Active substanceHydroxyethyl starchHydroxyethyl starch
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  • Dosage form: & nbspsolution for infusions
    Composition:

    1000 ml of solution contains:



    Active substance:

    6 %

    10 %

    Hydroxyethylated starch (Poly (0-2-hydroxyethyl) -starch) (HES) (average molecular weight 200,000 daltons, degree of molar substitution 0.45-0.55)

    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

    Concentration of electrolytes:

    Sodium

    154 mmol / l


    Chlorides

    154 mmol / l


    Physico-chemical characteristics:


    Theoretical osmolality

    310 mOsm / l


    pH

    4,0 - 7,0




    Description:
    Colorless or yellowish, slightly opalescent liquid.
    Pharmacotherapeutic group:Plasmasuberant
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:
    Mechanism of action, therapeutic effect
    Hemhem cells contains hydroxyethyl starch with an average molecular weight of 200,000 daltons and a degree of molar substitution of 0.45-0.55. Thanks to this, both Hemohes 6% and Hemohes 10% lead to a normalization or increase in the volume of circulating blood (BCC) for at least 3 to 4 hours.
    Hemochesis 6% is an isonicotic solution, so an increase in BCC when infusion of the solution is 100% of the administered volume.
    Hemoches 10% is a hyperoncotic solution, the increase in bcc upon infusion is about 145% of the administered volume.
    Hemohes is not a drug for correcting hypoproteinemia.
    Hemoches has a positive effect on microcirculation by improving the rheological properties of the blood.
    Pharmacokinetics:
    Distribution
    Like all colloids, hydroxyethyl starch is temporarily deposited, including in the cells of the reticulo-endothelial system, but does not have any irreversible toxic effects on the liver, lungs, spleen and lymph nodes. Small amounts of deposited hydroxyethyl starch are determined by the histological method for several months after application. Perhaps this is the cause of skin itching as a result of prolonged use of HES preparations in high doses.
    Metabolism / Inference
    The half-life of hydroxyethyl starch from the bloodstream is 3-6 hours. Hydroxyethyl starch is subjected to cleavage with amylase and is excreted by the kidneys. 50% of the administered dose is excreted in the urine within 24 hours.
    Hydroxyethyl starch is not dialyzed.
    Pharmacokinetics in special clinical situations
    In the case of renal failure, there is a risk of accumulation of the drug depending on the degree of disturbance of glomerular filtration rate.
    Indications:
    Hemoches 6% and 10%:
    - Treatment and prevention of deficiency of bcc (hypovolemia) and shock.
    For primary replenishment of the volume in urgent situations, it is necessary to give preference to the preparation Hemohes 6%.
    For the preparation Hemohes 6% extra:
    - Preoperative normovolemic hemodilution.
    Contraindications:
    The drug can not be administered under the following conditions:
    - An increase in the volume of circulating blood (hypervolemia),
    - Expressed hyperhydration (water intoxication),
    - Acute pulmonary edema,
    - Severe heart failure,
    - Severe hypernatremia,
    - Severe hyperchloremia,
    - Hypersensitivity reactions to starch or any of the components,
    - Severe renal insufficiency with oligo- or anuria,
    - Expressed violations of blood coagulation,
    - Intracranial bleeding,
    - Children under 12 years.
    Carefully:
    The drug should be used with extreme caution when:
    - Severe hepatic insufficiency,
    - Deficiency of fibrinogen.
    Pregnancy and lactation:
    Pregnancy
    The experience of using the drug Hemohes during pregnancy is limited. Since it is possible to develop anaphylactoid reactions that can lead to acute oxygen starvation and / or damage to the fetal brain up to a lethal outcome, Hemhemes can be used during pregnancy for vital signs if the expected benefit of treatment for the mother exceeds the possible risk of complications in the fetus.
    Do not use the drug in the early stages of pregnancy.
    Breastfeeding period
    Since it is not known whether HES penetrates into breast milk, breast-feeding should be avoided when using the drug.
    Dosing and Administration:
    Mode of application
    It is administered intravenously by drip or jet.
    It is necessary to take into account the risk of developing circulatory overload due to exceeding the recommended dose or rate of administration. It should be borne in mind that the volemic effect of the drug Hemohes 10% more than the volume of the injected solution, so there is an increased risk of developing hypervolemia.
    Doses
    The daily dose and rate of administration depend on the magnitude of the deficit of bcc and hematocrit.The daily dose is limited by the degree of hemodilution. Do not lower the hemoglobin or hematocrit lower than the critical values. Transfusion of blood or erythrocyte mass may be required.
    For the early detection of anaphylactoid reactions, the first 20-30 ml of the drug should be administered slowly (dropwise) under constant control.
    Adults and children from the age of 12
    Prevention and treatment of hypovolemia and shock
    The maximum daily dose
