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Sodium chloride (Solution, Spray, Solvent) Instructions for Use

ATC Code

B05BB01 (Electrolytes)

Active Substance

Sodium chloride (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Solvent

Pharmacological Action

It has a detoxifying and rehydrating effect. It replenishes sodium deficiency in various pathological conditions of the body and temporarily increases the volume of fluid circulating in the vessels.

The pharmacodynamic properties of the solution are due to the presence of sodium ions and chloride ions. A number of ions, including sodium ions, penetrate the cell membrane through various transport mechanisms, among which the sodium-potassium pump (Na-K-ATPase) is of great importance. Sodium plays an important role in signal transmission in neurons, electrophysiological processes of the heart, as well as in metabolic processes in the kidneys.

Sodium is excreted primarily by the kidneys, but a large amount of sodium is reabsorbed (renal reabsorption). A small amount of sodium is excreted in feces and through sweating.

Indications

  • Isotonic extracellular dehydration;
  • Hyponatremia;
  • Dilution and dissolution of parenterally administered drugs (as a base solution).

ICD codes

ICD-10 code Indication
E86 Volume depletion (including dehydration, hypovolemia)
E87.1 Hypo-osmolality and hyponatremia
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
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

Intravenously (usually by drip). The required dose can be calculated in mEq or mmol of sodium, mass of sodium ions or mass of sodium chloride (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol Na and Cl).

The dose is determined depending on the patient’s condition, loss of body fluid, Na+ and Cl-, age, and body weight of the patient. Serum electrolyte concentrations in plasma and urine should be carefully monitored.

The dose of sodium chloride solution for adults is from 500 ml to 3 liters per day.

The dose of sodium chloride solution for children is from 20 ml to 100 ml per day per kg of body weight (depending on age and total body weight). The rate of administration depends on the patient’s condition.

The recommended dose when used for dilution and dissolution of parenterally administered drugs (as a base solvent solution) is in the range from 50 ml to 250 ml per single dose of the administered drug. In this case, the dose and rate of administration of the solution are determined by the recommendations for the use of the administered drug.

Solvent

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

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 liters/day is administered intravenously.

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

Spray

Applied intranasally 3-4 times/day.

The course of prevention and treatment is 2-4 weeks.

In young children, it should be used in an appropriate dosage form.

Adverse Reactions

Acidosis, hyperhydration, hypokalemia.

With correct use, adverse effects are unlikely.

When using sodium chloride solution 0.9% as a base solution (solvent) for other drugs, the likelihood of side effects is determined by the properties of these drugs. In this case, if adverse reactions occur, the administration of the solution should be suspended, the patient’s condition should be assessed, adequate measures should be taken, and the remaining solution should be kept for analysis if necessary.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Contraindications

  • Hypernatremia, acidosis, hyperchloremia, hypokalemia, extracellular hyperhydration;
  • Circulatory disorders threatening cerebral and pulmonary edema;
  • Cerebral edema, pulmonary edema, acute left ventricular failure, concomitant administration of corticosteroids in large doses.

When adding other drugs to the solution, contraindications to these drugs must be taken into account.

With caution decompensated chronic heart failure, arterial hypertension, peripheral edema, preeclampsia, chronic renal failure (oligo-, anuria), aldosteronism and other conditions associated with sodium retention in the body.

Use in Pregnancy and Lactation

The solution can be administered during pregnancy and lactation.

Use in Renal Impairment

With caution: chronic renal failure (oligo-, anuria).

Pediatric Use

In children, due to immature renal function, sodium excretion may be slowed. Therefore, in such patients, repeated infusions should be carried out only after determining the plasma sodium concentration.

Special Precautions

During any infusion, it is necessary to monitor the patient’s condition, clinical and biological indicators, and it is especially important to assess plasma electrolytes. In children, due to immature renal function, sodium excretion may be slowed. Therefore, in such patients, repeated infusions should be carried out only after determining the plasma sodium concentration.

Use only a clear solution, without visible inclusions, if the packaging is undamaged. Administer immediately after connection to the infusion system. Do not use serial connection of plastic containers. This may lead to air embolism due to suction of air remaining in the first container, which may occur before the solution from the next container enters. The solution should be administered using sterile equipment in compliance with the rules of asepsis and antisepsis. To avoid air entering the infusion system, it should be filled with the solution, completely releasing the residual air from the container. Other drugs can be added to the solution before or during the infusion by injection into a specially designated area of the container.

As with all parenteral solutions, the compatibility of added substances with the solution should be determined prior to dissolution.

Drugs known to be incompatible with it should not be used with sodium chloride 0.9% solution. The compatibility of added medicinal substances with sodium chloride 0.9% solution should be determined by a doctor by checking for possible color change and/or appearance of precipitate, insoluble complexes or crystals.

Before adding, it is necessary to determine whether the substance being added is soluble and stable in water at the pH level of the sodium chloride 0.9% solution.

When adding a drug, the isotonicity of the resulting solution must be determined before infusion. Before adding drugs to the solution, they must be thoroughly mixed in compliance with aseptic rules. The prepared solution should be administered immediately after preparation, do not store!

Adding other drugs or violating the administration technique may cause fever due to the possible entry of pyrogens into the body. If adverse reactions develop, the administration of the solution must be stopped immediately. Before starting to use the solution, the container should not be removed from the external protective polypropylene/polyamide bag in which it is placed, as it maintains the sterility of the drug.
Instructions for using Viaflo containers

1. Opening the package.

A. Remove the Viaflo container from the outer bag immediately before use.

B. By squeezing the container firmly, check it for integrity. If mechanical damage is detected, the container should be disposed of, as sterility may be compromised.

C. Check the solution for clarity and absence of inclusions. The container should be disposed of if clarity is impaired or if inclusions are present.

2. Preparation for use.

To prepare and administer the solution, use sterile materials. a. Hang the container by the loop on a stand. Remove the plastic protector from the outlet port located at the bottom of the container

  • Grasp the small wing on the neck of the outlet port with one hand,
  • Grasp the large wing on the cap with the other hand and twist,
  • The cap will open.

C. When installing the infusion system, the rules of antisepsis should be observed.

D. Install the infusion system in accordance with the instructions for connecting, filling the system and administering the solution contained in the system instructions.

3. Adding other drugs to the solution.

Warning: added drugs may be incompatible with the solution.

