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Rheodex 40 (Solution) Instructions for Use

ATC Code

B05AA05 (Dextran)

Active Substance

Dextran (Rec.INN registered by WHO)

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 aggregation of blood formed elements, and blood viscosity.

Dextran solutions containing mannitol also exert an osmotic diuretic action, 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 the increase in diuresis, ensures accelerated detoxification of the body.

Pharmacokinetics

T1/2 is 6 hours.

It is excreted by the kidneys, 60% within 6 hours (up to 70% during the first 24 hours), 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 case of blood loss in pediatrics. For priming extracorporeal circulation apparatus (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

ICD-10 code Indication
E86 Volume depletion (including dehydration, hypovolemia)
I26 Pulmonary embolism
I74 Embolism and thrombosis of arteries
I82 Embolism and thrombosis of other veins
O08.1 Delayed or excessive hemorrhage following abortion and ectopic and molar pregnancy
O67 Labor and delivery complicated by intrapartum hemorrhage, not elsewhere classified
R57.0 Cardiogenic shock
R57.1 Hypovolemic shock
R57.2 Septic shock
R57.8 Other types of shock
R58 Hemorrhage, not elsewhere classified
T78.2 Anaphylactic shock, unspecified
T78.3 Angioneurotic edema (Quincke's edema)
T79.4 Traumatic shock
T79.5 Traumatic anuria
ICD-11 code Indication
1G41 Sepsis with septic shock
4A84.30 Exercise-induced anaphylaxis
4A84.31 Cold-induced anaphylaxis
4A84.3Z Anaphylaxis caused by unspecified physical factors
4A84.4 Anaphylaxis caused by inhalation of allergens
4A84.5 Anaphylaxis caused by contact with allergens
4A84.6 Secondary anaphylaxis in mast cell disease
4A84.Z Anaphylaxis, unspecified
5C70.Z Decrease of volume of fluid [hypovolemia], unspecified
BB00.Z Thromboembolism in the pulmonary artery system, unspecified
BD5Z Diseases of arteries or arterioles, unspecified
BD70.2 Migratory thrombophlebitis
BD7Z Diseases of veins, unspecified
DB98.5 Budd-Chiari syndrome
EB04 Idiopathic angioedema
JA05.1 Delayed or excessive hemorrhage following abortion, ectopic or molar pregnancy
JA42.Z Other intrapartum haemorrhage, unspecified
MG27 Hemorrhage, not elsewhere classified
MG40.0 Cardiogenic shock
MG40.1 Hypovolemic shock
MG40.Z Shock, unspecified
NF0A.4 Traumatic shock, not elsewhere classified
NF0A.5 Traumatic anuria, not elsewhere classified
BD72 Venous thromboembolism
XA60H0 Vena cava

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

Intravenously by bolus, bolus-drip, and drip infusion, as well as by electrophoresis (in ophthalmology). The dosage regimen is set 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 liters (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 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 minutes. If more than 15 minutes have passed, 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 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 means for intensive therapy 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 no significant dilution occurs during the injection.

When using dextran, monitoring of hematocrit is necessary; do not allow the hematocrit to decrease 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 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Vilana Company, LLC (Russia)

Manufactured By

Yugrapharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Rheodex 40 Infusion solution 10%: vial or bottle 200, 250, 400 or 500 ml 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 100 ml
Dextran 10 g

200 ml – low-density polyethylene vials (1) – cardboard boxes.
250 ml – low-density polyethylene vials (1) – cardboard boxes.
400 ml – low-density polyethylene vials (1) – cardboard boxes.
500 ml – low-density polyethylene vials (1) – cardboard boxes.
200 ml – low-density polyethylene vials (10) – cardboard boxes.
250 ml – low-density polyethylene vials (10) – cardboard boxes.
400 ml – low-density polyethylene vials (10) – cardboard boxes.
500 ml – low-density polyethylene vials (10) – cardboard boxes.
200 ml – glass bottles with a capacity of 250 ml (1) – cardboard boxes.
250 ml – glass bottles with a capacity of 250 ml (1) – cardboard boxes.
400 ml – glass bottles (1) with a capacity of 500 ml – cardboard boxes.
500 ml – glass bottles (1) with a capacity of 500 ml – cardboard boxes.
200 ml – glass bottles with a capacity of 250 ml (10) – cardboard boxes.
250 ml – glass bottles with a capacity of 250 ml (10) – cardboard boxes.
400 ml – glass bottles (10) with a capacity of 500 ml – cardboard boxes.
500 ml – glass bottles (10) with a capacity of 500 ml – cardboard boxes.

