Hesol^®-SOLOpharm (Solution) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

B05BB01 (Electrolytes)

Active Substances

Sodium chloride (Ph.Eur.)

Potassium chloride (Ph.Eur.)

Sodium acetate (BP)

Dosage Form

Hesol^®-SOLOpharm

Solution for infusion 4.75 g+3.6 g+1.5 g/1 L: bottle 100 ml, 200 ml, 250 ml, 400 ml, 500 ml or 1000 ml

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

	1 L
Sodium chloride	4.75 g
Sodium acetate trihydrate	3.6 g
Potassium chloride	1.5 g
Ionic composition: Na⁺ 107.7 mmol/L Cl^– 101.4 mmol/L CH₃COO^– 26.5 mmol/L K⁺ 20.1 mmol Theoretical osmolarity 256 mOsm/L

Excipients : water for injections – up to 1 L.

100 ml – polypropylene bottles (1) – cardboard boxes.
200 ml – polypropylene bottles (1) – cardboard boxes.
250 ml – polypropylene bottles (1) – cardboard boxes.
400 ml – polypropylene bottles (1) – cardboard boxes.
500 ml – polypropylene bottles (1) – cardboard boxes.
1000 ml – polypropylene bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Rehydrating agent

Pharmacological Action

A combined medicinal product. It has detoxifying, plasma-substituting, rehydrating, diuretic, anti-shock, and antiplatelet effects.

It reduces hypovolemia, prevents blood thickening and the development of metabolic acidosis, enhances diuresis, and improves microcirculation.

Pharmacokinetics

K⁺ and Na⁺ ions are not retained in the vascular bed for long and are quickly distributed throughout all body tissues.

They are excreted primarily by the kidneys, and in small amounts through the intestines, sweat, and tears.

In the body, acetate is activated into acetyl-coenzyme A (acetyl-CoA).

The main amount of active acetate is then completely oxidized in the Krebs cycle to carbon dioxide and water.

The process of acetate oxidation occurs in muscle cells, so the body’s ability to metabolize it mainly depends on muscle mass.

Acetyl-CoA metabolism can also proceed via the minor oxidation pathway with the formation of fatty acids, keto acids, and cholesterol.

Indications

Dehydration; intoxication (dysentery, food toxicoinfection, cholera El Tor).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A00	Cholera
A03	Shigellosis
A05	Other bacterial food poisonings, not elsewhere classified
A09	Other and unspecified gastroenteritis and colitis of infectious origin
E86	Volume depletion (including dehydration, hypovolemia)
R54	Acute intoxication

ICD-11 code	Indication
1A00	Cholera
1A02	Intestinal infections due to Shigella
1A1Z	Bacterial foodborne intoxications, unspecified
1A40.Z	Infectious gastroenteritis or colitis, unspecified
5C70.Z	Decrease of volume of fluid [hypovolemia], unspecified
MG2A	Frailty syndrome

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.

Administer intravenously only.

For severe dehydration and intoxication, administer by intravenous bolus over 1 to 3 hours.

For mild forms, administer by intravenous drip at a rate of 40 to 120 drops per minute over 24 to 48 hours.

Determine the total infusion volume individually based on the patient’s clinical condition and fluid losses.

Select the volume necessary to correct hypovolemia and restore water-electrolyte balance.

Adjust the dosage and infusion rate according to the patient’s age, body weight, and severity of electrolyte disturbances.

Continuously monitor hematocrit, serum electrolyte concentrations (especially potassium), and clinical signs of hydration during therapy.

Discontinue the infusion immediately if signs of hyperkalemia develop.

Warm the solution to approximately body temperature (37°C/98.6°F) prior to administration.

Use only if the solution is clear, colorless, and the container is undamaged.

Do not administer in series with other potassium-containing solutions.

Adverse Reactions

Systemic reactions edema, tachycardia, chills, hyperkalemia.

Contraindications

Hypersensitivity; hyperkalemia; alkalosis; chronic renal failure; presence of contraindications to the introduction of a large amount of fluid into the body.

Use in Pregnancy and Lactation

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding should be avoided during use due to the lack of relevant clinical data.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Special Precautions

The solution must be warmed to body temperature before use.

Treatment should be carried out under the control of hematocrit and blood electrolyte concentrations.

In case of hyperkalemia development, the drug containing this combination should be replaced with a drug containing the combination of sodium acetate + Sodium chloride until the electrolyte balance normalizes.

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