Sodium Chloride 0.45% Solution for Infusion is indicated for the treatment of hypertonic extracellular dehydration or hypovolaemia in cases where the intake of fluids and electrolytes by normal routes is not possible.
It can also be used as a vehicle or diluent of compatible medicinal products.

Posology

Adults, older people , adolescents and children:

The dosage, rate and duration of administration is to be individualised as determined by several factors including age, weight, clinical condition, concomitant treatment and in particular the patient's hydration state, clinical and laboratory response to treatment. Fluid balance and plasma electrolyte concentrations must be monitored during treatment.
- Recommended dosage
- For adults, older people and adolescents: 500 ml to 3 litres/24h,
- For babies and children: 20 to 100 ml per 24 h and per kg of body weight, depending on the age and the total body mass.
- The recommended dosage when used as a vehicle or diluent ranges from 50 to 250 ml per dose of medicinal product to be administered.
Administration rate:
The infusion rate depends on the patient clinical conditions. It is usually:
- 40 ml/kg/24h for adults, older people and adolescents,
- 5 ml/kg/h in average for paediatric patients but the value varies with age:
- 6-8 ml/kg/h for infants,
- 4-6 ml/kg/h for toddlers,
- 2-4 ml/kg/h for schoolchildren. Note: - Infants and toddlers: age ranges from about 28 days to 23 months (a toddler is an infant who can walk),
- Children and schoolchildren: age ranges from about 2 years to 11 years.
When Sodium Chloride 0.45% Solution for Infusion is used as a diluent for injectable preparations of other medicinal products, the infusion rate will also be dictated by the nature and the dose regimen of the prescribed medicinal products.
Method of Administration:

The solution is for administration by intravenous infusion through a sterile and non-pyrogenic administration set, using aseptic technique. The equipment should be primed with the solution to
prevent air entering the system.
The product should be inspected visually for particulate matter and discoloration prior to
administration. Do not administer unless solution is clear, free from visible particles and the seal
is intact Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the solution. Administer immediately following the insertion of infusion set.
Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Pressurizing intravenous solutions contained in
flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration
set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.
Additives may be introduced before infusion or during infusion through the injection site. Adding
other medication or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. If an adverse event occurs the patient evaluated and appropriate countermeasures started, if needed the infusion should be stopped.
For information on incompatibilities and preparation of the product with additives, please see sections 6.2 and 6.6.

The solution is contra-indicated in patient presenting: • Hyponatraemia, hypochloraemia, • Extracellular hyperhydration or hypervolaemia, • Severe renal insufficiency (with oliguria/anuria), • Fluid and sodium retention, • Uncompensated cardiac failure, • General oedema and ascitic cirrhosis. The contra-indications related to the added medicinal product should be considered.

Electrolyte balance
Hyponatraemia/Hypernatraemia
The infusion of solutions with sodium concentrations <0.9% may result in hyponatraemia. Close clinical monitoring may be warranted. Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema and death. The risk for hyponatraemia is increased, for example,

• in children
• in elderly patients
• in women
• postoperatively
• in persons with psychogenic polydipsia • in patients treated with medications that increase the risk of hyponatraemia (such as certain antiepileptic and psychotropic medications).
The risk for developing hyponatraemic encephalopathy is increased, for example,
• in paediatric patients (≤16 years of age)
• in women (in particular pre-menopausal women)
• in patients with hypoxemia • in patients with underlying central nervous system disease
Acute symptomatic hyponatraemic encephalopathy is considered a medical emergency.
Hyponatraemia should be corrected at a calculated rate to prevent hyponatraemic encephalopathy.
Rapid correction of hyponatraemia and hypernatremia is potentially dangerous (risk of serious neurologic complications). Rapidly correcting hypernatremia once adaptation has occurred may lead to cerebral oedema, potentially resulting in seizures, permanent brain damage, or death. Dosage, rate, and duration of administration should be determined by a physician experienced in
intravenous fluid therapy

Fluid balance/renal function
Use in patients with moderate renal impairment
The product should be administered with particular caution, to patients with moderate renal impairment. In such patients administration of Sodium Chloride 0.45% Solution for Infusion may result in sodium retention.
Risk of fluid and/or solute overload and electrolyte disturbances
Depending on the volume and rate of infusion, intravenous administration of 0.45% Sodium Chloride Injection can cause

Fluid and/or solute overload resulting in over hydration/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 is inversely proportional to the electrolyte concentrations in the solution and additions. The risk of solute overload causing congested states is directly proportional to the electrolyte concentration in the solution and its additions.
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. Use in patients at risk for sodium retention, fluid overload and oedema
Sodium Chloride 0.45% Solution for Infusion should be used with particular caution, if at all, in patients with or at risk for:
• Hypervolemia • Conditions that may cause sodium retention, fluid overload and oedema (central and peripheral), such as 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 that may increase the risk of sodium and fluid retention, such as corticosteroids

Infusion reactions
Symptoms of unknown aetiology which can appear to be hypersensitivity reactions have been reported very rarely in association with parenteral infusion of Sodium Chloride. 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.

Specific 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 hypernatremia is potentially dangerous (risk of serious neurologic complications). See section “Hyponatraemia/hypernatraemia” above.
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 only be given after determination of serum sodium level.
The infusion of hypotonic fluids together with the non-osmotic secretion of ADH may result in hyponatraemia. Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema and death, therefore acute symptomatic hyponatraemic encephalopathy is considered a
medical emergency.
Geriatric population
In older people, the risk for hyponatraemia is increased. When selecting the type of infusion
solution and the volume/rate of infusion for a geriatric patient, consider that geriatric patients are generally more likely to have cardiac, renal, hepatic, and other diseases or concomitant drug therapy.

