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Dosage form: & nbspSolution for infusion.
Composition:

Active substances:

Macrogol-20000

(Polyethylene glycol-20000)

15.0 grams

Sodium fumarate

(Sodium fumaric acid)

14.0 grams

Sodium chloride

6.0 g

Potassium iodide

0.5 g

Magnesium chloride hexahydrate

(in terms of magnesium chloride anhydrous)

0.12 g

Excipients:

Water for injection up to 1 liter

Ionic composition of the preparation (mmol / l):

Sodium ion

280,0

Potassium ion

3,0

Magnesium ion

1,2

Chloride ion

106,0

Fumarate ion

86,0

Iodide ion

3,0

Theoretical osmolality

479.2 mOsm / l

Description:Colorless, clear liquid.
Pharmacotherapeutic group:plasma-substituting agent
ATX: & nbsp
  • Blood plasma preparations and plasma-substituting drugs
  • Pharmacodynamics:

    Polyoxyfumarin is a polyfunctional blood substitute for hemodynamic action with pronounced antihypoxic properties.

    The composition of the drug includes components that provide a stable correction of hemodynamics, macrogol-20000 (polyethylene glycol-20000); normalization of the acid-base state and energy metabolism at the cellular level (sodium fumarate (sodium fumarate)) and maintaining a stable water-electrolyte balance (ions of sodium, potassium, magnesium and chlorine).

    With the use of Polyoxyfumarin, postinfusion hemodilution occurs, as a result of which the viscosity of the blood decreases and its rheological properties are improved.

    Infusions of the drug increase diuresis, promote the activation of detoxification processes.

    Pharmacokinetics:

    After the infusions of Polyoxifumarin electrolytes and fumarate are completely metabolized. The colloidal base - macrogol-20000 (polyethylene glycol-20000) - is not metabolized. The main way to remove macrogol-20000 (polyethylene glycol-20000) is the kidney: 95% of the colloid after a single injection is excreted in the urine for 5 days, about 5% - through the gastrointestinal tract at the same time.

    Multiple introduction of Polyoxifumarin does not result in the accumulation of macrogol-20,000 (polyethylene glycol-20,000) in organs and tissues, the organism is released from it by 8-14 days.

    Indications:

    Polyoxyfumarin is used in adults and children (from 1 year) with hypovolemic conditions of various origins (blood loss, shock, burns, trauma, intoxication) in order to restore systemic hemodynamics, water-salt balance, correction of metabolic acidosis and energy metabolism.

    Polyoxyfumarin is also used as a component of the perfusion mixture to fill the cardiopulmonary bypass.

    Contraindications:

    Hypersensitivity to the drug.

    Conditions in which intravenous administration of large volumes of fluid is contraindicated, including in cases of craniocerebral trauma, intracranial hypertension and chronic heart failure.

    Carefully:

    Compensated heart failure, chronic renal failure, pregnancy, lactation.

    Dosing and Administration:

    Polyoxyfumarin is used intravenously (jet or drip).

    Doses and the speed of administration of the drug should be selected in accordance with the indications and condition of the patient.

    Shake before use.

    In shock (hemorrhagic, burn, traumatic, operating) Polyoxyfumarin is administered adults intravenously in a dose of 400-800 ml per administration, children - 15-20 ml per kg of body weight.

    Begin the introduction of the drug struyno, and with the stabilization of blood pressure - drip. If repeated injections are necessary, the drug may be administered adults in a volume of up to 2 liters per day, and children - up to 30 ml per kg of body weight.

    In severe intoxication (peritonitis, sepsis, intestinal obstruction, burn toxemia, etc.) Polyoxyfumarine is administered adults intravenously drip in a dose of 400-800 ml for 1-3 days, and children 15-20 ml per kg of body weight per day in combination with other detoxification agents.

    In operations using the apparatus of artificial circulation Polyoxyfumarin is used as a hemodiluent to fill the device of artificial circulation (30-40% perfusion solution).

    Side effects:

    There were no side effects, but as the formulation includes potassium iodide, capable of releasing histamine and other biologically active substances, the use of polyoxyfumarin in some patients with increased sensitivity to iodine preparations does not preclude the possibility of developing allergic reactions.

    Interaction:

    The use of Polyoxyfumarin in shock treatment schemes suggests the possibility of administering the drug in conjunction with transfusion of donor blood, erythrocytes, plasma and other blood products.

    Polyoxyfumarin is allowed to be administered in combination with other colloidal media (Polyglukin, Reopoliglyukin, gelatin-based preparations, etc.) and crystalloid solutions (0.9% sodium chloride solution, Ringer's solution, Mafusol, etc.).

    The use of polyoxyfumarin also does not interfere with the use of commonly used anti-shock drugs from analgesics, barbiturates, tranquilizers, glucocorticosteroids, protease inhibitorsaprotinin) and metabolic drugs (phosphocreatine).

    Form release / dosage:

    Solution for infusion.

    Packaging:

    400 ml in bottles of glass with a capacity of 450 ml, corked with rubber stoppers and rolled with aluminum caps. Each label is labeled with paper. A bottle with instructions for use is placed in a pack of cardboard.

    Or 15 bottles together with no less than 5 instructions for use, packed in boxes of corrugated cardboard (for hospitals).

    Storage conditions:

    At a temperature of 0 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the date shown on the package.

    Terms of leave from pharmacies:For hospitals
    Registration number:LP-000196
    Date of registration:08.02.2011
    Expiration Date:08.02.2016
    The owner of the registration certificate:SAMSON-MED, LLC SAMSON-MED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp15.12.2016
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