Active substanceHuman albuminHuman albumin
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  • Dosage form: & nbspsolution for infusions
    Composition:

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

    Description:Transparent slightly viscous liquid, from light yellow to yellow, a greenish shade is allowed.

    Pharmacotherapeutic group:Plasmasuberant
    ATX: & nbsp

    B.05.A.A.01   Albumen

    Pharmacodynamics:

    Plazbumin 20 is a 20% sterile aqueous solution of albumin and is produced from human 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 norm or increased). Every 50 ml of Plasbumin 20, when administered intravenously, provides an increase in the oncotic pressure equivalent to about 200 ml of nitrate plasma. When 50 ml of Plasbumin 20 is injected into the vascular bed, about 125 ml of liquid from the intercellular space is drawn into the circulatory system for 15 minutes, thus increasing the volume of circulating blood,reducing the hematocrit and the viscosity of whole blood.

    Indications:

    - in the complex treatment of hypovolemic shock;

    - for the treatment and prevention of hypovolemia and hypoproteinemia:

    - with extensive surgical operations, sepsis, acute respiratory distress syndrome adults;

    - When removing fluids rich in protein from the body - ascites, exudative pleurisy;

    - with transfusion of large amounts 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);

    - with acute liver failure to maintain the oncotic pressure of the plasma and to bind excess amount of free bilirubin in blood plasma;

    - for preoperative hemodilution (obtaining an additional volume of blood to fill the device of artificial circulation during aortocoronary bypass surgery);

    - to increase 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 procedure of hemodialysis.
    Contraindications:

    - increased individual sensitivity;

    - hypervolemia;

    - pulmonary edema.

    Carefully:

    - with thrombosis;

    - heart failure (danger of exacerbation!);

    - renal failure;

    - anemia of severe course;

    - arterial hypertension;

    - continuing internal bleeding.

    Pregnancy and lactation:

    Appropriate experimental studies with Plazbumin 20 have not been conducted. Therefore, the appointment of pregnant women is possible only for life indications.

    Dosing and Administration:

    Doses and mode of administration are set individually, taking into account the nature of the disease and the age of the patient. The average daily dose of Plazbumin 20 for adults is 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 body weight) in the absence of active bleeding.

    Plasbumin 20 should be administered only intravenously!

    Therapy of burns

    As a rule, Plasbumin 20 is recommended to be used to maintain the colloidal osmotic pressure of the plasma 24 hours after the thermal damage (in the first day large volumes of saline solutions are poured to restore a reduced volume of extracellular fluid).It is recommended to maintain a concentration of plasma albumin at a level of 20-30 g / l with an oncotic plasma pressure equal to 20 mmHg (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 with urine.

    Hypoproteinemia with or without edema of tissues

    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 quantities. Since patients with hypoproteinemia usually have a normal blood volume, the infusion rate of Plasbumin 20 should not exceed 2 ml / min, as a more rapid administration can cause circulatory disorders and pulmonary edema.

    Acute Respiratory Distress Syndrome Adult (ARDS)

    If patients have clinical signs indicating simultaneously hypoproteinemia and hypervolemia, it is advisable to designate Plasbumin 20 in the above doses together with a diuretic.

    Aorto / coronary bypass

    The common practice of hemodilution therapy (to fill the APC during surgery) is the use of albumin and crystalloids until the patient achieves a hematocrit 20% and a plasma albumin concentration of 25 g / l.

    Hemolytic disease of newborns

    Plazbumin 20 is prescribed approximately one hour before the beginning of the procedure of exchange transfusion in a dose of 1 g / kg of body weight. Care must be taken in the presence of initial hypervolemia in children.

    Transfusion of erythrocyte mass

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

    Acute nephritis

    To increase the effectiveness of therapy with cyclophosphamide or steroids, as well as with the onset of edematous syndrome against the background of steroids, 100 ml of Plasbumin 20 and loop diuretics can be administered daily for 7-10 days under the control of diuresis and potassium concentration in the blood plasma.

    Hemodialysis

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

    Side effects:

    In rare cases, it is possible to develop allergic reactions, which include urticaria, chills, fever, dyspnea, tachycardia, lowering blood pressure, pain in the lumbar region.

    Overdose:

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

    Interaction:

    Plazbumin 20 is compatible with whole blood, erythrocyte mass, standard electrolyte and carbohydrate solutions for intravenous administration. Do not mix Plasbumin 20 with protein hydrolysates, amino acid solutions and alcohol-containing solutions.

    Special instructions:

    Before use, each bottle should be carefully examined. Muddy or frozen solutions, as well as partially used bottles, must be destroyed.

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

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

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

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

    In acute massive blood loss, the use of albumin can be supplemented by transfusion of erythrocyte mass 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 a lower blood pressure (doctor's control!).

    Effect on the ability to drive transp. cf.and fur:

    The effects of plasbumin 20 on the ability to drive a car or work with machines have not been revealed.

    Form release / dosage:A solution of 20% for infusion.
    Packaging:A solution of 20% for infusions in bottles of 50 ml (10 g of albumin) and 100 ml (20 g of albumin).
    Storage conditions:

    In the dark place at a temperature of no higher than 30 ° C.

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

    Shelf life:

    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014887 / 01
    Date of registration:06.05.2008
    The owner of the registration certificate:Grifols Therapyutics Inc.Grifols Therapyutics Inc. USA
    Manufacturer: & nbsp
    Representation: & nbspR-PHARM, JSC R-PHARM, JSC Russia
    Information update date: & nbsp29.08.2015
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