Other warnings
Osmolarity
Sodium Chloride 0.45% Solution for Infusion is hypotonic with an osmolarity of approximately 154 mOsmol/L.
Administration with Blood Products
Do not mix or administer Sodium Chloride 0.45% Solution for Infusion through the same administration set with whole blood or cellular blood components.
During long-term infusion, the doctor can decide to give you an appropriate nutritive supply.
As with all parenteral solutions, compatibilities should be checked when additives are used (see section 6.2).

 

 

 

 

Interaction related to the presence of sodium:
Corticoids/Steroids and carbenoxolone, which are associated with the retention of sodium and
water (with oedema and hypertension), see section 4.4 special warnings and precautions for use.
Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be decreased in the presence of hyponatraemia. Administration of Sodium Chloride 0.45% Solution
for Infusion may result in increased lithium levels.

There are no adequate data from the use Sodium Chloride 0.45% Solution for Infusion in pregnant or lactating women. The physician should carefully consider the potential risks and benefits for each specific patient before administering Sodium Chloride 0.45% Solution
When a medicinal product is added, the nature of the drug and its use during pregnancy and
lactation have to be considered separately.

There is no information on the effects of Sodium Chloride 0.45% Solution for Infusion on the ability to operate an automobile or other heavy machinery

The following undesirable effects have been reported to have occurred during or following
infusion of 0.45% Sodium Chloride Injection. The frequency of the adverse drug reactions listed
in this section cannot be estimated from the available data

Metabolism and nutrition disorders

Overhydration* (associated or not with polyuria) in patients with
cardiac disorder or pulmonary oedema

Asymptomatic electrolyte disturbance

Hyponatraemia

Cardiac disorders

Heart failure in patients with cardiac disorder or pulmonary oedema

Vascular disorders

Thrombophlebitis
Venous thrombosis

General disorders and administration site conditions

Fever

Injection site pain
Injection site reaction

Injection site phlebitis

 Injection site irritation

Injection site infection

Extravasation

Adverse reactions associated with the technique of administration
The following adverse reactions have not been reported with this product but may occur: • Hyperchloraemic metabolic acidosis
• Infusion reactions, including hypotension, tremor, chills, urticaria, rash, and pruritus.
Adverse reactions may be associated to the medicinal products added to the solution; the nature of theadditive will determine the likelihood of any other undesirable effects.
If an adverse event occurs the patient should be evaluated and appropriate countermeasures started, if needed the infusion should be stopped

An excessive volume of Sodium Chloride 0.45% Solution for Infusion may lead to:
• hypo- and hypernatremia (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).
See also section 4.4.
Excessive administration of chloride salts may cause a loss of bicarbonate with an acidifying effect.
When Sodium Chloride 0.45% Solution for Infusion is used as a diluent for injectable preparations of other medicinal products, 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 and supportive measures should be provided as necessary.

Pharmacotherapeutic group “Electrolyte solutions”,
ATC code B05XA03.
Sodium Chloride 0.45% Solution for Infusion is a hypotonic solution, with an approximate osmolarity of 154 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, among which is the sodium pump (Na-K-
ATPase). Sodium plays an important role in neurotransmission and cardiac electrophysiology, and
also in renal function.
Chloride is mainly an extracellular anion. Intracellular chloride is in high concentration in red blood cells and gastric mucosa. Reabsorption of chloride follows reabsorption of sodium.
When medication is added to Sodium Chloride 0.45% Solution for Infusion, the overall pharmacodynamics of the solution will depend on the nature of the medicinal product used.

Sodium and Chloride are mainly distributed in blood and extracellular compartiments (Na+: 142
mmol/l – Cl-: 103 mmol/l).
Sodium is predominantly excreted by the kidney with a renal reabsorption.
Small amounts of sodium are lost in the faeces and sweat at the skin level.
When medication is added to 0.45% Sodium Chloride Injection, the overall pharmacokinetics of
the solution will depend on the nature of the medicinal product used.

Preclinical safety data of this solution for infusion in animals are not relevant since its constituents
are physiological components of animal and human plasma.
Toxic effects are not to be expected under the condition of clinical application.
The safety of potential additives should be considered separately.

Water for Injections

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.

2 Years

Do not store above 30°C.

The container is made of Low Density-Polyethylene (LDPE) The primary packaging material
Low Density-Polyethylene (LDPE) is used for several years in the pharmaceutical industry for
the primary packaging of comparable drug products. The material is known for its compatibility
with the ingredients of the drug product. 

The container material, LD (Low Density)-polyethylene meets the requirements of the European
Pharmacopoeia (Ph. Eur. 3.2.2).
The material shows a density of 0.9%26-0.9%30 g/cm3.The container can be sterilised at temperatures between 106-112 °C. Bag size: 500 ml
Outer carton contents: 20 bags of 500 ml

Please see section 4.2 for information regarding the method of administration.
Before adding a drug, verify it is soluble and stable in water at the pH range of 0.45% Sodium Chloride Injection (pH 4.5 to 7.0). Additives may be introduced before infusion or during infusion
through the injection site.
It is the responsibility of the healthcare professional to judge the incompatibility of an additive medication with 0.45% Sodium Chloride Injection, by checking for eventual colour change and/or eventual appearance of precipitate, insoluble complexes or crystals. The instruction for use of the medicinal product to be added must be consulted.
When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bottle.
Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the product.
1. Techniques for injection of additive medications:
a) Clean the injection site using antiseptic solution. b) Carefully introduce the sterile needle into the sterile chamber in the injection site. attach the needle to the container with the medicinal product.
c) introduce the needle through the second membrane into the bag and inject the medicine. d) Carefully withdraw the needle. e) Mix thoroughly with the solution.
f) Use immediately.