Hydroxyethyl starch 200 / 0.5 (Hydroxyethyl starch 200 / 0.5)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceHydroxyethyl starchHydroxyethyl starch
Similar drugsTo uncover
  • Venofundin
    solution d / infusion 
    B. Brown Mehlungen AG     Germany
  • To the Voles
    solution d / infusion 
    MEDSINTEZ FACTORY, LTD.     Russia
  • Volekam® GEK-200
    solution d / infusion 
    En.S. Pharmaceuticals, LLC     Russia
  • Volemcor
    solution in / in 
    FIRM MEDPOLIMER, JSC     Russia
  • Voluven
    solution in / in 
    Fresenius Kabi Deutschland GmbH     Germany
  • Hemohes
    solution d / infusion 
    B. Brown Mehlungen AG     Germany
  • HETA-SORB
    solution d / infusion 
    Hemofarm AD     Serbia
  • Hydroxyethyl starch 130 / 0.4
    solution d / infusion 
    EAST-FARM, CJSC     Russia
  • HydroxyethylCrymal 200
    solution d / infusion 
    KRASFARMA, JSC     Russia
  • HydroxyethylCrymal 200
    solution in / in 
    KRASFARMA, JSC     Russia
  • Hydroxyethyl starch 200 / 0.5
    solution d / infusion 
    EAST-FARM, CJSC     Russia
  • Hydroxyethyl starch-Eskom
    solution in / in 
    ESKOM NPK, OAO     Russia
  • Infukol GEK
    solution in / in d / infusion 
    Zermumverk Bernburg AG     Germany
  • IONOCHES
    solution d / infusion 
    EAST-FARM, CJSC     Russia
  • RheHES 130
    solution d / infusion 
    COMPANY VILANA, LLC     Russia
  • RheHES 200
    solution in / in 
    COMPANY VILANA, LLC     Russia
  • Refortan® HES 10%
    solution in / in 
    BERLIN-PHARMA, CJSC     Russia
  • Refortan® HES 6%
    solution in / in 
    BERLIN-PHARMA, CJSC     Russia
  • Stabisol® HES 6%
    solution in / in 
    BERLIN-PHARMA, CJSC     Russia
  • HAES-steril
    solution in / in 
    Fresenius Kabi Deutschland GmbH     Germany
    • Dosage form: & nbspRAster for infusions
    Composition:Per 1 liter:

    Active substance:

    Hydroxyethyl starch 200 / 0.5 (with an average molecular weight of 200,000 Da and a degree of substitution of 0.5)

    60.0 grams

    100.0 g

    Excipients:


    Sodium chloride

    9.0 g

    9.0 g

    Water for injections

    up to 1 liter

    up to 1 liter

    Theoretical osmolarity - 308 mOsm / l

    Description:

    Transparent or slightly opalescent, colorless or pale yellow solution.

    Pharmacotherapeutic group:Plasmasuberant
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:

    Hydroxyethyl starch 200 / 0.5 with a concentration of 6% and 10% contains artificially produced hydroxyethyl starch, replacing the volume of circulating plasma, with a degree of substitution of 0.45-0.55.

    Due to this degree of substitution at an average molecular weight of 200,000 Da, the duration of the drug lasts 3-4 hours.

    Changing the rheological properties of blood, Hydroxyethyl starch 200 / 0.5 is used not only for infusion therapy, but also for improving microcirculation by reducing hematocrit, plasma viscosity and erythrocyte aggregation.

    Like all colloidal substances, hydroxyethyl starch is also temporarily deposited in the cells of the reticulo-endothelial system without causing irreversible toxic effects on the liver, lungs, spleen and lymph nodes.

    Hydroxyethyl starch with a concentration of 6% is an isonicotic solution, as a result of which the relative volume of the plasma is increased by 100%, the solution with a concentration of 10% is hyperoncotic, the relative volume of the plasma is increased by 145%.

    Rapid infusion (approximately 500 ml for 20 min) of a 6% solution of the drug results in a plateau-like increase in the volume of circulating blood by approximately 100% of the administered volume, which lasts for 3-4 hours. Subsequently, the volume of circulating blood gradually decreases.
    Pharmacokinetics:

    Hydroxyethyl starch is hydrolyzed by serum amylase, and is also metabolized by the kidneys. After 24 hours, approximately 47% of the injected hydroxyethyl starch is excreted in the urine and approximately 10% is found in the blood. Intravascular half-life is about 3-6 hours. Hydroxyethyl starch Do not undergo dialysis.

