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

    In 1000 ml of solution contains:

    Active substance:

    proteins of human plasma 200 g

    of which albumin is not less than 96%

    Excipients:

    Sodium caprylate * 2.66 g (16 mmol)

    N-acetyl-DL-tryptophan * 3.94 g (16 mmol)

    Sodium chloride 3.69 g (63 mmol)

    Water for injection up to 1000 ml

    * as a stabilizer.

    The total amount of sodium ions in the preparation is 122 mmol / l

    Description:

    Transparent viscous liquid from light yellow to yellow (amber) color.

    Pharmacotherapeutic group:Plasmasuberant
    ATX: & nbsp

    B.05.A.A.01   Albumen

    Pharmacodynamics:

    Human albumin Biotest is a 20% sterile aqueous solution of albumin and is produced from human blood plasma.

    Human albumin Biotest fills the deficiency of plasma albumin, increases the volume of circulating blood, helps reduce hematocrit and the viscosity of whole blood, and also supports colloid osmotic (oncotic) blood pressure. The drug is involved in the excretion of hormones, enzymes, drugs, toxins, etc.

    Pharmacokinetics:

    Under normal conditions, the average half-life is 19 days.The balance between synthesis and elimination is usually achieved by regulating the response.

    If albumin is replenished from the outside, equilibrium is established within approximately 48 hours of administration. After 1-3 hours of infusion, an increase in the volume of circulating blood is established, due to the diffusion of fluid from the interstitial space.

    Indications:

    - Hypovolemic shock;

    - burns;

    - hypoproteinemia with concomitant edema of tissues or without it (after extensive surgical operations, with sepsis);

    - acute respiratory distress syndrome of adults (with vollemic overload together with the use of diuretics);

    - acute liver failure (to maintain the oncotic pressure and the binding of excess bilirubin plasma);

    - hemolytic disease of the newborn (to bind free bilirubin);

    - when removing biological fluids rich in protein (ascites, peritonitis, mediastinitis);

    - resuspension of erythrocytes;

    - acute nephrosis (together with diuretics in the absence of effect from steroid therapy);

    - Hemodialysis (with the development of hypovolemic shock and hypotension during the session)

    Contraindications:

    Chronic heart failure II-III degree; severe anemia; hypervolemia; pulmonary edema; hypersensitivity to albumin or any components of the drug.

    Carefully:

    Human albumin Biotest should be administered with caution in those clinical situations where hypervolemia and its consequences (eg, increased stroke volume, high blood pressure) or hemodilution present a particular risk to the patient. In this way, Human albumin Biotest should be used with caution in patients with heart failure, hypertension, esophagus dilatation, pulmonary edema, acute anemia, bleeding, renal and postrenal anuria.

    Pregnancy and lactation:

    Controlled studies on the use of human albumin Biotest during pregnancy have not been conducted. However, the experience of clinical use indicates that the drug does not adversely affect the course of pregnancy, fetus or newborn.

    Dosing and Administration:

    Human albumin Biotest is administered by intravenous infusion.The drug is administered undiluted or diluted with an isotonic solution, for example, 0.9% sodium chloride solution.

    When hypovolemic shock the volume and speed of infusion are selected individually, according to the condition and response of the patient to ongoing therapy. When dehydrating the patient, crystalloid solutions are additionally prescribed. The total dose should not exceed the albumin level of a healthy person, i.e. approximately 2 g per kg of body weight in the absence of active bleeding.

    In the treatment burns The introduction of human albumin Biotest is usually started no earlier than 24 hours after thermal damage to maintain colloidal osmotic pressure of the plasma (in the first day large volumes of saline solutions are poured to restore a reduced volume of extracellular fluid). Conducted therapy should maintain a concentration of plasma albumins at a level of 25 ± 5 g / l with 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 dynamics of protein loss from the burned areas and with urine.

    When hypoproteinemia Human albumin Biotest is prescribed only as a symptomatic or maintenance therapy against the background of the correction of the underlying pathology that caused this condition. The usual daily dose for adults is 50 -75 g, for children - 25 g. Patients with severe hypoproteinemia who continue to lose albumin, the dose of the drug may be increased. Because patients with hypoproteinemia usually have a normal volume of circulating blood, the infusion rate should not exceed 2 ml / min, since a faster administration can cause circulatory disorders and pulmonary edema.

    When adult respiratory distress syndrome patients with clinical signs, simultaneously indicating hypoproteinemia and hypervolemia, Human albumin Biotest is prescribed in the above doses together with diuretics.

    When hemolytic disease of newborns the drug is prescribed at a dose of 1 g / kg body weight 1 hour before the exchange transfusion procedure.

