RheHES 130 (ReoHES 130)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydroxyethyl starchHydroxyethyl starch
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    • Dosage form: & nbspsolution for infusions
    Composition:
    1 liter of solution contains:
    Active ingredient:
    hydroxyethyl starch - 130 / 0.42 - 60.0 g;
    auxiliary components:
    sodium chloride - 9.0 g;
    water for injection - up to 1 liter.
    Theoretical osmolarity - 309 mOsmol / l
    Description:Transparent or slightly opalescent, colorless or pale yellow solution.
    Pharmacotherapeutic group:plasma-substituting agent
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:
    ReoHES 130 is a hypertonic colloidal solution based on hydroxyethylated starch (hereinafter referred to as HES), a high-molecular compound consisting of polymerized dextrose residues. The source of HES production is native starch (amylopectini), which undergoes cleavage in order to obtain molecules with a certain molecular mass, and also 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.
    ReoHES 130 solution for infusion 6% - a preparation of HES (pentahrachmal) with an average molecular weight of 130,000 Da and a degree of substitution of about 0.42.
    Due to the ability to bind and retain water, it has a volatile effect - the ability to increase the volume of circulating blood (hereinafter BCC) by 85-100% of the withdrawn volume, which persists for about 4 hours.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 and with bile.
    A small amount accumulates in the reticulo-endothelial system (without toxic effects on the liver, lungs, spleen and lymph nodes), where it is cleaved by amylase and subsequently excreted in the night through the intestine.
    Indications:
    Prevention and treatment of hypovolemia (shock in the aftermath of 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 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 coagulation blood systems (including severe hemorrhagic diathesis, hypocoagulation), hyperchloremia, hyperparathyemia, hypokalemia, children under 3 years old.
    Carefully:Lactation period, pregnancy, compensated chronic heart failure and chronic renal failure, chronic liver disease, Villebraid's disease, hemorrhagic diathesis, hypofibrinogenemia.
    Dosing and Administration:
    Enter intravenously drip or jet.
    The dose and rate of administration are set individually, depending on the severity of hemodynamic disorders and the severity of the patient's condition.
    The first 10-20 ml should be administered slowly (anaphylactoid reactions).
    With the development of shock the average daily dose for adults and children at the start of 12 years is 0.5-1.5 liters, the maximum daily dose is 33 ml / kg of 6% solution. When hemorrhagic shock is injected at a rate of up to 20 ml / kg / h. With septic and burn shock, the infusion rate is somewhat less. The maximum infusion rate should not exceed 20 ml / kg / h.
    The daily dose and rate of administration are calculated depending on the magnitude of hemorrhage, hemoglobin and hematocrit. In patients without 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. For children from 3 to 12 years, the maximum daily dose is 25 ml / kg.
    For hemodilution, the daily dose of 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 is 33 ml / kg. The duration of application is determined by the duration and level of hypovolemia.
    Hemodilution: 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 of the solution is 10 days.
    Acute normovolemic hemodilution to reduce the introduction of donor blood during surgical operations: the 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 is 2-3 times 500 ml of own blood, daily dose 2-3 times 500 ml of solution, the rate of blood sampling - 1 liter 15-30 minutes, the rate of drug administration - 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.
    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 administration of the drug and conduct appropriate symptomatic therapy.
    Interaction:Pharmaceutically incompatible with solutions of other drugs. If mixing with other medicinal products is necessary, a complete asepsis should be followed; it is necessary to ensure compatibility and good mixing of drugs.
    Special instructions:
    In connection with the possibility of developing allergic reactions, administer the first 10-20 ml of the solution 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. At the limit values ​​of creatinine content (1.2-2 mg / dL or 106-177 μmol / L - compensated renal failure), it is necessary to carefully weigh the need for therapy and carry out dynamic monitoring of the fluid balance.
    It should be borne in mind that the HES can affect clinical and chemical indices (glucose, protein, erythrocyte sedimentation rate, cholesterol, sorbitol dehydrogenase, specific gravity of urine).
    The introduction of high doses of the drug leads to a decrease in hematocrit, concentration of Hb 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 by the predominant loss of water and electrolytes (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, the airways released, intravenously injected epinephryles, after diluting 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 should 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 (it may complicate the laboratory diagnosis of pancreatitis without affecting the clinical picture).
    Form release / dosage:
    Solution for infusions 6%.
    Packaging:
    1. 250 and 500 ml bottles of low-density polyethylene. Vials have a device for fixation on a tripod, a measuring scale on the side wall. On the bottles are welded euro-caps of polyethylene with the control of the first autopsy. Each bottle is placed in a pack of cardboard with instructions for use.
    2. 250, 500 ml in bottles of glass with a capacity of 250, 500 ml respectively, corked with plugs of rubber compound and crimped with aluminum caps. Each bottle is placed in a pack of cardboard with instructions for use.
    3. For 10 bottles or bottles of 500 ml or 250 ml are placed in boxes of corrugated cardboard. In the box, insert instructions for use in an amount corresponding to the number of bottles or bottles (for hospitals).
    Storage conditions:In a dry place at a temperature of 10 ° to 25 ° C. In a place inaccessible to children. Freezing of the drug is not allowed.
    Shelf life:3 years. Use at the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002223/08
    Date of registration:31.03.2008
    The owner of the registration certificate:COMPANY VILANA, LLC COMPANY VILANA, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.01.2016
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