Active substanceHydroxyethyl starchHydroxyethyl starch
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  • Composition:

    1000 ml of the solution contain

    6% solution

    10% pasterium

    active substance:

    hydroxyethyl starch (HES) 200 / 0.5

    60.00 grams

    100.00 grams

    Excipients:

    sodium chloride

    9.00 g

    9.00 g

    water for injections

    up to 1000 ml

    up to 1000 ml

    Sodium (Na +) 154.00 mmol / l
    Chloride (Cl-) 154.00 mmol / l
    Theoretical osmolarity 309 mOsm / l
    pH 5.0-7.0
    Description:Clear or slightly opalescent, colorless or pale yellow solution.
    Pharmacotherapeutic group:plasma-substituting agent
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:
    Colloidal plasma-based solution hydroxyethyl starch (HES) - high molecular compound consisting of dextrose polymerized residues. The source of HES is natural starch (amylopectin), which is subjected to cleavage to produce molecules with a certain molecular weight, as well as hydroxyethylation, wherein the free hydroxyl groups are replaced by residues dextrose hydroxyethyl groups Relations C2 / C6. The latter reduces the rate of hydrolysis of amylopectin serum amylase increase and the duration of its stay inblood.
    A geta-sorb solution for infusions of 6% and 10% is a preparation of HES (penta-stemmal) with an average molecular weight of 200 thousand daltons and a degree of substitution of about 0.5. Due to the ability to bind and retain water, it has a volitional effect - the ability to increase the volume of circulating blood by 85-100 and 130-140% of the injected volume for 6 and 10% solution, respectively (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 hydroxyethyl starch with the structure of glycogen explains the high level of tolerance and the practical absence of adverse reactions.
    Pharmacokinetics:After intravenous administration is excreted by the kidneys (for 24 hours - about 50% of the administered dose of penta starch) and with bile. Half-life from the vascular bed. 3-6 hours. A small amount of HES accumulates in the reticulo-endothelial. system (without exerting toxic effects on the liver, lungs, spleen and lymph nodes), where it is broken down by amylase and subsequently excreted by the kidneys and through the intestine.
    Indications:Treatment of hypovolemia in acute blood loss, if the use of crystalloid solutions is insufficient.
    Contraindications:
    Hypersensitivity (including starch), intracranial hypertension, arterial hypertension, intracranial hemorrhage, severe heart failure, renal dysfunction, severe hepatic insufficiency, cardiogenic pulmonary edema, hyperhydration, hypervolemia, dehydration (for a solution with a concentration of 10%), severe disorders coagulation system (including severe hemorrhagic diathesis, hypocoagulation), hyperchloremia, hypernatremia, hypokalemia, hemodialysis; children under 18 years of age (efficacy and safety not established,
    application can only be considered after a careful comparison of risk and benefit).
    Do not use with open heart operations.
    Do not use in critically ill patients, including patients with sepsis and patients in intensive care units.
    Carefully:
    Compensated chronic heart failure, chronic liver disease, von Willebrand's disease, hemorrhagic diathesis, hypophybrinogenemia,lactation period.
    Pregnancy and lactation:There are no data on the use of the drug in pregnant and lactating mothers. The use of the drug during pregnancy and lactation is possible only for life indications, when the intended benefit for the mother exceeds the potential risk for the fetus and the baby.
    Dosing and Administration:
    The use of hydroxyethyl starch (HES) is limited in time, its administration is allowed only within the first 24 hours after hemorrhage, i.e. only at the initial stage of reimbursement of blood volume.
    Enter intravenously, drip. It is necessary to apply the minimum effective dose. Treatment should be conducted with continuous hemodynamic monitoring; when the target hemodynamic parameters are reached, the infusion should be stopped.
    At the beginning of therapy, careful monitoring of serum creatinine concentration, kidney function, edema (fluid retention) is necessary. It should be taken into account that the creatinine value in the range of 106 - 177 μmol / l is a sign of compensated renal failure.
    It should be strictly observed the recommended dose, do not exceed the maximum daily dose,observe the proper infusion rate of the Geta-Sorb solution, since the volatile effect of the Geta-Sorb preparation exceeds the amount of the injected solution (risk of circulatory overload).
    The first 10-20 ml of the preparation Geta-sorb solution for infusions should be administered slowly, with careful monitoring of the patient's condition; for the timely detection of possible anaphylactoid reactions and the adoption of adequate measures, in particular the cessation of infusion.
    The dose and speed of administration are set individually and depend on the severity of hemodynamic disorders, the severity of the patient's condition. 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 hematocrit (should be at least 30%).
    Geta-sorb 6% solution for infusions
    The maximum infusion rate is 20 ml / kg body weight / h. The maximum daily dose is 30 ml / kg of body weight, which corresponds to 1.8 g of hydroxyethyl starch per kilogram of body weight per day (for patients weighing 75 kg, this corresponds to 2,250 ml of the preparation Geta Sorb 6%).
    Geta-sorb 10% solution for infusions
    The maximum infusion rate is 18 ml / kg body weight / h. The maximum daily dose is 18 ml / kg body weight, which corresponds to 1.8 g of hydroxyethyl starch per kilogram of body weight per day (for patients weighing 75 kg, this corresponds to 1350 ml of Geta-Sorb 10%).
    Elderly patients
    When appointing elderly patients, a careful dose selection is necessary because of the possibility of developing heart failure.
    Side effects:
    The most common adverse reactions occur, directly related to the therapeutic effect and the dose administered, i. E. dilution of blood as a result of replenishment of intravascular volume without the introduction of blood components. In the future this can have a negative effect on the blood clotting system.
    Hypersensitivity reactions, which develop very rarely, do not depend on the administered dose of the drug.
    The frequency of side effects is given in accordance with the WHO classification: very often (> 10%), often (> 1% and <10%), infrequently (> 0.1% and <1%), rarely (> 0.01% and <0.1%), very rarely (<0.01%), including individual cases.
    Violations of the blood and limthe phasic system
    Often: reduction of hematocrit and development of diluted hypoproteinemia.
