Infukol GEK (Infukoll HES)

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:



    Pharmacologically active components:

    Hydroxyethyl starch (penta starch)

    (degree of substitution 0.45-0.55, average molecular weight 200,000 daltons)

    - 60.0 and 100.0 g (for 6% and 10% solution, respectively)

    Other active components:

    Sodium chloride

    - 9 g

    Excipients:

    Water for injections

    - up to 1 liter

    Sterile and apyrogenic solution:

    pH

    - 5,0 - 7,0

    Na +

    - 154.0 mmol / l

    C1-

    - 154.0 mmol / l

    Theoretical osmolality

    - 309 mOsm / l
    Description:
    INFUKOL® HES is a colorless or yellowish, translucent or slightly opalescent liquid.
    Pharmacotherapeutic group:Plasmasuberant
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:Infusion solution INFUKOL® HES is a 6% or 10% isotonic solution of a synthetic colloid of hydroxyethyl starch, obtained from potato starch. Physico-chemical parameters of the original substance of the drug INFUKOL® HES provide high therapeutic efficacy in hypovolemia and shock, and also when used for therapeutic hemodilution due to the normalization of central and peripheral hemodynamics, microcirculation,improve the delivery and consumption of oxygen by organs and tissues, restore the porous walls of the capillaries (normalize the permeability of the vessel wall), reduce the local inflammatory response, activate the immune response, mobilize the blood elements from the physiological deposition and involve them in active metabolism against moderate hemodilution. Due to the ability to bind and retain water, the drug has a volatile effect in the range of 85-100% and 130-140% (for 6% and 10% solution, respectively) of the introduced volume, which stably persists for 4-6 hours. In addition, the preparation improves the rheological properties of the blood by reducing the hematocrit, reduces the viscosity of the plasma, reduces platelet aggregation and prevents the aggregation of erythrocytes. INFUKOL® HES is deposited in the cells of the reticuloendothelial system without manifestations of toxic effects on the liver, lungs, spleen and lymph nodes. Under the action of amylase serum INFUKOL® HES is broken down to low-molecular fragments (less than 70,000 daltons), which are removed by the kidneys. The similarity of the structure of INFUKOL® HES with the structure of glycogen explains the high level of tolerance and the almost complete absence of adverse reactions.It was found that the drug does not have embryotoxic and teratogenic effects.
    Pharmacokinetics:At the time of 12 hours after the administration of the drug, the elimination half-life is 4.94 hours. The clearance is 7.33 ml / min. The maximum concentration of the drug in the serum is 11.1 ± 2.7 mg / ml; on the third day after administration in the serum trace amounts of hydroxyethyl starch are determined. During the first 12 hours after the initiation of the drug, 24.48 ± 3.93 g of hydroxyethyl starch (49% of the administered amount) is present in the urine.
    Indications:Prophylaxis and treatment of hypovolemia and shock in connection with operations, acute blood loss, trauma, burns and infections. Microcirculatory disorders, Therapeutic dilution of blood (hemodilution), including in the treatment of ischemic stroke, twin-placental insufficiency and gestosis in pregnant women, phospholipid syndrome in women, IVF, polycythemia in newborns, obliterating lesions of the lower limbs, chronic obstructive pulmonary disease and m.
    Contraindications:
    Hyperhydration, hypervolemia, decompensated heart failure,renal failure with decompensated oliguria or anuria, allergy to starch, cardiogenic pulmonary edema, intracranial bleeding, coagulation disorders expressed.
    Carefully:

    In the first three months of pregnancy.

    With hemorrhagic diathesis.

    With intracranial hypertension.

    With dehydration conditions (preliminary corrective therapy is required) and pronounced disturbances in the water-electrolyte balance.

    Dosing and Administration:

    The drug INFUKOL® GEK is intended for intravenous infusion. In the absence of other requirements INFUKOL® HES drug is administered intravenously according to need replacement or circulating fluid volume required level of hemodilution in the following age dosages:

    Age group

    The average daily dose, ml / kg body weight

    The maximum daily dose, ml / kg of body weight

    6% solution

    10% solution

    6% solution

    10% solution

    Adults and children over 12 years of age

    33

    20

    33

    20

    Children from 6 to 12 years

    15-20

    10-15

    33

    20

    Children from 3 to 6 years

    15-20

    10-15

    33

    20

    Newborns and children under 3 years old

    10-15

    8-10

    33

    20

    The daily dose and the rate of intravenous administration are calculated depending on blood loss, hemoglobin concentration and hematocrit.In young patients without the risk of affecting the cardiovascular system and lungs, the limit of the drug INFUKOL® HES is considered to be a hematocrit value equal to 30% or less.

    The maximum daily dose: up to 33 and 20 ml of the preparation (for 6% and 10% solution, respectively) per 1 kg of body weight per day (2.0 g of hydroxyethyl starch per 1 kg of body weight per day).

    Maximum infusion rate: depends on the initial parameters of hemodynamics and is approximately 20 ml per 1 kg of body weight per hour.

    Side effects:

    Allergic reactions are possible and very rarely anaphylactoid reactions to hydroxyethyl starch.

    Too rapid intravenous administration, as well as the use of too large doses, can lead to disturbances in hemodynamics.

    Occasionally, a persistent but reversible itching may occur.

    The introduction of the drug has an effect on the results of the determination of serum amylase activity, which is not associated with the clinical manifestations of pancreatitis. The drug INFUKOL® HES can be used for conservative and surgical treatment of patients with destructive pancreatitis.

    Overdose:No cases of an overdose of INFUKOL® HES were reported.
    Interaction:Do not mix the drug with other drugs in the same container and in the same system.
    Special instructions:
    • In newborns and children under three years of age, it is recommended to adhere to the average daily dose of the drug. In connection with the peculiarities of the water-electrolyte status, careful monitoring of the level of hydration and the content of electrolytes is recommended in children.
    • It is necessary to monitor the ionogram of the serum.
    • It is necessary to monitor the sufficient introduction and balance of the liquid.
    • When performing treatment, kidney function should be monitored.
    • In case of intolerance reactions, intravenous administration of the drug should be stopped immediately and the necessary emergency measures should be taken.
    • Given the possible anaphylactoid reactions, the first 10 to 20 ml of the drug INFUKOL® HES should be administered slowly, with careful monitoring of the patient's condition. Consider the risk of overloading the circulatory system with too rapid administration or too high a dose of the drug.
    • In the treatment of feto-placental insufficiency and gestosis in pregnant women with high blood pressure treatment should be conducted against a background of antihypertensive therapy.
    • The introduction of the drug to patients with diabetes mellitus is not accompanied by an increase in blood glucose, so the drug INFUKOL® HES can be used for conservative and surgical treatment of this category of patients.
    • Use the drug INFUKOL® HES only if the solution is clear, and the packaging is not damaged!
    Form release / dosage:Solution 6% and 10%.
    Packaging:
    Bottles of 100, 250 and 500 ml, polymeric bags of 250 and 500 ml.
    Storage conditions:

    At temperatures not above 25 ° C and out of the reach of children!

    Do not use INFUKOL® HEK after the expiration date stated on the package!

    Shelf life:
    5 years for the drug in glass bottles; 3 years for the drug in polymer bags. Do not use the product after the expiry date indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:P N014908 / 01-2003
    Date of registration:29.04.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Zermumverk Bernburg AGZermumverk Bernburg AG Germany
    Manufacturer: & nbsp
    Information update date: & nbsp15.11.2017
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