Dinadex (Solution) Instructions for Use

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

ATC Code

B05AA05 (Dextran)

Active Substance

Dextran (Rec.INN registered by WHO)

Dosage Form

Dinadex

Solution for infusion 10%: bottles 100 ml, 200 ml, 250 ml, 400 ml, or 500 ml

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a transparent colorless or slightly yellowish liquid.

Excipients: sodium chloride – 9 g, water for injections – up to 1 L.

100 ml – polyethylene bottles (1) – cardboard packs.
200 ml – polyethylene bottles (1) – cardboard packs.
250 ml – polyethylene bottles (1) – cardboard packs.
400 ml – polyethylene bottles (1) – cardboard packs.
500 ml – polyethylene bottles (1) – cardboard packs.

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, contribute to the improvement of microcirculation, reduce the aggregation of blood formed elements and blood viscosity.

Dextran solutions containing mannitol also have 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 an increase in diuresis, ensures accelerated detoxification of the body.

Pharmacokinetics

T_1/2 is 6 hours.

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

30% enters the reticuloendothelial system and liver, where it is broken down by the enzyme acid alpha-glucosidase into glucose, but 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 case of blood loss in pediatrics. For filling cardiopulmonary bypass machines (in certain proportions with blood).

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

Dextran is also used in ophthalmic practice.

ICD codes

Dosage Regimen

Intravenously by bolus, bolus-drip, and drip, 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 the 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 minutes before the intravenous infusion of the dextran solution.

The interval between the administration of dextran with a molecular weight of 1000 and the infusion of the dextran solution should not exceed 15 minutes.

If more than 15 minutes have passed, then Dextran with a molecular weight of 1000 should be administered again.

It can be administered before each infusion of the dextran solution, especially if more than 48 hours have passed since the previous infusion.

Adverse Reactions

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

Rarely arterial hypotension.

Contraindications

Head injuries with increased intracranial pressure, cerebral hemorrhage and other cases where the administration of a large amount 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 case of maceration of the skin 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 developing arterial hypertension, 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 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 release 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 15°C (59°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.