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

    Per 1 liter:

    active substance: dextran [co-sol. mass 35000-45000] 100.0 g;

    Excipients: sodium chloride 9.0 g, water for injection up to 1 liter.

    Theoretical osmolarity 310 mOsm / l

    Description:

    Transparent, colorless or slightly yellowish viscous liquid.

    Pharmacotherapeutic group:plasma-substituting agent
    ATX: & nbsp

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

    Pharmacodynamics:

    Plasma-substituting agent, increases the suspension stability of blood, reduces its viscosity, restores blood flow in small capillaries, normalizes arterial and venous circulation, prevents and reduces the aggregation of blood elements, exerts detoxification action.

    By the osmotic mechanism it stimulates diuresis (it is filtered in the glomeruli, creates high oncotic pressure in the primary urine and prevents reabsorption of water in the tubules), which promotes (and accelerates) the excretion of poisons, toxins, degradation products of metabolism. 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. It causes a rapid and short-term increase in the volume of circulating blood, which increases the return of venous blood to the heart. In vascular insufficiency increases blood pressure, minute blood volume and central venous pressure. Has an average molecular weight (40 thousand Da). With a rapid introduction, the plasma volume can be increased by a factor of 2 compared with the volume of the injected drug, Each gram of dextrose polymer with a molecular weight of 35-45 thousand Da promotes the redistribution of 20-25 ml of fluid from the tissues into the bloodstream. It is pyrogen-free, non-toxic. Prevents or reduces the aggregation of red blood cells, which improves microcirculation.Reduces the adhesiveness of platelets, prevents the formation of thrombi after surgery and trauma, increases their solubility (due to a change in the structure of fibrin). When applied at a dose of up to 15 ml / kg, there is no noticeable change in bleeding time.

    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 circulating tissue plasminogen activator (t-PA) by blocking the action of the plasminogen activator inhibitor (PAI-1).

    Pharmacokinetics:

    The half-life is 6 hours. The excretion is performed by the kidneys, 60% are excreted in 6 hours, and 70% in 24 hours. 30% goes to the reticulo-endothelial system, the liver, where the enzyme is digested with acidic alpha-glucosidase to glucose, but is not a source of carbohydrate nutrition.

    Indications:

    Prevention and treatment of traumatic, surgical and burn shock, replenishment of circulating blood volume; violations of arterial, venous and capillary blood circulation, treatment and prevention of thrombosis and thrombophlebitis, endarteritis, etc.circulatory disorders; for addition to a perfusion fluid in cardiac operations performed using an artificial circulation device; for improving local circulation in vascular and plastic surgery; for detoxification with burns, peritonitis, pancreatitis.

    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; 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 hyperglycaemia and hyperosmolarity, in violation of water-electrolyte balance.

    Pregnancy and lactation:

    During pregnancy, apply in cases where the expected benefit to 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 use of the drug, except for urgent conditions, a skin test is performed.

    Intradermal test is carried out 24 hours before the infusion of the drug. To do this, from a bottle with Rheopolyglucin by puncturing a sterile syringe connected to it with a single-use system, 0.2-0.3 ml of the drug is taken, which is administered intradermally at a dose of 0.05 ml to form a lemon crust on the inside of the forearm, shoulder or other area, available for visual evaluation of the skin test. The doctor evaluates the reaction after 24 hours.

    The presence of redness on the spot (diameter more than 1.5 mm), the formation of a papule or the appearance of symptoms of a general reaction in the form of nausea, dizziness or other manifestations through 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. If any reactions are absent, the patient is administered the required amount of the preparation of the series that was used to conduct the intradermal test. The result of the test is recorded in the medical history.

    It should be remembered that the skin test does not allow to reveal sensibilization to Reopoliglukin in 100% of patients. Therefore, in the first 5-10 minutes as the intravenous drug in each case, you need to carefully 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 inject another 30 drops and 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.

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

    2. With cardiovascular and plastic operations injected intravenously drastically, immediately before surgery, for 30 to 60 minutes to adults and children in 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.

    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. 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, for children - at the rate of 5-10 ml / kg.

    Side effects:

    Allergic reactions (skin hyperemia, skin rash), nausea, fever, anaphylactic shock.

    Overdose:

    Symptoms: if dextran is introduced very quickly or too large a volume of overload symptoms may occur (eg, 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.

    In case of anaphylactic type reactions (reddening and itching of the skin, swelling of the Quincke, etc.) during the infusion, it is necessary to immediately stop the injection of the drug and, without removing the needle from the vein,to start carrying out all the therapeutic measures provided 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 advisable to combine reopolyglucin with infusion solutions (9 mg / ml sodium chloride solution, 50 mg / ml glucose solution (dextrose), etc.) in the amount necessary to replenish and maintain the volume of circulating blood.

    When used simultaneously with anticoagulants and antiplatelet agents, their dose should be reduced.

    Special instructions:

    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 liquid and electrolyte balance. This is especially important in the treatment of dehydrated patients and after severe surgical operations.

    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 intravenously colloidal solutions to replenish and maintain the water electrolyte balance. In the case of oliguria, it is necessary to introduce saline solutions and 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.

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

    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 dextran is administered 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.

    Do not freeze!

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

    Clinical studies to assess the effect of the drug on the ability to manage vehicles and mechanisms have not been conducted.

    Form release / dosage:

    Solution for infusion, 100 mg / ml.

    Packaging:

    For 100, 200, 250, 400, 500 or 1000 ml in polypropylene bottles, sealed with welded polypropylene caps. One bottle together with instructions for use in a pack of cardboard.

    For hospitals

    From 1 to 40 vials of 100, 200, 250, 400, 500 or 1000 ml together with instructions for use in an amount equal to the number of vials in a corrugated box of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-002614
    Date of registration:05.09.2014 / 04.02.2015
    Date of cancellation:2019-09-05
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspGROTEKS, LLCGROTEKS, LLC
    Information update date: & nbsp10.01.2016
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