    2 g of HES / kg of body weight / day, corresponding to 33 ml / kg of body weight / day of the preparation Hemohes 6% (corresponding to 2500 ml / day for a patient with a body weight of 75 kg) or 20 ml / kg of body weight / 10% (this corresponds to 1500 ml / day for a patient with a body weight of 75 kg).
    Maximum injection rate
    The maximum rate of administration depends on the hemodynamic status of the patient and is up to 20 ml / kg of body weight / h, which corresponds to 1.2 g of HES / kg of body weight / h with the administration of Hemohes 6% and 2.0 g / kg body weight / h with the introduction of the drug Hemohes 10%.
    In a critical situation, 500 ml of the drug can be rapidly administered under pressure. In this case, the drug of choice is Hemohes 6%.After stabilization of the hemodynamic status of the patient, further infusion should be proportional to the deficit of BCC.
    Preoperative normovolemic hemodilution (only for Hemohes 6%)
    The volume of the injected Gemohes 6% corresponds to the amount of blood taken (substitution 1: 1); the amount administered depends on the actual and target hematocrit values, but should not exceed 20 ml / kg of body weight.
    Elderly patients
    When appointing elderly patients, a careful dose selection is necessary because of the possibility of developing heart failure.
    Duration of application
    From the point of view of toxicology, it is possible to prescribe hydroxyethyl starch for 1 to 2 weeks or more. However, the likelihood of developing adverse adverse reactions, in particular pruritus, increases with the increase in the total dose administered. Therefore, when administering HES solutions for a long time, as a rule, the daily dose and the preparation of Hemohes 6%, and the drug Hemohes 10% should not exceed 500 ml. The total amount of injected HES should not exceed 250 g.
    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 coagulation system. Hypersensitivity reactions, which develop very rarely, do not depend on the administered dose of the drug.
    The following classification of adverse reactions by frequency of development is used:
    Very frequent (1/10)
    Frequent (1/100, <1/10)
    Infrequent (1/1000, <1/100)
    Rare (1/10000, <1/1000)
    Very rare (≤1 / 10000)
    Violations of the blood and lymphatic system
    Very Frequent: reduction of hematocrit and development of diluted hypoproteinemia.
    Frequent (however, the frequency depends on the dose administered): Elevated doses of HES can cause disturbances in the blood coagulation system - bleeding time and activated partial thromboplastin time (APTT) can increase, and the content of the coagulation factor VIII and vWF complex is reduced.
    Immune system disorders
    Very rare: anaphylactoid reactions of varying severity.
    General disorders and disorders at the site of administration
    Frequent: Infusion of HES leads to an increase in the activity of plasma a-amylase.This is due to the formation of a complex of HES with a-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.
    Infrequent: multiple administration of HES solution for several days, especially when exceeding 250 g of the total amount of HES injected, 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 injected.
    Additional information on certain adverse reactions
    Anaphylactoid reactions
    After infusion of the HES solution, like any colloidal plasma substitute, anaphylactoid reactions of varying severity can develop. These reactions begin with skin rashes and can progress with sudden redness of the face and neck, a drop in blood pressure, development of shock, cardiac and respiratory failure.Therefore, careful monitoring of the condition of patients to whom HES solutions are administered is necessary.
    General guidelines for the prevention of anaphylactoid reactions
    - Informing doctors and nurses about possible adverse side effects that may develop after the introduction of colloidal plasma substitutes, and the degree of their severity.
    - Careful observation of the patient during infusion, especially during the introduction of the first 20 to 30 ml of the drug.
    - Availability of necessary equipment and medications for cardiopulmonary resuscitation.
    - Immediate cessation of infusion if any symptoms of adverse side effects occur.
    Emergency therapy of anaphylactoid reactions depends on the degree of their severity and is conducted in accordance with accepted standards.
    There are no tests for preliminary detection of possible anaphylactic and anaphylactoid reactions, the course and severity of these reactions can not be foreseen. The prophylactic use of corticosteroids has not been proven effective. Adverse adverse reactions can occur both in patients in the mind,and in a state of general anesthesia. In the acute phase of hypovolemic shock, there have been no anaphylactoid reactions to date.
    The pathogenesis of the development of anaphylactoid reactions due to the use of HES has not been studied. The main drug for emergency therapy of anaphylactoid reactions should be epinephrine.
    Overdose:
    Symptoms
    Hypervolaemia and hyperhydration, accompanied by venous congestion, edema (up to the pulmonary or brain edema), electrolyte balance disorders, as well as symptoms arising from subsequent impairment of heart and lung functions.