    Indications:

    Treatment of hypovolemia in acute blood loss, if the use of crystalloid solutions is insufficient.

    Contraindications:

    Hypervolaemia, hyperhydration, severe hypernatremia, severe hyperchloremia, severe disorders of the blood coagulation system (including severe hemorrhagic diathesis, hypocoagulation), dehydration, when correction of the water-electrolyte balance is required (for 6% and 10% solutions), decompensated chronic heart failure, hypersensitivity to the components of the drug, pulmonary edema, intracranial hemorrhage, children under 18 years of age, renal dysfunction, hemodialysis patients, sepsis, burns, use in critically ill patients in critical condition, renal failure with decompressed oliguria or anuria, use in patients on renal replacement therapy, intracranial bleeding, use at open x heart surgery, post-organ transplantation, the first trimester of pregnancy.

    Carefully:

    Compensated chronic heart failure, chronic renal failure, chronic liver disease, von Willebrand's disease, hemorrhagic diathesis, hypofibrinogenemia.

    Pregnancy and lactation:

    Information about the use of the drug during pregnancy and during breastfeeding is absent, the use of the drug during pregnancy and during breastfeeding is possible if the expected benefit for the mother exceeds the risk for the fetus and the baby.

    Dosing and Administration:

    The use of the drug should be limited only to the first 24 hours of recovery of the BCC. To avoid undesirable drug reactions, including anaphylactoid, the first 20-30 ml of the drug should be administered slowly, carefully observing the patient.

    With the rapid introduction of large doses of the drug should take into account the risk of overload volume.

    The daily dose and the rate of infusion are determined by the lack of volume of circulating blood and hematocrit, with a hematocrit less than 30%, the administration of the drug is not recommended (see section "Special instructions"). The drug is administered drip depending on the deficit of the volume of circulating blood.

    For a solution with a concentration of 6%

    The maximum infusion rate is determined by the state of hemodynamics and amounts to 20 ml / kg / h (1.2 g / kg / h of hydroxyethyl starch).

    The maximum daily dose is 30 ml / kg / day (2 g / kg / day hydroxyethyl starch or 2500 ml of the drug per day at a body weight of 75 kg).

    For a solution with a concentration of 10%

    The maximum infusion rate is determined by the state of hemodynamics and amounts to 20 ml / kg / h (1.2 g / kg / h of hydroxyethyl starch).

    The maximum daily dose is 20 ml / kg / day (2 g / kg / day hydroxyethyl starch or 1500 ml of the drug per day at a body weight of 75 kg). It is necessary to use the lowest effective concentration.

    Duration of administration

    The administration of the drug can last up to two weeks, but with repeated administration, if necessary, adjust the daily dose. The risk of unwanted drug reactions increases with an increase in the total administered dose.

    Side effects:

    The most frequent undesirable drug reactions are directly related to the therapeutic effects of hydroxyethyl starch and depend on the administered dose. They arise due to insufficient simultaneous administration of blood components, as well as due to a relative decrease in the content of coagulation factors.

    Allergic reactions that occur with a frequency of "very rare" do not depend on the dose.

    Gradation of the frequency of undesirable drug reactions: very often (> 1/10), often (> 1/100, but <1/10), infrequently (> 1/1000, but <1/100), rarely (> 1/10000, but <1/1000), very rarely (<1/10000), the frequency is unknown.

    On the part of the blood and lymphatic system

    Very often: a decrease in hematocrit, hypoproteinemia.

    Often: violations of the blood coagulation system, increased time bleeding.

    From the immune system

    Very rarely: anaphylactic reactions of varying severity (see subsection "Anaphylactoid reactions").

    General violations and violations at the site of introduction

    Often: itching, difficult to treat (with long-term administration in medium and high doses). Itching can continue for up to a week after stopping therapy and even for several months and be high-intensity.

    From the laboratory indicators

    Often: increased activity of alpha-amylase in plasma, not associated with impaired pancreatic function. Hyperamilazemia develops as a result of the formation of a complex of hydroxyethyl starch-amylase, which is not excreted by the kidneys.

    Anaphylactoid reactions

    After the introduction of hydroxyethyl starch, anaphylactoid reactions of varying severity, characteristic of all colloidal solutions, may occur.These reactions are manifested in the form of sudden reddening of the face and neck, lowering blood pressure, shock, stopping breathing and circulatory system.

    General recommendations for the prevention and treatment of anaphylactic reactions:

    - Inform medical staff of the nature and severity of possible anaphylactoid reactions due to the introduction of colloidal solutions.

