ARDEAELYTOSOL D 1/1 Solution for Infusion

Due to the presence of lactate, the product is suitable only for patients with normoxaemia, intact hepatic function and adequate hepatic blood flow. Fluid balance, serum electrolytes and acid-base balance may need to be monitored before and during administration. Serum potassium levels must be monitored throughout therapy. Particular care should be taken to monitor serum sodium levels, especially in patients with increased non-osmotic release of vasopressin (syn‍‍‍‍‍‍​​​‍​​​​​​drome of inappropriate antidiuretic hormone secretion, SIADH) and in patients concomitantly treated with vasopressin agonists, due to the risk of hyponatraemia (see sections 4.4, 4.5 and 4.8). Large-volume infusions must be administered under specific monitoring in patients with cardiac or pulmonary failure and in patients with non-osmotic release of vasopressin (including SIADH) due to the risk of hyponatraemia (see below). Hyponatraemia Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema). A particular risk of severe and life-threatening cerebral oedema caused by acute hyponatraemia exists in children, women of childbearing age and in patients with reduced cerebral compliance (e.g. meningitis, intracranial haemorrhage, cerebral contusion and cerebral oedema). An appropriate infusion rate must be maintained. Increased caution is required during concomitant therapy with cardiac glycosides.