INSTRUCTION

for medical use of the medicinal product

 

SODIUM CHLORIDE ANANTA

 

Composition:

active substance: sodium chloride;

100 ml of solution contain 0.9 g of sodium chloride;

excipients: water for injection.

 

Pharmaceutical form. Solution for infusion.

Basic physical and chemical properties: clear colourless solution.

 

Pharmacotherapeutic group. Blood substitutes and perfusion solutions. Electrolyte solutions.

ATC code В05Х А03.

 

Pharmacological properties.

Pharmacodynamics.

Sodium chloride 0.9%, intravenous infusion, is an isotonic solution with an approximate osmolarity of 308 mOsm/L.

The pharmacodynamic properties of the solution are those of the sodium and chloride ions in maintaining the fluid and electrolyte balance. Ions, such as sodium, circulate through the cell membrane, using various mechanisms of transport, including the sodium pump (Na-K-ATPase). Sodium plays an important role in neurotransmission, cardiac electrophysiology and the renal metabolism as well.

Pharmacokinetics.

Sodium is predominantly excreted by the kidney, but there is extensive renal reabsorption.

Small amounts of sodium are observed in the faeces and sweat.

 

Clinical particulars.

Indications.

Isotonic dehydration.

Sodium deficiency.

Use as a base or diluent for other compatible medicinal products intended for parenteral administration.

 

Contraindications.

The solution is contraindicated in patient with hypernatraemia or hyperchloraemia.

The contraindications related to the added medicinal product should be considered.

 

Interaction with other medicinal products and other forms of interaction.

Drugs causing an increased vasopressin effect

The drugs listed below increase the effect of vasopressin, leading to reduced renal electrolyte excretion and an increased risk of hospital-acquired hyponatraemia following improperly balanced intravenous fluid therapy (see sections “Precautions for use”, “Method of administration and dosage”, “Adverse reactions”):

• - Drugs stimulating vasopressin release: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, neuroleptics, anaesthetic agents.
• - Drugs potentiating vasopressin action: chlorpropamide, NSAIDs, cyclophosphamide.
• - Vasopressin analogues: desmopressin, oxytocin, terlipressin.

Other medicinal products that increase the risk of hyponatraemia also include diuretics and antiepileptics such as oxcarbazepine.

Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be increased during administration of sodium chloride 0.9%. Administration of sodium chloride 0.9% may result in decreased lithium levels.

Corticosteroids/steroids and carbenoxolone are associated with sodium and water retention (with oedema and arterial hypertension) (see section “Precautions for use”).

 

Precautions for use.

• o Fluid balance/renal function

Use in patients with severe renal impairment

Sodium chloride 0.9% should be administered with particular caution to patients with or at risk of severe renal impairment. In such patients, administration of sodium chloride 0.9% may result in sodium retention (see below “Use in patients at risk of sodium retention, fluid overload, and oedema”).

Risk of fluid and/or solute overload and electrolyte imbalance

Depending on the volume and rate of infusion, intravenous administration of sodium chloride 0.9% can cause:

• - Fluid and/or solute overload resulting in hyperhydration/hypervolemia and, for example, congested states, including central and peripheral oedema.
• - Clinically relevant electrolyte disturbances and acid-base imbalance.

In general, the risk of dilutional states (retention of water relative to sodium) is inversely proportional to the electrolyte concentrations of sodium chloride 0.9% and its additions. Conversely, the risk of solute overload causing congested states (retention of solute relative to water) is directly proportional to the electrolyte concentrations of sodium chloride 0.9% and its additions.

Special clinical monitoring is required at the beginning of any intravenous infusion. Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hyponatraemia (see section “Hyponatraemia”).

Hyponatraemia

Patients with non-osmotic vasopressin release (e.g., in acute illnesses, pain, postoperative stress, infections, burns, and central nervous system [CNS] diseases), patients with cardiac, hepatic, or renal disorders, and patients exposed to vasopressin agonists (see section “Interaction with other medicinal products and other forms of interaction”) are at particular risk of developing acute hyponatraemia during infusion of hypotonic fluids.

Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury.

Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

Use in patients at risk for sodium retention, fluid overload and oedema

Sodium chloride 0.9% should be used with extreme caution in patients at risk of:

• - Rapidly correcting hypernatraemia once adaptation has occurred may lead to cerebral oedema, potentially resulting in seizures, permanent brain damage, or death.
• -
• - Metabolic acidosis, which may be worsened by prolonged use of this product, especially in patients with renal impairment.
• - Hypervolaemia such as congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease.
• - Iatrogenic hyperchloraemic metabolic acidosis (e.g., during intravenous volume resuscitation)
• - Conditions that may cause sodium retention, fluid overload and oedema (central and peripheral) in patients with:
• primary hyperaldosteronism,
• secondary hyperaldosteronism, associated with, for example,
  •  hypertension,
  •  congestive heart failure,
  •  liver disease (including cirrhosis),
  •  renal disease (including renal artery stenosis, nephrosclerosis) or pre-eclampsia.

