Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

This solution should only be administered with particular caution in the following conditions:
●       hypertonic dehydration
●       hyperkalaemia
●       hypernatraemia
●       hyperchloraemia
●       hypercalcaemia

High volume infusions must only be used under specific monitoring in patients with cardiac or pulmonary failure, lung or brain oedema and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatraemia (see below).

Hyponatraemia Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress, infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists (see section       4.5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids.

Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury.
Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.
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Lactate utilisation may be impaired in the presence of hypoxia or hepatic insufficiency.

Compound sodium lactate contains an amount of potassium that is similar to that of the physiological concentration of potassium in human blood. Nevertheless it is not suitable for the treatment of patients with severe potassium deficiency.

As the solution contains metabolisable ions (e.g. lactate) it may cause metabolic alkalosis. Therefore the solution has to be administered with caution in patients with metabolic alkalosis.

Solutions containing sodium chloride should be administered with caution to patients with
• cardiac insufficiency or peripheral oedema,
• present or imminent eclampsia, aldosteronism or other conditions or treatment (e. g. corticoids/steroids) associated with sodium retention (see also section 4.5).

Solutions containing potassium salts should be administered with caution to patients with cardiac disease, conditions predisposing to hyperkalaemia such as adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns.
Because of the presence of calcium:
• Care should be taken to prevent extravasation during intravenous infusion.
• The solution should be given cautiously to patients withdiseases associated with elevated vitamin D concentrations such as sarcoidosis. Thus administration of calcium containing solutions should be avoided in patients with nephroliths or with a history of nephroliths.
• In case of concomitant blood transfusion, the solution must not be administered via the same in-fusion set.

Patients with chronic hyponatraemia:
Too rapid correction of serum sodium levels must be avoided in patients with chronic hyponatraemia as rapid increases of serum sodium levels may in rare cases lead to osmotic adverse effects, e.g. the osmotic demyelinisation syndrome.

Paediatric patients
The solution should be administered only with special care to newborns younger than 3 months.

Clinical monitoring should include checks of serum electrolyte levels, acid-base balance and water balance.

Serum lactate should be monitored carefully and if lactate accumulates during infusion, the dosage and infusion rate should be reduced or administration of the solution should eventually be discontinued.

In case of pressure infusion, which may be necessary in vital emergencies, all air must be removed from the plastic container and the infusion set before the solution is administered.


Effects on Driving

4.7   Effects on ability to drive and use machines

This medicinal product has no influence on the ability to drive and use machines.