first clinical signs of cardiovascular overload (headache, shortness of breath, blood congestion in jugular vein) or an increase in blood pressure, an increase in venous pressure or pulmonary edema, the drug should be stopped immediately.

Albumin solutions are used after warming to room temperature (20-25 ° C). When administered to patients with hypothermia or the threat of its development, albumin solutions can be warmed up to a temperature of 30-35 ° C immediately before administration using in-line heaters.

Before use, the drug solution should be carefully examined. Only a completely transparent solution of albumin, which does not contain suspension and sediment, is allowed for use, provided that the tightness and closure are preserved, there are no cracks on the bottles and ampoules, and the label is intact.

The infusion is performed immediately after opening the vial (ampoule), after which the "Protocol for the transfusion of blood components and products" is filled in and inserted into medical card inpatient or outpatient.

The unused remainder of the drug must be destroyed.

Before transfusing albumin solutions, a biological test is necessary: ​​60 drops (2-3 milliliters) of the solution are poured once for 1-2 minutes, then the transfusion is stopped and the patient is monitored for 3 minutes. The procedure is repeated twice under control general condition the patient. With absence adverse reactions the required volume of albumin solution is poured.

Pregnancy and lactation

There are no results of clinical studies on the possible side effect albumin during pregnancy and lactation. Existing experience clinical use albumin solution does not give grounds to expect any harmful effect on the course of pregnancy, on the fetus or newborn, since human albumin is a normal component of human blood plasma.

Special warnings and precautions when using the drug

If the tightness is broken, the solution must be destroyed due to the danger of bacterial contamination. If the solution becomes cloudy, flakes or suspended matter, the solution is not suitable for use!

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms.

Does not affect.

20 ml each for a 10% solution in ampoules made of glass of the NS-1, NS-2, NS-3 brands according to the State Pharmacopoeia of the Republic of Kazakhstan, volume 1.3.2. or GOST 10782-85. With rev. 1-6.

Bottles are hermetically sealed with rubber stoppers of grade 4C according to TU9398-001-44111344-2005 or grades 25 P, 52-369 / 1 according to TU 38-0062-69-80 or TU 38.106618-95, crimped with aluminum caps in accordance with GOST R 51314-99. The ampoules are sealed.

On bottles and ampoules, labels made of label paper according to GOST 7625-86E or writing paper according to GOST 18510-87 are glued and placed in boxes made of cardboard box grade A according to GOST 7933-90 or chrome-ersatz type according to TU U 05509659-008-2000 bottles - one at a time, ampoules - 5 each together with instructions for medical use in the state and Russian languages.

Storage conditions

Store in a dry, dark place at a temperature of 20 ° C to 8 ° C

Keep out of the reach of children!

Shelf life

3 years at a temperature not exceeding 25 ° С.

Do not freeze!

Do not use after the expiration date!

Expiration of the shelf life is prohibited!

Pharmacy dispensing conditions

On prescription

Manufacturer

Republican Blood Center of the Ministry of Health and Social Development of the Republic of Kazakhstan

Republic of Kazakhstan, 050060, Almaty

5 out of 5

Albumin is the most important component in blood plasma, accounting for 60% of all protein in plasma... Albumin is synthesized in liver cells at 14-20 g per day. In nature, albumin is found in the fruits of some plants and in egg whites.

Albumin in human blood

The main functions of this substance are: transportation of nutrients, maintenance of normal circulating blood volume, active participation in colloidal osmotic pressure. Albumin molecules are very small, so they perfectly carry waste products throughout the body, nutrients, hormones, as well as some medications (antibiotics) and even poisons. The level of this substance in the body indicates the state of health in general. Its rate depends entirely on the age of the person. In babies, it ranges from 25 to 55 g per 1 liter of blood, in adults - from 35 to 50 g per liter. The elderly have the lowest rate. If the level of albumin in the body exceeds the norm, it means that the person is dehydrated, his blood becomes thicker, which negatively affects the entire state of the body. With prolonged vomiting or diarrhea, the amount of albumin in the body increases. Also his elevated level speaks of a possible disease. There may be a decrease in the albumin content in the blood. It is this substance that stores protein in our body. During a long hunger strike or an unbalanced diet, the amount of albumin drops, as it makes up for the lack of protein in the body. The same process occurs during pregnancy and lactation. A low albumin level is observed in all smokers, since the liver simply does not have time to cope with the load and produce the required amount of the beneficial substance. There is also congenital decreased production. Also, a low level may indicate the presence serious illnesses: oncology, liver disease and others internal organs... Therefore, if you suspect any disease of the internal organs, doctors always prescribe an analysis for the level of albumin.

