Active substanceDextran [average molecular weight 35,000-45,000]Dextran [average molecular weight 35,000-45,000]
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  • Dosage form: & nbspRAster for infusion.
    Composition:

    Active substance:

    Dextran [average molecular weight 35,000-45,000]

    100 g

    Excipients:

    Sodium chloride

    9 grams

    Water for injections

    up to 1 liter.

    Theoretical osmolality

    310 mOsmol / l

    Description:PColorless, colorless or yellow liquid.
    Pharmacotherapeutic group:plasma-substituting agent
    ATX: & nbsp

    B.05.A.A   Blood plasma preparations and plasma-substituting drugs

    Pharmacodynamics:

    Dextran is a 10% colloidal solution with an average molecular weight of 35,000-45,000 Da. It is used as a plasma-substituting anti-shock medication for hemodynamic action.Promotes an increase in the volume of blood plasma by almost 2 times compared with the volume of the injected drug, since every gram of dextrose polymer with an average molecular weight of 35,000-45,000 causes the transfer of 20-25 ml of fluid from the tissues to the bloodstream. Due to high oncotic pressure dextran very slowly passes through the vascular wall, and for a long time circulates in the vascular bed, normalizing hemodynamics due to the fluid flow along the concentration gradient - from the tissues to the vessels. As a result, blood pressure rises rapidly and is maintained at a high level for a long time, the return of venous blood to the heart increases, cardiac output increases, and tissue swelling decreases. The duration of action is from 3 to 4 hours.

    Reopoliglyukin-40-ESCOM can be used as a detoxification agent and, to some extent, as a means of improving microcirculation in tissues.

    When it is introduced, the viscosity of the blood decreases, its fluidity improves, aggregation of the formed elements decreases, which improves microcirculation in the tissues.The mechanism of the antithrombotic effect is explained, among other things, by the effect of "coating." Studies have shown that dextrans form a monomolecular film on the intima of the vessels, as well as the surface of platelets, which prevents both aggregation of platelets and their adhesion to the wall of the vessel. It has also been shown that dextrans increase the amount of circulating tissue plasminogen activator (t-PA) by blocking the action of the plasminogen activator inhibitor (RAI-1). In addition, there are data on the effect on the shape of a molecule of fibrin, the changes of which lead to its more rapid destruction with endogenous fibrinolysis, which leads to the prevention of the formation of thrombi and increases their solubility (thrombolysis).

    When administered at a dosage of up to 15 ml / kg, there is no noticeable change in bleeding time. It is pyrogen-free, non-toxic.

    Dextran also stimulates diuresis according to osmotic mechanisms (it is filtered in the glomeruli, creates high oncotic pressure in the primary urine and prevents reabsorption of water in the tubules), which facilitates the removal of poisons, toxins, degradation products of metabolism from the body.The pronounced vollemic effect positively affects hemodynamics and is simultaneously accompanied by the washing out of metabolic products from the tissues, which together with an increase in diuresis provides an accelerated detoxification of the organism.

    Pharmacokinetics:

    The half-life (T1/2) - 6 hours Excretion by the kidneys, 60% are deduced for 6 hours, and for 70 hours 70%. 30% goes to the reticuloendothelial system (RES), the liver, where the enzyme is digested with acidic alpha-glucosidase to glucose, but it is not a source of carbohydrate nutrition.

    Indications:

    Prevention and treatment of traumatic, surgical and burn shock, replenishment of the volume of circulating blood.

    Violations of arterial and venous circulation, treatment and prevention of thrombosis and thrombophlebitis, endarteritis and other circulatory disorders.

    For addition to the perfusion fluid in cardiac operations performed using the apparatus of artificial circulation.

    To improve local circulation in vascular and plastic surgery.

    For detoxification with burns, peritonitis, pancreatitis and other conditions that require detoxification.

    Contraindications:

    Hypersensitivity to the components of the drug; Decompensated cardiovascular insufficiency; pulmonary edema; craniocerebral trauma with increased intracranial pressure; hemorrhagic stroke; ongoing internal bleeding; hypocoagulation; thrombocytopenia; marked violations of kidney function, accompanied by oligo- and anuria; hypervolemia, hyperhydration, and other situations in which the introduction of large volumes of fluid is contraindicated.