For addition before administration

A. Disinfect the area for injection of drugs on the container (drug injection port).

B. Using a syringe with a 19-22 gauge (1.10-0.70 mm) needle, puncture this area and inject the drug.

C. Thoroughly mix the drug with the solution. For drugs with high density, such as potassium chloride, carefully inject the drug with a syringe, holding the container so that the drug injection port is at the top (upside down), then mix.

Warning: do not store containers to which drugs have been added.

For adding a drug during administration

A. Move the system clamp regulating the supply of solution to the “Closed” position.

B. Disinfect the area for injection of drugs on the container (drug injection port).

C. Using a syringe with a 19-22 gauge (1.10-0.70 mm) needle, puncture this area and inject the drug.

D. Remove the container from the stand and/or turn it upside down.

E. Remove air from both ports.

F. Thoroughly mix the drug with the solution.

G. Return the container to the operating position, move the system clamp to the “Open” position and continue administration.

Containers should be disposed of after single use. Any unused dose should be disposed of.

Do not reconnect partially used containers (regardless of the amount of solution remaining in it).

Effect on ability to drive vehicles and mechanisms

Not described.

Overdose

Symptoms nausea, vomiting, diarrhea, cramping abdominal pain, thirst, decreased salivation and lacrimation, sweating, fever, tachycardia, increased blood pressure, renal failure, peripheral edema, pulmonary edema, respiratory arrest, headache, dizziness, anxiety, irritability, weakness, muscle cramps and rigidity, generalized seizures, coma and death. Excessive administration of the solution may cause hypernatremia.

Excessive intake of chloride into the body can lead to hyperchloremic acidosis.

When used as a base solution for dilution and dissolution of other drugs, symptoms and complaints during excessive administration are most often associated with the properties of the administered drugs.

In case of unintentional excessive administration of the solution, treatment should be stopped and the patient’s condition assessed.

Treatment symptomatic.

Drug Interactions

Not described.

When mixing with other drugs, compatibility must be visually monitored. To do this, the resulting solution should be observed for changes in its color and/or precipitation, the appearance of crystals, and insoluble complexes. It is also necessary to take into account the instructions for use of the added drugs.

Storage Conditions

At a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life: 50 ml – 18 months; 100 ml – 2 years; 250, 500 and 1000 ml – 3 years.

Dispensing Status

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.

Medical Disclaimer

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

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: bottles 50 ml, 100 ml, 200 ml, 250 ml, 400 ml or 500 ml.

Dosage Form, Packaging, and Composition

Infusion solution in the form of a clear, colorless liquid.

1 L
Sodium chloride 9 g

Excipients : water for injections – up to 1 L.

Theoretical osmolarity 308 mOsm/L.

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

Marketing Authorization Holder

Baxter, S.L. (Spain)

Manufactured By

Bieffe Medital, S.A. (Spain)

Dosage Forms

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: bottles 50 ml 50 pcs.
Infusion solution 0.9%: bottles 100 ml 50 pcs.
Infusion solution 0.9%: bottles 250 ml 30 pcs., 500 ml 20 pcs., 1 L 10 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 0.9% clear, colorless.

1 L
Sodium chloride 9 g

Excipients : water for injections – up to 1 L.

100 ml – Viaflo containers (50) – cardboard boxes.

Infusion solution 0.9% clear, colorless.

1 L
Sodium chloride 9 g

Excipients : water for injections – up to 1 L.

250 ml – Viaflo containers (30) – cardboard boxes.
500 ml – Viaflo containers (20) – cardboard boxes.
1 L – Viaflo containers (10) – cardboard boxes.

Infusion solution 0.9% clear, colorless.

1 L
Sodium chloride 9 g

Excipients : water for injections – up to 1 L.

50 ml – Viaflo containers (50) – cardboard boxes.

Marketing Authorization Holder

Baxter, S.L. (Spain)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 50 ml or 100 ml containers 50 pcs., 250 ml containers 30 pcs., 500 ml containers 20 pcs., 1 L containers 10 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 0.9% clear, colorless.

1 L
Sodium chloride 9 g

Excipients : water for injections – up to 1 L.

50 ml – (1) Viaflo containers – polymer bags (50) – cardboard boxes.
100 ml – (1) Viaflo containers – polymer bags (50) – cardboard boxes.
250 ml – (1) Viaflo containers – polymer bags (30) – cardboard boxes.
500 ml – (1) Viaflo containers – polymer bags (20) – cardboard boxes.
1 L – (1) Viaflo containers – polymer bags (10) – cardboard boxes.

Marketing Authorization Holder

Mapichem AG (Switzerland)

Manufactured By

Shandong Shenglu Pharmaceutical, Co.Ltd. (China)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: amp. 5 ml or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution clear, colorless.

100 ml
Sodium chloride 0.9 g

Excipients : water for injections – up to 100 ml.

5 ml – glass ampoules (10) – contour cell packaging (1) – cardboard boxes.
10 ml – glass ampoules (10) – contour cell packaging (1) – cardboard boxes.

Marketing Authorization Holder

Mapichem AG (Switzerland)

Manufactured By

Shandong Shenglu Pharmaceutical, Co.Ltd. (China)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: amp. 5 ml or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 0.9% 100 ml
Sodium chloride 900 mg

5 ml – ampoules (10) – carton packs.
10 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Avexima Siberia LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 250 mL, 400 mL, or 500 mL containers

Dosage Form, Packaging, and Composition

Infusion solution 0.9% 100 ml
Sodium chloride 900 mg

250 ml – polymer containers (1) – polyethylene bags (24) – carton boxes.
500 ml – polymer containers (1) – polyethylene bags (24) – carton boxes.
400 ml – bottles for blood and blood substitutes – carton packs.
400 ml – bottles for blood and blood substitutes.
400 ml – bottles for blood and blood substitutes (15) – carton boxes.