With an acute shortage of a substance in the blood, patients are prescribed an albumin solution, which is obtained from donated blood... Preparations with a high vitamin A content can increase the natural production of albumin.

Application of Albumin

Albumin is a protein solution from human plasma. It looks like a transparent liquid with a slightly viscous consistency. Has anabolic effect, partially replaces blood plasma. The use of Albumin compensates for the lack of protein in the blood. During the intake, blood pressure may increase, the deficit of circulating blood is replenished. The drug is available in the form of a solution of albumin 5, 10, 20% for intravenous administration. The most commonly used are Albumin 10 and Albumin 20.

The instructions for Albumin indicate the following indications for use:

• Shock conditions: toxic, traumatic, purulent-septic, operational, hemorrhagic shock;
• Hypovolemia;
• Decreased amount of total protein in the blood;
• Severe burns associated with a large loss of fluid and blood clotting;
• Nephrotic syndrome - kidney disease with a large loss of protein;
• Hemolytic disease in infants;
• Liver disease associated with impaired protein production;
• Accumulation of fluid in the abdominal cavity;
• Diseases of the gastrointestinal tract, accompanied by impaired protein absorption;
• Cerebral edema;
• Purulent-septic diseases of a long-term nature with ongoing protein deficiency;
• Operation with artificial circulation, hemodialysis, therapeutic plasmapheresis.

Instructions for Albumin

The instructions for Albumin indicate the following contraindications to the use of the drug:

• Chronic heart failure;
• Prolonged bleeding;
• Thrombosis;
• Chronic renal failure
• Pulmonary edema;
• Hypersensitivity to albumin;
• Hypervolemia.

The drug should be used with caution in people with chronic diseases heart, since there is a possible risk of overflow of the disease into acute stage... The instructions for Albumin say that the drug increases blood pressure due to its positive oncotic activity. Therefore, during the operation, after the transfusion of the drug, bleeding may open in the area of ​​damaged vessels that did not previously bleed due to low pressure.

Albumin 5, Albumin 10 and Albumin 20 are administered intravenously by drip at 50 drops per minute (3 ml each). The daily volume of the solution is 100-500 ml. The dosage is selected individually, based on the severity of the disease and the age of the patient. Albumin 10 is usually prescribed according to the formula: 1-2 ml per 1 kg of body weight. Droppers are made once a day or every other day. Albumin 20 is prescribed in severe cases and should not be used in elderly patients..

Before starting the procedure, it is necessary to check the bottle with the solution, it should not have sediment, the color should be transparent and clean. Otherwise, the drug cannot be used. If the bottle has been opened, but not fully used, it is prohibited to reuse it. Cracked or otherwise damaged vials should also not be used.

Side effects are extremely rare. Allergic reactions are possible: Quincke's edema, urticaria, elevated temperature, low blood pressure, anaphylactic shock. If allergic reactions occur, it is necessary to immediately stop the administration of the Albumin solution and, without removing the needle from the vein, inject an antihistamine drug.

The use of Albumin by women during pregnancy should be carried out under the close supervision of a physician. however, no harmful effects of the drug on the fetus have been identified. The medicine can be combined with transfusion of other blood components and electrolyte solutions. Cannot be combined with amino acid solutions and alcohol solutions... It is necessary to store the drug at a temperature of 2 to 10 ° C in the refrigerator. Use only within the expiration date.

Albumin: instructions for use and reviews

Latin name: Albumin

ATX code: B05AA01

Active substance: albumin (albumin)

Manufacturer: Sverdlovsk Regional Blood Transfusion Station GUZ (Russia), Microgen NPO FGUP (Russia), Sangvis SPK No. 2 SO GUZ (Russia)

Description and photo update: 16.09.2019

Albumin is a plasma-substituting agent.

