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Sodium chlorid (Solution) Instructions for Use

ATC Code

B05BB01 (Electrolytes)

Active Substance

Sodium chloride (Ph.Eur.)

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; solutions for intravenous administration; solutions affecting water-electrolyte balance

Pharmacological Action

Sodium and chloride ions are the most important inorganic components of the extracellular fluid, maintaining the appropriate osmotic pressure of the blood plasma and extracellular fluid.

The isotonic solution replenishes the fluid deficit in the body during dehydration.

The hypertonic sodium chloride solution when administered intravenously provides correction of the osmotic pressure of the extracellular fluid and blood plasma.

When used locally in ophthalmology, Sodium chloride has an anti-edema effect.

Pharmacokinetics

Sodium ions penetrate the placental barrier and into breast milk.

It is excreted by the kidneys (potassium ions – in the distal tubules in exchange for sodium or hydrogen ions), a small amount is excreted with sweat.

Indications

Isotonic solution: dehydration of various origins. To maintain blood plasma volume during and after surgeries. As a solvent for various drugs.

Hypertonic solution: disorders of water-electrolyte metabolism – deficiency of sodium and chloride ions; hypoosmolar dehydration of various origins (due to prolonged vomiting, diarrhea, burns; with gastric fistula, pulmonary hemorrhage, intestinal hemorrhage).

ICD codes

ICD-10 code Indication
E86 Volume depletion (including dehydration, hypovolemia)
E87.1 Hypo-osmolality and hyponatremia
E87.8 Other disorders of electrolyte and fluid balance, not elsewhere classified
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
5C70.Z Decrease of volume of fluid [hypovolemia], unspecified
5C72 Hypo-osmolality or hyponatremia
5C7Y Other specified disorders of fluid, electrolyte or acid-base balance
QB9A Preparatory procedures for subsequent treatment

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.

Solution

Individual, depending on the indications, clinical situation, therapy regimen and the used dosage form.

The isotonic sodium chloride solution is administered intravenously, subcutaneously and in enemas, and is also used for washing wounds, eyes, and the nasal mucosa. Depending on the clinical situation, up to 3 L/day is administered intravenously.

The hypertonic sodium chloride solution is administered intravenously. A single dose for intravenous bolus administration can be 10-30 ml. For conditions requiring immediate replenishment of sodium and chloride ions, it is administered intravenously by drip at a dose of 100 ml.

Adverse Reactions

Possible nausea, vomiting, diarrhea, stomach cramps, thirst, lacrimation, sweating, fever, tachycardia, arterial hypertension, impaired renal function, edema, shortness of breath, headache, dizziness, anxiety, weakness, muscle twitching and hypertonia.

For external and local use, adverse reactions have not been established to date.

Contraindications

Hypersensitivity to sodium chloride; hypernatremia, states of hyperhydration, threat of pulmonary edema, brain edema.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it is possible to use according to indications in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Use in Renal Impairment

Large volumes of sodium chloride should be used with caution in patients with impaired renal excretory function.

Pediatric Use

It is possible to use in children according to indications in doses and dosage forms recommended according to age.

Special Precautions

Large volumes of sodium chloride should be used with caution in patients with impaired renal excretory function, with hypokalemia.

Administration of large amounts of the solution can lead to chloride acidosis, hyperhydration, increased excretion of potassium from the body.

The hypertonic solution is not used subcutaneously and intramuscularly.

With long-term use, control of electrolyte concentration in plasma and daily diuresis is necessary.

The temperature of the infusion solution should be 38°C (100.4°F).

Drug Interactions

NSAIDs, androgens, estrogens, anabolic hormones, corticotropin, mineralocorticoids, vasodilators, ganglion blockers lead to increased retention of Na+.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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

B.Braun Melsungen AG (Germany)

Dosage Form

Bottle Rx Icon Sodium chloride Braun Infusion solution 0.9%: bot. 100 ml, 500 ml or 1 L

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

100 ml – polyethylene bottles (10) – cardboard packs.
500 ml – polyethylene bottles (10) – cardboard packs.
1 L – polyethylene bottles (10) – cardboard packs.
100 ml – polyethylene bottles.
1 L – polyethylene bottles.
250 ml – polyethylene bottles.
500 ml – polyethylene bottles.
100 ml – polyethylene bottles (20) – cardboard boxes.

