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Mafusol® (Solution) Instructions for Use

ATC Code

B05BB01 (Electrolytes)

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Rehydrating agent

Pharmacological Action

A drug for the correction of water-salt metabolism, which helps to reduce tissue hypoxia.

Sodium fumarate is present in all cells of the body with an aerobic type of respiration; it helps eliminate acidemia by chemically neutralizing acidic metabolic products, similar to sodium lactate and acetate (components widely used in the manufacture of saline solutions).

The drug reduces blood viscosity and improves its rheological properties, and also improves hemodynamic parameters, has a diuretic and detoxifying effect.

Pharmacokinetics

Data on the pharmacokinetics of Mafusol® are not provided.

Indications

Hypovolemic and hypoxic conditions of various etiologies

  • Blood loss;
  • Shock (hemorrhagic, burn, traumatic, surgical);
  • Intoxication (including in peritonitis, sepsis, intestinal obstruction);
  • Trauma.

As a component of the perfusion mixture for filling the heart-lung machine.

ICD codes

ICD-10 code Indication
A40 Streptococcal sepsis
A41 Other sepsis
K56 Paralytic ileus and intestinal obstruction without hernia
K65.0 Acute peritonitis (including abscess)
R57.1 Hypovolemic shock
R57.8 Other types of shock
R58 Hemorrhage, not elsewhere classified
T14 Injuries to unspecified parts of body
T79.4 Traumatic shock
ICD-11 code Indication
1G40 Sepsis without septic shock
DA91.Z Unspecified obstruction of small intestine
DB30.Z Unspecified obstruction of large intestine
DC50.0 Primary peritonitis
DC50.2 Peritoneal abscess
DC50.Z Peritonitis, unspecified
DE2Z Diseases of the digestive system, unspecified
MG27 Hemorrhage, not elsewhere classified
MG40.1 Hypovolemic shock
MG40.Z Shock, unspecified
ND56.Z Unspecified injury of unspecified part of trunk, limb or body region
NF0A.4 Traumatic shock, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution

The drug is administered intravenously and intra-arterially. Doses and rate of administration are set individually depending on the indications and the patient’s condition.

In mild and moderate shock, the drug is administered intra-arterially and intravenously by bolus. After normalization of hemodynamic parameters – intravenously by drip at a daily dose of up to 2-2.5 liters. In severe shock, the administration of Mafusol® (not less than 1 liter/day) is combined with the administration of blood and colloid plasma substitutes with hemodynamic action.

In severe intoxications, the drug is administered at a dose of up to 2-3 liters/day in combination with other detoxification drugs.

When filling the heart-lung machine, Mafusol® constitutes up to 50-70% of the entire volume of the perfusion solution introduced into the apparatus.

Adverse Reactions

When used according to the indications in recommended doses, no adverse effects were noted.

Contraindications

Conditions in which a large amount of fluid should not be introduced into the body, including:

  • Increased intracranial pressure in closed head injury;
  • Chronic heart failure in the stage of decompensation.

Use in Pregnancy and Lactation

The safety and efficacy of the drug during pregnancy and lactation have not been established.

Special Precautions

Mafusol® can be used in combination with blood and colloid plasma substitutes with hemodynamic action, as well as in combination with other detoxification agents.

Overdose

There are currently no data on overdose of Mafusol®.

Drug Interactions

The drug interaction has not been studied.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature from 0°C (32°F) to 25°C (77°F). Freezing is allowed.

Shelf Life

The shelf life is 2 years.

Dispensing Terms

The drug is dispensed by prescription.

Dispensing Status

Rx Only

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Contact Information

BIOSINTEZ PJSC (Russia)

Dosage Form

Bottle Rx Icon Mafusol® Solution for infusion: 400 ml or 450 ml bottle.

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless, odorless.

1 L
Sodium fumarate 14 g
Sodium chloride 6 g
Potassium chloride 300 mg
Magnesium chloride 120 mg

400 ml – bottles for blood substitutes.
450 ml – bottles for blood substitutes.

Marketing Authorization Holder

Medpolymer Firm, JSC (Russia)

Dosage Form

Bottle Rx Icon Mafusol® Solution for infusion: 100, 250, 500 or 1000 ml bottle.

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless, odorless.

1 L
Sodium chloride 6 g
Potassium chloride 300 mg
Magnesium chloride 120 mg
Sodium fumarate 14 g

100 ml – bottles for blood substitutes.
250 ml – bottles for blood substitutes.
500 ml – bottles for blood substitutes.
1000 ml – bottles for blood substitutes.

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