Release form and composition

The drug is released in the form of a solution for infusion: clear liquid yellow color with a possible green tint (20% solution of 50 or 100 ml, 5% and 10% solutions of 50, 100, 200 or 400 ml in a glass bottle with a volume of 50, 100, 250 or 500 ml, respectively, the bottle is hermetically closed with a rubber stopper and crimped with an aluminum cap, 5%, 10% and 20% solutions of 10 or 20 ml in a glass ampoule, in a cardboard box 1 bottle or 10 ampoules complete with an ampoule knife and instructions for using Albumin; if the ampoules have a colored ring with a break, notch or of the identification colored dot on the clamping of the ampoule, the ampoule knife is missing in the pack).

1 ml of the preparation contains:

• active substance: albumin - 50, 100 or 200 mg;
• additional components: sodium chloride, sodium caprylate, water for injection.

Pharmacological properties

Albumin is a natural protein that is part of the protein fraction of human blood plasma. The molecular weight of albumin is 69,000 daltons. Solutions of the drug 5%, 10% and 20% are used to correct hypoalbuminemia of various nature, restore and maintain colloid-osmotic (oncotic) pressure and water-electrolyte balance, eliminate violations of central and peripheral hemodynamics. The product also demonstrates detoxification properties.

In the body, albumin provides the binding and transport of fatty acids, pigments (including bilirubin), ions of certain metals and medicinal substances. The drug is characterized by a high binding capacity in relation to toxins and further inactivates the latter.

Indications for use

• a decrease in the level of total protein below 50 g / l, a decrease in the concentration of albumin in plasma below 30 g / l or the level of colloidal osmotic pressure below 15 mm Hg. Art .;
• hypoalbuminemia of various etiologies: acute blood loss[decrease in circulating blood volume (BCC) by more than 25-30%], shock (traumatic, hemorrhagic, thermal), purulent-septic conditions, burn disease, kidney disease (including nephritis and nephrotic syndrome), liver disease proceeding with its albumin-producing function;
• hemolytic disease of newborns during exchange (exchange) blood transfusion;
• operations carried out using artificial circulation;
• preoperative hemodilution and preparation of autologous blood components;
• swelling of the brain;
• therapeutic plasmapheresis.

Contraindications

Absolute:

• severe heart failure (stage IIB – III);
• uncontrolled arterial hypertension;
• cerebral hemorrhage;
• thrombosis;
• internal bleeding;
• pulmonary edema;
• hypervolemia;
• hypersensitivity to any of the components of the product.

Relative (the drug must be used with extreme caution):

• arterial hypertension;
• stage I heart failure;
• renal failure.

Albumin, instructions for use: method and dosage

Albumin solution is administered intravenously, drip or stream.

A single dose of the drug is set individually, taking into account the severity of the lesion, the condition and age of the patient, as well as the concentration of the solution. The average single dose of 5%, 10% and 20% Albumin is 200-300 ml. If necessary, it is possible to increase the dose of 5% solution to 500-800 ml at an infusion rate of no more than 50-60 drops per minute. A single dose of 20% Albumin should not exceed 100 ml.

If a rapid increase in blood pressure (blood pressure) is necessary against the background of shock of various origins (hemorrhagic, traumatic, thermal), jet injection of the drug is allowed.

Before carrying out a drug transfusion, the attending physician must conduct a thorough visual examination of the solution and the container in which it is contained. In the absence of transparency of the solution or detection of suspension and sediment in it, it is prohibited to inject the drug. Plasma-replacing agent can be used for infusion only if the tightness of the closure is preserved, the label is intact and there are no cracks on the bottle. The medical history must record the results of the examination of the drug and the data indicated on the label (including the name of the drug, batch number, manufacturer).

Side effects

Against the background of drug therapy, in rare cases, the appearance of such unwanted effects, as fever, urticaria, chills, shortness of breath, tachycardia, decreased blood pressure, pain in the lumbar region.

