NACL

Adults:

The volume and rate of infusion will depend on the condition of the individual patient and the judgement of the physician. The rate of infusion should not exceed 10-20mmols of potassium per hour. The total daily dosage of potassium should not exceed 200mmols.

Paediatric population:

The volume and rate of infusion will depend on the condition of the individual patient and the judgement of the physician. Correspondingly reduced volumes and rates of infusion may be required.

Elderly:

The volume and rate of infusion may need to be reduced in the elderly to avoid circulatory overload, particularly in patients with cardiac or renal insufficiency. Fluid balance, serum glucose, serum sodium and other electrolytes may need to be monitored before and during administration, especially 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 hyponatraemia.

Monitoring of serum sodium is particularly important for physiologically hyptonic fluids. 8). For intravenous infusion

Tabulated list of adverse reactions System Organ Class Symptoms (LLT terms MedDRA) Frequency Metabolism and nutrition disorders Hospital acquired hyponatraemia* Hyperkalaemia Neurological disorders Hyponatraemic encephalopathy* General disorders and administration site conditions Listlessness Weakness Cardiac disorders Arrhythmias Cardiac arrest.

4). 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

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Caution should be exercised in the volume and rate of infusion since fluid overload and hyperkalaemia may compromise cardiac function. Before administering potassium by the intravenous-route a non-potassium containing hydrating solution should be administered to ensure adequate renal function.

Intravenous infusions containing glucose are usually isotonic solutions. 2). Intravenous administration of fluids containing glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatraemia. g. 5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids.

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

g. meningitis, intracranial bleeding, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

Addison's disease, adrenal insufficiency, acute or chronic renal disease, oliguria, anuria and patients with hyperkalaemia. The intravenous infusion of dextrose solutions may also be hazardous in patients with impaired hepatic function.