Neorondex (Solution) Instructions for Use

Marketing Authorization Holder

Mistletoe LLC (Russia)

Manufactured By

Belmedpreparaty RUP (Republic of Belarus)

ATC Code

B05AA05 (Dextran)

Active Substance

Dextran (Rec.INN registered by WHO)

Dosage Form

Neorondex

Infusion solution 60 mg/ml: bot. 400 ml 1 or 24 pcs.

Dosage Form, Packaging, and Composition

Infusion solution transparent, light yellow or yellow in color.

Excipients: sodium chloride 9 mg.

400 ml – bottles (1) – cardboard packs.
400 ml – bottles (24) – cardboard boxes.

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Solutions of high molecular weight dextran with sodium chloride, glucose, or mannitol are multifunctional plasma-substituting solutions.

They normalize hemodynamics and increase the volume of fluid in the bloodstream. Solutions of low molecular weight dextran, in addition, promote improvement of microcirculation, reduce the aggregation of blood cells, and blood viscosity.

Dextran solutions containing mannitol also exert an osmotic diuretic effect, which promotes the elimination of poisons, toxins, and metabolic products.

The pronounced volemic effect positively affects hemodynamics and is simultaneously accompanied by the washing out of metabolic products from tissues, which, together with increased diuresis, ensures accelerated detoxification of the body.

Pharmacokinetics

T_1/2 – 6 h. It is excreted by the kidneys, 60% within 6 h (up to 70% during the first day), a small part is excreted by the gastrointestinal tract within 24 hours.

30% enters the reticuloendothelial system, the liver, where it is broken down by the enzyme acid alpha-glucosidase into glucose, however, it is not a source of carbohydrates.

Indications

Solutions of high molecular weight dextran: pronounced post-hemorrhagic hypovolemia, hypovolemic shock due to trauma, blood loss during childbirth, as a result of ectopic pregnancy, etc. Hypovolemia due to plasma loss (burns, crush syndrome). Preoperative and postoperative prevention of embolism.

Solutions of low molecular weight dextran: microcirculation disorders, traumatic shock, burn shock, crush syndrome. Septic shock. Replacement of plasma volume in blood loss in pediatrics. For priming cardiopulmonary bypass machines (in certain proportions with blood).

Dextran with a molecular weight of 1000: prevention of severe allergic reactions to intravenous administration of dextran solutions.

Dextran is also used in ophthalmic practice.

ICD codes

Dosage Regimen

Intravenously by bolus, bolus-drip, and drip infusion, as well as by electrophoresis (in ophthalmology). The dosage regimen is established individually, depending on the indications and clinical situation.

Solutions of high molecular weight dextran are administered intravenously at a rate of 60-80 drops/min in an amount of up to 2-2.5 L (with significant blood loss – with additional blood transfusion).

Solutions of low molecular weight dextran, when used as a blood substitute, are usually administered in the same doses. In other cases, the daily dose should not exceed 20 ml/kg. The rate of intravenous infusion is determined by the indications and severity of the patient’s condition.

Dextran with a molecular weight of 1000 is administered intravenously as a bolus to adults at a dose of 3 g (20 ml), to children – at a dose of 45 mg/kg (0.3 ml/kg) – 1-2 min before intravenous infusion of dextran solution. The interval between the administration of dextran with a molecular weight of 1000 and the infusion of dextran solution should not exceed 15 min. If more than 15 min have passed, then Dextran with a molecular weight of 1000 should be administered again. It can be administered before each infusion of dextran solution, especially if more than 48 hours have passed since the previous infusion.

Adverse Reactions

Possible allergic reactions, fever, chills, pyrexia, nausea.

Rarely arterial hypotension.

Contraindications

Head injuries with increased intracranial pressure, cerebral hemorrhage and other cases where the administration of large amounts of fluid is not indicated. Oliguria and anuria due to organic kidney disease, heart failure, coagulation and hemostasis disorders, tendency to allergic reactions. For solutions with glucose – diabetes mellitus and other carbohydrate metabolism disorders.

In ophthalmic practice: electrophoresis is contraindicated in cases of skin maceration of the eyelids.

Use in Renal Impairment

Contraindicated in oliguria and anuria due to organic kidney disease.

Pediatric Use

Can be used in children according to indications in recommended doses and dosage forms appropriate for body weight.

Special Precautions

Due to possible allergic reactions, it is recommended to administer the first 10-20 ml of the infusion solution slowly, monitoring the patient’s condition. Considering the possibility of arterial hypertension development, it should be borne in mind that appropriate intensive care means may be required.

Dextran with a molecular weight of 1000 should not be diluted or mixed with dextran solutions for infusion. Dextran with a molecular weight of 1000 can be administered intravenously through a Y-connector or the rubber tube of the infusion system, provided that significant dilution does not occur during the injection.

When using dextran, monitoring of hematocrit is necessary; do not allow the hematocrit to fall below 25-30%. It may interfere with blood group determination.

Dextran causes an increase in diuresis (if a decrease in diuresis with the excretion of viscous, syrup-like urine is observed, this may indicate dehydration; in this case, it is necessary to administer intravenous colloid solutions to replenish and maintain water-electrolyte balance). In patients with reduced renal filtration capacity, the administration of sodium chloride should be limited.

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.