If the development of adverse events or complications is noted, it is necessary to immediately stop the administration of the drug and, without removing the needle from the vein, inject glucocorticoids, cardiotonic, antihistamines, vasopressor drugs (with the appropriate indications).

Overdose

There is no data.

special instructions

In case of dehydration of the body, the use of the drug is possible only after preliminary implementation of oral and parenteral rehydration (fluid replacement).

If the solution was frozen during transportation, it can be administered in the case when it has not changed its appearance after defrosting.

When using the product, there is a risk of infection with blood-borne infections.

Application during pregnancy and lactation

The use of a plasma substitute during pregnancy / lactation is allowed only when the expected benefit of therapy for the mother outweighs to a large extent the possible threat to the health of the fetus / child.

Childhood use

For children, the dosage of Albumin solutions, taking into account their concentration, must be calculated in ml / kg of body weight, the maximum dose should not exceed 3 ml / kg.

With impaired renal function

In the presence of renal failure, the drug should be used with caution.

Use in the elderly

Elderly patients are not recommended to use concentrated (20%) solutions of the drug, and patients with this age category you should beware of the rapid introduction of Albumin 10% and 5%, as this can overload the cardiovascular system.

Drug interactions

• phenylbutazone, penicillins, barbiturates, sulfonamides, salicylates: weakening is noted therapeutic action albumin;
• amino acid solutions, protein hydrolysates, alcohol-containing preparations: it is recommended to avoid the simultaneous use of these funds with the preparation.

Analogs

Analogues of Albumin are: Human serum albumin, Uman albumin, Alburex, Plasbumin-20, Human albumin Biotest, Zenalb-20, Albiomin 20%, Zenalb-4.5.

Terms and conditions of storage

Store out of the reach of children at a temperature of 2-10 ° C.

The shelf life is 5 years.

**** Altex, LLC Bayer Healthcare AG BAKSTER AG BELGOROD OSPK BIISKAYA GSPK BIOMED Biomed named after I.I. Mechnikov, OJSC VOLOGODSKAYA OSPK GUZ VORONEZH SPK GUZ GUZ Nizhny Novgorod region st. blood transfusion EKATERINBURG COMPANY FOR PRODUCTION OF BACPR Ivanovskaya Regional blood transfusion station IMBIO IMMUNOPREPARAT, State Unitary Enterprise IRKUTSK PR-E ON PR-WU IMMUNOBIOLOGISTS LIPETSK REGION. ST. OVERFLOW. BLOOD MICROGEN NPO FSUE Microgen NPO FSUE Ministry of Health and Social Development Omsk Microgen NPO FSUE (Yekaterinburg Prospect for PBP) Microgen NPO FSUE Ministry of Health and Social Development Russia / PharmV MICROGEN NPO FSUE (Khabarovskoe Ministry of Healthcare, Federal State Institution of Healthcare of the Russian Federation) Russia PERM MIKROGEN 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 Novgo MICROGEN / IRKUTSK PPBP MIN. PASTERA Octapharma Pharmaceuticals Productions m.b.Kh. PKF "InterGRIM", JSC Samara Regional Clinical Transfusion Station Sanofi-Aventis S.А. Talekris Biotherapeutic Inc. F. Hoffmann-La Roche Ltd / Pharmstandard-Leksredstva, JSC CHELYABINSKAYA REGION ST. BLOOD TRANSFUSION

Country of origin

Austria Russia UNITED STATES

Product group

Blood and circulation

Means for parenteral nutrition

Forms of issue

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

Description of the dosage form

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

pharmachologic effect

Plasma-substituting agent obtained by fractionation of plasma, serum from healthy donors. Replenishes the deficiency of blood plasma albumin, maintains colloidal-osmotic (oncotic) blood pressure, rapidly increases blood pressure and BCC, promotes the transfer of fluid from tissues to the bloodstream, has detoxification properties. Albumin is a natural protein that is an integral part of the human blood protein fraction, with a molecular weight of 69,000 daltons. In normal human blood plasma, albumin is approximately 60%. The albumin protein molecule contains all 20 amino acids. Albumin is synthesized in the liver. Albumin has 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 detoxifying properties. Albumin binds and transports pigments (bilirubin), fatty acids, ions of certain metals, and medicinal substances inside the body. In addition, albumin binds toxins and inactivates them.

