SODIUM CHLORIDE

Warning:

This product must be diluted in drinks, breast milk or formula feed before administration. Treatment with Sodium Chloride 1 mmol/ml Oral Solution should only be initiated under the supervision of specialist paediatric physicians. Dosage should be adjusted if necessary according to clinical need and after plasma sodium monitoring.

Infants: 3 to 5 mmol (3 to 5 ml of Sodium Chloride 1mmol/ml Oral Solution) per kg daily in divided doses. Dosages can be adjusted according to patient requirements. Example dilutions are 2 mmol (2 ml) diluted in 100ml formula feed, or 3 to 4 mmol (3 to 4 ml) diluted in 100 ml breast milk.

Always ensure the product is added and thoroughly mixed into the drink, breast milk or formula feed immediately before administration.

Paediatric population Hypernatremia is an adverse outcome associated with excessive sodium chloride intake. A major symptom of hypernatremia is thirst, which is not always obvious in young infants. Other clinical manifestations are neurologic, due to an osmotic shift of water out of brain cells.

Patients may exhibit lethargy, weakness, irritability, confusion, or neuromuscular excitability. In more extreme cases this can lead to seizures and coma. 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. uk

For oral or enteral administration only.

Warning:

This product must be diluted in drinks, breast milk or formula feed before administration. Care should be taken when administering in conditions where normal electrolyte balance may be disturbed. g. medication or intravenous fluids.

1. Sodium Chloride 1 mmol/ml Oral Solution is contraindicated in any situation where salt retention is undesirable, such as oedema, heart failure and aldosteronism. Sodium Chloride 1 mmol/ml Oral Solution should not be administered to patients with intestinal obstruction.

During the first few days after birth, there is a physiological reduction of extracellular fluid volume as the infant adjusts to extra-uterine life. Hyponatraemia in this situation may reflect water retention rather than sodium deficiency, and treatment should be undertaken by monitoring and adjustment of water balance rather than administration of sodium chloride.