Sodium chloride ananta

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SODIUM CHLORIDE ANANTA (SODIUM CHLORIDE ANANTA)

Composition:

Active substance: sodium chloride;

100 ml of solution contain 0.9 g of sodium chloride;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Electrolyte solutions. ATC code B05X A03.

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 due to the presence of sodium and chloride ions, which help maintain fluid and electrolyte balance. Ions such as sodium cross the cell membrane via various transport mechanisms, including the sodium pump (Na-K-ATPase). Sodium plays an important role in neurotransmission and cardiac electrophysiology, as well as in renal metabolism.

Pharmacokinetics.

Sodium is primarily excreted by the kidneys, but extensive renal reabsorption is observed.

Small amounts of sodium are found in feces and sweat.

Clinical characteristics.

Indications.

Isotonic dehydration.

Sodium deficiency.

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

Contraindications.

The solution is contraindicated in patients with hypernatraemia or hyperchloraemia.

Contraindications related to the added medicinal product must also be taken into account.

Interaction with other medicinal products and other forms of interactions.

Medicinal products that enhance the effect of vasopressin

The following medicinal products enhance the effect of vasopressin, leading to reduced renal excretion of electrolytes and an increased risk of hospital-acquired hyponatraemia when intravenous fluid therapy is inadequately balanced (see sections "Special precautions for use", "Dosage and administration", "Side effects"):

• Medicinal products that stimulate vasopressin release: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine (MDMA), ifosfamide, neuroleptics, anaesthetic agents.
• Medicinal products that potentiate the action of vasopressin: chlorpropamide, non-steroidal anti-inflammatory drugs, cyclophosphamide.
• Vasopressin analogues: desmopressin, oxytocin, terlipressin.

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

Sodium chloride should be used with caution in patients receiving lithium. Renal clearance of both sodium and lithium may increase during administration of 0.9% sodium chloride. Administration of 0.9% sodium chloride may lead to reduced lithium levels.

Corticosteroids/steroids and carbenoxolone are associated with sodium and water retention (with oedema and arterial hypertension) (see section "Special precautions for use").

Special precautions for use.

• Fluid balance/kidney function

Use in patients with severe renal impairment

Sodium chloride 0.9% should be administered with particular caution to patients with severe kidney dysfunction or those at risk of developing it. In such patients, administration of sodium chloride 0.9% may lead to sodium retention (see below "Use in patients at risk of sodium retention, fluid overload, and edema").

Risk of fluid and/or solute overload and electrolyte imbalance

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

• Fluid and/or solute overload, leading to hyperhydration/hypervolemia and overloaded states, including central and peripheral edema.
• Clinically significant disturbances in electrolyte and acid-base balance.

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

Careful clinical monitoring is necessary at the beginning of any intravenous infusion. Clinical assessment and periodic laboratory tests may be required to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or when the patient's condition or infusion rate necessitates such evaluation.

Large-volume infusions should be administered with careful monitoring in patients with cardiac or pulmonary insufficiency, as well as in patients with non-osmotic vasopressin release, including syndrome of inappropriate antidiuretic hormone secretion (SIADH), due to the risk of hyponatremia (see below "Hyponatremia").

Hyponatremia

Patients with non-osmotic vasopressin release (e.g., due to acute illness, pain, postoperative stress, infections, burns, or central nervous system [CNS] disorders), patients with heart, liver, or kidney disease, 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 hyponatremia when receiving hypotonic fluids.

Acute hyponatremia may lead to acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at increased risk of severe, irreversible, and life-threatening brain injury.

Children, women of reproductive age, and patients with brain disorders (e.g., meningitis, intracranial hemorrhage, traumatic brain injury, cerebral edema) are at increased risk of severe and life-threatening cerebral edema caused by acute hyponatremia.

Use in patients at risk of sodium retention, fluid overload, and edema

Sodium chloride 0.9% should be used with particular caution in patients at risk of developing the following conditions:

• Hypernatremia. Rapid correction of hypernatremia after adaptation may lead to cerebral edema, potentially resulting in seizures, irreversible brain damage, or death.
• Hyperchloremia.
• Metabolic acidosis, which may worsen with prolonged use of this product, especially in patients with impaired renal function.
• Hypervolemia, such as congestive heart failure and pulmonary edema, particularly in patients with cardiovascular disorders.
• Iatrogenic hyperchloremic metabolic acidosis (e.g., during intravenous volume resuscitation).
• Conditions that may cause sodium retention, fluid overload, and edema (central and peripheral):
  • primary hyperaldosteronism,
  • secondary hyperaldosteronism associated, for example, with:
    • arterial hypertension,
    • congestive heart failure,
    • liver disease (including cirrhosis),
    • kidney disease (including renal artery stenosis, nephrosclerosis), or preeclampsia.