Pharmacokinetics

The total exchangeable 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. With such pathological conditions like severe burns or septic shock, a significant increase in capillary permeability disrupts the kinetics of albumin and can lead to its pathological distribution. The average half-life of albumin is normally 19 days. The balance between synthesis and degradation is usually achieved through a mechanism feedback... Elimination occurs mainly 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 increased for several hours. However, critically ill patients can lose significant amounts of albumin, and the rate of its release from the vascular bed is unpredictable.

Special conditions

Application during pregnancy and during the period breastfeeding... The safety of using albumin during pregnancy in controlled clinical research not installed. However, clinical experience with albumin does not give grounds to expect any harmful effects on the course of pregnancy, fetus or newborn. Reproductive toxicity studies on albumin have not been conducted. Experimental data on animals are insufficient to assess safety in relation to reproduction, embryo-fetal development, and the course of pregnancy, peri- and postnatal development. Albumin is a normal protein constituent of human blood. If you suspect an allergic or anaphylactic reaction, you must immediately stop the drug administration. In case of shock, it is necessary to take standard measures of anti-shock therapy, for which the premises where the drug is administered should 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 veins of the esophagus; -pulmonary edema; - hemorrhagic diathesis; - severe anemia; -renal and postrenal anuria. In the elderly, you should avoid the use of a concentrated solution of albumin 20% and the rapid introduction of a solution of albumin 10%, as this can lead to overload of the cardiovascular system. The colloidal 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, proper hydration of the patient (oral and parenteral) should be ensured. Careful monitoring of the patient's condition must be carried out to avoid circulatory overload and overhydration. The electrolyte content 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%. When albumin is administered, it is necessary to monitor the patient's electrolyte status (see the Dosing Regimen subsection) and take appropriate measures to restore or maintain electrolyte balance... Albumin solutions should not be diluted with water for injection, as this can lead to hemolysis in the recipient. With extensive substitution therapy monitoring of blood coagulation and hematocrit is necessary. Particular attention should be paid to 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 match 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, 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. Such measures include careful selection of blood and plasma donors to ensure that no donation is allowed from those 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 the observance of these measures, the risk of transmission of infection, including unknown or recently discovered viruses or other types of infection, cannot be completely excluded when making medicinal products from human blood or administering plasma. For each dose of albumin medicinal product, it is strongly recommended to register its name and batch in order to retain information about it. Influence on the ability to manage vehicles and mechanisms. Does not affect the ability to drive vehicles and mechanisms.

Structure

• 1 ml 1 fl. human albumin 100 mg 10 g 1 ml 1 vial human albumin 100 mg 10 g human albumin 20 g Plasma albumin for fractionation with the addition of sodium caprylic acid, sodium chloride, water for injection. Human albumin - in 1 ml - 200 mg (in 1 bottle - 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 the content of albumin in plasma below 30 g / l, or the 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 artificial blood circulation; therapeutic plasmapheresis; hemolytic disease of newborns during exchange blood transfusion. During preoperative hemodilution and preparation of autologous blood components; with cerebral edema.

Albumin contraindications

• Thrombosis, arterial hypertension, ongoing internal bleeding, severe anemia, severe heart failure, hypersensitivity to human albumin.

Albumin dosage

• 10 % 20% 5%, 10%, 20%

Albumin side effects

• The administration of an albumin solution, as a rule, is not accompanied by adverse reactions and complications. In some, previously sensitized patients, allergic reactions of varying severity may occur. The possibility (extremely rare) of adverse reactions and complications is not excluded in patients at risk, i.e. with a history of intolerance to intravenous injections of protein drugs and other plasma substitutes, drugs, serums, vaccines. In case of reactions or complications, you should immediately stop the transfusion of albumin solution and, without removing the needle from the vein, inject antihistamines, cardiotonic drugs, glucocorticosteroids, vasopressor drugs (if indicated).

Drug interactions

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

Overdose

At a high dose or 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 drug should be stopped immediately and the blood circulation parameters should be constantly monitored.

Storage conditions

• keep away from children
• store in a dark place

Information provided