Active substanceHydroxyethyl starchHydroxyethyl starch
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  • Dosage form: & nbspsolution for infusions
    Composition:
    Active substance:
    hydroxyethyl starch 200 / 0.5 to 60 g.
    Excipients:
    sodium chloride - 9 g;
    water for injection - up to 1 liter.
    Theoretical osmolarity - 308 mOsm / l
    Description:Transparent, or slightly opalescent, colorless or pale yellow liquid.
    Pharmacotherapeutic group:Plasmasuberant
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:
    Hydroxyethyl starch-Eskom is a colloidal plasma-substituting solution based on hydroxyethyl starch (HES), a high-molecular compound consisting of polymerized dextrose residues. The source of HES production is native starch (amylopectin), which undergoes cleavage to produce molecules with a certain molecular mass, as well as hydroxyethylation, in which free hydroxyl groups of dextrose residues are replaced by hydroxyethyl groups over C2 / C6 bonds. HES is subjected to prolonged hydrolysis with serum amylase to form oncotically active oligo- and polysaccharides of different molecular weights.
    Hydroxyethyl starch-Eskom, 6% solution for infusions - a preparation of HES (pentahrachmal) with an average molecular weight of 200 thousand Da and a degree of substitution of about 0.5.
    Due to the ability to bind and retain water, it has a volatile effect - the ability to increase the volume of circulating blood (BCC) by 85-100% of the injected volume, which persists for 4-6 hours.
    Providing plazmozameschayuschee action, restores the disturbed hemodynamics, improves microcirculation, rheological properties of blood (by reducing the hematocrit), reduces the viscosity of plasma, reduces platelet aggregation and prevents the aggregation of erythrocytes.
    The similarity of the structure of HES with the structure of glycogen explains the high level of tolerability and the practical absence of adverse reactions.
    Pharmacokinetics:
    After intravenous administration is excreted by the kidneys (for 24 hours - about 70% of the administered dose of penta-starch) and with bile.
    A small amount accumulates in the reticuloendothelial system (without manifestation of toxic effects on the liver, lungs, spleen and lymph nodes), where it is cleaved by amylase and subsequently excreted by the kidneys and through the intestine.
    Indications:
    Prophylaxis and treatment of hypovolemia (shock due to acute blood loss, including intraoperative, trauma, burns, sepsis).
    Prevention of arterial hypotension when administered to general anesthesia, with spinal and epidural anesthesia.
    Disturbance of microcirculation and therapeutic hemodilution, incl. isovolemic.
    Contraindications:
    Hypersensitivity (including to starch), intracranial hypertension, intracranial bleeding, decompensated chronic heart failure, acute renal failure (oligo-, anuria), cardiogenic pulmonary edema, hyperhydration, hypervolemia, dehydration (if necessary correction of electrolyte metabolism) expressed disorders of the blood coagulation system (including severe hemorrhagic diathesis, hypocoagulation), hyperchloremia, hypernatremia, hypokalemia, hemodialysis, childhood.
    Carefully:Lactation period, pregnancy, compensated chronic heart failure and chronic renal failure, chronic liver disease, von Willebrand's disease, hemorrhagic diathesis, hypofibrinogenemia.
    Dosing and Administration:
    Enter intravenously drip or jet.
    Dose and speed of administration are set individually, depending on the severity of hemodynamic disorders, the severity of the patient's condition.
    The first 10-20 ml should be administered slowly (the possibility of developing anaphylactoid reactions).
    With the development of shock, the average daily dose is 0.5-1.5 liters, the maximum daily dose is 33 ml / kg. When hemorrhagic shock is injected at a rate of up to 20 ml / h / kg. With septic and burn shock, the infusion rate is somewhat less.
    The daily dose and rate of administration are calculated depending on the magnitude of hemorrhage, hemoglobin and hematocrit. In young patients without the risk of cardiovascular and pulmonary complications, the duration of therapy is determined by the level of hematocrit (should be at least 30%).
    The maximum infusion rate depends on the initial parameters of hemodynamics and is 20 ml / kg / h.
    With a view to hemodilution, the daily dose is 500 ml for several days to a total dose of 5 liters, which can be exceeded in exceptional cases and distributed for up to 4 weeks.
    In the absence of an emergency situation, the recommended infusion rate is 30 minutes per 500 ml of solution.
    Treatment and prevention of hypovolemia and shock: the maximum daily dose for a 6% solution is 33 ml / kg, which corresponds to 2.5 liters per 75 kg of body weight or 2 g / kg of HES; the maximum rate of administration is 20 ml / kg / h (1.5 l / 75 kg / h or 1.2 g / kg / h). The duration of application is determined by the duration and level of hypovolemia.
    HemodilutionI: the administration is carried out isovolemically (with blood sampling) or hypervolemic (without sampling own blood) at small (250 ml), medium (500 ml) and high daily doses (2 times 500 ml). The criterion of effectiveness is the reduction of the hematocrit value determined for each patient. Infusion rate: 250 ml for 0.5-2 hours, 500 ml for 4-6 hours, 2 times 500 ml for 8-24 hours. The duration of administration of 6% solution is 10 days.
    Acute normovolemic hemodilution to reduce the introduction of donor blood during surgical operations: 6% solution is injected immediately before the operation in a ratio of 1: 1 with a hematocrit index according to Tsilya after acute normovolemic hemodilution of at least 30. Blood sampling - 2-3 times 500 ml of own blood, daily dose of 2-3 times for 500 ml of solution, the rate of blood sampling - 1 liter for 15-30 minutes, the rate of administration of the drug - 1 liter for 15-30 minutes. Usually use a single injection of the drug immediately before the operation.Repeated use is possible if the initial hematocrit is within normal limits.