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

Manufactured By

B. Braun Medical, S.A. (Spain)

Dosage Form

Bottle Rx Icon Sodium chloride Braun Infusion solution 0.9%: bot. 100 ml, 250 ml, 500 ml or 1 L

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

100 ml – polyethylene bottles (10) – cardboard packs.
250 ml – polyethylene bottles (10) – cardboard packs.
500 ml – polyethylene bottles (10) – cardboard packs.
1 L – polyethylene bottles (10) – cardboard packs.
100 ml – polyethylene bottles.
1 L – polyethylene bottles.
250 ml – polyethylene bottles.
500 ml – polyethylene bottles.
100 ml – polyethylene bottles (20) – cardboard boxes.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Renewal Infusion solution 0.9%

Dosage Form, Packaging, and Composition

Solution for infusion

1 L
Sodium chloride 9 g

100 ml – bottles – cardboard packs – By prescription
100 ml – bottles (20 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (24 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (28 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (32 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (36 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (40 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (42 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (56 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (60 pcs.) – cardboard boxes – for hospitals
150 ml – bottles – cardboard packs – By prescription
150 ml – bottles (10 pcs.) – cardboard boxes – for hospitals
150 ml – bottles (15 pcs.) – cardboard boxes – for hospitals
150 ml – bottles (20 pcs.) – cardboard boxes – for hospitals
150 ml – bottles (24 pcs.) – cardboard boxes – for hospitals
150 ml – bottles (28 pcs.) – cardboard boxes – for hospitals
150 ml – bottles (32 pcs.) – cardboard boxes – for hospitals
150 ml – bottles (36 pcs.) – cardboard boxes – for hospitals
150 ml – bottles (40 pcs.) – cardboard boxes – for hospitals
150 ml – bottles (42 pcs.) – cardboard boxes – for hospitals
150 ml – bottles (56 pcs.) – cardboard boxes – for hospitals
200 ml – bottles – cardboard packs – By prescription
200 ml – bottles (10 pcs.) – cardboard boxes – for hospitals
200 ml – bottles (15 pcs.) – cardboard boxes – for hospitals
200 ml – bottles (20 pcs.) – cardboard boxes – for hospitals
200 ml – bottles (24 pcs.) – cardboard boxes – for hospitals
200 ml – bottles (28 pcs.) – cardboard boxes – for hospitals
200 ml – bottles (32 pcs.) – cardboard boxes – for hospitals
200 ml – bottles (36 pcs.) – cardboard boxes – for hospitals
200 ml – bottles (40 pcs.) – cardboard boxes – for hospitals
200 ml – bottles (42 pcs.) – cardboard boxes – for hospitals
200 ml – bottles (56 pcs.) – cardboard boxes – for hospitals
250 ml – bottles – cardboard packs – By prescription
250 ml – bottles (10 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (15 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (20 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (24 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (28 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (32 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (36 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (40 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (42 pcs.) – cardboard boxes – for hospitals
250 ml – bottles (56 pcs.) – cardboard boxes – for hospitals
300 ml – bottles – cardboard packs – By prescription
300 ml – bottles (10 pcs.) – cardboard boxes – for hospitals
300 ml – bottles (12 pcs.) – cardboard boxes – for hospitals
300 ml – bottles (15 pcs.) – cardboard boxes – for hospitals
300 ml – bottles (16 pcs.) – cardboard boxes – for hospitals
300 ml – bottles (20 pcs.) – cardboard boxes – for hospitals
300 ml – bottles (24 pcs.) – cardboard boxes – for hospitals
300 ml – bottles (28 pcs.) – cardboard boxes – for hospitals
300 ml – bottles (32 pcs.) – cardboard boxes – for hospitals
300 ml – bottles (35 pcs.) – cardboard boxes – for hospitals
300 ml – bottles (40 pcs.) – cardboard boxes – for hospitals
350 ml – bottles – cardboard packs – By prescription
350 ml – bottles (10 pcs.) – cardboard boxes – for hospitals
350 ml – bottles (12 pcs.) – cardboard boxes – for hospitals
350 ml – bottles (15 pcs.) – cardboard boxes – for hospitals
350 ml – bottles (16 pcs.) – cardboard boxes – for hospitals
350 ml – bottles (20 pcs.) – cardboard boxes – for hospitals
350 ml – bottles (24 pcs.) – cardboard boxes – for hospitals
350 ml – bottles (28 pcs.) – cardboard boxes – for hospitals
350 ml – bottles (32 pcs.) – cardboard boxes – for hospitals
350 ml – bottles (35 pcs.) – cardboard boxes – for hospitals
350 ml – bottles (40 pcs.) – cardboard boxes – for hospitals
400 ml – bottles – cardboard packs – By prescription
400 ml – bottles (10 pcs.) – cardboard boxes – for hospitals
400 ml – bottles (12 pcs.) – cardboard boxes – for hospitals
400 ml – bottles (15 pcs.) – cardboard boxes – for hospitals
400 ml – bottles (16 pcs.) – cardboard boxes – for hospitals
400 ml – bottles (20 pcs.) – cardboard boxes – for hospitals
400 ml – bottles (24 pcs.) – cardboard boxes – for hospitals
400 ml – bottles (28 pcs.) – cardboard boxes – for hospitals
400 ml – bottles (32 pcs.) – cardboard boxes – for hospitals
400 ml – bottles (35 pcs.) – cardboard boxes – for hospitals
400 ml – bottles (40 pcs.) – cardboard boxes – for hospitals
50 ml – bottles – cardboard packs – By prescription
50 ml – bottles (20 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (24 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (28 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (32 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (36 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (40 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (42 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (56 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (60 pcs.) – cardboard boxes – for hospitals

