Polyoxifumarin (Solution) Instructions for Use

Marketing Authorization Holder

Samson-Med LLC (Russia)

ATC Code

B05AA (Blood substitutes and plasma preparations)

Dosage Forms

	Polyoxifumarin	Solution for infusion: 200 ml or 100 ml bottle 1 pc., 400 ml bottle 1 or 5 pcs.
		Solution for infusion: bottle 200 ml or 400 ml

Dosage Form, Packaging, and Composition

Excipients : water for injections.

400 ml – bottles (15) – cardboard boxes.
450 ml – bottles (15) – cardboard boxes.

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Polyoxifumarin is a multifunctional hemodynamic blood substitute with pronounced antihypoxic properties.

The preparation contains components that provide stable correction of hemodynamics Macrogol-20000 (polyethylene glycol-20000), normalization of the acid-base state and energy metabolism at the cellular level ( Sodium fumarate) and maintenance of a stable water-electrolyte balance (sodium, potassium, magnesium and chloride ions).

When Polyoxifumarin is used, post-infusion hemodilution occurs, which reduces blood viscosity and improves its rheological properties. Infusions of the preparation increase diuresis and contribute to the activation of detoxification processes.

Pharmacokinetics

After infusions of Polyoxifumarin, electrolytes and fumarate are completely metabolized. The colloidal base – Macrogol-20000 (polyethylene glycol – 20000) – is not metabolized. The main route of excretion of macrogol-20000 (polyethylene glycol-20000) is the kidneys: 95% of the colloid is excreted in the urine within 5 days after a single administration, about 5% is excreted through the gastrointestinal tract within the same period. Repeated administration of Polyoxifumarin does not lead to accumulation of macrogol-20000 (polyethylene glycol – 20000) in organs and tissues; the body is cleared of it by 8-14 days.

Indications

Polyoxifumarin is used in adults and children (from 1 year of age) for hypovolemic conditions of various origins (blood loss, shock, burns, trauma, intoxications) to restore systemic hemodynamics, water-salt balance, correct metabolic acidosis and energy metabolism.

Polyoxifumarin is also used as a component of the perfusion mixture for filling the cardiopulmonary bypass machine.

ICD codes

Dosage Regimen

Polyoxifumarin is administered intravenously (bolus or drip). The doses and rate of administration of the preparation should be selected according to the indications and the patient’s condition. Shake before use.

In shock (hemorrhagic, burn, traumatic, surgical), Polyoxifumarin is administered to adults intravenously at a dose of 400-800 ml per administration, to children – 15-20 ml per kg of body weight. The administration of the preparation begins as a bolus, and when blood pressure stabilizes, as a drip. If repeated administrations are necessary, the preparation is allowed to be administered to adults in a volume of up to 2 L per day, and to children – up to 30 ml per kg of body weight. In severe intoxications (peritonitis, sepsis, intestinal obstruction, burn toxemia, etc.), Polyoxifumarin is administered to adults intravenously by drip at a dose of 400-800 ml for 1-3 days, and to children 15-20 ml per kg of body weight per day in combination with other detoxification agents.

In operations using a cardiopulmonary bypass machine, Polyoxifumarin is used as a hemodiluent for filling the cardiopulmonary bypass machine (30-40% of the perfusion solution).

Adverse Reactions

No side effects have been identified, but since the preparation contains Potassium iodide, which is capable of releasing histamine and other biologically active substances, the possibility of developing allergic reactions in some patients with increased sensitivity to iodine preparations cannot be excluded when using Polyoxifumarin.

Contraindications

Hypersensitivity to the preparation. Contraindicated for intravenous administration of large volumes of fluid; including in traumatic brain injury, intracranial hypertension and chronic heart failure.

With caution. Compensated heart failure, chronic renal failure, pregnancy, lactation period.

Use in Pregnancy and Lactation

With caution: pregnancy, lactation period.

Use in Renal Impairment

With caution: chronic renal failure.

Pediatric Use

Use is possible according to the dosage regimen.

Drug Interactions

The use of Polyoxifumarin in shock treatment regimens implies the possibility of administering the preparation together with transfusion of donor blood, erythrocyte-containing media, plasma and other blood preparations. Polyoxifumarin is allowed to be administered in combination with other colloidal media (Polyglucin, Reopolyglucin, gelatin-based preparations, etc.) and crystalloid solutions (sodium chloride solution 0.9%, Ringer’s solution, Mafusol, etc.). The use of Polyoxifumarin also does not prevent the use of commonly used anti-shock agents from among analgesic drugs, barbiturates, tranquilizers, glucocorticosteroids, protease inhibitors (aprotinin) and metabolic drugs (phosphocreatine).

Storage Conditions

At a temperature from 0°C (32°F) to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life. 2 years Do not use after the date indicated on the packaging.

Dispensing Status

For hospitals.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.