Medicinal products such as corticosteroids may increase the risk of sodium and fluid retention.

Infusion reactions

Very rarely, symptoms of unknown etiology, possibly indicative of hypersensitivity reactions, have been reported with the use of 0.9% sodium chloride infusion. These included arterial hypotension, hyperthermia, tremor, chills, urticaria, rash, and pruritus. If signs or symptoms of such reactions occur, the infusion should be stopped immediately. Therapeutic measures should be taken according to clinical guidelines.

• Special patient groups

The physician should have experience regarding the safety of using the product in special populations who are particularly sensitive to rapid changes in serum sodium levels.

Rapid correction of hyponatremia and hypernatremia is potentially dangerous (risk of serious neurological complications) (see above "Hyponatremia" / "Use in patients at risk of sodium retention, fluid overload, and edema. Hypernatremia").

Children

Serum electrolyte concentrations should be carefully monitored in children, as this patient group may have impaired ability to regulate fluids and electrolytes. Therefore, repeated infusions of sodium chloride should be administered only after determining serum sodium levels.

Elderly patients

When selecting the type of infusion solution and the volume/infusion rate for elderly patients, it should be considered that geriatric patients often have cardiac, renal, or hepatic impairment or are receiving concomitant medication.

• Added medicinal products

Before adding a medicinal product, ensure that it is soluble and stable in water within the pH range of 0.9% sodium chloride solution for intravenous infusion. Additives may be introduced before or during infusion through the injection site.

Compatibility of the medicinal product with 0.9% sodium chloride solution for intravenous infusion must be verified. The solution should also be inspected for changes in color and for the presence of precipitate, insoluble components, or crystals. The package leaflet of the added medicinal product should be consulted.

If a medicinal product is added for parenteral administration, isotonicity should be verified. Careful and precise aseptic mixing of any added medicinal product is mandatory.

Solutions containing additives should be used immediately and not stored.

Adding other medicinal products or using an inappropriate administration method may result in fever due to possible pyrogen administration. In case of an adverse reaction, the infusion should be stopped immediately.

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

Partially used containers must not be reused.

Do not remove the infusion device from the outer packaging until ready to use. The inner bag maintains product sterility.

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

Use during pregnancy or breastfeeding

Adequate data on the use of 0.9% sodium chloride in pregnant and breastfeeding women are lacking. The physician must carefully weigh the potential risks and benefits for each individual patient before administering 0.9% sodium chloride.

Sodium chloride 0.9% should be used with particular caution in pregnant women during labor, especially considering serum sodium levels, particularly if administered in combination with oxytocin (see sections "Interaction with other medicinal products and other forms of interaction", "Special precautions for use", "Side effects").

Caution is recommended when using sodium chloride in patients with preeclampsia (see section "Special precautions for use").

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

Ability to affect reaction speed when driving or operating machinery

No studies have been conducted on the effect of 0.9% sodium chloride on the ability to drive or operate machinery.

Method of Administration and Dosage

Adults, including elderly patients, and children

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

Fluid balance, serum electrolyte levels, and acid-base balance must be monitored before and during administration. Special attention should be paid to monitoring serum sodium levels in patients with increased non-osmotic vasopressin release (SIADH) and in patients receiving concomitant therapy with vasopressin agonists due to the risk of hospital-acquired hyponatremia (see sections "Interaction with Other Medicinal Products and Other Forms of Interaction", "Special Warnings and Precautions for Use", "Adverse Reactions"). Monitoring of serum sodium levels is particularly important when hypotonic fluids are used.

The theoretical osmolarity of 0.9% sodium chloride for intravenous infusion is 308 mOsmol/L.

The rate and volume of infusion depend on age, body weight, clinical condition of the patient (e.g., burns, surgery, head trauma, infection), and should be determined 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:

• For adults: 500 mL to 3 L / 24 hours.
• For infants and children: 20 to 100 mL per kilogram of body weight per day, depending on age and total body weight.

