SYRISAL Oral solution Ref.[49958] Active ingredients: Sodium chloride

Posology

Adults (including the elderly)

The recommended dosing regimen has been impirically derived. It is therefore important that the dosage selection should be adjusted according to the age, weight, the extent of sodium deficit and clinical condition of the patient. A typical oral replacement dose of Syrisal in chronic salt-losing conditions is about 40-80 mmol (40-80 ml; 2.4-4.8 g) of sodium daily, given as divided doses. A maximum rate of administration of 10-12 mmol per litre of body water per 24 hour period, or 18 mmol/L/48 hours should observed.

Paediatric population

As for adults dosage should be adjusted to individual needs. Typically, children should receive 1- 2 mmol per kg (1-2ml/kg; 60-120 mg/kg) over a 24 hour period. In neonates, the dose should be administered in breast milk (3-4 mmol/100ml; 3-4ml/100ml) or formula milk (2 mmol/100ml; 2ml/100ml).

Renal impairment

Dose adjustment may be necessary depending on the clinical condition of the patient and close monitoring of serum sodium levels.

Method of administration

For oral administration.

The oral solution may be diluted in a glass of water or baby’s bottle.

Syrisal solution should not be used to induce emesis as there is a danger of induction of hypernatraemia.

Signs and symptoms

Excessive intake of sodium chloride can result in hypernatraemia. Symptoms of hypernatraemia include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypertension, tachycardia, delirium, hyperpnoea and respiratory arrest.

Treatment

Treatment requires the use of sodium-free liquids and the cessation of excessive sodium intake. In the event of a significant overdose serum sodium levels should be evaluated as soon as possible and appropriate steps taken to correct any abnormalities. The use of a loop diuretic e.g. frusemide (with potassium supplementation as required) may be appropriate in severe cases of hypernatraemia. Levels should be monitored until they return to normal.

24 months.

Discard 30 days after first opening.

This medicinal product does not require any special storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.

Bottle: Amber or clear glass.

Closure: Child resistant plastic screw cap.

Pack size: 100ml and 300ml.

Not all pack size may be marketed.

Dosing Device: 20 ml dosage syringe with 1 ml graduation mark and a syringe adaptor.

No special requirements.