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

    1 liter of solution contain

    6% solution

    10% solution

    Hydroxyethyl starch (HES) (200 / 0.5)

    60 grams

    100 g

    Sodium chloride

    9 grams

    9.00 g

    Water for injections

    up to 1 liter

    up to 1 liter

    Sodium hydroxide (for adjusting pH)

    q.s.

    q.s.


    Na + 154 mmol / l
    Cl-154 mmol / l
    pH 3.5-6.0
    Titrated acidity less than 1 mmol NaOH / L
    Theoretical osmolarity 308 mOsm / l
    Description:
    transparent or slightly opalescent, colorless or slightly yellowish solution
    Pharmacotherapeutic group:plasma-substituting agent
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:Infusion of the Haes Steril preparation (500 ml in 15 min) to a hypovolemic patient results in an increase in the plasma volume by approximately 100% of the administered volume (with a 6% Hayes infusion) or 145% (in case of 10% Hayes steril infusion) for 3-4 hours, Hayes steril provides improvement of hemodynamics and microcirculation for 3-4 hours.
    Pharmacokinetics:HES is subjected to enzymatic digestion with alpha-amylase of blood, which leads to the formation of oligo- and polysaccharides of different molecular weights. HES has a half-life from the bloodstream about 4 hours. It is excreted mainly through the kidneys; 50% of the administered dose is excreted in the urine in less than 24 hours.A small amount of the drug is temporarily deposited in the tissues, and only 10% continues to circulate in the blood serum. Sodium chloride is excreted primarily through the kidneys, and a small amount is removed with sweat through the skin.
    Indications:
    Hayes steril 6%, 10% is used in adults and children over 3 years old for:
    1. Treatment and prevention of hypovolemia and shock in:
    -surgical interventions (hemorrhagic shock);
    -Traumatic lesions (traumatic shock);
    -infections (septic shock);
    burns (burn shock).
    2. Acute normovolemic hemodilution, to reduce the introduction of donor blood during surgical interventions.
    3. Therapeutic hemodilution.
    Contraindications:
    Hypersensitivity (including starch), intracranial hypertension, arterial hypertension, intracranial hemorrhage, decompensated chronic heart failure, acute renal failure (oligonuria, anuria), severe hemorrhagic diathesis, cardiogenic pulmonary edema, hypocoagulation, coagulopathy, hyperhydration, hypervolemia, dehydration ( if necessary correction of electrolyte metabolism), hypofibrinogenemia, expressed thrombocytopenia, hypernatremia, hemodialysis, children under 3 years old.
    Carefully:
    Lactation period, compensated chronic heart failure, chronic renal failure, chronic liver disease, von Willebrand's disease, hemorrhagic diathesis.
    Pregnancy and lactation:There are no data on the use of Hayes sterile in pregnant and lactating mothers. Use of the drug during pregnancy and during lactation is possible only for life indications.
    Dosing and Administration:
    Intravenously.
    The doses used to treat and prevent hypovolemia and shock.
    The maximum daily dose:
    6% solution: 33 ml / kg / day. (= 2500 ml per 75 kg body weight per day or = 2 g HES / kg / day).
    10% solution: 20 ml / kg / day. (= 1500 ml per 75 kg of body weight per day or = 2 g of HES / kg / day). Maximum infusion rate:
    6% solution: 20 ml / kg / hour (= 1500 ml per 75 kg body weight per hour or = 1.2 g HES / kg / h).
    10% solution: 20 ml / kg / hour (= 1500 ml per 75 kg body weight per hour or 2 g HES / kg / hour).
    In children under 10 years of age, the infusion rate should not exceed 15 ml / kg / h.
    Children older than 12 years: the average daily dose is 33 ml / kg, the maximum daily dose is 33 ml / kg (2 g of hydroxyethyl starch per kg / day); children from 3 to 12 years, respectively - 15-20 ml / kg and 33 ml / kg.
    Doses used to reduce the amount of donor blood during surgical operations (acute normovolemic hemodilution).
    Simultaneous administration of Hayes sterile 6% in a ratio of 1: 1 (up to a hematocrit of at least 30%) is recommended for direct preoperative replacement of one's own blood.
    Blood sampling: 2-3 times with 500 ml of own blood.
    Daily dose: 2-3 infusions of 500 ml of Hayes sterile 6%.
    The rate of blood sampling is 1000 ml for 15-30 min.
    The rate of administration of Hayes sterile is 6% -1000 ml for 15-30 min.
    Recommended doses for hemodilution therapy.
    The criterion is the decrease in the hematocrit indicator, determined for each patient. Infusion of Hayes sterile 6%, 10% can be carried out isovolemically (with simultaneous selection of own blood) or hypervolemically (without selection of own blood) in small (250 ml), medium (500 ml) or high doses (twice 500 ml). Avoid hypervolemia with too rapid administration and too large doses of the drug, the limiting dose is 1.2 g HES / kg / day.
    The following daily doses and rate of administration are used:
