SODIUM CHLORIDE

Adults, the Elderly and Children The dosage depends on the age, weight, clinical and biological (acid-base balance) conditions of the patient, concomitant therapy and should be determined by the consulting physician. 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. 4. 8).

General guidelines Daily dose:

Up to 40 ml/kg body weight per day, corresponding to 2 g glucose/kg body weight per day. 25 g glucose/kg body weight per hour. The prescribing doctor may determine individual adaptation of the dose and infusion rate, especially for children.

Monitoring Adequate urine flow must be ensured and careful monitoring of serum electrolytes and glucose is essential. Method of administration Intravenous infusion This container contains a significant volume of air. To avoid risk of air embolism, this product must not be administered by pressure infusion.

4). Adverse reactions may be associated with the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis. Adverse reactions may be associated with the medications added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Special warnings In diabetic patients, the amount of infused glucose has to be taken into account and insulin requirements may be modified. 45 % w/v and Glucose 5 % w/v Intravenous Infusion should only be administered with caution in cases of: – hyponatraemia, – hyperglycaemia, – renal insufficiency.

Precautions for use 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 metabolise 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. g. meningitis, intracranial bleeding, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

g. hypertension, heart failure). Clinical supervision should include checks of the serum electrolytes and the water balance. Special attention should be paid to regular monitoring of the serum potassium concentration. In post-operative and post-traumatic conditions and in conditions of impaired glucose tolerance: only administer with monitoring of blood glucose level.

For correction of hypertonic dehydration, solutions containing not less than 70 mmol/l of sodium should be used. The time for correction should not be shorter than 48 hours.

45 % w/v and Glucose 5 % w/v Intravenous Infusion must not be used in cases of – hyperhydration – hypotonic dehydration – acute ischaemic stroke – head trauma (first 24 hours)