    Carefully:When the blood clotting system is violated, dehydration, in patients with diabetes mellitus with severe hyperkalemia and hyperosmolarity, in violation of water-electrolyte balance.
    Pregnancy and lactation:

    When pregnancy is used in the case when the expected benefit for the mother exceeds the possible risk to the fetus.

    It should refrain from breastfeeding during the use of the drug because of the lack of relevant clinical data.

    Dosing and Administration:

    Intravenously sprayed, drip-drip and drip.

    Dosage and rate of administration the drug should be selected individually in accordance with the indications and the patient's condition, the amount of blood pressure, heart rate, hematocrit.

    Immediately before the application of dextran, with the exception of urgent conditions, a skin test is performed.

    Intradermal test is carried out 24 hours before the infusion of the drug. For this purpose, 0.05 ml of the preparation is injected intradermally with the formation of lemon crust on the inside of the forearm, shoulder or other area accessible for visual evaluation of the skin test. The doctor evaluates the reaction after 24 hours.

    Presence of redness on the injection site, formation of a papule or the appearance of symptoms of a general reaction in the form of nausea, dizziness, or other manifestations 10-15 minutes after the injection, indicates an increased sensitivity of the patient to the drug and the impossibility of using the drug in this patient. In the absence of any reactions, the patient is given the required amount of the preparation of the series that was used to conduct the intradermal test. The results of the sample are recorded in the medical history.

    It should be remembered that the skin test does not allow to reveal sensitization to dextran in 100% of patients. Therefore, in the first 5-10 minutes as the intravenous drug is administered in each case, it is necessary to closely monitor the patient's condition.In the case of emergency conditions, when applying the drug, it is necessary to conduct a bioassay: after a slow introduction of the first 5 drops of the drug, stopping for 3 minutes. then add another 30 drops and again stop the infusion for 3 minutes. In the absence of a reaction, continue the injection. The results of the bioassay must be recorded in the medical history.

    When there is a violation of capillary blood flow (various forms of shock) injected intravenously drip or drip-drop, at a dose of 0.5 to 1.5 liters, until the hemodynamic parameters stabilize at the life-supporting level. If necessary, the amount of the drug can be increased to 2 liters.

    Children with various forms of shock are administered at the rate of 5-10 ml / kg, the dose can be increased if necessary to a maximum of 15 ml / kg. It is not recommended to reduce the hematocrit value below 25%.

    With cardiovascular and plastic operations injected intravenously drastically, immediately before surgery, for 30-60 minutes adults and children at a dose of 10 ml / kg, during surgery, adults - 500 ml, children - 15 ml / kg.

    After operation the drug is administered intravenously drip (within 60 minutes) for 5-6 days at the rate of:

    adults - 10 ml / kg once,

    children up to 2-3 years - 10 ml / kg 1 time per day,

    children under 8 years - 7-10 ml / kg 1-2 times a day,

    children under 13 years - 5-7 ml / kg 1-2 times a day,

    for children older than 14 years - the doses are the same as for adults.

    In operations with artificial circulation the drug is added to the blood at the rate of 10-20 ml / kg of the patient's body weight to fill the oxygenator pump, the concentration of dextran in the perfusion solution should not exceed 3%. In the postoperative period, the doses of the drug are the same as for a violation of capillary blood flow.

    With the aim of detoxification injected intravenously drip in a single dose of 500 to 1250 ml (in children 5-10 ml / kg) for 60-90 minutes. If necessary, you can introduce another 500 ml of the drug in the first day (in children the administration of the drug in the first day can be repeated in the same doses). In the following days, the drug is administered drip, adults - in a daily dose of 500 ml, children - at a rate of 5-10 ml / kg

    Side effects:

    Allergic reactions (skin rash, anaphylactoid reactions - depression of blood pressure, collapse, oliguria), fever, chills, fever, nausea, pruritus.