Marketing Authorization Holder

Senderesis, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride-Senderesis Infusion solution 0.9%: 200 ml, 250 ml, 400 ml or 500 ml bottle 1 pc.

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

200 ml – bottles for blood substitutes (1) – cardboard packs.
250 ml – bottles for blood substitutes (1) – cardboard boxes.
400 ml – bottles for blood substitutes (1) – cardboard packs.
500 ml – bottles for blood substitutes (1) – cardboard boxes.

Marketing Authorization Holder

All-Russian Research Institute for Animal Protection, FSU (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride-Sinco Infusion solution 0.9%: 200 ml bottle 1 or 28 pcs, 400 ml bottle 1 or 15 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

200 ml – bottles for blood substitutes (1) – cardboard packs.
200 ml – bottles for blood substitutes (28) – cardboard boxes.
400 ml – bottles for blood substitutes (1) – cardboard packs.
400 ml – bottles for blood substitutes (15) – cardboard boxes.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride-SOLOpharm Infusion solution 0.9%: 100 ml, 200 ml, 250 ml, 400 ml, 500 ml or 1000 ml fl.

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

1 L
Sodium chloride 9 g

Excipients: water for injection – up to 1 L.

100 ml – polypropylene bottles (1) – cardboard packs.
200 ml – polypropylene bottles (1) – cardboard packs.
250 ml – polypropylene bottles (1) – cardboard packs.
400 ml – polypropylene bottles (1) – cardboard packs.
500 ml – polypropylene bottles (1) – cardboard packs.
1000 ml – polypropylene bottles (1) – cardboard packs.
100 ml – polypropylene bottles (30) – cardboard boxes (for hospitals).
200 ml – polypropylene bottles (20) – cardboard boxes (for hospitals).
250 ml – polypropylene bottles (20) – cardboard boxes (for hospitals).
400 ml – polypropylene bottles (20) – cardboard boxes (for hospitals).
500 ml – polypropylene bottles (20) – cardboard boxes (for hospitals).
1000 ml – polypropylene bottles (10) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Hebei Tiancheng Pharmaceutical Co., Ltd (China)

Dosage Form

Bottle Rx Icon Sodium chloride-Vial Solution for infusion 0.9%: 200 ml bottle 1 or 40 pcs., 400 ml bottle 1 or 30 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

1 L
Sodium chloride 9 g

Excipients : water for injections – up to 1 L.

200 ml – polypropylene bottles.
400 ml – polypropylene bottles.
200 ml – polypropylene bottles (40) – cardboard boxes (for hospitals).
400 ml – polypropylene bottles (30) – cardboard boxes (for hospitals).

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