Rheosorbilact^® (Solution) Instructions for Use

Marketing Authorization Holder

YURIA-PHARM, LLC (Ukraine)

Contact Information

YURIA-PHARM LLC (Ukraine)

ATC Code

B05XA31 (Electrolytes in combination with other drugs)

Dosage Form

Rheosorbilact®

Solution for infusion: fl. 200 ml or 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

Excipients : water for injections.

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

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Plasma-substituting drug. It has rheological, anti-shock, detoxifying, and alkalizing effects. The main pharmacologically active substances are Sorbitol and Sodium lactate. In the liver, Sorbitol is first converted to fructose, which is then converted to glucose, and then to glycogen. Part of the sorbitol is used for urgent energy needs, another part is stored as a reserve in the form of glycogen. An isotonic solution of sorbitol has an antiplatelet effect and thus improves microcirculation and tissue perfusion.

Unlike a bicarbonate solution, the correction of metabolic acidosis with sodium lactate occurs more slowly as it is included in the metabolism, without causing sharp fluctuations in pH. The effect of sodium lactate appears 20-30 minutes after administration.

Sodium chloride is a plasma-substituting agent that exhibits detoxifying and rehydrating effects. It eliminates the deficiency of sodium and chloride ions in various pathological conditions.

Calcium chloride eliminates the deficiency of calcium ions. Calcium ions are necessary for the process of nerve impulse transmission, contraction of skeletal and smooth muscles, myocardial activity, bone tissue formation, and blood clotting. It reduces the permeability of cells and the vascular wall, prevents the development of inflammatory reactions, increases the body’s resistance to infections, and can significantly enhance phagocytosis.

Potassium chloride restores the water-electrolyte balance. It exhibits negative chronotropic and bathmotropic effects, in high doses – negative inotropic, dromotropic and moderate diuretic effects. It takes part in the process of nerve impulse conduction. It increases the content of acetylcholine and causes excitation of the sympathetic part of the autonomic nervous system. It improves the process of contraction of skeletal muscles in muscular dystrophy, myasthenia.

Pharmacokinetics

Sorbitol is quickly included in the general metabolism, 80-90% of which is utilized in the liver and accumulates in the form of glycogen. 5% is deposited in the tissues of the brain, heart muscle and skeletal muscles. 6-12% is excreted in the urine.

When introduced into the vascular bed, Sodium lactate interacts with carbon dioxide and water, forming sodium bicarbonate, which leads to an increase in the alkaline reserve of the blood. Only half of the administered sodium lactate (L-isomer) is considered active, and the other half (D-isomer) is not metabolized and is excreted in the urine.

Sodium chloride is quickly excreted from the vascular bed, only temporarily increasing the circulating blood volume. It enhances diuresis.

Indications

• To improve capillary blood flow for the prevention and treatment of traumatic, surgical, hemolytic, toxic and burn shock, in acute blood loss, burn disease;
• Infectious diseases accompanied by intoxication, exacerbation of chronic hepatitis;
• Sepsis;
• For preoperative preparation and in the postoperative period;
• To improve arterial and venous circulation for the prevention and treatment of thrombosis, thrombophlebitis, endarteritis;
• Raynaud’s disease.

ICD codes

Dosage Regimen

Rheosorbilact^® is administered to adults intravenously by bolus or drip.

For traumatic, burn, postoperative and hemolytic shock – 600-1000 ml (10-15 ml/kg body weight) once and repeatedly, first by bolus, then – by drip.

For chronic hepatitis – 400 ml (6-7 ml/kg body weight) by drip, repeatedly.

For acute blood loss – 1500-1800 ml (up to 25 ml/kg body weight). In this case, it is recommended to carry out infusions of the drug Rheosorbilact^® at the prehospital stage, in a specialized ambulance.

In the preoperative period and after various surgical interventions – in a dose of 400 ml (6-7 ml/kg body weight) by drip, once or repeatedly, daily, for 3-5 days.

For thrombo-obliterating diseases of blood vessels – at the rate of 8-10 ml/kg body weight, by drip, repeatedly, every other day. The course of treatment is up to 10 infusions.

For children under 6 years of age, administration of the drug is recommended at a dose of 10 ml/kg body weight; for children aged 6 to 12 years – at a dose that is half the adult dose; for children over 12 years of age, the dose of the drug is the same as for adults.

Adverse Reactions

Possible alkalosis, allergic reactions (skin rash, itching).

Contraindications

• Alkalosis;
• In cases where the infusion of large volumes of fluid is contraindicated (cerebral hemorrhage, thromboembolism, cardiovascular decompensation, stage III arterial hypertension);
• Hypersensitivity to the components of the drug.

With caution the drug should be prescribed to patients with impaired liver function, peptic ulcer disease, hemorrhagic colitis.

Use in Pregnancy and Lactation

Data on the use of the drug Rheosorbilact^® during pregnancy and breastfeeding are not available.

Use in Hepatic Impairment

With caution the drug should be prescribed to patients with impaired liver function.

Pediatric Use

For children under 6 years of age, administration of the drug is recommended at a dose of 10 ml/kg body weight; for children aged 6 to 12 years – at a dose that is half the adult dose; for children over 12 years of age, the dose of the drug is the same as for adults.

Special Precautions

The drug is used under the control of acid-base status and blood electrolyte parameters, as well as the functional state of the liver.

Use with caution in patients with calculous cholecystitis.

Overdose

Symptoms phenomena of alkalosis occur, which quickly disappear on their own provided that the administration of the drug is immediately stopped.

Drug Interactions

Rheosorbilact^® should not be mixed with phosphate- and carbonate-containing solutions.

It is not used as a carrier solution for other drugs.

Storage Conditions

List B. The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature from 2°C (35.6°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 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.