Active substanceHydroxyethyl starchHydroxyethyl starch
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  • Dosage form: & nbspsolution for infusions
    Composition:
    Active substance: Hydroxyethyl starch 200 / 0.5 to 100 g.
    Excipients: sodium chloride - 9 grams, water for injection - up to 1 liter. Theoretical osmolarity is 308 mOsm / l.
    Description:Transparent colorless or light yellow liquid.
    Pharmacotherapeutic group:plasma-substituting agent
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:A colloidal plasma-substitution solution based on hydroxyethylated starch (HES) is a high-molecular compound consisting of polymerized dextrose residues. The source of HES is natural starch (amylopectin), mainly obtained from potato tubers, corn wax grains, rice, wheat, which (starch) is cleaved to produce molecules with a certain molecular weight, as well as hydroxyethylation, in which free hydroxyl groups dextrose residues are replaced by hydroxyethyl groups over the C2 / C6 bonds. The latter contributes to a decrease in the rate of hydrolysis of aminopectin with serum amylase and an increase in the duration of its stay in the blood.Due to its ability to bind and retain water, it has the ability to increase the volume of circulating blood (BCC) by 130-140% of the injected volume (the plasma-replacing effect persists for 4-6 hours). It restores 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:
    A small amount of HES accumulates in the reticuloendothelial system (RES) (without manifestation of toxic effects on the liver, lungs, spleen and lymph nodes), where it is cleaved with amylase. After intravenous (iv) administration is excreted by the kidneys (for 24 hours - about 5-100% of the administered dose) and with bile.
    Indications:
    Prophylaxis and treatment of hypovolemia and 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. Filling the apparatus of extracorporeal circulation.
    Contraindications:Hypersensitivity (including to starch), intracranial hypertension, arterial hypertension, intracranial hemorrhage, decompensated chronic heart failure (CHF) acute renal failure (oligo, anuria), pulmonary edema (including cardiogenic), hyperhydration ( including pulmonary edema), hypervolemia, dehydration (if necessary correction of electrolyte metabolism), severe disorders of the blood coagulation system (including severe hemorrhagic diathesis, severe hypocoagulation, severe hypophybrinogenemia), gi erhloremiya, hypernatremia, hypokalemia, hemodialysis, severe liver failure, pregnancy, breast-feeding, age up to 2 years.
    Carefully:Compensated CHF and chronic, renal failure (CRF), chronic liver disease, von Willebrand's disease, hemorrhagic diathesis, hypofibrinogenemia, hepatic insufficiency, hyperosmolarity.
    Pregnancy and lactation:Use during pregnancy is contraindicated.If it is necessary to use the drug during lactation it is necessary to stop breastfeeding.
    Dosing and Administration:
    Intravenous drip or stream. 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). The duration of therapy depends on the duration and severity of hypovolemia, the hemodynamic effect as a result of the therapy and the degree of hemodilution.
    The maximum daily dose is 20 ml / kg per day. The maximum rate of administration is 20 ml / kg. Average daily doses for children 2-3 years - 8-10 ml / kg; 3-6 years - 10-15 ml / kg; 6-12 years - 10-15 ml / kg; 12-18 years-20 ml / kg.
    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.
    With a developed shock, 0.5-1.5 liters. 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.
    In young patients without the risk of cardiovascular and pulmonary complications, the duration of therapy is determined by hematocrit (should be at least 30%).
    In the absence of an emergency situation, the recommended infusion rate is 30 minutes per 500 ml of solution.
    Hemodilution: The administration is carried out isovolemically (with blood sampling) or hypervolemically (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 is 10 days.
    Acute normovolemic hemodilution to reduce the introduction of donor blood in surgical operations: Immediately before the operation in a ratio of 1: 1 with a hematocrit index according to Tsilya after acute normovolemic hemodilution is not less than 30. Blood sampling - 2-3 times 500 ml of own blood, daily dose 2 -3 times for 500 ml of solution; the rate of blood sampling is 1 liter for 15-30 minutes, the rate of administration of the drug is 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 therapeutic hemodilution, a multi-day or multi-week infusion scheme is used.
    The multi-day scheme: daily infusion dose - 0.5-1 l solution; with sudden deafness or intermittent claudication - 500-750 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, a loading dose of 250-500 ml can be additionally administered, with the rate of administration being increased at 250-500 ml / hr.