    Treatment
    The drug should be discontinued immediately and, if necessary, diuretics should be prescribed.
    Interaction:
    Against the background of the introduction of HES, the damaging effect of aminoglycosides on the kidneys can be intensified, therefore prolonged simultaneous use of these drugs should be avoided.
    Despite the low probability of drug interactions, it is necessary to take into account the possible incompatibility of HES when mixed with other drugs.
    Special instructions:
    With dehydration, infusion of electrolyte solutions is primarily carried out.It is necessary to ensure the introduction of an adequate volume of fluid and electrolytes to meet the needs of the extravascular space, especially when using the 10% hemocoenosis preparation, which is a hyperoncotic solution.
    When large volumes of HES are introduced, there is a decrease in hematocrit, hemoglobin, and plasma protein concentration.
    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 with no cardiovascular or pulmonary insufficiency. In patients with cardiovascular, pulmonary insufficiency, sepsis, or in critically ill patients, the hematocrit should not fall below 30%, and 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.
    When the total plasma protein is below 5 g / 100 ml, albumin administration may be required.
    Patients with blood coagulation system diseases, such as hemophilia, von Willebrand syndrome, should be given increased dosages of HES only for vital signs, and also in the absence of alternative medications.It is necessary to compensate for clotting factors and carefully monitor the condition of these patients.
    If the kidney function is severely impaired, the dose should be selected in accordance with the glomerular filtration rate or the concentration of plasma creatinine, and adequate fluid volume must be provided.
    At the beginning of therapy, it is necessary to monitor the concentration of plasma creatinine. At a threshold concentration of creatinine (1.2-2.0 mg / 100 ml (106-177 mmol / l), which corresponds to compensated renal failure), daily monitoring of fluid balance and diuresis is necessary. Despite normal blood plasma creatinine levels, changes in urine tests may indicate compensated renal damage. If the therapy is carried out for several days, control diuresis 1 - 2 times a day is necessary. The administration of the HES solution should be discontinued if the plasma creatinine concentration during treatment exceeds 2.0 mg / 100 ml.
    In cases of deficiency of fibrinogen, the drug should be administered only according to vital indications, until the possibility of transfusion of blood components appears.
    In the case of repeated infusion, blood coagulation indicators, in particular bleeding time and activated partial thromboplastin time (ACTTV), should be closely monitored. Particular attention should be paid to patients receiving drugs that affect hemostasis (for example, non-steroidal anti-inflammatory drugs, anticoagulants or valproic acid) and patients with blood group 0 (1), whose coagulation factor VIII and Willebrand complex are physiologically lower than in patients with other blood groups. Control of electrolyte concentration and fluid balance is required. It is necessary to replace electrolytes in accordance with individual needs.
    When the drug is administered under pressure, which may be necessary in case of emergency, all air from the bottle must be removed before the infusion begins.
    Infusion of HES can lead to an increase in the activity of α-amylase in blood plasma in laboratory tests. This effect should not be considered as a violation of pancreatic function, it is associated with the formation of a complex of HES with α-amylase and its delayed excretion by the kidney and adrenal pathways.
    Bottle for single use. The remaining unused quantities of the drug should be discarded.
    Use the solution only if it is transparent and the bottle is not damaged.
    After mixing with other compatible preparations in terms of microbiological safety, Hemohes should be used immediately. If the preparation is not used immediately, it can be used no later than 24 hours after mixing, and it is allowed to store it during this period at a temperature of 2 to 8 ° C, only if aseptic conditions are observed during mixing.
    Effect on the ability to drive transp. cf. and fur:
    The drug does not affect the ability to drive vehicles, mechanisms, as well as engage in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:
    Solution for infusions 6%, 10%.
    Packaging:

    250 ml per bottle of hydrolytic glass class 2, which meets the requirements of the European Pharmacopoeia for infusion solutions.

    10 bottles along with an equal number of instructions for use are placed in a cardboard box.

    Storage conditions:
    Store at a temperature not exceeding 25 ° C. Do not freeze.
    Keep out of the reach of children.
    Shelf life:
    3 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013823 / 01
    Date of registration:25.01.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany
    Manufacturer: & nbsp
    Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company
    Information update date: & nbsp21.03.2017
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