Plasbumin-20 solution for infusion 20% vials 50ml, 1pc

Composition

Plasbumin 20 contains a 20% solution of human albumin. The drug is stabilized with 0.016 M sodium caprylate and 0.016 M acetyltryptophan. The sodium content of the product is 145 meq/l. The product does not contain preservatives.

Pharmacological action

Pharmacotherapeutic group: plasma-substituting agent.

ATX code B 05 AA 01

Pharmacological properties: Plasbumin 20 is a 20% sterile aqueous solution of albumin and is produced from human blood plasma using a cold ethanol fractionation process.

Plasbumin 20 is a hyperoncotic protein solution and, when administered intravenously, increases the volume of circulating plasma due to the diffusion of fluid from the interstitial space (provided that the volume of the latter is within the normal range or increased). Every 50 ml of Plasbumin 20 administered intravenously to a patient provides an increase in oncotic pressure equivalent to approximately 200 ml of citrate plasma. When injected into the vascular bed,50 ml of Plasbumin 20 draws about 125 ml of fluid from the intercellular space into the circulatory system for 15 minutes, thus increasing the volume of circulating blood, reducing hematocrit and viscosity of whole blood.

Indications

– in the complex treatment of hypovolemic shock; – for the treatment and prevention of hypovolemia and hypoproteinemia: – for extensive surgical operations, sepsis, acute respiratory distress syndrome of adults;- when removing protein-rich fluids from the body-ascites, exudative pleurisy;- when transfusing large volumes of thawed washed red blood cells;- in the complex therapy of hemolytic disease of newborns in order to reduce the level of free bilirubin in the blood (therapeutic plasma exchange);- in acute hepatic insufficiency to maintain oncotic plasma pressure and bind an excessive amount of free bilirubin in the blood plasma;- for preoperative hemodilution (obtaining an additional volume of blood to fill the cardiopulmonary bypass device during aorto-coronary bypass surgery);- to increase the therapeutic response in patients with acute nephritis who are resistant to treatment with cyclophosphamide or steroids;- with the development of shock or hypotension in patients during the hemodialysis procedure.

Use during pregnancy and lactation

The corresponding experimental studies with Plasbumin 20 were not conducted. Therefore, the appointment of pregnant women is possible only for vital indications.

Contraindications

-increased individual sensitivity;

– hypervolemia;

– pulmonary edema.

Use with caution:

– for thrombosis;

– heart failure (risk of exacerbation!);

– renal failure;

– severe anemia;

– arterial hypertension;

– ongoing internal bleeding.

Side effects

In rare cases, allergic reactions may occur, including hives, chills, fever, shortness of breath, tachycardia, low blood pressure, and low back pain.

Interaction

Plasbumin 20 is compatible with whole blood, red blood cell mass, standard electrolyte and carbohydrate solutions for intravenous use. Do not mix Plasbumin 20 with protein hydrolysates, amino acid solutions, or alcohol-containing solutions.

How to take, course of use and dosage

The dose and mode of use are set individually, taking into account the nature of the disease and the age of the patient. The average daily dose of Plasbumin 20 for adults is from 50 to 75 g; for children – 25 g. The total dose of the drug should not exceed the normal level of albumin (about 2 g/kg of body weight) in the absence of active bleeding.

Plasbumin 20 should only be administered intravenously!

Burn therapy As a rule, Plasbumin 20 is recommended for maintaining the colloidal osmotic pressure of plasma 24 hours after thermal damage (large volumes of saline solutions are poured on the first day to restore the reduced volume of extracellular fluid). It is recommended to maintain the concentration of plasma albumin at the level of 20-30 g / l with an oncotic plasma pressure of 20 mm Hg (equivalent to a total protein concentration of 52 g/l). The duration of therapy is determined by the loss of protein from the burned areas and in the urine.

Hypoproteinemia with or without tissue edema The usual daily dose of Plasbumin 20 for adults is 50 to 75 g; for children,25 g. Patients with severe hypoproteinemia who continue to lose albumin may require large amounts. Since patients with hypoproteinemia usually have a normal blood volume, the infusion rate of Plasbumin 20 should not exceed 2 ml / min, since faster use can cause circulatory disorders and pulmonary edema.

Adult Acute Respiratory Distress syndrome (ARDS)If patients have clinical signs that indicate both hypoproteinemia and hypervolemia, it is advisable to prescribe Plasbumin 20 in the above doses together with a diuretic.

Aorto / coronary bypass grafting It is common practice to perform hemodilution therapy (to fill the AIC during surgery) using albumin and crystalloids until the patient reaches a hematocrit level of 20% and a plasma albumin concentration of 25 g/l.

Hemolytic disease of Newborns Plasbumin 20 is prescribed approximately one hour before the start of the exchange transfusion procedure at a dose of 1 g/kg of body weight. Caution should be exercised in the presence of initial hypervolemia in children.

Transfusion of erythrocyte mass Usually Plasbumin 20 is added to the isotonic suspension of washed red blood cells in a dose of 25 g of albumin per 1 liter of red blood cell mass immediately before transfusion of thawed washed red blood cells. If the patient has concomitant hypoproteinemia or severe liver damage, the dose of Plasbumin 20 may be increased.

Acute nephritis To increase the effectiveness of cyclophosphamide or steroid therapy, as well as with an increase in edematous syndrome against the background of steroid treatment, it is possible to use a combined daily appointment of 100 ml of Plasbumin 20 and loop diuretics for 7-10 days under the control of diuresis and potassium concentration in blood plasma.

Hemodialysis Plasbumin 20 is indicated for shock or hypotension in patients with chronic renal failure during standard hemodialysis. The standard dose is 100 ml of Plasbumin 20. It is necessary to avoid volume overload, which is often observed in such patients (which is why they cannot tolerate the introduction of large volumes of saline solutions).

Overdose

Clinical manifestations of overdose can be a hypervolemic symptom complex: increased blood pressure, the appearance or increase of heart failure, etc.

Description

Transparent viscous liquid of amber color.

Special instructions

Each bottle should be carefully examined before use. Turbid or frozen solutions, as well as partially used vials, must be destroyed.

Plasbumin 20 can be used either undiluted or in combination with 0.9% sodium chloride solution or 5% glucose (dextrose) solution. If sodium restriction is necessary, Plasbumin 20 should only be used undiluted or with a carbohydrate solution that does not contain sodium chloride, such as 5% glucose (dextrose) solution.

Only 0.9% sodium chloride solution or 5% glucose solution can be used as a solvent for Plasbumin 20: use of Plasbumin 20 or any other hyperoncotic protein solutions in combination with water for injection in large quantities can lead to hemolysis and acute renal failure.

During the use of Plasbumin 20, it is necessary to monitor the patient’s hemodynamic parameters, observing the usual precautions to prevent hypervolemia.

In the presence of concomitant dehydration, albumin transfusion should be accompanied by the introduction of saline solutions.

In acute massive blood loss, the use of albumin can be supplemented with a transfusion of red blood cells or whole blood.

The rapid increase in blood pressure that follows a Plasbumin 20 transfusion may be accompanied by increased bleeding from those vessels that did not bleed at a lower blood pressure (doctor’s control!).

Impact on driving ability:

The effect of Plasbumin 20 on the ability to drive a car or work with machines was not revealed.

Form of production

20% solution for infusions in vials

Storage conditions

In a place protected from light, at a temperature not exceeding 30°C. Do not freeze it. Keep out of reach of children.

Shelf

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

Active ingredient

Human albumin

Conditions of release from pharmacies

By prescription

Dosage form

infusion solution