Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
The solution is contra-indicated in patient presenting:
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).
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 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.
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.
Depending on the volume and rate of infusion, intravenous administration of Sodium Chloride 0.45% Solution for Infusion can cause
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.
Sodium Chloride 0.45% Solution for Infusion should be used with particular caution, if at all, in patients with or at risk for:
Medications that may increase the risk of sodium and fluid retention, such as corticosteroids.
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.
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.
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.
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.
Sodium Chloride 0.45% Solution for Infusion is hypotonic with an osmolarity of approximately 154 mOsmol/L.
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).
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).
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)
Metabolism and nutrition disorders:
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:
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 suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard
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.
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