Reopolyglucin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT REOPOLYGUCIN (Reopolyglucin)

Composition:

Active substances: dextran 40 for injections, sodium chloride;

100 ml of solution contain: dextran 40 for injections – 10 g, sodium chloride – 0.9 g;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid; theoretical osmolarity – approximately 311 mosmole/L; pH 4–6.5.

Pharmacotherapeutic group. Blood substitutes and perfusion solutions. Dextran.

ATC code B05A A05.

Pharmacological properties.

Pharmacodynamics. Reopolyglucin is a plasma-substituting colloid solution of dextran (a glucose polymer), whose pharmacological effects are manifested in improving the rheological properties of blood, reducing its viscosity, restoring microcirculatory blood flow, preventing and eliminating aggregation of blood cells, and normalizing arterial and venous circulation. With rapid administration of Reopolyglucin, plasma volume may increase by nearly twice the volume of the infused solution, as every 10 mL of the drug promotes redistribution of 20–25 mL of fluid from tissues into the bloodstream.

Pharmacokinetics. The half-life is 6 hours. The drug is primarily excreted by the kidneys: approximately 60% within the first 6 hours and 70% within 24 hours. The remaining amount enters the reticuloendothelial system and the liver, where it is gradually broken down by alpha-glucosidase into glucose; however, it does not serve as a source of carbohydrate nutrition.

Clinical characteristics.

Indications. Prevention and treatment of hypovolemic, distributive shock.

Vascular and reconstructive transplant surgeries.

Additive to perfusion fluid in cardiopulmonary bypass machines during cardiac surgeries.

Contraindications. Hyperhydration, hypervolemia, thrombocytopenia (platelet count 80 × 10⁹/L and below), kidney diseases accompanied by oliguria, anuria, decompensated cardiovascular insufficiency stage II–III, disseminated intravascular coagulation syndrome (DIC syndrome), predisposition to severe allergic reactions, hypersensitivity to dextran. Reopolyglucin with 0.9% sodium chloride solution should not be administered in case of pathological kidney changes, and with 5% glucose solution — in case of carbohydrate metabolism disorders, especially in diabetes mellitus.

Conditions where fluid administration in large volumes is contraindicated.

Interaction with other medicinal products and other types of interactions. When used concomitantly with anticoagulants, their doses should be reduced. The presence of dextran in blood may affect test results for bilirubin, protein, and blood group determination. Therefore, these tests should be performed before administration of the medicinal product.

Special precautions for use.

Use only under medical supervision. After slowly administering the first 10 drops, stop administration for 3–5 minutes, then administer another 30 drops and again pause for 3–5 minutes. If no allergic reactions occur, continue administration of the drug.

Use with caution in patients with impaired renal excretory function. When sodium chloride restriction is required, administer Reopoliglyukin with 5% glucose solution. In cases of carbohydrate metabolism disorders or other conditions where carbohydrate administration is contraindicated, Reopoliglyukin should be administered with 0.9% sodium chloride solution. Use with caution in patients with hypertension due to the possible increase in arterial pressure, and in patients with impaired cardiac function.

The contents of a bottle should be used for only one patient. After the seal has been broken, any unused portion of the bottle's contents must be discarded.

Use during pregnancy or breastfeeding. The medicinal product should be used only for life-threatening indications and based on risk/benefit assessment.

Ability to influence reaction rate when driving or operating machinery. Has not been studied, but possible adverse effects such as general weakness and dizziness should be taken into account.

Administration and Dosage

Administer intravenously by drip infusion. Warm the solution to 35–37 °C prior to administration. The dosage and rate of infusion should be determined individually. In cases of impaired capillary circulation (various forms of shock), the maximum daily dose for adults is 20 ml/kg; for children, it is 5–10 ml/kg (if necessary, up to 15 ml/kg).

During surgeries involving cardiopulmonary bypass, add to blood at a rate of 10–20 ml/kg to fill the oxygenator pump; the dextran concentration in the perfusion solution must not exceed 3%. In the postoperative period, administer the medicinal product in the same doses as used for impaired capillary circulation.

The medicinal product must be administered without mixing with other drugs. In life-threatening situations, the agent may be administered rapidly, even by bolus injection, at a dose of 15 ml/kg. For patients with hemorrhagic stroke or traumatic brain injury, administer at a dose of 10–15 ml/kg and not more.