Marketing Authorization Holder

Akapharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: vial 100 ml, 200 ml or 400 ml

Dosage Form, Packaging, and Composition

Infusion solution 0.9% 100 ml
Sodium chloride 900 mg

100 ml – blood substitute bottles (1) – carton packs.
200 ml – blood substitute bottles (1) – carton packs.
400 ml – blood substitute bottles (1) – carton packs.
100 ml – bottles for blood and blood substitutes (40) – carton boxes.
100 ml – bottles for blood and blood substitutes – carton packs.
100 ml – bottles for blood and blood substitutes.
200 ml – bottles for blood and blood substitutes – carton packs.
200 ml – bottles for blood and blood substitutes.
200 ml – bottles for blood and blood substitutes (28) – carton boxes.
400 ml – bottles for blood and blood substitutes.
400 ml – bottles for blood and blood substitutes – carton packs.
400 ml – bottles for blood and blood substitutes (15) – carton packs.
100 ml – bottles for blood and blood substitutes (40) – shrink-wrap packaging.
200 ml – bottles for blood and blood substitutes (25) – shrink-wrap packaging.
400 ml – bottles for blood and blood substitutes (15) – shrink-wrap packaging.

Marketing Authorization Holder

Altayvitamins, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: vial 100 ml, 200 ml, 250 ml, 400 ml or 500 ml

Dosage Form, Packaging, and Composition

Infusion solution 0.9% 100 ml
Sodium chloride 900 mg

100 ml – blood substitute bottles (1) – carton packs.
200 ml – blood substitute bottles (1) – carton packs.
250 ml – blood substitute bottles (1) – carton packs.
400 ml – blood substitute bottles (1) – carton packs.
500 ml – blood substitute bottles (1) – carton packs.

Marketing Authorization Holder

Armavir Biopharmaceutical Plant, FSE (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: 2 ml, 5 ml or 10 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml
Sodium chloride 9 mg

Excipients: water for injections up to 1 ml.

2 ml – ampoules (10) – carton packs.
2 ml – ampoules (5) – contour cell packs (2) – carton packs.
5 ml – ampoules (10) – carton packs.
5 ml – ampoules (5) – contour cell packs (2) – carton packs.
10 ml – ampoules (10) – carton packs.
10 ml – ampoules (5) – contour cell packs (2) – carton packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for preparation of injectable dosage forms 0.9%: amp. 2 mL, 5 mL, or 10 mL 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for preparation of injectable dosage forms transparent, colorless.

1 ml
Sodium chloride 9 mg

Excipients: water for injections – up to 1 ml.

2 ml – ampoules (5) – contour cell packs – carton packs.
2 ml – ampoules (5) – contour cell packs (2) – carton packs.
5 ml – ampoules (5) – contour cell packs – carton packs.
5 ml – ampoules (5) – contour cell packs (2) – carton packs.
10 ml – ampoules (5) – contour cell packs – carton packs.
10 ml – ampoules (5) – contour cell packs (2) – carton packs.
Ampoules (50) – group packaging.
Ampoules (100) – group packaging.
Ampoules (150) – group packaging.
Ampoules (200) – group packaging.
Ampoules (250) – group packaging.
Ampoules (300) – group packaging.
Ampoules (350) – group packaging.
Ampoules (400) – group packaging.
Ampoules (450) – group packaging.
Ampoules (500) – group packaging.
Ampoules (1000) – group packaging.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Infusion solution 0.9% as a colorless, transparent liquid.

1 ml
Sodium chloride 9 mg
Theoretical osmolarity 308 mOsm/L

Excipients: water for injections – 1 ml.

200 ml – glass bottles (20) – polyethylene bags (1) – carton boxes.
200 ml – glass bottles (24) – polyethylene bags (1) – carton boxes.
250 ml – polymer containers (24) – polyethylene bags (1) – carton boxes.
400 ml – glass bottles (12) – polyethylene bags (1) – carton boxes.
500 ml – polymer containers (12) – polyethylene bags (1) – carton boxes.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for preparation of injectable dosage forms 0.9%: amp. 5 mL or 10 mL 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for preparation of injectable dosage forms transparent, colorless.

1 ml
Sodium chloride 9 mg

Excipients: water for injections – 1 ml.

5 ml – glass ampoules (5) – contour cell packs (1) – carton packs.
5 ml – glass ampoules (5) – contour cell packs (2) – carton packs.
10 ml – glass ampoules (5) – contour cell packs (1) – carton packs.
10 ml – glass ampoules (5) – contour cell packs (2) – carton packs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: amp. 5 ml or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 100 ml
Sodium chloride 900 mg

5 ml – ampoules (10) – carton packs.
5 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: amp. 1 ml, 2 ml, 5 ml or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 0.9% 100 ml
Sodium chloride 900 mg

1 ml – ampoules (10) – carton packs.
2 ml – ampoules (10) – carton packs.
5 ml – ampoules (10) – carton packs.
10 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Gematek, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: fl. 250 ml 15 pcs., fl. 500 ml 10 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 0.9% 100 ml
Sodium chloride 900 mg

250 ml – polyethylene bottles (10) – carton boxes.
250 ml – polyethylene bottles (15) – carton boxes.
250 ml – polyethylene bottles.
250 ml – polyethylene bottles (15) with infusion system “Intrafix SafeSet” 180 cm long – carton boxes.
250 ml – polyethylene bottles (15) with infusion system “Intrafix SafeSet” 220 cm long – carton boxes.
250 ml – polyethylene bottles (10) with Ecoflac Mix cannulas – carton boxes.
250 ml – polyethylene bottles (15) with Ecoflac Mix cannulas – carton boxes.
500 ml – polyethylene bottles (10) – carton boxes.
500 ml – polyethylene bottles.
500 ml – polyethylene bottles (10) with infusion system “Intrafix SafeSet” 180 cm long – carton boxes.
500 ml – polyethylene bottles (10) with infusion system “Intrafix SafeSet” 220 cm long – carton boxes.
500 ml – polyethylene bottles (10) with Ecoflac Mix cannulas – carton boxes.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for preparation of injectable dosage forms 0.9%: 2 mL, 5 mL, or 10 mL amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for preparation of injectable dosage forms transparent, colorless.

1 L
Sodium chloride 9 g

Excipients: water for injections up to 1 L.

2 ml – polymer ampoules (5) – strips (1) – carton packs.
2 ml – polymer ampoules (5) – strips (2) – carton packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: bot. 100 ml, 200 ml or 400 ml

Dosage Form, Packaging, and Composition

Infusion solution colorless, transparent.

1 ml
Sodium chloride 9 mg

Excipients: water for injections – up to 1 ml.
Theoretical osmolarity: 308 mOsm/L.

