Sodium fumarate compound (Solution) Instructions for Use

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

ATC Code

B05BB01 (Electrolytes)

Dosage Form

Sodium fumarate compound

Solution for infusion: bottle 200 ml or 400 ml

Dosage Form, Packaging, and Composition

200 ml – bottles for blood and blood substitutes (1) – cardboard packs.
400 ml – bottles for blood and blood substitutes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Rehydrating agent

Pharmacological Action

Sodium fumarate compound is a saline infusion solution, the main pharmacologically active component of which is sodium fumarate – an antihypoxant that activates cell adaptation to oxygen deficiency.

Its action is due to participation in the reactions of reversible oxidation and reduction in the Krebs cycle. During these reactions, ATP is synthesized in an amount sufficient to maintain the functions of the body’s cells during hypoxia.

In metabolic acidosis, it exhibits an alkalizing effect; its osmolarity is 400-410 mOsm/L; in hypovolemic conditions, it quickly replenishes the volume of circulating blood and prevents tissue dehydration.

It reduces blood viscosity and improves its rheological properties, increases diuresis, promotes the activation of detoxification processes; reduces the concentration in the blood of intermediate and final products of lipid peroxidation (antioxidant properties).

Indications

Hypovolemic and hypoxic conditions (blood loss, shock, trauma, intoxication); acute cerebrovascular accidents in adults, occurring as ischemic and hemorrhagic types; as a component of the perfusion mixture for filling the circuit of the cardiopulmonary bypass machine during cardiac surgeries in adults and children.

ICD codes

Dosage Regimen

Administer intravenously, by bolus or drip infusion. Use intra-arterial administration less frequently.

Determine the total volume and infusion rate individually based on the clinical condition, indication, and patient’s age.

For hypovolemic shock and significant blood loss, administer a bolus of 400-800 ml rapidly to restore circulating blood volume.

For maintenance therapy, dehydration, and detoxification, administer by drip infusion at a rate of 40-60 drops per minute. The total daily volume for adults typically ranges from 400 ml to 1200 ml.

In cases of acute cerebrovascular accident (ischemic or hemorrhagic), administer 200-400 ml intravenously daily for 7-10 days.

As a component of the perfusion mixture for cardiopulmonary bypass, use according to the specific surgical protocol for adults and children.

Adjust the dosage for pediatric patients based on body weight and clinical status; carefully calculate the infusion rate.

Do not exceed a total daily volume of 2000 ml for adults without reassessment.

Monitor the patient’s clinical status, electrolyte balance, and circulating blood volume continuously during infusion.

Adverse Reactions

Systemic reactions allergic reactions, cerebral edema, pulmonary edema, respiratory arrest (brainstem herniation).

Contraindications

Hypersensitivity; traumatic brain injury accompanied by increased intracranial pressure; conditions in which the intravenous administration of large volumes of fluid is contraindicated (including arterial hypertension and chronic heart failure).

Pediatric Use

If it is necessary to use the drug in children, the instructions should be carefully studied.

Special Precautions

It is necessary to perform regular blood tests to determine electrolytes, pH and pCO₂ indicators, and circulating blood volume.

Drug Interactions

It can be used in combination with colloidal solutions (dextran preparations, Neohemodes, Hemodes, Gelatinol); it is also compatible with donor blood, erythrocyte mass, plasma, and other blood products.

It does not interfere with the administration of commonly used anti-shock drugs, including drugs for neuroleptanalgesia (fentanyl, droperidol), benzodiazepines (diazepam), as well as muscle relaxants (suxamethonium), protease inhibitors (aprotinin), and alpha-adrenergic stimulants (dopamine, epinephrine).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.