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
Hypersensitivity to sodium chloride or to any of the excipients listed in section 6.1.
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.
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. These include co-existing hepatic or renal impairment, additional sodium loss through diuretic therapy, or additional sodium intake through other sources e.g. medication or intravenous fluids.
None stated.
No adverse effects during pregnancy are anticipated.
No adverse effects during breast feeding are anticipated.
Sodium chloride is not expected to have an adverse effect on fertility.
Sodium Chloride 1 mmol/ml Oral Solution would not be expected to affect the ability to drive or use machines.
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 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 at www.yellowcard.mhra.gov.uk.
None known.
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