SODIUM CHLORIDE

Posology Adults The dose is adjusted according to the individual requirements of fluid, electrolyte and energy. thus the patient`s age, weight, clinical and biological (acid-base balance) conditions and concomitant therapy should be taken into account.

25 g glucose/kg BW per hour. Partial coverage of energy requirements, i. e. substitution of the obligatory daily glucose requirements, is only possible with the maximum dose stated above. Padiatric patients The dose is adjusted according to the individual requirements of fluid, electrolytes and energy.

Thus the patients age, weight, clinical and biological (acid-base balance) conditions and concomitant therapy should be taken into account. When administering this solution the total daily fluid and glucose requirements should be taken into account.

Elderly patients 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.

g. in the early post-operative or post-traumatic period or in the presence of hypoxia or organ failure), the dosage should be adjusted to keep the blood glucose level close to normal values. Close monitoring of blood glucose levels is recommended in order to prevent hyperglycaemia.

See also section

Adverse reactions may be associated to the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis. Adverse reactions may be associated with the medications added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects.

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/yellowcard.

4. Method of administration Intravenous use Hypertonic solutions should be administered in a large peripheral or central vein to diminish the risk of causing irritaion. This container contains a significant volume of air. To avoid risk of air embolism, this product must not be administered by pressure infusion.

3. 9 % w/v and Glucose 5 % w/v Intravenous Infusion BP should only be administered with caution in cases of • hypernatraemia • hyperchloraemia • disorders where restriction of sodium intake is indicated, such as cardiac insufficiency, generalized oedema, pulmonary oedema, hypertension, eclampsia, severe renal insufficiency In patients with acute ischaemic stroke and hyperglycaemia the glucose level should be corrected before application of this solution.

In diabetic patients, the amount of infused glucose has to be taken into account and insulin requirements may be modified. 5 mmol/h corresponding to 8 - 12 mmol/l/d.

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. Clinical monitoring should include checks of the serum electrolytes (especially potassium), glucose level, the acid-base and water balance.

In post-operative and post-traumatic conditions, and in conditions of impaired glucose tolerance: only administer with monitoring of blood glucose level. The solution should not be administered through the same infusion equipment simultaneously, before or after an administration of blood because of the possibility of pseudo-agglutination.

In case of an adverse reaction, infusion must be stopped immediately.

9 % w/v and Glucose 5 % w/v Intravenous Infusion BP must not be used in cases of • hyperhydration • hypertonic dehydration • untreated hypokalaemia • metabolic acidosis • persistent hyperglycaemia not responding to insulin doses of up to 6 units/hour • pulmonary or brain oedema • decompensated cardiac insufficiency