Sodium chloride

INSTRUCTION for medical use of the medicinal product Sodium chloride (Sodium chloride)

Composition:

Active substance: sodium chloride;

1 ml of solution contains sodium chloride 50 mg;

Excipients: water for injections, sodium hydroxide, hydrochloric acid concentrated.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: colorless clear liquid.

Ion content per 1 l of the product: Na+ — 855.57 mmol/l, Cl– — 855.57 mmol/l.

Theoretical osmolarity — 1710 mosmol/l, pH — from 4.5 to 7.0.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Electrolyte solutions. ATC code B05XA03.

Pharmacological properties.

Pharmacodynamics.

A 5% solution of sodium chloride normalizes the water and electrolyte balance and eliminates electrolyte and fluid deficits in the human body, inducing diuresis depending on the patient's clinical condition. Sodium is the principal cation of the extracellular space, primarily controlling water distribution, fluid balance, and osmotic pressure in body fluids. The association of sodium ions with chloride and bicarbonate ions regulates the acid-base balance of body fluids. Chloride is the main anion of the extracellular space; it is closely linked to sodium metabolism and influences the body's acid-base balance in response to changes in chloride concentration.

Pharmacokinetics.

Rapidly excreted by the kidneys in unchanged form, although a large amount of sodium undergoes reabsorption. A small amount of sodium is lost in feces and through sweating.

Clinical characteristics.

Indications.

For the replenishment of fluid and electrolyte deficits in the body.

A 5 % sodium chloride solution may induce diuresis depending on the patient's clinical condition.

Contraindications.

Hypernatremia, hyperchloremia.

Acidosis.

Fluid retention.

Hyperhydration.

Special precautions.

This medicinal product is a hypertonic solution. Rapid administration of a hypertonic solution may lead to sudden cardiac arrest or circulatory overload.

Interaction with other medicinal products and other types of interactions.

The use of corticosteroids or steroids may lead to water, sodium and chloride retention in the body, resulting in edema and increased blood pressure.

When used concomitantly with lithium preparations, renal clearance of sodium and lithium may increase. Administration of sodium chloride may lead to decreased lithium levels.

Special precautions for use

Before administering the medicinal product, check the integrity of the infusion system packaging and the container. Under no circumstances should the container be reused for subsequent procedures.

Electrolyte levels in plasma and urine, as well as diuresis, should be monitored during prolonged administration or when the patient's condition requires such monitoring.

Exercise caution when administering to patients with hypervolemia, renal insufficiency, urinary tract obstruction, or in the presence of cardiac decompensation or risk of its development.

During prolonged nasogastric aspiration, vomiting, diarrhea, or drainage of gastrointestinal fistulas, unpredictable electrolyte losses may occur, which may require additional administration of other electrolyte solutions, vitamins, and minerals.

Solutions containing sodium should be administered with caution to patients receiving corticosteroids or corticotropin, and to other patients with salt retention.

Use with caution in patients with renal or cardiovascular insufficiency, with congestive heart failure or at risk of its development, especially in elderly patients or postoperative patients.

Excessive administration of hypertonic sodium chloride solutions may increase serum concentrations of sodium and chloride, leading to hypernatremia. Excessive chloride administration may cause bicarbonate loss, resulting in acidifying effects.

Sodium chloride should be used with caution in patients taking lithium medications (see section "Interaction with other medicinal products and other forms of interaction").

Polymer containers should not be used in series connection.

If administration is performed using an infusion pump, care must be taken to stop infusion before the container is completely emptied in order to avoid air embolism. If an infusion pump is not used, avoid applying excessive pressure (> 300 mmHg), as this may cause container deformation (e.g., crushing or twisting) and lead to container damage.

Rapid correction of hyponatremia may cause osmotic demyelination of the pons, leading to the development of osmotic demyelination syndrome (central pontine myelinolysis). The possibility of very rapid administration of hypertonic solution should therefore be minimized.

Use during pregnancy or breastfeeding

Studies on the effects of 5% sodium chloride solution on reproductive function in animals have not been conducted. Administration to pregnant women should only occur if clearly necessary.

It is not known whether this medicinal product is excreted into breast milk. Caution should be exercised when administering 5% sodium chloride solution to breastfeeding women.

Ability to influence reaction rate when driving or operating machinery

No effect.

Method of Administration and Dosage

For intravenous infusion only.

The dosage depends on the patient's age, body weight, clinical condition, biochemical parameters, and concomitant therapy.

The infusion should be administered into a large vein through a fine needle to minimize the damaging effect of the drug on vessel walls. The solution must not be administered subcutaneously or intramuscularly due to its strong irritant properties.

Maximum single dose is 100 ml administered over 60 minutes. During administration, monitoring of fluid balance, plasma electrolyte concentrations, and pH is required.

Maximum daily dose is 400 ml.

Elderly Patients

When selecting the dosage for elderly patients, caution should be exercised, starting at the lower end of the dosing range, taking into account the higher likelihood of impaired hepatic, renal, or cardiac function, concomitant diseases, and concomitant drug therapy.

This drug is substantially excreted by the kidneys, and therefore the risk of toxic reactions is increased in patients with impaired renal function. Since elderly patients more frequently have decreased renal function, caution should be used in dose selection, and renal function should be monitored.

Children

Experience with use in children is lacking.

Overdose

Administration of excessive volumes of the drug may lead to:

• Hypernatremia, which may cause central and/or peripheral edema, manifested by symptoms such as seizures, coma, cerebral edema, and death;
• Hypokalemia, which may cause cardiac arrhythmias, cardiac arrest, acute confusional state, or death.

In case of overdose, administration of the drug must be discontinued, the patient's condition should be assessed, and appropriate treatment initiated.

Adverse reactions.

Adverse reactions may occur, including fever, changes at the injection site, thrombosis or phlebitis starting from the injection site, extravasation, and hypervolemia.

Too rapid administration of hypertonic solutions may cause local pain and venous irritation. The infusion rate should be individually adjusted according to patient tolerance. To reduce the irritant effect, it is recommended to use a small-diameter needle and administer the injection into the largest peripheral vein (see section "Dosage and administration").

Electrolyte metabolism disturbances may also occur; therefore, plasma and urine electrolyte levels as well as diuresis should be monitored.

If adverse reactions occur, administration of the solution should be discontinued, the patient's condition should be assessed, and symptomatic treatment should be initiated.

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 30 °C in the original packaging.

Keep out of reach of children.

Incompatibility.

Combinations with other medicinal products may be incompatible. Complete information is not available.

Packaging.

200 ml in bottles; 200 ml or 400 ml in polymer containers.

Prescription category. Prescription only.

Manufacturer. LLC "Yuria-Pharm".

Manufacturer's address and location of business activity.

108, Kozbirska St., Cherkasy, Cherkasy region, 18030, Ukraine.

Tel.: (044) 281-01-01.