    In a critical situation, a quick injection of 500 ml of solution (under pressure) is possible. When the preparation is administered under pressure, all air from the vial must be previously removed (risk of developing embolism). Speed ​​with intraoperative administration, as well as in patients with burn and septic shock should be reduced.
    In therapeutic hemodilution, the drug is used for multi-day or multi-part infusion regimens.
    Multi-day infusion regimen: daily infusion dose - usually 0.5-1 L of 6% solution of HES; with sudden deafness and "intermittent" lameness - from 500 to 750 ml / day, in the acute phase of ischemic stroke - 750-1000 ml / day; the rate of administration is 75-250 ml / h, the course duration is 5-10 days. In the acute phase of ischemic stroke at the beginning of therapy, it is possible to additionally introduce a so-called. a loading dose of 250-500 ml, while the rate of administration is at an increased rate (for example, up to 250-500 ml / h).
    With a multi-week infusion scheme, infusion is carried out 2-3 times a week for 250-500 ml at a rate of 125-250 ml / h, the duration of therapy is usually 3-6 weeks.In many cases, adaptation of the injected volume of the drug (and, if necessary, bleeding) is recommended to hemodynamic and / or haemorheological indices (central venous pressure is 15 mm Hg, hematocrit is 38-42, etc.).
    Side effects:Allergic reactions: rarely - anaphylactoid reactions, nausea, vomiting, hypotension, tachycardia, fever, headache (stopping the drug). Hemodynamic disorders, persistent reversible skin itching (with rapid administration or use of high doses). Increased activity of serum amylase (not associated with clinical manifestations of pancreatitis).
    Overdose:
    With rapid introduction into large volumes, it is possible to provoke the development of acute left ventricular failure and pulmonary edema.
    In the case of complaints about a feeling of tightness in the chest, difficulty breathing, low back pain, as well as in case of chills, cyanosis, circulatory disturbance and breathing, it is necessary to stop the drug administration and conduct appropriate symptomatic therapy.
    Interaction:If mixing with other medicinal products is necessary, a complete asepsis should be followed; is necessaryEnsure compatibility and good mixing of medicines.
    Special instructions:
    In connection with the possibility of developing allergic reactions, the introduction of the first 10-20 ml of the solution should be carried out slowly (drip), carefully monitoring the patient's condition.
    Treatment should be carried out under the control of bcc, the content of electrolytes, leukocytes, platelets, hemoglobin, blood coagulation indicators, kidney function.
    At the beginning of therapy, it is required to monitor the serum levels of creatinine. If creatinine levels are too low (1.2-2 mg / dL or 106-177 μmol / L - compensated renal failure), it is necessary to carefully weigh the possibility and necessity of the therapy and necessarily to monitor the fluid balance frequently.
    It should be borne in mind that the HES can affect clinical and chemical indices (glucose, protein, erythrocyte sedimentation rate, fatty acids, cholesterol, sorbitol dehydrogenase, specific gravity of urine).
    The introduction of high doses of the drug leads to a decrease in hematocrit, hemoglobin concentration and plasma protein. Values ​​of hemoglobin below 10 g% and hematocrit below 27 are considered critical.Starting with a total protein of less than 5 g / dL, the administration of albumin is indicated. When blood loss is more than 20-25% of bcc, an additional introduction of erythrocyte mass is shown.
    In the case of shock conditions caused mainly by loss of water and electrolytes (severe vomiting, diarrhea, burns), after initial treatment with the drug, further treatment should be carried out using a balanced solution of electrolytes.
    Do not mix the drug with other drugs in the same container and in the same system.
    During treatment, it is necessary to ensure a sufficient supply of fluid in the body. When anaphylactoid reactions occur, the drug should be discontinued, the patient should be transferred to the "lying" position with the lower limbs raised above the head level, and the airways released; then enter intravenously epinephrine, previously diluted 1 ml of the solution (1: 1 thousand) to 10 ml - first, slowly introduce 1 ml of the resulting solution (0.1 mg), while monitoring the pulse and blood pressure; the introduction of epinephrine can be repeated. Then 5% solution of human albumin (for replenishment of BCC), glucocorticosteroid preparations (250-1000 mg of prednisolone), antihistamine drugs are intravenously administered.
    Patients should be under continuous medical supervision, additional therapeutic measures should be taken depending on the condition of the patients.
    In the treatment of patients whose blood group is not established, it must be borne in mind that the introduction of large volumes of HES can make it difficult to interpret the results of the agglutination reaction in determining the blood group.
    After the administration of the drug, the activity of amylase in the blood increases markedly, which returns to the norm in 3-5 days (may interfere with the laboratory diagnosis of pancreatitis without affecting the clinical picture).
    Form release / dosage:
    Solution for infusions 6%.
    Packaging:
    100, 200, 250, 400 and 500 ml in glass bottles for blood, transfusion and infusion solutions with a capacity of 100, 250, 450 and 500 ml.
    One bottle with instructions for medical use of the drug is placed in a pack of cardboard.
    For 28 bottles with a capacity of 100 or 250 ml or 15 bottles with a capacity of 450 or 500 ml with the appropriate number of instructions for medical use of the drug placed in a box of corrugated cardboard (for hospitals).
    Storage conditions:Storage conditions. At a temperature of 10 to 25 ° C. Keep out of the reach of children.
    Shelf life:2 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002127/08
    Date of registration:27.03.2008 / 01.11.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:ESKOM NPK, OAO ESKOM NPK, OAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.04.2017
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