100 ml – bottles (1) – carton packs.
200 ml – bottles (1) – carton packs.
400 ml – bottles (1) – carton packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for the preparation of dosage forms for injections 0.9%: amp. 1 ml, 2 ml, 5 ml or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 0.9% 100 ml
Sodium chloride 900 mg

1 ml – ampoules (10) – carton packs.
2 ml – ampoules (10) – carton packs.
5 ml – ampoules (10) – carton packs.
10 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for preparation of injectable dosage forms 0.9%: 1 mL, 2 mL, 5 mL, or 10 mL amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for preparation of injectable dosage forms 100 ml
Sodium chloride 900 mg

1 ml – ampoules (10) – carton packs.
2 ml – ampoules (10) – carton packs.
5 ml – ampoules (10) – carton packs.
10 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Medsintez Plant, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solution for infusion 0.9%: containers 250 ml or 500 ml

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

100 ml – polymer containers (1) with 2 ports – polyethylene bags.

250 ml – polymer containers (1) with 2 ports – polyethylene bags.

250 ml – polymer containers (1) – polyethylene bags.

500 ml – polymer containers (1) with 2 ports – polyethylene bags.

500 ml – polymer containers (1) – polyethylene bags.

1000 ml – polymer containers.

1500 ml – polymer containers (1) with 2 ports – polyethylene bags.

1500 ml – polymer containers (1) with 2 ports – polyethylene bags (4) – cardboard boxes.

Marketing Authorization Holder

Medsintez Plant, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: container with 2 ports 50 ml, 100 ml, 200 ml, 250 ml, 400 ml, 500 ml, 1000 ml, 1500 ml, 2000 ml, 2500 ml, 3000 ml, 3500 ml, 4000 ml, 4500 ml or 5000 ml

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a colorless, transparent liquid.

1 L
Sodium chloride 9 g

Excipients: water for injections – up to 1 L.

Theoretical osmolarity 308 mOsmol/L.

50 ml – single-use containers with 2 sterile ports (1) – bags*.

50 ml – single-use containers with 2 sterile ports (2) – bags*.

100 ml – single-use containers with 2 sterile ports (1) – bags*.

100 ml – single-use containers with 2 sterile ports (2) – bags*.

200 ml – single-use containers with 2 sterile ports (1) – bags*.

200 ml – single-use containers with 2 sterile ports (2) – bags*.

250 ml – single-use containers with 2 sterile ports (1) – bags*.

250 ml – single-use containers with 2 sterile ports (2) – bags*.

400 ml – single-use containers with 2 sterile ports (1) – bags*.

400 ml – single-use containers with 2 sterile ports (2) – bags*.

500 ml – single-use containers with 2 sterile ports (1) – bags*.

500 ml – single-use containers with 2 sterile ports (2) – bags*.

1000 ml – single-use containers with 2 sterile ports (1) – bags*.

1000 ml – single-use containers with 2 sterile ports (2) – bags*.

1500 ml – single-use containers with 2 sterile ports (1) – bags*.

1500 ml – single-use containers with 2 sterile ports (2) – bags*.

2000 ml – single-use containers with 2 sterile ports (1) – bags*.

2000 ml – single-use containers with 2 sterile ports (2) – bags*.

2500 ml – single-use containers with 2 sterile ports (1) – bags*.

2500 ml – single-use containers with 2 sterile ports (2) – bags*.

3000 ml – single-use containers with 2 sterile ports (1) – bags*.

3000 ml – single-use containers with 2 sterile ports (2) – bags*.

3500 ml – single-use containers with 2 sterile ports (1) – bags*.

3500 ml – single-use containers with 2 sterile ports (2) – bags*.

4000 ml – single-use containers with 2 sterile ports (1) – bags*.

4000 ml – single-use containers with 2 sterile ports (2) – bags*.

4500 ml – single-use containers with 2 sterile ports (1) – bags*.

4500 ml – single-use containers with 2 sterile ports (2) – bags*.

5000 ml – single-use containers with 2 sterile ports (1) – bags*.

5000 ml – single-use containers with 2 sterile ports (2) – bags*.

* (double sterile vacuum packaging)

Marketing Authorization Holder

IST-Pharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: bot. 50 ml,100 ml, 200 ml, 250 ml, 400 ml or 500 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a colorless, transparent liquid.

1 L
Sodium chloride 9 g

Excipients: water for injections – up to 1 L.

Theoretical osmolarity 308 mOsm/L.

50 ml – bottles (1) – cardboard packs.

100 ml – bottles (1) – cardboard packs.

200 ml – bottles (1) – cardboard packs.

250 ml – bottles (1) – cardboard packs.

400 ml – bottles (1) – cardboard packs.

500 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Deko Company, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for the preparation of dosage forms for injections 0.9%: amp. 1 ml, 2 ml or 5 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for the preparation of dosage forms for injections colorless transparent, with a salty taste.

1 ml
Sodium chloride 9 mg

Excipients: water for injections up to 1 ml.

1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

1 ml – ampoules (10) – contour cell packs (1) – cardboard packs.

2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

2 ml – ampoules (10) – contour cell packs (1) – cardboard packs.

5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

5 ml – ampoules (10) – contour cell packs (1) – cardboard packs.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: fl. 200 ml 1 or 24 pcs., fl. 400 ml 1 or 12 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

200 ml – vials for blood substitutes (1) – cardboard packs.

200 ml – vials for blood substitutes (24) – cardboard boxes.

400 ml – vials for blood substitutes (1) – cardboard packs.

400 ml – vials for blood substitutes (12) – cardboard boxes.

Marketing Authorization Holder

Kursk Biofactory – Firm “BIOK”, FSUE (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: vial 200 ml, 400 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

200 ml – vials for blood substitutes (1) – cardboard packs.

400 ml – vials for blood substitutes (1) – cardboard packs.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: amp. 1 ml, 5 ml or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 0.9% 100 ml
Sodium chloride 900 mg

1 ml – ampoules (10) – cardboard packs.

5 ml – ampoules (10) – cardboard packs.

10 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Mosfarm LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 200 mL or 400 mL bottle

Dosage Form, Packaging, and Composition

Solution for infusion 100 ml
Sodium chloride 900 mg

200 ml – vials for blood substitutes (1) – cardboard packs.

400 ml – vials for blood substitutes (1) – cardboard packs.