    Daily dose:
    -250 ml (low dose)
    -500 ml (medium dose)
    -2 times 500 ml per day (high dose)
    Infusion rate:
    -250 ml for 0.5-2 hours
    -500 ml for 4-6 hours
    -2 times 500 ml for 8-24 hours.
    Duration of use.
    Treatment and prevention of hypovolemia and shock:
    The degree and duration of hypovolemia determine the daily dose and duration of application of Hayes sterile.
    Reduction of the use of donor blood during surgical interventions (acute normovolemic hemodilution).
    Acute normovolemic hemodilution is used once in surgical interventions. Repeated application of Hayes steril is possible at normal values ​​of hematocrit (not lower than 30%). Therapeutic hemodilution. The use of Hayes Steril for hemodilution therapy is recommended for 10 days.
    Side effects:
    Rarely - allergic reactions of varying severity: skin rash, tachycardia, a sharp decrease in blood pressure, dizziness, nausea, vomiting, bronchospasm, anaphylactic shock until stopping breathing and cardiac activity. When allergic reactions occur, the solution should be immediately discontinued, and immediate emergency measures are initiated, depending on the clinical symptoms and severity. It is necessary to prescribe antihistamines, glucocorticosteroids (prednisolone 120 mg intravenously), epinephrine 0,05-0,1 mg intravenously, the introduction of albumin 5%.
    Prolonged daily use of Hayes sterile in moderate to high doses often causes difficult to treat itching. In these cases, it is recommended to reduce the maximum daily dose to 250 ml per day.
    Occasionally - pain in the lumbar region. In this case, the infusion of the drug should be discontinued, provide abundant fluid administration and frequent monitoring of serum creatinine.
    High doses of Hayes sterile as a result of the dilution effect can cause an increase in bleeding time, but the infusion of Hayes sterile does not cause clinically significant bleeding. One should pay attention to the possible decrease in hematocrit and the development of hypoproteinemia. When using Hayes steril, serum amylase activity may increase, which may interfere with the diagnosis of pancreatitis.
    Interaction:
    The simultaneous use of hydroxyethyl starch with heparin or oral anticoagulants can increase bleeding time.
    Particular attention should be paid to patients taking other medications, especially when taking beta-blockers and vasodilators, as changes in systemic blood pressure and heart rate may not be detected despite volume-substituting therapy.
    It should be borne in mind that HES can affect clinical and chemical indices (glucose, protein, ESR, fatty acid, cholesterol, sorbitol dehydrogenase, specific gravity of urine).
    There are no data on the interaction of hydroxyethyl starch with food.
    Special instructions:At the beginning of treatment, it is necessary to monitor the serum creatinine concentration. At boundary values ​​of creatinine content (106-177 μmol / l - compensated renal failure), daily monitoring of intracellular and extracellular fluid balance and excretory function of kidneys is necessary. When mixing with other medicinal products is necessary, a complete asepsis should be observed. It is necessary to ensure the compatibility of drugs and their good mixing. Because of possible anaphylactic reactions, the first 10-20 ml of Hayes sterile should be infused slowly and with careful monitoring of the patient's condition. When using the drug, regular monitoring of the water-electrolyte balance and the number of leukocytes and platelets is necessary.
    Form release / dosage:
    Solution for infusions 6%, 10%.
    Packaging:
    For 250 or 500 ml in glass bottles for infusion solutions of glass of hydrolytic class II, sealed with rubber (halobutyl) stoppers, coated with aluminum caps, equipped with plastic caps-control the first opening (He.F.). For 10 vials, together with holders for the dropper or without them, with instructions for use are placed in a cardboard box (for hospitals).
    In plastic bottles, equipped with a loop-holder for a dropper, ukuporenny combined plastic proprietary lid "spike-shape." 10 or 20 bottles are placed together with instructions for use in a carton box (for hospitals).
    In the polyolefin container (bag) "friffex". Each container is placed in an outer plastic bag. For 10, 15, 20 or 30 containers together with instructions for use are placed in a cardboard box (for hospitals).
    Storage conditions:At a temperature of no higher than 25 ° C in a protected from light. Freezing is not allowed. Keep out of the reach of children.
    Shelf life:
    5 years - in glass or plastic bottles.
    3 years - in containers "friffex".
    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013101 / 01
    Date of registration:07.06.2010
    The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany
    Information update date: & nbsp18.01.2016
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