Plasbumin-20, 20% 50 ml

Pharmacotherapeutic group: plasma substitute.

ATX code B05AA01

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

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

Indications

– in the complex treatment of hypovolemic shock;

– for the treatment and prevention of hypovolemia and hypoproteinemia:

– for major surgical operations, sepsis, acute respiratory distress syndrome in adults;

– when removing protein-rich fluids from the body – ascites, exudative pleurisy;

– when transfusing large volumes of thawed, washed red blood cells;

– in complex therapy of hemolytic disease of newborns in order to reduce the level of free bilirubin in the blood (therapeutic plasma exchange);

– in acute liver failure to maintain plasma oncotic pressure and bind excess free bilirubin in blood plasma;

– for preoperative hemodilution (obtaining additional blood volume to fill the heart-lung machine during coronary artery bypass surgery);

– to improve the therapeutic response in patients with acute nephritis resistant to treatment with cyclophosphamide or steroids;

– with the development of shock or hypotension in patients during the hemodialysis procedure.

Pharmacological effect

Pharmacotherapeutic group: plasma replacement agent.

ATX code B05AA01

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 normal limits or increased). Every 50 ml of Plasbumin 20, when administered intravenously to a patient, provides an increase in oncotic pressure equivalent to approximately 200 ml of citrated plasma. When 50 ml of Plasbumin 20 is introduced into the vascular bed, it attracts about 125 ml of fluid from the intercellular space into the circulatory system within 15 minutes, thus increasing the volume of circulating blood, reducing the hematocrit and viscosity of whole blood.

Special instructions

Each bottle must be carefully inspected before use. Cloudy or frozen solutions, as well as partially used vials, must be destroyed.

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

As a solvent for Plasbumin 20, it is possible to use only 0.9% sodium chloride solution or 5% glucose solution: administration 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 administration 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 must be accompanied by the administration of saline solutions.

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

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

Effect on ability to drive:

The effect of Plasbumin 20 on the ability to drive a car or work with machines has not been identified.

Active ingredient

Human albumin

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 drug does not contain preservatives.

Pregnancy

Corresponding experimental studies with Plasbumin 20 have not been conducted. Therefore, administration to pregnant women is possible only for health reasons.

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 develop, which include urticaria, chills, fever, shortness of breath, tachycardia, decreased blood pressure, and pain in the lumbar region.

Interaction

Plasbumin 20 is compatible with whole blood, red blood cells, standard electrolyte and carbohydrate solutions for intravenous administration. Plasbumin 20 should not be mixed with protein hydrolysates, amino acid solutions and alcohol-containing solutions.

Overdose

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

Storage conditions

In a place protected from light, at a temperature not exceeding 30°C.

Do not freeze. Keep out of the reach of children.

Shelf life

3 years. Do not use after expiration date.

Manufacturer

Grifolz Therapeutics Inc., USA