Medications, such as corticosteroids, that may increase the risk of sodium and fluid retention.

Infusion reactions

Symptoms of unknown aetiology which can appear to be hypersensitivity reactions have been reported very rarely in association with infusion of sodium chloride 0.9 %. These have been characterized as hypotension, pyrexia, tremor, chills, urticaria, rash and pruritus. Stop the infusion immediately if signs or symptoms of these reactions develop. Appropriate therapeutic countermeasures should be instituted as clinically indicated.

• o Special patient groups

The consulting physician should be experienced in this product's use and safety in these special populations that are especially sensitive to rapid changes in serum sodium levels.

Rapid correction of hyponatraemia and hypernatraemia is potentially dangerous (risk of serious neurological complications) (see above “Hyponatraemia” / “Use in patients at risk of sodium retention, fluid overload, and oedema. Hypernatraemia”).

Paediatric population

Plasma electrolyte concentrations should be closely monitored in the paediatric population as this population may have impaired ability to regulate fluids and electrolytes. Repeated infusions of sodium chloride should therefore only be given after determination of the serum sodium level.

Elderly

When selecting the type of infusion solution and the volume/rate of infusion for elderly patients, it is necessary to take into account that elderly patients are generally more likely to have cardiac, renal, hepatic, and other diseases or concomitant drug therapy.

• o Added medicinal products

Before adding a medicinal product, it should be ensured that it is soluble and stable in water within the pH range of 0.9% sodium chloride solution for intravenous infusion. Additives can be administered before or during the infusion via the injection site.

The compatibility of the medicinal product with 0.9% sodium chloride solution for intravenous infusion must be checked, as well as the solution for any changes in colour, presence of precipitate, insoluble components, or crystals. The attached instructions for use should be read carefully.

If an additive medicinal product is used prior to parenteral administration, isotonicity must be verified. Careful and precise aseptic mixing of any additive product is mandatory.

Solutions containing additives should be used immediately and not stored.

The addition of other medicinal products or the use of an inappropriate administration method may cause fever due to possible introduction of pyrogens. In the event of an adverse reaction, the infusion should be stopped immediately.

The solution is intended for single use only. Any unused portion of the solution must be discarded.

Partially used containers must not be reused.

Do not remove the infusion device from the outer packaging until it is ready to use. The inner pouch maintains the sterility of the product.

Do not remove the container from the protective film until it is ready to use. The container maintains the sterility of the solution.

 

Pregnancy and lactation.

There are no adequate data from the use of 0.9% sodium chloride solution in pregnant or lactating women. The physician should carefully consider the potential risks and benefits for each specific patient before administering 0.9% sodium chloride solution.

0.9% sodium chloride solution should be used with particular caution in pregnant women during labour, specifically taking into account serum sodium levels, especially if administered in combination with oxytocin (see sections “Interaction with other medicinal products and other forms of interaction”, “Precautions for use”, “Adverse reactions”).

Sodium chloride should be used with caution in patients with pre-eclampsia (see section “Precautions for use”).

If another medicinal product is added, the use of that product during pregnancy and breastfeeding should be considered separately.

 

Effects on ability to drive and use machines.

No studies have been conducted on the influence of sodium chloride 0.9% on the ability to drive vehicles or operate other machines.

 

Method of administrations and dosage.

Adults, elderly and children

Doses may be expressed in terms of mEq or mmol of sodium, mass of sodium, or mass of sodium salt (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol of Na and Cl).

Fluid balance, serum electrolytes and acid-base balance should be monitored before and during administration, with particular attention to serum sodium in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs, due to the risk of hospital acquired hyponatremia (see sections “Interaction with other medicinal products and other forms of interaction”, “Precautions for use”, “Adverse reactions”). Monitoring of serum sodium is particularly important for hypotonic fluids.

Theoretical osmolarity of 0.9% sodium chloride solution for intravenous infusion is 308 mOsm/L.

The rate and volume of infusion depend on the patient’s age, weight, and clinical condition (e.g., burns, surgery, head trauma, infection), and concomitant therapy should be prescribed by a physician experienced in intravenous infusion therapy (see sections “Special warnings and precautions for use” and “Adverse reactions”).

• Recommended dosage:

Treatment of isotonic dehydration and sodium deficiency:

– Adults: 500 ml to 3 L per 24 hours.

– Infants and children: 20 to 100 ml per kilogram of body weight per day, depending on age and total body weight.

The recommended dosage when used as a diluent ranges from 50 to 250 ml per dose of medicinal product to be administered.

When 0.9% sodium chloride solution is used as a diluent for other injectable medicinal products, the doses and infusion rate will depend on the properties and dosing regimen of the prescribed medicinal product.

