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Chlosol (Solution) Instructions for Use

ATC Code

B05BB01 (Electrolytes)

Active Substances

Sodium chloride (Ph.Eur.)

Potassium chloride (Ph.Eur.)

Sodium acetate (BP)

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Rehydrating agent

Pharmacological Action

A combined drug. 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 to 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 body muscle mass. The metabolism of acetyl-CoA can also proceed via a minor oxidation pathway with the formation of fatty acids, keto acids, and cholesterol.

Indications

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

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.

Determine the infusion rate and total volume based on the severity of dehydration and the patient’s clinical condition.

For severe forms of disease, administer as an intravenous bolus over 1 to 3 hours.

For mild to moderate forms, administer as an intravenous drip infusion at a rate of 40 to 120 drops per minute.

Continue the drip infusion for a duration of 24 to 48 hours as required.

Calculate the total infusion volume to correct the existing fluid deficit and maintain adequate water-electrolyte balance.

Adjust the dosage based on the patient’s body weight, serum electrolyte levels, and hematocrit values.

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

Monitor cardiovascular status and renal function continuously during therapy.

Discontinue the potassium-containing formulation immediately upon signs of hyperkalemia.

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

Before use, the solution must be warmed to body temperature. Treatment is carried out under the control of hematocrit and blood electrolyte concentration.

In case of hyperkalemia development, the drug containing this combination is 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

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

Marketing Authorization Holder

Nesvizh Medical Products Plant OJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Chlosol Infusion solution 4.75 g+1.5 g+3.6 g/1 L: fl. 200 ml, 400 ml

Dosage Form, Packaging, and Composition

Infusion solution 1 L
Sodium chloride 4.75 g
Potassium chloride 1.5 g
Sodium acetate trihydrate 3.6 g

200 ml – blood substitute bottles (40) – cardboard boxes.
400 ml – blood substitute bottles (24) – cardboard boxes.
400 ml – blood substitute bottles.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Dosage Form

Bottle Rx Icon Chlosol Infusion solution 4.75 g+1.5 g+3.6 g/1 L: fl. 200 ml 1, 24, or 28 pcs., 400 ml 1, 12, or 15 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 1 L
Sodium chloride 4.75 g
Potassium chloride 1.5 g
Sodium acetate trihydrate 3.6 g

200 ml – blood substitute bottles (1) – cardboard packs.
400 ml – blood substitute bottles (1) – cardboard packs.
200 ml – blood and blood substitute bottles (for hospitals).
400 ml – blood and blood substitute bottles (for hospitals).
200 ml – blood and blood substitute bottles (28) (for hospitals) – cardboard boxes.
400 ml – blood and blood substitute bottles (15) (for hospitals) – cardboard boxes.
200 ml – blood substitute bottles (24) – cardboard boxes.
200 ml – blood substitute bottles (28) – cardboard boxes.
400 ml – blood substitute bottles (12) – cardboard boxes.
400 ml – blood substitute bottles (15) – cardboard boxes.

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