Children. The medicinal product may be used in children; dosage should be calculated according to body weight.

Overdose. Hyperhydration and hypocoagulation may occur. Treatment is symptomatic.

Adverse Reactions.

Allergic reactions: anaphylactic shock, angioneurotic edema, rash, itching, sensation of warmth, fever, increased sweating, hypersensitivity reactions.

Cardiovascular system: fluctuations in arterial pressure, tachycardia, dyspnea, edema.

Gastrointestinal tract: nausea, vomiting, dry mouth, abdominal pain.

Nervous system: headache, dizziness, tremor.

Urinary system: usually, especially in hypovolemia, the drug causes an increase in diuresis. However, sometimes when Reopolyglucin is administered, a decrease in diuresis is observed and urine becomes viscous, indicating patient dehydration. In such cases, intravenous administration of crystalloid solutions is necessary to restore and maintain plasma osmolarity.

When the drug is administered at doses exceeding 15 mL/kg, hyperosmolarity may occur, which can lead to renal tubular necrosis and subsequent development of acute renal failure. Accordingly, a decrease in diuresis and viscous urine are observed.

Blood system: acrocyanosis, hyperemia, impaired platelet function. The drug complicates blood group determination.

Other: general weakness, limb edema, back pain, retrosternal pain, sensation of air shortage, seizures.

In case of adverse reactions (depending on the clinical situation), infusion of the drug should be stopped immediately, and without removing the needle from the vein, all emergency measures indicated in relevant guidelines for managing transfusion reactions should be initiated (administration of cardiovascular drugs, corticosteroids, antihistamines, crystalloid solutions; vasopressors and cardiotonics in case of collapse).

Shelf life. 4 years.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Incompatibility. Due to possible physicochemical incompatibility, no other medicinal products should be added to the Reopolyglucin solution.

Packaging. 200 mL, 250 mL, 400 mL, or 500 mL in bottles.

Prescription status. Prescription only.

Manufacturer. Private Joint-Stock Company "Infuziya".

Manufacturer's location and address of business activity.

Ukraine, 23219, Vinnytsia region, Vinnytsia district, village Vinnytski Khutory, Nemirivske Highway, 84A.

INSTRUCTION

for medical use of the medicinal product

REOPOLYGUCIN

(Reopolyglucin)

Composition:

Active substances: dextran 40 for injection, sodium chloride;

100 mL of solution contains: dextran 40 for injection — 10 g, sodium chloride — 0.9 g;

Excipients: water for injection.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid; theoretical osmolarity — approximately 311 mOsmol/L; pH 4–6.5.

Pharmacotherapeutic group. Blood substitutes and perfusion solutions. Dextran.

ATC code B05AA05.

Pharmacological properties.

Pharmacodynamics. Plasma substitute colloid solution of dextran (a glucose polymer), whose pharmacological action is manifested in improving blood rheological properties, reducing blood viscosity, restoring microcirculatory blood flow, preventing and eliminating aggregation of blood cells, and normalizing arterial and venous circulation. When Reopolyglucin is administered rapidly, plasma volume may increase by nearly twice the volume of the infused drug, as every 10 mL of the drug promotes redistribution of 20–25 mL of fluid from tissues into the bloodstream.

Pharmacokinetics. Elimination half-life is 6 hours. Mainly excreted by the kidneys: about 60% within the first 6 hours, 70% within 24 hours. The remainder enters the reticuloendothelial system and liver, where it is gradually broken down by alpha-glucosidase into glucose, although it does not serve as a source of carbohydrate nutrition.

Clinical characteristics.

Indications. Prevention and treatment of hypovolemic and distributive shock.

Vascular and plastic transplant surgeries.

Supplement to perfusion fluid in cardiopulmonary bypass machines during cardiac surgery.

Contraindications. Hyperhydration, hypervolemia, thrombocytopenia (platelet count ≤ 80 × 10⁹/L), kidney diseases associated with oliguria or anuria, uncompensated cardiovascular insufficiency stages II–III, disseminated intravascular coagulation (DIC) syndrome, predisposition to severe allergic reactions, hypersensitivity to dextran. Reopolyglucin with 0.9% sodium chloride solution should not be administered in case of pathological kidney changes, and with 5% glucose solution — in case of carbohydrate metabolism disorders, especially in diabetes mellitus.