Marketing Authorization Holder

Vilana Company, LLC (Russia)

Manufactured By

PFC Alium, LLC (Russia)

Dosage Form

Bottle Rx Icon Rheodex 40 Infusion solution 10%: vial or bottle 200, 250, 400 or 500 ml 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 100 ml
Dextran 10 g

200 ml – low-density polyethylene vials (1) – cardboard boxes.
250 ml – low-density polyethylene vials (1) – cardboard boxes.
400 ml – low-density polyethylene vials (1) – cardboard boxes.
500 ml – low-density polyethylene vials (1) – cardboard boxes.
200 ml – low-density polyethylene vials (10) – cardboard boxes.
250 ml – low-density polyethylene vials (10) – cardboard boxes.
400 ml – low-density polyethylene vials (10) – cardboard boxes.
500 ml – low-density polyethylene vials (10) – cardboard boxes.
200 ml – glass bottles with a capacity of 250 ml (1) – cardboard boxes.
250 ml – glass bottles with a capacity of 250 ml (1) – cardboard boxes.
400 ml – glass bottles (1) with a capacity of 500 ml – cardboard boxes.
500 ml – glass bottles (1) with a capacity of 500 ml – cardboard boxes.
200 ml – glass bottles with a capacity of 250 ml (10) – cardboard boxes.
250 ml – glass bottles with a capacity of 250 ml (10) – cardboard boxes.
400 ml – glass bottles (10) with a capacity of 500 ml – cardboard boxes.
500 ml – glass bottles (10) with a capacity of 500 ml – cardboard boxes.

Marketing Authorization Holder

Vilana Company, LLC (Russia)

Manufactured By

Yugrapharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Rheodex 60 Infusion solution 6%: bottle or vial 200, 250, 400 or 500 ml 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 100 ml
Dextran 6 g

200 ml – low-density polyethylene vials (1) – cardboard boxes.
250 ml – low-density polyethylene vials (1) – cardboard boxes.
400 ml – low-density polyethylene vials (1) – cardboard boxes.
500 ml – low-density polyethylene vials (1) – cardboard boxes.
200 ml – low-density polyethylene vials (10) – cardboard boxes.
250 ml – low-density polyethylene vials (10) – cardboard boxes.
400 ml – low-density polyethylene vials (10) – cardboard boxes.
500 ml – low-density polyethylene vials (10) – cardboard boxes.
200 ml – glass bottles with a capacity of 250 ml (1) – cardboard boxes.
250 ml – glass bottles with a capacity of 250 ml (1) – cardboard boxes.
400 ml – glass bottles (1) with a capacity of 500 ml – cardboard boxes.
500 ml – glass bottles (1) with a capacity of 500 ml – cardboard boxes.
200 ml – glass bottles with a capacity of 250 ml (10) – cardboard boxes.
250 ml – glass bottles with a capacity of 250 ml (10) – cardboard boxes.
400 ml – glass bottles (10) with a capacity of 500 ml – cardboard boxes.
500 ml – glass bottles (10) with a capacity of 500 ml – cardboard boxes.

Marketing Authorization Holder

Vilana Company, LLC (Russia)

Manufactured By

PFC Alium, LLC (Russia)

Dosage Form

Bottle Rx Icon Rheodex 60 Infusion solution 6%: bottle or vial 200, 250, 400 or 500 ml 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 100 ml
Dextran 6 g

200 ml – low-density polyethylene vials (1) – cardboard boxes.
250 ml – low-density polyethylene vials (1) – cardboard boxes.
400 ml – low-density polyethylene vials (1) – cardboard boxes.
500 ml – low-density polyethylene vials (1) – cardboard boxes.
200 ml – low-density polyethylene vials (10) – cardboard boxes.
250 ml – low-density polyethylene vials (10) – cardboard boxes.
400 ml – low-density polyethylene vials (10) – cardboard boxes.
500 ml – low-density polyethylene vials (10) – cardboard boxes.
200 ml – glass bottles with a capacity of 250 ml (1) – cardboard boxes.
250 ml – glass bottles with a capacity of 250 ml (1) – cardboard boxes.
400 ml – glass bottles (1) with a capacity of 500 ml – cardboard boxes.
500 ml – glass bottles (1) with a capacity of 500 ml – cardboard boxes.
200 ml – glass bottles with a capacity of 250 ml (10) – cardboard boxes.
250 ml – glass bottles with a capacity of 250 ml (10) – cardboard boxes.
400 ml – glass bottles (10) with a capacity of 500 ml – cardboard boxes.
500 ml – glass bottles (10) with a capacity of 500 ml – cardboard boxes.

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