• Method of administration

The medicinal product is intended for administration by intravenous infusion via a sterile, pyrogen-free set (infusion system) using aseptic technique. The equipment should be primed with the solution to prevent air from entering the system.

Before use, the medicinal product should be visually inspected for particulate matter and discoloration.

The solution may only be used if it is clear, free from visible particles, and if the sealing film is intact. Do not remove the container from the protective film until it is ready for use. The container maintains the sterility of the solution. The container should be set up immediately after the infusion set is installed.

Plastic containers must not be connected in series to avoid air embolism due to residual air in the primary container. Squeezing plastic containers with intravenous solutions to increase flow rate may cause air embolism if residual air in the container has not been completely removed before administration.

The use of a ventilated intravenous infusion set with an open vent may lead to air embolism. Ventilated intravenous infusion sets with an open vent should not be used with flexible plastic containers.

For incompatibilities, see section “Incompatibilities”.

 

Children.

Children with isotonic dehydration and sodium depletion should be administered 20 to 100 ml/kg body weight/day, depending on age and body weight.

Electrolyte concentrations in plasma must be closely monitored, as the ability to regulate water-electrolyte balance may be reduced in paediatric patients. Repeat infusions of sodium chloride should only be given after serum sodium levels have been determined.

 

Overdose.

General adverse effects of sodium excess in the body include nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivation and lacrimation, sweating, fever, tachycardia, hypertension, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma, and death.

An excessive volume of 0.9% sodium chloride solution may lead to hypernatraemia (which can lead to CNS manifestations, including seizures, coma, cerebral oedema and death) and sodium overload (which can lead to central and/or peripheral oedema) and should be treated by an attending specialised physician.

Excess chloride in the body may cause a loss of bicarbonate with an acidifying effect.

When 0.9% sodium chloride solution is used as a diluent for injectable preparations of other drugs, the signs and symptoms of over infusion will be related to the nature of the additives being used. In the event of accidental over infusion, treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the drug administered. The relevant measures should be provided as necessary.

 

 

Adverse reactions.

The following adverse reactions have been reported in post-marketing experience. The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data.

System organ class	Adverse reactions	Frequency
Nervous system disorders	Tremor Acute hyponatraemic encephalopathy*	Not known
Metabolism and nutrition disorders	Hospital acquired hyponatraemia*	Not known
Vascular disorders	Hypotension	Not known
Skin and subcutaneous tissue disorders	Urticaria Rash Pruritus	Not known
General disorders and administration site conditions:	Infusion site reactions, such as -       Infusion site erythema. -       Injection site streaking, burning sensation. -       Infusion site urticaria. -       Fever. -       Chills.	Not known

* Hospital-acquired hyponatraemia may lead to irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy (see sections “Interaction with other medicinal products and other forms of interaction”, “Precautions for use”, “Method of administration and dosage”).

 

Adverse reactions not reported during the use of this medicinal product but which may occur:

– Hypernatraemia (e.g., in patients with nephrogenic diabetes or high nasogastric losses).

– Hyperchloremic metabolic acidosis.

– Hyponatraemia, which may be symptomatic. Hyponatraemia may occur when normal water excretion is impaired (e.g., in SIADH or in the postoperative period).

General adverse effects of sodium excess are described in the section “Overdose.”

Additives

When 0.9% sodium chloride solution is used as a diluent for other medicinal products, the properties of these added substances will determine the likelihood of any additional adverse reaction.

In the event of an adverse reaction, the patient should be examined and appropriate measures initiated if necessary, and the infusion should be discontinued. If required, the remaining solution should be retained for investigation.

 

Adverse Reactions Reporting

Adverse reactions reporting after the registration of a medicinal product is of great importance. It enables the monitoring of the benefit/risk ratio associated with the use of the medicinal product. Healthcare professionals, pharmacists, as well as patients or their legal representatives, should report all suspected adverse reactions and cases of lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

 

Shelf life.

3 years.

In-use shelf life: Additives.

Chemical and physical stability of any additive at the pH of sodium chloride 0.9% intravenous infusion should be established prior to use.

From a microbiological point of view, the diluted product must be used immediately unless dilution has taken place in controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.

 

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °С.

Keep out of reach of children.

 

Incompatibilities.

As with all parenteral solutions compatibility of the additives with the solution must be assessed before addition. In the absence of compatibility studies, this solution must not be mixed with other medicinal products. Those additives known to be incompatible should not be used.

 

Packaging.

100 ml of preparation in a container. 1 film-coated container in a box.

 

Terms of dispensing.

On prescription.

 

Manufacturer.

Eurolife Healthcare Pvt. Ltd.

 

Manufacturer’s registered address.

Khasra No. 520, Bhagwanpur, Roorkee, Haridwar, Uttarakhand, India.

 

Applicant.

Ananta Medicare Ltd.

 

Applicant’s registered address.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.

 

Date of last update.

16.09.2025