    Can provoke bleeding, the development of acute renal failure.

    Overdose:

    Symptoms: if dextran administered rapidly or in too large an amount may cause symptoms of volume overload (e.g. left ventricular heart failure, arrhythmias, pulmonary hypertension, and others.).

    Allergic reactions are possible.

    Treatment: In the case of an overload, volume is usually sufficient to stop the infusion, but symptomatic therapeutic interventions, including urgent ones, may be required.

    In case of during infusion anaphylactic shock reactions (redness and itching of the skin, angioedema et al.) It is necessary to immediately stop administering the drug and without removing the needle from the vein to initiate all provided by appropriate instructions therapeutic measures to eliminate transfusion reaction ( calcium preparations, antihistamines and cardiovascular agents, corticosteroids, respiratory analeptics, etc.) or resuscitation.

    Possible plazmaferez, hemodialysis is ineffective.

    Interaction:

    It is necessary to check in advance for compatibility with the medicines that are planned for introduction into the infusion solution.

    It is allowed to use together with other traditional transfusion means.

    Dextran potentiates the effect of anticoagulants and antiaggregants, so their doses should be reduced.

    Special instructions:

    When the drug is injected into the peripheral veins, a burning sensation and tenderness may appear in the limb along the vein.

    Together with the preparation, it is advisable to administer crystalloid solutions (0.9% sodium chloride solution, 5% dextrose solution in such quantity to replenish and maintain the water-electrolyte balance.This is especially important in the treatment of dehydrated patients and patients after severe surgical operations.Make special care, when there is a risk for circulatory overload, especially in the case of latent and clinically evident heart failure.

    Dextran reduces the plasma levels of the VIII coagulation factor and von Willebrand platelet factor, mainly due to dilution, which may result in bleeding, especially when dextran is deficient in daily doses exceeding 1.5 g / kg body weight (approximately 15 ml / kg body weight).When used simultaneously with anticoagulants, their dose should be reduced.

    Causes an increase in diuresis (if there is a decrease in diuresis with the release of viscous syrupy urine, this may indicate dehydration). In this case, it is necessary to introduce IV crystalloid solutions to replenish and maintain the water electrolyte balance. In the case of an oliguria, it is necessary to intensify the therapy and prescribe furosemide. In patients with reduced filtration capacity of the kidneys, it is necessary to limit the administration of sodium chloride.

    Dextrans are able to envelop the surface of red blood cells, preventing the determination of the blood group, so it is necessary to use washed red blood cells.

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

    Given the mechanism of pharmacological action of the drug, its direct impact on the ability to drive vehicles seems unlikely. However, the side effects associated with the use of the drug in susceptible people can affect the ability to drive or work with machinery.

    Form release / dosage:

    Solution for infusion, 100 mg / ml.

    Packaging:

    For 100, 200 and 400 ml in glass bottles for blood, transfusion and infusion preparations with a capacity of 100, 250 and 450 ml respectively, corked with rubber stoppers and crimped with aluminum caps.

    One bottle with instructions for medical use is placed in a pack of cardboard.

    For 28 bottles with a capacity of 100 or 250 ml or 15 bottles with a capacity of 450 ml with the appropriate number of instructions for medical use placed in a box of corrugated cardboard with gaskets and nest boxes made of corrugated cardboard [for hospitals].

    Storage conditions:

    In the dark place at a temperature of 8 to 25 FROM. Freezing of the drug is not allowed. The enterprise guarantees the quality of the preparation under the conditions of storage and transportation temperatures from 8 to 25 FROM, otherwise dextran may appear as white flakes or films. Non-wetting of the inner surface of the bottle is not a contraindication to the use of the drug.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003781
    Date of registration:12.08.2016
    Expiration Date:12.08.2021
    The owner of the registration certificate:ESKOM NPK, OAO ESKOM NPK, OAO Russia
    Manufacturer: & nbsp
    Representation: & nbspESKOM NPK, OAOESKOM NPK, OAO
    Information update date: & nbsp07.09.2016
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