SODIUM CHLORIDE

Posology The dosage of this solution depends on the age, weight, clinical and biological (acid- base balance) conditions of the patient, concomitant therapy and in particular the patient's hydration state. It should be determined by a consulting physician experienced in adult or paediatric fluid therapy.

Adults For routine maintenance, normal daily fluid and electrolyte requirements are 25-30 ml/kg/day water, 1 mmol/kg/day sodium, and 50-100 g/day glucose (1-2 L of 5% glucose). 28 ml/kg body weight/min of 5% glucose), but may be only half of this in critically ill patients.

1 ml/kg/min). Elderly A reduced volume and rate of infusion may be necessary to avoid circulatory overload. Paediatric population Adolescents aged >16 years should be managed as adults. Basic fluid requirements for routine management for infants >28 days of age, toddlers, children and adolescents up to 16 years of age: Body weight 24-hour fluid requirement 0-10 kg 100 ml/kg body weight 10-20 kg 100 ml/kg body weight ≤10 kg, + 50 ml/kg body weight for second 10 kg >20 kg 100 ml/kg body weight ≤10 kg, + 50 ml/kg body weight for second 10 kg + 20 ml/kg body weight every kg thereafter Note that in a 24 hour period, males rarely need more than 2500 ml and females rarely need more than 2000 ml of fluids.

Basic fluid requirements for term neonates:

Age 24-hour fluid requirement Birth to day 1 50-60 ml/kg body weight Day 2 70-80 ml/kg body weight Day 3 80-100 ml/kg body weight Day 4 100-120 ml/kg body weight Day 5-28 120-150 ml/kg body weight In term neonates, infants, children, and adolescents up to 16 years of age requiring intravenous fluids for replacement or redistribution, the dosage (in addition to maintenance needs) should be adjusted to account for existing fluid and/or electrolyte deficits or excesses, ongoing losses, or abnormal distribution.

The infusion rate should not exceed the patient’s glucose oxidation capacity in order to avoid hyperglycaemia. 9% and Glucose 5%. 14 ml/kg body weight/min). 1 ml/kg body weight/min). 16 ml/kg body weight/min). g. pyrexia or burns). Patients with cardiac and renal impairment A reduced volume and rate of infusion may be necessary to avoid circulatory overload.

Method of administration Intravenous use. Monitoring Clinical monitoring including vital signs, fluid balance, urinary output and electrolytes, laboratory assessments (full blood count, urea, creatinine, and electrolytes), and weight should be performed throughout the course of treatment.

4). Thrombosis of the chosen vein may occur with intravenous infusion. If infusion is protracted then another vein should be selected after 12 – 24 hours. 9% and Glucose 5% include venous irritation and thrombophlebitis. Unduly rapid, or excessive, administration may lead to hypervolaemia or hypecholaemiac acidosis.

9% and Glucose 5% is not known. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows the continued monitoring of the benefit/risk balance of the medicinal product.

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9% and Glucose 5% Solution for Infusion is a hyperosmolar, isotonic (with reference to the cell membrane), solution with an approximate osmolarity of 585 mOsm/l. When used for routine maintenance, the initial prescription should be restricted to approximately 1 mmol/kg/day of sodium and chloride.

9% and Glucose 5% Solution for Infusion contains a higher than physiological concentration of chloride (154 vs. 100 mmol/L); patients who develop hyperchloraemia or acidaemia should have their IV fluid prescription reassessed, and their acid base status assessed.

9% and Glucose 5% Solution for Infusion without adequate potassium provision (1 mmol/kg/day) may cause hypokalaemia. Serum electrolyte concentrations, including sodium, potassium and chloride, and fluid balance should be monitored during use.

9% and Glucose 5% Solution should be administered with caution to patients with conditions associated with sodium retention and/or with complex fluid and/or electrolyte redistribution issues or imbalances, or significant comorbidity, including: • obesity • older or frail patients • oedema • severe sepsis • hypernatraemia • renal, liver and/or cardiac impairment • post-operative fluid retention and redistribution • malnourished and refeeding issues • pregnancy, especially in the presence of (pre-) eclampsia • hypertension.

If administered to patients with diabetes mellitus or renal failure, close monitoring of glucose levels is recommended, and insulin and/or potassium requirements may require modification. 9% and Glucose 5% Solution to patients with traumatic brain injury and/or raised intracranial pressure, particular attention should be paid to serum glucose concentrations, given the known risks of secondary brain injury associated with hyperglycaemia; hypoglycaemia should also be avoided.

Monitoring of serum glucose is recommended. 0 mmol/l has been suggested. Administration of glucose containing solutions may lead to hyperglycaemia. Solutions containing glucose should not be used routinely after ischaemic stroke, unless specifically indicated, as hyperglycaemia has been implicated in increasing cerebral ischaemic brain damage and impairing recovery.

Paediatric Population Plasma electrolyte concentrations and blood glucose should be measured before starting IV fluids for routine maintenance and at least every 24 hours thereafter. Subsequent IV fluid prescriptions should be based upon the results of these assessments.

9% and Glucose 5% solutions should not be administered rapidly or for prolonged periods, particularly in neonates and infants. Intravenous fluid should only be prescribed to a premature or term neonates by a consulting physician experienced in paediatric intravenous fluid therapy.

Premature or term neonates may retain an excess of sodium due to immature renal function. In premature or term neonates, repeated infusions of sodium chloride should therefore only be given after determination of the current serum sodium and chloride level.

No or minimal sodium should be given in term neonates in the critical postnatal adaption phase until postnatal diuresis with weight loss occurs. Newborns – especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycaemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycaemic control in order to avoid potential long term adverse effects.

Hypoglycaemia in the newborn period may have a deleterious effect on the neurodevelopmental outcome; clinical signs of hypoglycaemia include tremors, seizures, respiratory distress, cyanosis, irritability, apnea, and poor feeding. Hyperglycaemia has been associated with intraventricular haemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, prolonged length of hospital stay, and death.

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.

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.

1. • Severe chronic kidney disease, or acute kidney injury associated with oliguria/anuria • Decompensated heart failure • Extracellular hyperhydration or hypervolaemia • Fluid and sodium retention • Hyperchloraemia • Gross oedema or ascitic cirrhosis • Decompensated diabetes mellitus, other known glucose intolerances, hyperosmolar coma, hyperglycaemia • Hyperlactataemia • Rehydration in hyperemesis gravidarum