    For resuspension of erythrocytes When transfusing the erythrocyte mass, 25 g of human albumin is used. Biotest per 1 liter of erythrocyte mass just before the transfusion of thawed washed erythrocytes.If the patient has concomitant hypoproteinemia or severe liver damage, the dose of the drug may be increased.

    When acute nephrosis in the absence of response to therapy with cyclophosphamide or steroids or with worsening of edematous syndrome during therapy with steroids, there may be a combined use of 100 ml of human biotest and diuretics daily for 7-10 days under the control of diuresis and potassium concentration in the blood.

    In carrying out hemodialysis The introduction of human albumin Biotest is indicated in the development of hypovolemic shock or hypotension in patients with chronic renal insufficiency. The dose of administration is usually 100 ml. 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).

    When introducing human albumin, biotest should regularly monitor hemodynamic parameters:

    - blood pressure and heart rate

    - central venous pressure

    - pulmonary artery pressure

    - diuresis

    - electrolytes

    - hematocrit / hemoglobin

    After opening the vial, the solution should be used immediately. Unused solution is not subject to storage.

    Side effects:

    Rarely: mild reactions, such as a rush of blood to the face and a feeling of heat, hives, fever and nausea. In some cases, chills, vomiting, erythema, a drop in blood pressure with tachycardia and dyspnea may occur. These reactions, as a rule, quickly pass with decreasing rate of infusion or its termination. In very rare cases, very severe reactions can occur up to anaphylactic shock. In these cases, the infusion should be discontinued and immediately begin the necessary therapy.

    Overdose:

    It is necessary to constantly monitor the parameters of hemodynamics, since at too high doses or the speed of infusion, hypervolemia may occur. At the first clinical signs of cardiovascular overload (headache, dyspnoea, swelling of the jugular veins or with an increase in arterial or central venous pressure, pulmonary edema), the human albumin infusion should be stopped immediately.

    Interaction:

    Human albumin Biotest can not be mixed with other medicinal products, blood components (for example, erythrocyte mass).To prepare a solution of a drug with a lower concentration, only isotonic solutions (for example, 0.9% sodium chloride solution) should be used. Human albumin Biotest can not be diluted with water for injection, as this can lead to hemolysis.

    Specific interaction of human albumin Biotest with other drugs is unknown.

    Special instructions:

    If allergic and anaphylactic reactions occur, the infusion should be immediately discontinued and appropriate therapy should be carried out. If an anaphylactic shock occurs, anti-shock therapy should be given.

    Colloid-osmotic pressure 20% solution of human albumin Biotest is four times higher than blood plasma. Therefore, with the appointment of concentrated plasma solutions, care should be taken to ensure sufficient hydration of the patient. It is necessary to constantly monitor the patient's condition in order to avoid overloading the circulatory system or hyperhydration.

    20% albumin solutions have a relatively low electrolyte content compared to 4-5% albumin solutions. Therefore, when 20% Human albumin Biotest should monitor the electrolytes of blood serum and, if necessary, carry out activities to restore or maintain the water-electrolyte balance.

    If it is necessary to replace large volumes, it is necessary to control blood clotting and hematocrit. It is necessary to monitor the adequacy of substitution of other blood components (clotting factors, electrolytes, platelets, erythrocytes).

    Incorrect selection of the dosing regimen and the speed of infusion without regard to the state of the circulatory system of the patient can lead to hypervolemia. At the first clinical signs of cardiovascular overload (headache, dyspnoea, swelling of the cervical veins, with increased arterial or venous pressure, pulmonary edema), the infusion should be stopped immediately.

    When using medicines from human blood or plasma, it is impossible to completely exclude the risk of transmission of known and as yet unknown virus infections. To reduce the risk of transmission of pathogens, donor criteria are selected according to strict criteria, donor plasma is tested and selected and the pool of plasma is monitored.In addition, the stages of virus removal and inactivation are included in the production process. Until now, there have been no reports of the transmission of any viral infections through the drug Human albumin Biotest, manufactured in accordance with the European Pharmacopeia and through proven production methods.

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

    There is no indication that Human albumin Biotest can affect the ability to drive a car or service machinery.

    Form release / dosage:Solution for infusions, 20%.
    Packaging:

    50 ml each, and 100 ml each in colorless glass bottles (EF, glass type 2), sterilely sealed with a stopper of chlorobutyl rubber (EF: Type 1) with an aluminum cap, in a pack of cardboard with instructions for use.

    The cardboard bundle is sealed from above with a non-damaged self-adhesive film (first opening control).

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Do not freeze!

    Keep out of the reach of children!

    Shelf life:

    3 years. After the expiration date the drug should not be used.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-007947/08
    Date of registration:08.10.2008 / 10.04.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Biotest Pharma GmbHBiotest Pharma GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspBIOTEST PHARMA GmbHBIOTEST PHARMA GmbHRussia
    Information update date: & nbsp14.07.2017
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