Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical complications with the access device, and hyperglycaemia can help recognize early infections. Children, the elderly, women, postoperative patients, patients with hypoxia and patients with central nervous system disease or psychogenic polydipsia are at particular risk for this complication. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in paediatric intravenous fluid therapy (see section 4.4).

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To reduce the risk of hyperglycaemia-associated complications, the infusion rate must be adjusted and/or insulin administered. overhydration/hypervolemia and, for example, congested states, including pulmonary congestion and oedema. Enteral feeds may continue initially but if hypoglycaemia persists despite increasing volumes of IV Glucose then a temporary cessation of enteral feeds may be required.

Hyponatraemia can develop into acute hyponatraemic encephalopathy characterized by headache, nausea, seizures, lethargy, coma, cerebral oedema, and death.The product should be inspected visually for particulate matter and discoloration after admixing and prior to administration. Do not administer unless the solution is clear and the seal is intact.

The resultant admixture should be administered through a central or peripheral venous line depending on its final osmolarity. If the final mixture, to be administered, is hypertonic it may cause irritation of the vein when administered into a peripheral vein. Children (including neonates and older children) are at increased risk of developing hypoosmotic hyponatraemia as well as for developing hyponatraemic encephalopathy. For breast fed babies this will require top-ups. Top ups should be EBM* if sufficient available, otherwise formula should be used. Donor Breast Milk is an option and ensure families are aware this is available and can be used in this scenario. As indicated on an individual basis, vitamins and trace elements and other components (including amino acids and lipids) can be added to the parenteral regimen to meet nutrient needs and prevent deficiencies and complications from developing. The above effects do not only result from the administration of electrolyte-free fluid but also from glucose administration.

As with the intravenous administration of nutrients (e.g., glucose, amino acids and lipids) in general, metabolic complications may occur if the nutrient intake is not adapted to the patient's requirements, or the metabolic capacity of any given dietary component is not accurately assessed. Adverse metabolic effects may arise from administration of inadequate or excessive nutrients or from inappropriate composition of an admixture for a particular patient's needs. The dosage and rate of administration of Glucose 40% w/v are determined by several factors including the indication for use and the patient's age, weight and clinical condition. When Glucose 40% w/v is used in conjunction with amino acids, the rate of administration of glucose should not exceed 1g/kg/hour for optimal protein anabolism.