200 ml – bottles.

400 ml – bottles.

200 ml – bottles for blood and blood substitutes (1) – cardboard packs.

400 ml – bottles for blood and blood substitutes (1) – cardboard packs.

400 ml – bottles (15) – cardboard boxes.

200 ml – bottles for blood and blood substitutes.

200 ml – bottles for blood and blood substitutes (28) – cardboard boxes.

400 ml – bottles for blood and blood substitutes.

400 ml – bottles for blood and blood substitutes (28) – cardboard boxes.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: amp. 5 ml or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 0.9% 100 ml
Sodium chloride 900 mg

5 ml – ampoules (10) – cardboard packs.

10 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: 100 mL, 250 mL, 500 mL bottle

Dosage Form, Packaging, and Composition

Solution for injection 0.9% 100 ml
Sodium chloride 900 mg

100 ml – polyethylene vials.

250 ml – polyethylene vials.

500 ml – polyethylene vials.

Marketing Authorization Holder

Nesvizh Medical Products Plant OJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: fl. 200 ml 1 or 40 pcs., fl. 400 ml 1 or 24 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

200 ml – vials for blood substitutes (1) – cardboard packs.

200 ml – vials for blood substitutes (40) – cardboard boxes.

400 ml – vials for blood substitutes (1) – cardboard boxes.

400 ml – vials for blood substitutes (24) – cardboard boxes.

200 ml – bottles for blood and blood substitutes.

400 ml – bottles for blood and blood substitutes.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: amp. 5 ml or 10 ml 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent, colorless liquid.

1 ml
Sodium chloride 9 mg

Excipients: water for injections – up to 1 ml.

5 ml – neutral glass ampoules (10) – cardboard boxes.

10 ml – neutral glass ampoules (10) – cardboard boxes.

5 ml – neutral glass ampoules (5) – contour cell packs (1) – cardboard packs.

5 ml – neutral glass ampoules (5) – contour cell packs (2) – cardboard packs.

10 ml – neutral glass ampoules (5) – contour cell packs (1) – cardboard packs.

10 ml – neutral glass ampoules (5) – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 200 mL or 400 mL bottle 1 or 15 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 100 ml
Sodium chloride 900 mg

200 ml – vials for blood substitutes (1) – cardboard packs.

400 ml – vials for blood substitutes (1) – cardboard packs.

200 ml – glass bottles for blood (1) transfusion and infusion preparations – cardboard packs.

400 ml – glass bottles for blood (1) transfusion and infusion preparations – cardboard packs.

200 ml – vials for blood substitutes (15) – cardboard boxes.

400 ml – vials for blood substitutes (15) – cardboard boxes.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for the preparation of dosage forms for injections 0.9%: amp. 1 ml, 2 ml, 5 ml or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for the preparation of dosage forms for injections in the form of a transparent, colorless liquid.

1 ml
Sodium chloride 9 mg

Excipients: water for injections – up to 1 ml.

1 ml – ampoules (10) – cardboard packs/boxes.

1 ml – ampoules (5) – contour cassette packs (2) – cardboard packs.

2 ml – ampoules (10) – cardboard packs/boxes.

2 ml – ampoules (5) – contour cassette packs (2) – cardboard packs.

5 ml – ampoules (10) – cardboard packs/boxes.

5 ml – ampoules (5) – contour cassette packs (2) – cardboard packs.

10 ml – ampoules (10) – cardboard packs/boxes.

10 ml – ampoules (5) – contour cassette packs (2) – cardboard packs.

Marketing Authorization Holder

Oxyflurin, LLC (Russia)

Manufactured By

Vips-Med, LLC (Russia)

Dosage Forms

Bottle OTC Icon Sodium chloride Nasal spray 0.9%: 10 ml or 20 ml bottle
Nasal spray 0.65%: 10 ml or 20 ml bottle

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or slightly yellowish liquid.

1 ml
Sodium chloride 9 mg

Excipients: benzalkonium chloride – 0.15 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dodecahydrate – 7.13 mg, purified water – up to 1 ml.

10 ml – bottles (1) – cardboard packs.
20 ml – bottles (1) – cardboard packs.


Nasal spray as a clear, colorless or slightly yellowish liquid.

1 ml
Sodium chloride 6.5 mg

Excipients: benzalkonium chloride – 0.15 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dodecahydrate – 7.13 mg, purified water – up to 1 ml.

10 ml – bottles (1) – cardboard packs.
20 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Polisan NTFF, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 250 ml containers 32 pcs., 500 ml containers 20 pcs., 1000 ml containers 10 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 100 ml
Sodium chloride 900 mg

250 ml – polymer containers (32) – transport packaging.
500 ml – polymer containers (20) – transport packaging.
1000 ml – polymer containers (10) – transport packaging.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: fl. 200 ml 1, 24 or 28 pcs., fl. 400 ml 1, 12 or 15 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

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

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for preparation of injectable dosage forms 0.9%: amp. 2 mL or 5 mL 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for the preparation of dosage forms for injection clear, colorless.

1 ml
Sodium chloride 9 mg

Excipients: water for injection – up to 1 ml.

2 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
2 ml – ampoules (10) – cardboard boxes.
5 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
5 ml – ampoules (10) – cardboard boxes.

Marketing Authorization Holder

PFC Alium, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 200 mL or 250 mL bottle 1, 28, or 36 pcs., 400 or 500 mL bottle 1, 15, or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 100 ml
Sodium chloride 900 mg

200 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (28) – cardboard boxes.
200 ml – glass bottles (36) – cardboard boxes.
200 ml – plastic bottles (1) – cardboard packs.
200 ml – plastic bottles (28) – cardboard boxes.
200 ml – plastic bottles (36) – cardboard boxes.
250 ml – plastic bottles (1) – cardboard packs.
250 ml – plastic bottles (28) – cardboard packs.
250 ml – plastic bottles (36) – cardboard packs.
400 ml – glass bottles (1) – cardboard packs.
400 ml – glass bottles (15) – cardboard boxes.
400 ml – glass bottles (20) – cardboard boxes.
400 ml – plastic bottles (1) – cardboard packs.
400 ml – plastic bottles (15) – cardboard boxes.
400 ml – plastic bottles (20) – cardboard boxes.
500 ml – glass bottles (1) – cardboard packs.
500 ml – glass bottles (15) – cardboard boxes.
500 ml – glass bottles (20) – cardboard boxes.
500 ml – plastic bottles (1) – cardboard packs.
500 ml – plastic bottles (15) – cardboard boxes.
500 ml – plastic bottles (20) – cardboard boxes.

