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, Adolescents and Children:
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
hyponatraemia (see sections 4.4, 4.5 and 4.8). Monitoring of serum sodium is particularly
important for hypotonic fluids.
Sodium Chloride 0.45% Solution for Infusion has a tonicity of 154 mOsm/l (approx.)
The infusion rate and volume depend on age, weight, clinical condition (e.g. burns, surgery,
head-injury, infections) and concomitant therapy should be determined by the consulting
physician experienced in intravenous fluid therapy (see sections 4.4. and 4.8).
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.
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 hospital-acquired hyponatraemia (see below).
Hyponatraemia
Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress,
infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients
exposed to vasopressin agonists (see section 4.5) are at particular risk of acute hyponatraemia
upon infusion of hypotonic fluids.
Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema)
characterized by headache, nausea, seizures, lethargy, and vomiting. The risk for hyponatraemia
is increased, for example,
• In children
• In elderly patients
• In women
• In patients with hypoxemia
• In patients with underlying central nervous system disease
• Postoperatively
• In persons with psychogenic polydipsia in patients treated with medications that increase the
risk of hyponatraemia (such as certain antiepileptic and psychotropic medications).
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.
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 Sodium Chloride
0.45% Solution for Infusion 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.
Drugs leading to an increased vasopressin effect:
The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free
water excretion and may increase the risk of hospital acquired hyponatraemia following
inappropriately balanced treatment with i.v. fluids (see sections 4.2, 4.4 and 4.8).
• Drugs stimulating vasopressin release include: Chlorpropamide, clofibrate, carbamazepine,
vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine,
ifosfamide, antipsychotics, and narcotics
• Drugs potentiating vasopressin action include: Chlorpropamide, NSAIDs, and
cyclophosphamide
• Vasopressin analogues include: Desmopressin, oxytocin, terlipressin
Other medicinal products increasing the risk of hyponatraemia also include diuretics in general
and antiepileptics such as oxcarbazepine.
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.
Sodium Chloride 0.45% Solution for Infusion should be administrated with special caution for
pregnant women during labour particularly as to serum-sodium if administered in combination
with oxytocin (see section 4.4, 4.5 and 4.8).
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 Sodium Chloride 0.45% Solution for Infusion.

System Organ Class	Symptoms (LLT terms MedDRA)
	Overhydration* (associated or not with polyuria) in patients with cardiac disorder or pulmonary oedema Asymptomatic electrolyte disturbance Hyponatraemia Hospital acquired hyponatraemia**
Nervous system disorders	Acute hyponatraemic encephalopathy**
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*

The frequency of the adverse drug reactions listed in this section cannot be estimated from the
available data
* Adverse reactions associated with the technique of administration
**Hospital acquired hyponatraemia may cause irreversible brain injury and death, due to
development of acute hyponatraemic encephalopathy, frequency unknown (see sections 4.2. 4.4,
4.5).
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 the additive 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
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa
Other GCC States:
Please contact the relevant competent authority

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-KATPase).
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 Sodium Chloride 0.45% Solution for Infusion, 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

Incompatibility of the medicinal product to be added to the solution in Viaflo container must be
assessed before addition. Those additives known to be incompatible should not be used.
In the absence of compatibility studies, this solution must not be mixed with other medicinal
productsSee section 6.6 for further instructions on the use of the product with additives

2 years for Non-PVC Bags 4 years for Plastic Bottles

Do not store above 30°C.

250 ml, 500 ml and 1000ml Non-PVC Bags.
250 ml, 500 ml and 1000 ml Plastic bottle (polyethylene).

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 the Sodium
Chloride 0.45% Solution for Infusion (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 the Sodium Chloride 0.45% Solution for Infusion, 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 bags.
Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of
the product.