Rheogluman (Solution) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

ATC Code

B05AA05 (Dextran)

Active Substances

Sodium chloride (Ph.Eur.)

Dextran (Rec.INN)

Mannitol (BP)

Dosage Form

Rheogluman

Solution for infusion 10 g+5 g+0.9 g/100 ml: bot. 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless or slightly yellowish, odorless.

Excipients : water for injections – up to 100 ml.

400 ml – glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Plasma-substituting drug. Reduces blood viscosity by reducing the aggregation of blood cells, promotes the restoration of blood flow in small capillaries. It also has anti-shock, detoxifying and diuretic effects.

1 g of dextran, which is part of Rheogluman, promotes the transfer of 20-25 ml of fluid from the tissue into the bloodstream.

Pharmacokinetics

The drug is excreted from the body mainly in the urine: approximately 70% during the first day. The rest of the drug enters the reticuloendothelial system, where it is gradually biotransformed into glucose.

Indications

Prevention and treatment of diseases accompanied by microcirculation disorders of both local and general nature, combined with fluid retention in the body

• Impaired capillary blood flow (traumatic, burn, toxic, cardiogenic shock);
• Impaired arterial and venous circulation (thrombosis, thrombophlebitis, endarteritis, Raynaud’s disease);
• In vascular and plastic surgery (to improve local circulation and reduce the tendency to thrombosis in the graft);
• Renal and renal-hepatic insufficiency with preserved renal filtration function;
• Post-transfusion complications caused by transfusion of incompatible blood;
• For detoxification in burns, injuries, peritonitis, pancreatitis.

ICD codes

Dosage Regimen

Rheogluman is administered intravenously by drip (intravenous jet administration can lead to hypervolemia due to the pronounced colloid-osmotic effect of the drug). The doses and rate of administration of the drug are set individually in accordance with the indications, assessment of the patient’s condition and his hourly and daily diuresis.

In the complex therapy of shock with impaired capillary blood flow, the drug is administered at a dose of 400 to 800 ml under the control of hemodynamic parameters (blood pressure and CVP, BCC, hourly and daily diuresis).

In burn shock, 2-3-fold administration of the drug is acceptable during the first 24 hours from the moment of injury. The first dose of the drug 400 ml can be administered within 2 hours, the second – after 6-12 hours at the same infusion rate. If other dextran drugs (polyglucin, rheopolyglucin) are used at the same time, then their total dose should not exceed 1600 mg/day (100-130 g of dextran). During the second day of the shock period, with stabilization of BCC, blood pressure and diuresis, the drug is administered at 400 ml 1-2 times.

During the period of acute burn toxemia, Rheogluman can be used daily or every other day at 400 ml as part of combined infusion therapy with mandatory monitoring of daily diuresis, blood hemoglobin and hematocrit.

During the period of septicotoxemia, the use of Rheogluman in the same doses is most appropriate when preparing the patient for autodermoplasty surgery and during the first 2 days from the moment of its performance.

In cardiovascular and plastic surgery, Rheogluman is administered immediately before surgery (30-60 minutes before) at a dose of 10 ml/kg of body weight, during surgery 400 ml and after surgery daily for 5-6 days at the rate of 10 ml/kg of body weight for a single administration.

In acute renal-hepatic insufficiency with preserved filtration and in post-transfusion complications, Rheogluman is administered once at a dose of 400-800 ml. The infusion of the drug can be repeated daily for 3-5 days, at the rate of 10 ml/kg of body weight per administration under the control of water-electrolyte and acid-base balance and the blood coagulation system.

Adverse Reactions

Allergic reactions in some cases (in previously sensitized patients) allergic reactions of varying severity may occur; anaphylactic shock may occur (in patients with a history of intolerance to intravenous infusions of protein preparations, plasma substitutes /including dextran preparations/, as well as sera, vaccines).

From the cardiovascular system tachycardia, decreased blood pressure.

Contraindications

• Excessive hemodilution (hematocrit below 25 units);
• Hemorrhagic diatheses;
• Chronic heart failure with severe edema;
• Severe renal failure accompanied by anuria;
• Significant dehydration of the patient;
• Severe allergic conditions of unclear etiology.

Use in Pregnancy and Lactation

Data on the efficacy and safety of Rheogluman during pregnancy and lactation have not been provided.

Use in Renal Impairment

Contraindicated in severe renal failure accompanied by anuria.

Special Precautions

When using Rheogluman, a biological test is mandatory: after slow intravenous administration of the first 5 drops of the drug, the infusion is stopped for 3 minutes, then another 30 drops are administered and the infusion is stopped again for 3 minutes. If there is no reaction, the drug administration is continued.

In case of allergic reactions or complications, the infusion should be stopped immediately and, without removing the needle from the vein, symptomatic medications used in the treatment of anaphylactic shock (antihistamines, corticosteroids, vasoconstrictors and other drugs) should be administered.

To maintain water and electrolyte balance, it is advisable to administer solutions containing potassium and sodium together with Rheogluman.

Before administering Rheogluman, a visual inspection of the drug should be performed. The drug should be transparent, free from suspension, and the vial should not have cracks or broken seals.

Overdose

Data on overdose of Rheogluman have not been provided.

Drug Interactions

Pharmaceutical interaction

Rheogluman is compatible with other dextran preparations (polyglucin, rheopolyglucin) and crystalloid solutions.

Storage Conditions

The drug should be stored in a dry place at a temperature not exceeding 25°C (77°F). Freezing during transportation is allowed.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.