    - Careful observation of the patient during the administration of the drug, especially with the infusion of the first 20-30 ml.

    - Availability of necessary resuscitative equipment and medicines.

    - Immediate discontinuation of administration at the first sign of anaphylactoid reactions.

    Negative reaction to trial administration of the drug is not a guarantee that the patient does not develop anaphylactoid reactions. Allergic anamnesis is also not a prognostic sign. The effectiveness of preventive administration of glucocorticosteroids has not been proven.

    Anaphylactoid reactions can develop both in patients who are conscious, and in patients with anesthesia. In the acute phase of shock caused by the primary disease, the diagnosis of anaphylactoid reactions is difficult.

    In the case of anaphylactoid / anaphylactic reactions, urgent emergency care should be provided in accordance with current guidelines.

    The mechanism of the development of anaphylactoid reactions after the administration of hydroxyethyl starch preparations has not been fully established.

    Patients with anaphylactoid reactions in the first place are advised to enter epinephrine.

    Restrictions on use

    Cancel at the first sign of kidney damage, coagulopathy. Do not use with open heart operations.

    Overdose:

    With rapid introduction in large volumes, it is possible to develop acute left ventricular failure and pulmonary edema, and a disruption in blood coagulation.

    When there are complaints of a feeling of tightness in the chest, difficulty breathing, low back pain, chills, cyanosis, circulatory disorders and breathing, it is necessary to stop taking the drug and perform symptomatic therapy. Perhaps as a therapeutic measure, the introduction of diuretics.

    Interaction:

    With simultaneous use with aminoglycosides, the risk of nephrotoxicity increases, therefore it is recommended to avoid simultaneous prolonged use of hydroxyethyl starch and aminoglycosides.

    Special instructions:

    Adequate long-term data on the use of drugs hydroxyethyl starch in patients who underwent surgery or traumatized are absent. The expected benefit of treatment should be carefully correlated with uncertain long-term safety. Other available therapeutic measures should be considered.

    Along with colloid osmotic therapy, it is recommended to restore the electrolyte balance. It is necessary to provide adequate hydration (2-3 liters of fluid per day). It is necessary to correlate the dose depending on the frequency of itching, otoneurological diseases, such as sudden deafness, tinnitus.

    Due to the possible risk of anaphylactoid reactions, care should be taken when administering the drug to patients who have previously received hydroxyethyl starch therapy (see the "Side effect" section). In hypofibrinogenesis, the drug, in order to replenish the volume of circulating blood, should be administered only in life-threatening conditions.It is recommended to be careful in patients with hemorrhagic diathesis on the background of hypernatremia and dehydration.

    With a hematocrit less than 30%, simultaneous administration of erythrocyte mass or whole blood is recommended.

    It is recommended that special care be taken in patients with bleeding disorders, mild to moderate heart failure, renal insufficiency, and chronic liver disease.

    If it is necessary to administer the drug under pressure, it is recommended to check the absence of air in the container containing the drug.

    When re-introduction is recommended to monitor blood clotting. Hydroxyethyl starch does not affect the definition of the blood group.

    During treatment, kidney function should be monitored and adequate hydration maintained. After the infusion of the drug, it is necessary to monitor the kidney function for 90 days. The use of hydroxyethyl starch can lead to a false positive reaction to doping.

    In addition, for a solution with a concentration of 10%: due to hyperoncotility of the drug there is a risk of volume overload,in this connection it is recommended to be careful in the elderly and patients with cardiovascular diseases.

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

    The drug is used only in a hospital.

    Form release / dosage:Solution for infusions, 6%, 10%.
    Packaging:

    For 100, 200, 250, 400, 500 ml in polyethylene bottles without a cap or with a welded Euro cap or plastic cap or infusion plug.

    For 1 bottle in a hermetically sealed packet of polymer film or without a package in a pack of cardboard box together with instructions for use, or without a pack (for hospitals).

    From 1 to 96 bottles without packs in hermetically sealed bags or without packages with an equal number of instructions for use in a corrugated box (for hospitals).

    Storage conditions:

    At a temperature of 8 to 25 ° C. Freezing of the drug is not allowed.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003556
    Date of registration:11.04.2016
    Expiration Date:11.04.2021
    The owner of the registration certificate:EAST-FARM, CJSC EAST-FARM, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspEAST-FARM, CJSCEAST-FARM, CJSC
    Information update date: & nbsp16.04.2017
    Illustrated instructions
      Instructions
      Up