Marketing Authorization Holder

Rezerv-M, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 250 mL, 1 L, 2 L bottle

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

250 ml – blood substitute bottles (1) – cardboard packs.
1 L – blood substitute bottles (1) – cardboard packs.
2 L – blood substitute bottles (1) – cardboard packs.

Marketing Authorization Holder

Rester, CJS (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 100 mL containers 1 or 70 pcs., 250 mL containers 1 or 32 pcs., 500 mL containers 1 or 20 pcs. 1000 mL containers 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

250 ml – polymer containers.
500 ml – polymer containers.
100 ml – polymer containers with 1 port.
100 ml – polymer containers (70) with 1 port – cardboard boxes.
250 ml – polymer containers with 1 port.
250 ml – polymer containers (32) with 1 port – cardboard boxes.
250 ml – polymer containers with 2 ports.
250 ml – polymer containers (32) with 2 ports – cardboard boxes.
500 ml – polymer containers with 1 port.
500 ml – polymer containers (20) with 1 port – cardboard boxes.
500 ml – polymer containers with 2 ports.
500 ml – polymer containers (20) with 2 ports – cardboard boxes.
1000 ml – polymer containers with 1 port.
1000 ml – polymer containers (10) with 1 port – cardboard boxes.
1000 ml – polymer containers with 2 ports.
1000 ml – polymer containers (10) with 2 ports – cardboard boxes.

Marketing Authorization Holder

Rif LLC (Russia)

Manufactured By

Ozon Pharm, LLC (Russia)

Dosage Forms

Bottle OTC Icon Sodium chloride Nasal spray 0.9%: 20 ml, 30 ml, or 50 ml bottle with spray nozzle
Nasal spray 0.65%: 20 ml, 30 ml, or 50 ml bottle with spray nozzle

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or slightly yellowish liquid, odorless or with a faint characteristic odor.

1 ml
Sodium chloride 9 mg

Excipients: potassium dihydrogen phosphate, sodium phosphate dihydrate, benzalkonium chloride, purified water.

20 ml – bottles (1) with spray nozzle – cardboard packs.
30 ml – bottles (1) with spray nozzle – cardboard packs.
50 ml – bottles (1) with spray nozzle – cardboard packs.


Nasal spray as a clear, colorless or slightly yellowish liquid, odorless or with a faint characteristic odor.

1 ml
Sodium chloride 6.5 mg

Excipients: potassium dihydrogen phosphate, sodium phosphate dihydrate, benzalkonium chloride, purified water.

20 ml – bottles (1) with spray nozzle – cardboard packs.
30 ml – bottles (1) with spray nozzle – cardboard packs.
50 ml – bottles (1) with spray nozzle – cardboard packs.

Marketing Authorization Holder

Rosva Farm, LLC (Russia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Solution for infusion as a colorless, clear liquid.

1 L
Sodium chloride 9 g

Excipients: water for injection.

200 ml – bottles (1) – cardboard packsx.
250 ml – bottles (1) – cardboard packsx.
400 ml – bottles (1) – cardboard packsx.
500 ml – bottles (1) – cardboard packsx.

xholograms or films for first-opening control may be affixed to the cardboard pack.

Marketing Authorization Holder

Sanguis Blood Transfusion Station MUP (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Isotonic solution for infusion 0.9%: fl. 200 ml 1 or 28 pcs., fl. 400 ml 1 or 15 pcs.

Dosage Form, Packaging, and Composition

Isotonic solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

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

Marketing Authorization Holder

Sakhamedprom State Unitary Enterprise (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 250 mL or 500 mL containers 14 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

200 ml – polymer containers (1) – cardboard boxes.
250 ml – polymer containers (1) – cardboard boxes.
400 ml – polymer containers (1) – cardboard boxes.
500 ml – polymer containers (1) – cardboard boxes.
250 ml – polymer containers (14) – cardboard boxes.
500 ml – polymer containers (14) – cardboard boxes.

Marketing Authorization Holder

Sverdlovsk Regional Blood Transfusion Station State Healthcare Institution (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solution for infusion 0.9%: bottles 100 ml, 150 ml, 200 ml, 400 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

100 ml – blood substitute bottles (1) – cardboard packs.
150 ml – blood substitute bottles (1) – cardboard packs.
200 ml – blood substitute bottles (1) – cardboard packs.
400 ml – blood substitute bottles (1) – cardboard packs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: containers 200 ml, 250 ml, 400 ml, 500 ml, 800 ml or 1 L

Dosage Form, Packaging, and Composition

Isotonic solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

100 ml – polymer containers (1) – bags.
200 ml – polymer containers (1) – bags.
250 ml – polymer containers (1) – bags.
400 ml – polymer containers (1) – bags.
500 ml – polymer containers (1) – bags.
800 ml – polymer containers (1) – bags.
1 L – polymer containers (1) – bags.
200 ml – polymer containers (1) – polyethylene bags (5) – combined material bags.
250 ml – polymer containers (1) – polyethylene bags (5) – combined material bags.
200 ml – containers (1) polymer – bags.
250 ml – containers (1) polymer – bags.
400 ml – containers (1) polymer – bags.
500 ml – containers (1) polymer – bags.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for the preparation of dosage forms for injections 0.9%: amp. 5 ml, 10 ml or 20 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for the preparation of dosage forms for injection 0.9%.

100 ml
Sodium chloride 900 mg

5 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for the preparation of dosage forms for injections 0.9%: 5 ml amp. 5 or 10 pcs., 10 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for the preparation of dosage forms for injections 0.9% as a clear, colorless liquid.

1 ml
Sodium chloride 9 mg

Excipients: water for injections up to 1 ml.

5 ml – polymer ampoules (5) – carton packs.
5 ml – polymer ampoules (10) – carton packs.
10 ml – polymer ampoules (10) – carton packs.

Marketing Authorization Holder

St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for the preparation of dosage forms for injections 0.9%: amp. 5 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for the preparation of dosage forms for injections 0.9%.