    The multi-week scheme: infusion is carried out 2-3 times a week for 250-500 ml at a rate of 125-250 ml / h, duration 3-6 weeks. In many cases, adaptation of the injected volume (if necessary, bleeding) to hemodynamic and / or hemorheological parameters is recommended (central venous pressure is 15 mm Hg, hematocrit is 38-42, etc.)>
    With parallel blood collection, care must be taken to ensure that at no point in time a hypovolemic condition occurs (the infusion is performed either in parallel with bleeding or in front of it, and the amount administered should be greater than the amount of blood sampled). The daily dose is similar to that for replenishment of BCC.
    Side effects:
    Allergic and anaphylactoid reactions: vomiting, hyperthermia, chills, pruritus, an increase in the submandibular and parotid salivary gland,influenza-like syndrome (headache, myalgia, peripheral edema), Quincke's edema, rarely - shock, stopping breathing and heart. When administered in high doses - increased bleeding, blood circulation overload. Increase in serum amylase activity (3-5 days later returns to normal). Hypocoagulation of the breeding. Pain in the lumbar region, decreased hematocrit, hypoproteinemia (as a result of dilution),
    If any of the side effects listed in the manual are aggravated; shi You notice any other side effects not listed in the instructions; inform the doctor about it.
    Overdose:Symptoms: with the rapid introduction of large volumes, it is possible to develop acute left ventricular failure and pulmonary edema, a disruption of blood coagulation.
    Treatment: when there are complaints of a feeling of tightness in the chest, difficulty breathing, low back pain, the occurrence of chills, cyanosis, circulatory disorders and breathing, it is necessary to stop the drug and perform symptomatic therapy.
    Interaction:
    HES increases the nephrotoxicity of antibiotics. Anticoagulants increase the time of bleeding. Pharmaceutically incompatible with solutions of other drugs.
    If you are taking other drugs, consult a doctor.
    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), monitoring the patient's condition.
    Treatment should be carried out under the control of bcc, the concentration of electrolytes, leukocytes, platelets, hemoglobin, blood coagulation, kidney function (especially in children 2-3 years due to the water electrolyte status).
    At the beginning of therapy, it is required to monitor the serum creatinine concentration. At the limit values ​​of creatinine concentration (1.2-2 mg / dL or 106-177 μmol / l - compensated renal failure), it is necessary to correlate the possibility and necessity of the therapy and necessarily carry out a constant monitoring of the water-electrolyte balance.
    It should be borne in mind that HES can affect clinical and chemical indices (glucose, protein, erythrocyte sedimentation rate (ESR), 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.The hemoglobin values ​​below 10% and the 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 the loss of water and electrolytes (pronounced vomiting, diarrhea, burns), after initial treatment with the drug, further treatment should be carried out using a balanced solution of electrolytes. 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 placed in the "lying" position with the head down, the airway should be released, then the IV is injected epinephrine, first diluting 1 ml of the solution (1: 1 thousand) to 10 ml - first slowly injected 1 ml of the resulting solution (0.1 mg), while controlling the pulse and blood pressure, the introduction of epinephrine can be repeated. Then I / in appoint a 5% solution, human albumin (for replenishment of bcc), glucocorticosteroid drugs (250-1000 mg prednisolone), antihistamines.
    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.
    After iv introduction of the drug increases the activity of amylase in the blood, which returns to normal after 3-5 days (may interfere with the laboratory diagnosis of pancreatitis, without affecting the clinical picture).
    Care should be taken when driving a car and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:
    Solution for infusions 10%.
    Packaging:
    For 200 ml, 400 ml in bottles of glass. Bottle with instructions for use in a pack of cardboard.
    For hospitals:
    - 24 bottles of 200 ml, 12 bottles of 400 ml without packs with an equal number of instructions for use in a box of corrugated cardboard;
    - 1 bottle with instructions for use (from 1 to 24 bottles of 200 ml, from 1 to 12 bottles of 400 ml with an equal number of instructions for use) without a bundle in a box of corrugated cardboard.
    Storage conditions:
    2 years. Do not use after the expiration date.
    Use only clear solutions (not more than light yellow) in undamaged bottles.
    Shelf life:
    At a temperature of no higher than 25 ° C. Do not freeze. Keep out of the reach of children.
    After the expiry date of the drug, unused bottles should be carefully opened, the contents drained into the sewerage system.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000663
    Date of registration:28.09.2011
    The owner of the registration certificate:KRASFARMA, JSC KRASFARMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.01.2016
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