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: dextern [cf. Mol. weight 35000-45000] (in terms of anhydrous) - 100 g.

    Excipients: nAtria chloride - 9.0 grams, water for injection - up to 1 liter.

    Description:

    Colorless or slightly yellowish, clear 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.

    The osmotic mechanism stimulates diuresis (filtered in the glomeruli, creates high oncotic pressure in the primary urine and prevents the reabsorption of water in the tubules), which contributes (and accelerates) 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.

    It causes a rapid and short-term increase in the volume of blood, thereby increasing the return of venous blood to the heart. In vascular insufficiency increases blood pressure, minute blood volume and central venous pressure. With a rapid introduction, the volume of plasma can be increased by a factor of 2 compared with the volume of the injected drug, since every gram of dextrose polymer with a molecular weight of 35,000-45,000 contributes to the redistribution of 20-25 ml of fluid from 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. It is excreted by the kidneys (for 6 hours up to 60%, for 24 hours up to 70%). 30% goes to the reticulo-endothelial system, the liver where the enzyme is digested with acidic alpha-glucosidase to glucose, however, 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, prevention and treatment 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; hypervolaemia, hyperhydration and other situations, in which the introduction of large volumes of liquids is contraindicated.
    Carefully:

    The drug should be used with caution in case of disorders of the coagulation system blood (other than life-threatening condition), dehydration; patients with sugar Diabetes with severe hyperglycemia and hyperosmolarity; in violation of water-electrolyte balance.

    Pregnancy and lactation:

    The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential 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.

    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.

    Before applying the drug, a bioassay is performed and its result recorded in the medical history.

    If possible, conduct intradermal for 24 hours before the infusion of the drug. To do this, from the container with dextran by puncturing the disposable system using a sterile syringe, take 0.2-0.3 ml of the drug that 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 accessible to the visual evaluation of skin test. The doctor evaluates the reaction after 24 hours.The presence of redness (more than 1.5 mm in diameter) at 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 min after injection indicates an increased sensitivity of the patient to the drug and its inability to use it 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. It should be remembered that the skin test does not allow to reveal sensitization to dextran in 100% of patients. Therefore, in each case, the first 5-10 minutes of intravenous administration of the drug should be carefully monitored the patient.

    In the case of emergency conditions, the bioassay is performed as follows: after a slow administration of the first 5 drops of the drug, the infusion is stopped for 3 minutes, then another 30 drops are added and the infusion is again stopped for 3 minutes. In the absence of a reaction, continue the administration of the drug.

    1. When the capillary blood flow is disturbed (various forms of shock) are administered intravenously drip or drip-dropwise at a dose of 0.5 to 1.5 l 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 different forms of shock injected 5-10 ml / kg. If necessary, the dose may be increased to 15 ml / kg. It is not recommended to reduce the hematocrit value below 25%.

    2. With cardiovascular and plastic operations injected intravenously drip: immediately before surgery - 10 ml / kg for 30-60 minutes for adults and children; during the operation - 500 ml for adults and 15 ml / kg for children; for 5-6 days after the operation - for 60 min 10 ml / kg once for adults and children over 14 years, 10 ml / kg once a day for children up to 2-3 years, 7-10 ml / kg 1-2 once a day for children under 8 years, for 5-7 ml / kg 1-2 times a day for children under 13 years.

    3. In operations under conditions of artificial circulation the preparation is added to the blood of the patient at a rate of 10-20 ml / kg 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 (children 5-10 ml / kg) for 60-90 minutes. If necessary, in the first day you can introduce another 500 ml of the drug (for children, the drug can be repeated in the same doses). In the following days, the drug is administered in a daily dose of 500 ml (children 5-10 ml / kg).

    Side effects:

    Allergic reactions (skin rash, anaphylactoid reactions - lowering of arterial pressure, collapse, oliguria), fever, chills, fever, nausea.

    Can provoke bleeding, the development of acute renal failure.

    Overdose:

    Symptoms: if dextran is introduced very quickly or too large a volume of overload symptoms (left ventricular heart failure, arrhythmias, pulmonary hypertension, etc.) is possible. Allergic reactions are possible.

    Treatment: In the case of an overload, volume is usually sufficient to terminate infusion, but symptomatic therapeutic measures may be required, including urgent. In the case of an infusion of anaphylactic type (reddening and itching of the skin, swelling of Quincke, etc.) is necessary immediately to stop the administration of the drug and to eliminate the transfusion reaction, Without removing the needles from the vein, proceed to carrying out all the prescribed corresponding instructions of therapeutic (application of calcium preparations, antihistamine and cardiovascular agents, corticosteroids, respiratory analeptics, etc.) or resuscitation. Plasmapheresis is possible, 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:

    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.

    In the process of treatment, it is necessary to monitor kidney function. With an increase in diuresis, it is necessary to introduce intravenously crystalloid 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 factor of blood clotting and von Willebrand platelet factor mainly due to dilution, as a result of which, when using dextran in daily doses exceeding 1.5 g / kg body weight (about 15 ml / kg body weight) bleeding especially in patients with a deficiency of these factors.

    With the simultaneous use of the drug with anticoagulants, it is necessary to reduce their dose.

    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 manage vehicles and mechanisms is extremely 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 infusions, 10%.
    Packaging:

    By 100, 250, 500 ml into polymer containers made of polypropylene based film.

    70 containers with a capacity of 100 ml, or 32 containers with a capacity of 250 ml, or 20 containers with a capacity of 500 ml with an equal number of instructions for use are placed in boxes of cardboard corrugated (for hospitals).

    Storage conditions:

    In the dark place at a temperature of 10 to 25 ° C.

    Keep out of the reach of children.

    Transportation conditions

    Freezing of the drug during transportation is allowed. After transport under adverse temperatures, the containers in the shipping container must be conditioned under normal climatic conditions until completely thawed. Before use, the solution in the container should be mixed by shaking.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:For hospitals
    Registration number:LP-003481
    Date of registration:01.03.2016
    Expiration Date:01.03.2021
    The owner of the registration certificate:En.S. Pharmaceuticals, LLCEn.S. Pharmaceuticals, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.08.2016
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