Conditions where large-volume fluid administration is contraindicated.

Interaction with other medicinal products and other types of interactions.

Dosages of anticoagulants should be reduced when used concomitantly. The presence of dextran in blood may affect test results for bilirubin, protein, and blood group determination. Therefore, these tests should be performed before drug administration.

Special precautions. Use only under physician supervision. After slowly infusing the first 10 drops, stop infusion for 3–5 minutes, then infuse another 30 drops and again stop for 3–5 minutes. If no allergic reactions occur, continue drug infusion.

Use with caution in patients with impaired renal excretory function. In cases where sodium chloride administration needs to be limited, Reopolyglucin with 5% glucose solution should be used. In carbohydrate metabolism disorders and other conditions where carbohydrate administration is contraindicated, Reopolyglucin should be used with 0.9% sodium chloride solution. Use with caution in patients with hypertension due to possible increase in arterial pressure, and in patients with impaired cardiac function.

The contents of a bottle should be used for a single patient only. Any unused portion after opening must be discarded.

Use during pregnancy or breastfeeding. The drug may be used only when life-saving and based on risk/benefit assessment.

Effect on ability to drive or operate machinery. Not studied; the possibility of adverse effects such as general weakness and dizziness should be taken into account.

Administration and dosage. Administer intravenously by drip infusion. Warm the solution to 35–37 °C before administration. Dosage and infusion rate should be determined individually.

In impaired capillary circulation (various forms of shock), the maximum daily dose is 20 mL/kg for adults and 5–10 mL/kg for children (up to 15 mL/kg if necessary).

During surgeries with cardiopulmonary bypass, add to blood at a dose of 10–20 mL/kg to fill the oxygenator pump; the dextran concentration in the perfusion solution should not exceed 3%. In the postoperative period, the drug should be administered at the same doses as in impaired capillary circulation.

The drug should be administered without mixing with other medicinal products. In life-threatening situations, the drug may be administered rapidly, even by bolus infusion, at a dose of up to 15 mL/kg. In patients with hemorrhagic stroke or traumatic brain injury, the dose should not exceed 10–15 mL/kg.

Children. The drug may be used in children; dosage should be based on body weight.

Overdose. Hypervolemia and hypocoagulation may occur. Treatment is symptomatic.

Adverse reactions.

Allergic reactions: anaphylactic shock, angioneurotic edema, rash, itching, sensation of warmth, fever, increased sweating, hypersensitivity reactions.

Cardiovascular system: fluctuations in arterial pressure, tachycardia, dyspnea, edema.

Gastrointestinal tract: nausea, vomiting, dry mouth, abdominal pain.

Nervous system: headache, dizziness, tremor.

Urinary system: usually, especially in hypovolemia, the drug causes increased diuresis. However, sometimes during Reopolyglucin administration, decreased diuresis and viscous urine may occur, indicating patient dehydration. In such cases, intravenous crystalloid solutions should be administered to restore and maintain blood plasma osmolarity.

When the drug is administered at doses exceeding 15 mL/kg, hyperosmolarity may develop, potentially causing renal tubular necrosis and subsequent acute renal failure. Accordingly, decreased diuresis and viscous urine are observed.

Blood system: acrocyanosis, hyperemia, impaired platelet function. The drug complicates blood group determination.

Other: general weakness, limb edema, back pain, retrosternal pain, sensation of air shortage, seizures.

In case of adverse reactions (depending on clinical situation), infusion should be stopped immediately, and without removing the needle from the vein, all emergency measures specified in relevant guidelines for managing transfusion reactions should be initiated (administration of cardiovascular drugs, corticosteroids, antihistamines, crystalloid solutions; vasopressors and cardiotonics in case of collapse).

Shelf life. 4 years.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Incompatibility. Due to possible physicochemical incompatibility, no other medicinal products should be added to the Reopolyglucin solution.

Packaging. 200 mL, 250 mL, 400 mL, or 500 mL in bottles.

Prescription status. Prescription only.

Manufacturer. Private Joint-Stock Company "Infuziya".

Manufacturer's location and address of business activity.

Ukraine, 23219, Vinnytsia region, Vinnytsia district, village Vinnytski Khutory, Nemirivske Highway, 84A.