The recommended dose when used as a solvent is 50 to 250 mL per dose of medicinal product to be administered.

When 0.9% sodium chloride is used as a solvent for other injectable drugs, the dosage 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 intravenous infusion using a sterile, pyrogen-free infusion set (infusion system) under aseptic technique. The equipment should be primed with the solution to prevent air from entering the system.

Before administration, the medicinal product should be visually inspected for the presence of particulate matter and discoloration.

The solution may be used only if it is clear, free from visible particles, and if the seal film is undamaged. The container should not be removed from its protective film until ready for use. The container maintains the sterility of the solution. The container should be set up immediately after connecting the infusion set.

Plastic containers should not be connected in series to avoid the risk of air embolism due to possible residual air in the primary container. Squeezing plastic containers containing intravenous solutions to increase flow rate may lead to air embolism if residual air in the container has not been completely expelled before administration.

Using a vented intravenous administration set with an open vent may result in air embolism. Vented intravenous administration sets with an open vent must not be used with flexible plastic containers.

For incompatibilities, see section "Incompatibilities".

Children.

In children with isotonic dehydration and sodium deficiency, administer 20 to 100 mL/kg body weight per day, depending on age and body weight.

Plasma electrolyte concentrations must be carefully monitored, as the ability to regulate water and electrolyte balance in pediatric patients may be reduced. Repeat infusions of sodium chloride should be administered only after determination of serum sodium levels.

Overdose.

General adverse reactions due to excess sodium in the body include: nausea, vomiting, diarrhea, abdominal cramps, thirst, decreased salivation and lacrimation, increased sweating, fever, tachycardia, arterial hypertension, renal failure, peripheral and pulmonary edema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscle twitching and rigidity, seizures, coma, and fatal outcome.

Excessive administration of 0.9% sodium chloride may lead to hypernatremia (which may cause central nervous system reactions such as seizures, coma, cerebral edema, and death) and sodium overload (which may cause central and/or peripheral edema); therefore, medical supervision is required.

Excess chloride in the body may lead to bicarbonate loss with acidifying effect.

When 0.9% sodium chloride is used as a solvent for other injectable medicinal products, signs and symptoms of overdose will be related to the nature of the added drugs. In case of accidental overdose, treatment should be discontinued and the patient should be examined for signs and symptoms related to the administered drug. Appropriate measures should be taken if necessary.

Adverse reactions.

The adverse reactions listed below were reported during post-marketing studies. The frequency of these adverse reactions is unknown, as it cannot be estimated from the available data.

* Hospital-acquired hyponatremia may lead to irreversible brain damage and death due to the development of acute hyponatremic encephalopathy (see sections "Interaction with other medicinal products and other forms of interaction", "Special precautions for use", "Method of administration and dosage").

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

• Hypernatremia (e.g., when administered to patients with nephrogenic diabetes insipidus or high nasogastric output).
• Hyperchloremic metabolic acidosis.
• Hyponatremia, which may be symptomatic. Hyponatremia may occur due to impaired water excretion (e.g., in SIADH or in the postoperative period).

General adverse effects of sodium overload are described in the section "Overdose".

Added substances

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

If an adverse reaction occurs, 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.

Reporting of adverse reactions

Reporting of adverse reactions following medicinal product registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Shelf life after dilution: added substances.

Prior to use, chemical and physical stability of any additive at the pH of 0.9% sodium chloride for intravenous infusion must be established.

From a microbiological standpoint, the diluted product should be used immediately unless dilution has been carried out under controlled and validated aseptic conditions. If the diluted product is not used immediately, responsibility for storage conditions and duration rests with the user.

Storage conditions.

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

Keep out of reach of children.

Incompatibilities.

As with all parenteral solutions, compatibility of additives with the solution must be evaluated prior to addition. In the absence of compatibility studies, the solution should not be mixed with other medicinal products. Incompatible additives should not be used.

Packaging.

100 ml of the product in containers. 1 container in a pouch in a carton.

Prescription status.

Prescription only.

Manufacturer.

EuroLife Healthcare Pvt. Ltd.

Manufacturer's address and place of business.

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

Marketing Authorization Holder.

Ananta Medicare Ltd.

Address of the Marketing Authorization Holder.

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