100 ml
Sodium chloride 900 mg

5 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Statusfarm LLC (Russia)

Manufactured By

Pharmatek, CJSC (Armenia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Infusion solution clear, colorless.

1 L
Sodium chloride 9 g

Excipients: water for injections – up to 1 L.

100 ml – bags – carton packs.
100 ml – bags (80) – carton boxes (for hospitals).
200 ml – bags – carton packs.
200 ml – bags (60) – carton boxes (for hospitals).
250 ml – bags – carton packs.
250 ml – bags (45) – carton boxes (for hospitals).
400 ml – bags – carton packs.
400 ml – bags (35) – carton boxes (for hospitals).
500 ml – bags – carton packs.
500 ml – bags (30) – carton boxes (for hospitals).
1000 ml – bags (15) – carton boxes (for hospitals).
2000 ml – bags (8) – carton boxes (for hospitals).
3000 ml – bags (5) – carton boxes (for hospitals).
3000 ml – bags (6) – carton boxes (for hospitals).

Marketing Authorization Holder

Steritec Krasnodar Infusion Solutions Plant LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: containers 100 ml, 200 ml, 250 ml, 400 ml, 500 ml, 600 ml, 800 ml, 1000 ml, 1500 ml, 2000 ml, 3000 ml or 5000 ml

Dosage Form, Packaging, and Composition

Infusion solution clear, colorless.

1 L
Sodium chloride 9 g

Excipients: water for injections – up to 1 L.

Theoretical osmolarity 308 mOsm/L.

100 ml – polymer containers.
200 ml – polymer containers.
250 ml – polymer containers.
400 ml – polymer containers.
500 ml – polymer containers.
600 ml – polymer containers.
800 ml – polymer containers.
1000 ml – polymer containers.
1500 ml – polymer containers.
2000 ml – polymer containers.
3000 ml – polymer containers.
5000 ml – polymer containers.

Marketing Authorization Holder

Sphere-Pharm, LLC (Russia)

Manufactured By

Sphere-Pharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: bottles 250 ml or 500 ml 16 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 0.9% clear, colorless.

1 L
Sodium chloride 9 g

Excipients: water for injections – up to 1 L.

Theoretical osmolarity 308 mOsm/L.

250 ml – polymer bottles (16) – carton boxes (for hospitals).
500 ml – polymer bottles (16) – carton boxes (for hospitals).

Marketing Authorization Holder

Pharma International Company Russia-CIS, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solution for infusion 0.9%: containers 250 ml or 500 ml

Dosage Form, Packaging, and Composition

Solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

250 ml – polymer containers (1) – polyethylene bags.
500 ml – polymer containers (1) – polyethylene bags.
200 ml – polyethylene bottles.
400 ml – polyethylene bottles.

Marketing Authorization Holder

Pharmactive, LLC (Russia)

Manufactured By

Vips-Med, LLC (Russia)

Dosage Forms

Bottle OTC Icon Sodium chloride Nasal spray 0.9%: bottle 10 ml or 20 ml
Nasal spray 0.65%: bottle 10 ml or 20 ml

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or slightly yellowish liquid.

1 ml
Sodium chloride 9 mg

Excipients: benzalkonium chloride – 0.15 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, purified water – up to 1 ml.

10 ml – glass bottles (1) with microspray and applicator nozzle – carton packs.
20 ml – glass bottles (1) with microspray and applicator nozzle – carton packs.


Nasal spray as a clear, colorless or slightly yellowish liquid.

1 ml
Sodium chloride 6.5 mg

Excipients: benzalkonium chloride – 0.15 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, purified water – up to 1 ml.

10 ml – glass bottles (1) with microspray and applicator nozzle – carton packs.
20 ml – glass bottles (1) with microspray and applicator nozzle – carton packs.

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Injection solution 0.9%: amp. 2 ml, 3 ml, 5 ml or 10 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution as a clear, colorless liquid.

1 ml
Sodium chloride 0.009 g

Excipients: water for injections – up to 1 ml.

Theoretical osmolarity 308 mOsm/L.

2 ml – polyethylene ampoules (5), connected in cassettes – carton packs.
2 ml – polyethylene ampoules (10), connected in cassettes – carton packs.
3 ml – polyethylene ampoules (5), connected in cassettes – carton packs.
3 ml – polyethylene ampoules (10), connected in cassettes – carton packs.
5 ml – polyethylene ampoules (5), connected in cassettes – carton packs.
5 ml – polyethylene ampoules (10), connected in cassettes – carton packs.
10 ml – polyethylene ampoules (5), connected in cassettes – carton packs.
10 ml – polyethylene ampoules (10), connected in cassettes – carton packs.

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: bottles 50 ml, 100 ml, 200 ml, 250 ml, 400 ml or 500 ml.

Dosage Form, Packaging, and Composition

Infusion solution as a clear, colorless liquid.

1 L
Sodium chloride 9 g

Excipients: water for injections – up to 1 L.

Theoretical osmolarity 308 mOsm/L.

50 ml – bottles (1) – carton packs.
100 ml – bottles (1) – carton packs.
200 ml – bottles (1) – carton packs.
250 ml – bottles (1) – carton packs.
400 ml – bottles (1) – carton packs.
500 ml – bottles (1) – carton packs.

Marketing Authorization Holder

Pharmland SP, LLC (Republic of Belarus)

Dosage Form

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

Dosage Form, Packaging, and Composition

Isotonic solution for infusion 0.9% 100 ml
Sodium chloride 900 mg

100 ml – polymer containers (1) – bags.
250 ml – polymer containers (1) – bags.
500 ml – polymer containers (1) – bags.
1 L – polymer containers (1) – bags.

Marketing Authorization Holder

Medpolymer Firm, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: containers 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml, 500 ml, 750 ml, 800 ml, 1000 ml, 1250 ml, containers/bags 1500 ml, 2000 ml, 2500 ml, 3000 ml, 3500 ml, 4000 ml, 4500 ml, 5000 ml, 5500 ml or 6000 ml

Dosage Form, Packaging, and Composition

Infusion solution as a colorless, clear liquid.

1 L
Sodium chloride 9 g

Excipients: water for injections – up to 1 L.

Ionic composition per 1 L of the preparation contains: sodium ion (Na+) – 154 mmol, chloride ion (Cl) – 154 mmol.
Theoretical osmolarity: 358 mOsm/L.

