SODIUM CHLORIDE

Posology Adults The dose is adjusted according to the actual requirements of water and electrolytes.

Maximum daily dose:

Up to 40 mL per kg body weight per day, corresponding to 6 mmol of sodium per kg body weight. g. ) should be substituted according to the volume and composition of the lost fluids. e. g. by pressure infusion.

General recommendation for treatment of sodium deficiency:

The amount of sodium required for restoration of plasma sodium level can be calculated by the equation: Sodium requirement [mmol] = (desired – actual serum Na) × TBW where TBW (total body water) is calculated as a fraction of body weight.

45 in elderly males and females, respectively. 4). Elderly population Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.

Paediatric population The dose has to be adjusted according to the individual need of water and electrolytes as well as the patient`s age, weight and clinical condition. In case of severe dehydration repeated boluses of 10-20 mL/kg body weight are recommended for the first hour of treatment.

When administering this solution the total daily fluid intake should be taken into account. 9 % w/v Intravenous Infusion is used as vehicle solution, the dosage and the infusion rate will be principally guided by the nature and the dosage regimen of the additive.

Method of administration Intravenous use When performing pressure infusion, using solution packed in a flexible container, all air must be expelled from the container and the giving set prior to starting the infusion.

None known if used according to the instructions given. 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.

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9 % w/v Intravenous Infusion should only be administered with caution in cases of • hypokalaemia • hypernatraemia • hyperchloraemia • disorders where restriction of sodium intake is indicated, such as cardiac insufficiency, generalised oedema, pulmonary oedema, hypertension, eclampsia, severe renal insufficiency.

To prevent development of the osmotic demyelination syndrome the increase of the serum sodium level within the first 24 hours after presentation should not exceed 10 mmol/L or 8 mmol/L per 24 hours thereafter. Clinical monitoring should include checks of the serum electrolytes, the water balance, and the acid-base status.

9% NaCl is necessary.

Please note:

If this solution is used as vehicle solution the safety information of the additive provided by the respective manufacturer have to be taken into account. Paediatric population Premature or term infants may retain an excess of sodium due to immature renal function.

In premature or term infants, repeated infusion of sodium chloride should therefore only be given after determination of the serum sodium level.

9 % w/v Intravenous Infusion must not be administered to patients in states of • hyperhydration • severe hypernatraemia • severe hyperchloraemia