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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for infusion: 400 ml or 450 ml bottle.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Contact Information
BIOSINTEZ PJSC (Russia)
Dosage Form
 |
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.
Solution for infusion: 100, 250, 500 or 1000 ml bottle.
Marketing Authorization Holder
Medpolymer Firm, JSC (Russia)
Dosage Form
|
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.
![Mafusol® [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Mafusol® [Solution] 2")