Volekam® GEK-200 (Voleodicramen)

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 substance:
    hydroxyethyl starch (HES 200 / 0.5) - 60.0 g or 100.0 g;
    sodium chloride - 9.0 g;
    Excipients: water for injection - up to 1 liter.
    Theoretical osmolarity is 308 mOsm / l.
    Description:Transparent or slightly opalescent, colorless or slightly colored liquid.
    Pharmacotherapeutic group:Plasmasuberant
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:
    Volekam® HEK-200 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 (amylopectin), which undergoes cleavage to produce molecules with a certain molecular weight, 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.
    Volekam® HEK-200, a solution for infusions of 6% and 10% - a preparation of HES (penta starch) with an average molecular weight of 200 thousand daltons and a degree of substitution of about 0.5.
    Due to its ability to bind and retain water, it has a volemic effect-the ability to increase the volume of circulating blood (hereinafter BCC) by 85-100% of the injected volume, which persists for 4-6 hours.
    Provides plazmozameschayuschee action, restores the broken hemodynamics, improves microcerculation, 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 toxic effect 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). Disturbance of microcirculation and therapeutic hemodilution, including isovolemic.
    Contraindications:
    Hypersensitivity (including starch), intracranial hypertension, intracranial hemorrhage, 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 system (including severe hemorrhagic diathesis, hypocoagulation), hyperchloremia, hypernatremia, hypokalemia, children's age. Do not use in seriously ill patients, including sepsis or in intensive care units, in patients with impaired renal function, with open heart surgery.
    Carefully:Pregnancy, lactation; compensated chronic heart failure and chronic renal failure, chronic liver disease, von Willebrand's disease, hemorrhagic diathesis, hypophybrinogenemia.
    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.
    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).
    The first 10-20 ml should be administered slowly (anaphylactoid reactions may develop).
    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. Speed ​​with intraoperative administration, as well as in patients with burn and septic shock should be reduced.
    Prevention of hypovolemia and shock: the maximum daily dose for 6% solution is 33 ml / kg, 10% solution - 20 ml / kg.The duration of application is determined by the duration and level of hypovolemia.
    With the development of shock the average daily dose is 0.5-1.5 liters, the maximum daily dose is 20 ml / kg of a 10% solution (1.5 liters per 75 kg) or 33 ml / kg of a 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 daily dose is 33 ml / kg 6% solution or 20 ml / kg 10% solution.
    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 value according to Tsilya after acute normovolemic hemodilution of at least 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 drug administration 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.
    Hemodilution: the drug is administered isovolemically (with the collection of own blood) or hypervolemic (without sampling own blood) at small (250 ml),medium (500ml) and high daily doses (2 times 500 ml each). 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 the solution is 10 days.
    With therapeutic hemodilution the drug Volekam® GEK-200 is used for multi-day or multi-week infusion schemes.
    In most cases, adaptation of the injected drug to hemodynamic and / or hemorheological indices is recommended (central venous pressure is 15 mm Hg, hematocrit is 38-42%, etc.).
    Side effects:Allergic reactions: urticaria, skin itching, rarely anaphylactoid reactions, nausea, vomiting, hypotension, tachycardia, fever, headache (stopping the drug). Violations of hemodynamics (with rapid administration or use of high doses), resistant reversible skin itching. Increased activity of serum amylase (not associated with clinical manifestations of pancreatitis).
    Overdose:
    With rapid administration in large volumes, it is possible to provoke the development of a system of 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.
    Special instructions:
    In connection with the possibility of developing allergic reactions, the introduction of the first 10-20 ml of the solution is 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. 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 Volekam® HEK-200 can influence clinical and chemical indices (glucose, protein, erythrocyte sedimentation rate, cholesterol, fatty acids, 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.
    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 level of the head, to release the airways; intravenously epinephrine. Preliminarily diluting 1 ml of the solution (1: 1 thousand)
    up to 10 ml - first, slowly inject 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 Volekam® HES-200 may make it difficult to interpret the results of the agglutination test when determining the blood group.
    After the administration of the drug, the activity of amylase in the blood increases markedly, which returns to the norm after 3-5 days (it may complicate the laboratory diagnosis of pancreatitis without affecting the clinical picture).
    Cancel at the first sign of kidney damage, with the first signs of coagulopathy.
    It is necessary to monitor the function of the kidneys for 90 days after the infusion of the drug.
    Form release / dosage:
    Solution for infusions 6%, 10%.
    Packaging:
    200 ml or 400 ml are placed in glass bottles for blood, infusion and transfusion preparations with a capacity of 250 ml or 450 ml, respectively, sealed with rubber plugs and crimped with aluminum caps. Each bottle, together with instructions for use, is placed in a pack of cardboard.For 24 or 28 bottles of 200 ml, for 12 or 15 bottles of 400 ml, along with 5-10 instructions for use are placed in boxes of cardboard corrugated (for hospitals). 100, 200, 250, 400, 500 or 1000 ml in bags of polyolefin MID for bottling infusion solutions or in bags made of a film of multilayer polymeric M312A for manufacturing containers for storage and transportation of infusion solutions (for hospitals).
    For 56 packages of 100 ml, for 24 or 28 packages of 200 or 250 ml and for 12 or 15 packages of 400 or 500 ml, 12 packages of 1000 ml each are placed in boxes of cardboard corrugated together with instructions for use in an amount corresponding to number of packages (for hospitals). It is allowed to put the instruction text on the application directly on the package by hot stamping, thermal printing or self-adhesive labels.
    Storage conditions:
    In the dark place at a temperature of no higher than 25 ° C. Freezing of the drug is not allowed.
    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:LSR-003971/10
    Date of registration:06.05.2010 / 11.03.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:En.S. Pharmaceuticals, LLCEn.S. Pharmaceuticals, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.03.2017
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