SODIUM CHLORIDE

The choice of the specific sodium chloride and glucose concentration, dosage, volume, rate and duration of administration depends on the age, weight, clinical condition of the patient and concomitant therapy. It should be determined by a physician.

For patients with electrolyte and glucose abnormalities and for paediatric patients, consult a physician experienced in intravenous fluid therapy. Fluid balance, serum glucose, serum sodium and other electrolytes may need to be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs due to the risk of hyponatraemia.

Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. 8). Rapid correction of hyponatraemia and hypernatraemia is potentially dangerous (risk of serious neurologic complications). Electrolyte supplementation may be indicated according to the clinical needs of the patient.

Adults, older patients and adolescents (age 12 years and over):

The Recommended dosage is 500 ml to 3 L/24h Administration rate The infusion rate is usually 40 ml/kg/24h and should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia. Therefore the maximum acute administration rate is 5 mg/kg/min.

18% sodium chloride and 4% glucose should be restricted to specialist paediatric settings such as renal, hepatic and cardiac units, high dependency units and intensive care units. The dosage varies with weight: 0-10 kg body weight: 100 ml/kg/24h 10-20 kg body weight: 1000 ml + (50 ml/kg over 10 kg)/24h > 20 kg body weight: 1500 ml + (20 ml/kg over 20 kg)/24h.

The administration rate varies with weight: 0-10 kg body weight: 6-8 ml/kg/h 10-20 kg body weight: 4-6 ml/kg/h > 20 kg body weight: 2-4 ml/kg/h The infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia.

Therefore the maximum acute administration rate is 10-18 mg/kg/min, depending on the total body mass. For all patients, a gradual increase of flow rate should be considered when starting administration of glucose containing products.

The following adverse reactions have been reported in post-marketing experience, listed by MedDRA System Organ Class (SOC), then where feasible, by Preferred Term in order of severity. 4). Adverse reactions may be associated to the medicinal product(s) added to the solution; the nature of the additive will determine the likelihood of any other adverse reactions.

System Organ Class Adverse reactions (Preferred Terms) Frequency Metabolism and nutrition disorders Hypervolaemia Not known Vein injury Not known Vascular disorders Thrombophlebitis superficial Not known Chills Not known Pyrexia Not known Application site infection Not known Application site pain Not known Application site reaction Not known Injection site phlebitis Not known General disorders and administration site conditions Injection site extravasation Not known 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard

Glucose intravenous infusions are usually isotonic solutions. 2). Depending on the tonicity of the solution, the volume and rate of infusion and depending on a patient's underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances most importantly hypo- or hyperosmotic hyponatraemia.

9% may result in hyponatraemia. Close clinical monitoring may be warranted. g. 5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids. Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (brain oedema) characterized by headache, nausea, seizures, lethargy and vomiting.

Patients with brain oedema are at particular risk of severe, irreversible and life-threatening brain injury. g. 18 % w/v and Glucose 4 % w/v solution should be used with particular caution, in: • Patients with conditions that may cause sodium retention, fluid overload and oedema (central and peripheral), such as o Primary hyperaldosteronism, o Secondary hyperaldosteronism associated with, for example, - hypertension, - congestive heart failure, - liver disease (including cirrhosis), - renal disease (including renal artery stenosis, nephrosclerosis) o Pre-eclampsia.

18 % w/v and Glucose 4 % w/v solution may result in hypokalaemia. This medicine should be used with particular caution in patients with or at risk for hypokalemia. g. , pulmonary congestion) and peripheral oedema. 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.

Hyperglycaemia Rapid administration of glucose solutions may produce substantial hyperglycaemia and a hyperosmolar syndrome. In order to avoid hyperglycaemia the infusion rate should not exceed the patient’s ability to utilize glucose.

The solution is contraindicated in patients presenting with: • Known hypersensitivity to the product • Extracellular hyperhydration or hypervolaemia • Fluid and sodium retention • Severe renal insufficiency (with oliguria/anuria) • Uncompensated cardiac failure • Hyponatraemia or hypochloraemia • General oedema and ascitic cirrhosis Clinically significant hyperglycaemia.

The solution is also contraindicated in case of uncompensated diabetes, other known glucose intolerances (such as metabolic stress situations), hyperosmolar coma or hyperlactataemia.