50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml, 500 ml, 750 ml, 800 ml, 1000 ml, 1250 ml, 1500 ml, 2000 ml, 2500 ml, 3000 ml, 3500 ml, 4000 ml, 4500 ml, 5000 ml, 5500 ml or 6000 ml – single-use polymer containers for infusion solutions (1) with SFC type injection ports with tamper-evident caps (1) – bags (1) – carton boxes.
50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml, 500 ml, 750 ml, 800 ml, 1000 ml, 1250 ml, 1500 ml, 2000 ml, 2500 ml, 3000 ml, 3500 ml, 4000 ml, 4500 ml, 5000 ml, 5500 ml or 6000 ml – single-use polymer containers for infusion solutions (1) with SFC type injection ports with tamper-evident caps (2) – bags (1) – carton boxes.
1500 ml, 2000 ml, 2500 ml, 3000 ml, 3500 ml, 4000 ml, 4500 ml, 5000 ml, 5500 ml or 6000 ml – polyolefin bags for dispensing and storing infusion solutions (1) – bags (1) – carton boxes.

Marketing Authorization Holder

Ferment Firm, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for the preparation of dosage forms for injections 0.9%: amp. 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for the preparation of dosage forms for injections 1 ml
Sodium chloride 9 mg

5 ml – ampoules (5) – plastic contour packs (1) – carton packs.
5 ml – ampoules (5) – plastic contour packs (2) – carton packs.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Manufactured By

Kontsern “MIR”, LLC (Russia)

Or

NPC Eskom, PJSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: bottles or vials 25 ml, 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml or 500 ml

Dosage Form, Packaging, and Composition

Infusion solution as a colorless, clear liquid.

1 L
Sodium chloride 9 g

Excipients: water for injections – up to 1 L.

Theoretical osmolarity 308 mOsm/L.

25 ml, 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml or 500 ml – glass bottles (1) – carton packs.
25 ml, 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml or 500 ml – polymer vials (1) – carton packs.
25 ml, 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml or 500 ml – polymer vials (1) – polymer bags.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Manufactured By

NPC Eskom, PJSC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for preparation of injectable dosage forms 0.9%: amp. 2 mL, 5 mL, or 10 mL from 5 to 300 pcs.

Dosage Form, Packaging, and Composition

Solvent for preparation of injectable dosage forms in the form of a transparent, colorless liquid.

1 ml
Sodium chloride 9 mg

Excipients : water for injections – up to 1 ml.

2 ml – ampoules of neutral glass (5) – carton packs.
2 ml – ampoules of neutral glass (10) – carton packs.
2 ml – ampoules of neutral glass (30) – carton packs.
2 ml – ampoules of neutral glass (50) – carton packs.
2 ml – ampoules of neutral glass (5) – contour cell packs (from 1 to 30 pcs.) – carton packs.
2 ml – ampoules of neutral glass (10) – contour cell packs (from 1 to 30 pcs.) – carton packs.
5 ml – ampoules of neutral glass (5) – carton packs.
5 ml – ampoules of neutral glass (10) – carton packs.
5 ml – ampoules of neutral glass (30) – carton packs.
5 ml – ampoules of neutral glass (50) – carton packs.
5 ml – ampoules of neutral glass (5) – contour cell packs (from 1 to 30 pcs.) – carton packs.
5 ml – ampoules of neutral glass (10) – contour cell packs (from 1 to 30 pcs.) – carton packs.
10 ml – ampoules of neutral glass (5) – carton packs.
10 ml – ampoules of neutral glass (10) – carton packs.
10 ml – ampoules of neutral glass (30) – carton packs.
10 ml – ampoules of neutral glass (50) – carton packs.
10 ml – ampoules of neutral glass (5) – contour cell packs (from 1 to 30 pcs.) – carton packs.
10 ml – ampoules of neutral glass (10) – contour cell packs (from 1 to 30 pcs.) – carton packs.

Marketing Authorization Holder

Advanced Perm, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Infusion solution 0.9%: 200 mL or 400 mL bottle

Dosage Form, Packaging, and Composition

Infusion solution 0.9% 100 ml
Sodium chloride 900 mg

200 ml – bottles (1) – carton packs.
200 ml – bottles (28) – carton boxes.
200 ml – bottles (24) – carton boxes.
400 ml – bottles (1) – carton packs.
400 ml – bottles (12) – carton boxes.
400 ml – bottles (15) – carton boxes.

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium chloride Solvent for preparation of injectable dosage forms 0.9%: amp. 1 mL, 2 mL, 4 mL, 5 mL, or 10 mL 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for preparation of injectable dosage forms in the form of a colorless, transparent solution.

1 ml
Sodium chloride 9 mg

Excipients : water for injections – up to 1 ml.

1 ml – ampoules of neutral glass (5) – contour cell packs (1) – carton packs.
1 ml – ampoules of neutral glass (5) – contour cell packs (2) – carton packs.
2 ml – ampoules of neutral glass (5) – contour cell packs (1) – carton packs.
2 ml – ampoules of neutral glass (5) – contour cell packs (2) – carton packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (1) – carton packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (2) – carton packs.
5 ml – ampoules of neutral glass (5) – contour cell packs (1) – carton packs.
5 ml – ampoules of neutral glass (5) – contour cell packs (2) – carton packs.
10 ml – ampoules of neutral glass (5) – contour cell packs (1) – carton packs.
10 ml – ampoules of neutral glass (5) – contour cell packs (2) – carton packs.
1 ml – ampoules of neutral glass (5) – carton packs with corrugated insert.
1 ml – ampoules of neutral glass (10) – carton packs with corrugated insert.
2 ml – ampoules of neutral glass (5) – carton packs with corrugated insert.
2 ml – ampoules of neutral glass (10) – carton packs with corrugated insert.
4 ml – ampoules of neutral glass (5) – carton packs with corrugated insert.
4 ml – ampoules of neutral glass (10) – carton packs with corrugated insert.
5 ml – ampoules of neutral glass (5) – carton packs with corrugated insert.
5 ml – ampoules of neutral glass (10) – carton packs with corrugated insert.
10 ml – ampoules of neutral glass (5) – carton packs with corrugated insert.
10 ml – ampoules of neutral glass (10) – carton packs with corrugated insert.

Table of Contents

TABLE OF CONTENTS