    Often (frequency depends on the administered dose): an increase in the dose of HES can cause disturbances in the blood coagulation system - bleeding time and activated partial thrombotic-plate time may increase, and the content of the complex of coagulation factors VIII and von Willebrand is reduced.
    Immune system disorders
    Rarely: anaphylactoid reactions of varying severity.
    These reactions begin with skin rashes and can progress with sudden reddening of the face and neck, the development of shock, cardiac and respiratory failure. Therefore, careful monitoring of the condition of patients to whom HES solutions are administered is necessary. If any symptoms of adverse side effects occur, the infusion should be immediately discontinued
    General disorders and disorders at the site of administration
    Often: Infusion of HES leads to an increase in the activity of α-amylase in blood plasma. This is due to the formation of a complex of HES with α-amylase followed by a delay in its removal by the kidney and adrenal routes. This effect should not be regarded as a violation of the function of the pancreas.
    Infrequently: repeated administration of HES solution for several days, especially when exceeding 250 g of the total amount of HES introduced, can lead to skin itching, which is not amenable to therapy. Such an itch may appear even a few weeks after stopping the infusion of HES and may persist for several months. The likelihood of this unfavorable adverse reaction increases with the increase in the total amount of HES introduced.
    Overdose:With rapid introduction into large volumes, it is possible to provoke the development of acute left ventricular failure and edema of the lungs, a violation of blood coagulation. 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, possibly diuretics.
    Interaction:
    Hydroxyethyl starch increases the nephrotoxicity of aminoglycoside antibiotics. Simultaneous use with anticoagulants can increase bleeding time.
    When mixed with other drugs in a single container or system, pharmaceutical incompatibility phenomena may occur.
    Special instructions:Adequate long-term data on the use of hydroxyethyl starch in patients who underwent surgery or trauma are not available. The expected benefit of treatment should be carefully correlated with uncertain long-term safety. Other available therapeutic measures should be considered. Particular care should be taken when using solutions of HES in patients with coagulation disorders, as in patients with impaired liver function. High doses of hydroxyethyl starch should be avoided in patients with hypovolemia due to possible severe hemodilution.
    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.
    In the treatment should monitor the volume of circulating blood, the concentration of electrolytes, leukocytes, platelets, hemoglobin, blood coagulation indicators.At the first signs of coagulopathy, the drug should be discontinued. In open-heart surgery related to cardiopulmonary bypass, the risk of bleeding is increased, so the use of the drug is contraindicated.
    Before and during the use of the drug, it is necessary to check the function of the kidneys, to carry out a constant monitoring of the creatinine content in the blood serum, the water-electrolyte balance, and the urinary retention indices. In patients with impaired renal function, the use of hydroxyethyl starch is contraindicated. At the first signs of kidney damage against the background of treatment, the drug should be discontinued. Monitoring of kidney function should be carried out for 90 days after the infusion of the drug (the risk of kidney damage in a remote period). Disturbance of kidney function on the background of therapy with HES solution can aggravate the initial hepatic insufficiency (with portal hypertension), and can lead to mechanical obstruction of the bile ducts. It should be borne in mind that hydroxyethyl starch 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. A hematocrit of 25% or a hemoglobin content of 8 g / 100 ml is considered to be minimal for the administration of artificial colloids in order to replace the volume of blood plasma in patients without cardiovascular or pulmonary insufficiency. In patients with cardiovascular and / or pulmonary insufficiency, hematocrit below 30% is considered critical, the hemoglobin content is below 10 g / 100 ml. With a decrease in hematocrit and hemoglobin below these values, additional administration of blood or erythrocyte mass is required. Starting with a total protein of less than 5 g / 100 ml, the introduction of albumin is indicated.
    During treatment, it is necessary to ensure a sufficient supply of fluid in the body (at least 2-3 liters of fluid per day).
    When anaphylactoid reactions occur, the drug should be discontinued, the patient must be placed in the "lying" position with the head lowered, and the airways released; then injected epinephrine intravenously, first diluted 1 ml of the solution (1: 1000) 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 5% solution of human albumin (for replenishment of circulating blood volume), glucocorticosteroids (250-1000 mg of prednisolone), blockers of H1-histamine receptors 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 hydroxyethyl starch may make it difficult to interpret the results of the agglutination reaction. 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).
    HES can give a positive result in the conduct of doping control.
    The drug does not affect the definition of the blood group.
    The literature describes the relationship between the dose and frequency of itching in otoneurological diseases, such as severe hearing loss, tinnitus, and sound trauma. In these diseases, to reduce the incidence of itching, it is recommended that the dose be limited to 250 ml per day.In case of an itching, the drug should be discontinued and proper hydration should be ensured.
    Effect on the ability to drive transp. cf. and fur:Does not affect.
    Form release / dosage:
    Solution for infusions 6% or 10%.
    Packaging:
    For 500 ml of solution in a bottle of colorless glass II hydrolytic type, sealed with a rubber stopper, sealed with an aluminum cap and plastic cap-control the first dissection. 1 bottle together with a plastic holder and instructions for use in a cardboard pack.
    Storage conditions:
    Store at a temperature not exceeding 25 ° C. Do not freeze.
    Keep out of the reach of children.
    Shelf life:
    For a 6% solution, 5 years.
    For 10% solution 4 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001512
    Date of registration:16.02.2012
    The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia
    Manufacturer: & nbsp
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp06.01.2016
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