SODIUM CHLORIDE Oral Solution Ref.[8048] Active ingredients: Sodium chloride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Macarthys Laboratories Limited T/A Martindale Pharma, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom

Therapeutic indications

Correction of mild to moderate hyponatraemia in infants.

Posology and method of administration

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.

Overdose

In the event of significant overdose, serum electrolytes should be evaluated as soon as possible, appropriate steps taken to correct any abnormalities and levels monitored until return to normal levels is established.

Shelf life

2 years.

The product may be used for up to 1 month from first opening.

Special precautions for storage

Keep bottle in outer carton.

Nature and contents of container

Amber glass bottle with polypropylene screw cap and LDPE liner. The bottle is packed in a cardboard carton containing a 5ml oral syringe with an adaptor together with the patient information leaflet.

Pack Size: 100 ml.

Special precautions for disposal and other handling

No special requirements.

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