Active substanceDextranDextran
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  • Dosage form: & nbspsolution for infusions
    Composition:

    Per 1 ml:

    active substance: dextran (cf.m.m., mass 30000-40000) (in the form of 10% solution in water for injection) 1 ml, (in terms of dextran (average mol. mass 30,000-40000)) 100 mg;

    auxiliary substance: sodium chloride 9 mg.

    Description:Transparent, colorless or slightly yellowish 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 30,000-40000. Applicable at quality plasmasubstitution antishock medication hemodynamic action.Promotes an increase in the volume of blood plasma by almost 2 times compared with the volume of the injected drug, since each gram of dextrose polymer with an average molecular weight of 30,000-40000 causes the displacement of 20-25 ml of fluid from tissues into the bloodstream. Due to high oncotic pressure dextran very slowly passes through the vascular wall and circulates for a long time 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 edema of tissues decreases. The duration of action is from 3 to 4 hours.

    Reopoliglyukin 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 on 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 the circulating tissue plasminogen activator (t-PA) by blocking the action of the plasminogen activator inhibitor (PAI-1). In addition, there is evidence of the effect on the shape of the fibrin molecule, the changes of which lead to its more rapid destruction with endogenous fibrinolysis, which leads to the prevention of thrombus formation and increases their solubility (thrombolysis). When administered at a dosage of up to 15 ml / kg, there is no noticeable change in bleeding time.

    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 tissues,which together with an increase in diuresis provides an accelerated detoxification of the body.

    Pharmacokinetics:

    Excretion by the kidneys, for 6 hours 60% are deduced, and for 24 hours - 70%. 30% goes to the reticuloendothelial system, 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 an increase intracranial pressure; hemorrhagic stroke; ongoing internal bleeding; hypocoagulation; thrombocytopenia; marked violations of kidney function, accompanied by oligo- and anuria; hypervolaemia, hyperhydration and other situations, in which the introduction of large volumes of liquids is contraindicated.

    Carefully:With violations of the blood coagulation system, dehydration, in patients with diabetes mellitus with severe hyperglycemia and hyperosmolarity, with violations 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 period of use of the drug because of the lack of relevant clinical data.

    Dosing and Administration:

    Intravenously sprayed, drip-drip and drip.

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

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

    The 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.

    The presence of redness on the injection site, the 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 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 the slow introduction of the first 5 dropsthe drug is stopped for 3 minutes, then another 30 drops are added and the infusion is stopped again for 3 minutes. In the absence of a reaction, continue the injection. The results of the bioassay are necessarily recorded in the medical history.

    1. If capillary blood flow is disturbed (various forms of shock), 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 drug coins to 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%.

    2. In cardiovascular and plastic surgeries, intravenous drip is administered intravenously, just before surgery, for 30-60 minutes to adults and children at a dose of 10 ml / kg, during an operation, adults - 500 ml, children - 15 ml / kg.

    After the 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 once a day;

    children up to 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 over 14 years of age doses are the same as for adults.

    3. 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.

    4. For the purpose of detoxification, 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 hyperemia, skin rash, itching, anaphylactoid reactions - lowering blood pressure, collapse, oliguria, until the development of anaphylactic shock), nausea, fever.

    May provoke bleeding and develop acute renal failure.

    Overdose:

    Symptoms: if dextran is introduced very quickly or too much, there may be symptoms of overload volume (for example,left ventricular heart failure, arrhythmias, pulmonary hypertension, etc.). 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.

    If anaphylactic-type reactions (reddening and itching of the skin, Quincke's edema, etc.) occur during infusion, it is necessary to immediately stop the drug administration and, without removing the needles from the vein, proceed with all the therapeutic measures prescribed by the appropriate instructions for the elimination of the 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 as to replenish and maintain the water-electrolyte balance. This is especially important in the treatment of dehydrated patients and after severe surgical operations.

    Special care should be taken when there is a risk for circulatory overload, especially in the case of latent or clinically evident heart failure.

    Dextran reduces the plasma levels of the VIII coagulation factor and von Willebrand platelet factor, mainly due to dilution, which can lead to bleeding especially in patients with a deficiency of these factors when using dextrin in daily doses exceeding 1.5 g / kg body weight body (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:

    Care should be taken when driving vehicles and performing potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Solution for infusions, 10%.

    Packaging:

    For 200,400 ml in the glass bottles.

    Each bottle, along with instructions for use, is placed in a cardboard package.

    Packing for hospitals: 24 bottles of 400 ml or 40 bottles of 200 ml, together with an equal number of instructions for use in boxes of corrugated cardboard.

    Storage conditions:

    Store in a dry place, at a temperature of 10 to 25 ° C,

    The company guarantees the quality of the preparation under the conditions of storage and transport temperatures from 10 to 25 ° C, otherwise dextran may appear as white flakes or films.

    Keep out of the reach of children.

    Shelf life:

    4 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N016167 / 01
    Date of registration:02.10.2009 / 04.03.2015
    The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus
    Manufacturer: & nbsp
    BELMEDPREPARATY, RUP Republic of Belarus
    Representation: & nbsp"Belmedpreparaty" RUP "Belmedpreparaty" RUP
    Information update date: & nbsp10.01.2016
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