SODIUM CHLORIDE 0.2% AND GLUCOSE 5% INTRAVENOUS INFUSION BP [SIN08414P]

Product Info

SODIUM CHLORIDE 0.2% AND GLUCOSE 5% INTRAVENOUS INFUSION BP

[SIN08414P]

Indication

4.1 Therapeutic indications

• Hypertonic dehydration

• Partial coverage of energy requirements

• Vehicle solution for compatible electrolyte concentrates and medicinal products

Paediatric Population
This product should only be used in paediatric specialist settings (such as renal, hepatic and cardiac units, high dependency units and intensive care units) for intravenous fluid therapy requiring the use of 0.2% sodium chloride and 5% glucose to maintain fluid and electrolyte balance.

Dosing

4.2 Posology and method of administration

Posology

Adults

The dose is adjusted according to the individual requirements of fluid, electrolyte and energy. Thus the patient’s age, weight, clinical and biological (acid-base balance) conditions and concomitant therapy should be taken into account. 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. 0.20% Sodium Chloride and 5% Glucose Intravenous Infusion B.P. may become hypotonic after administration due to glucose metabolisation in the body (see sections 4.4. 4.5 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

General guidelines

Maximum daily dose:
Up to 40 ml/kg body weight per day, corresponding to approx. 2 g glucose per kg body weight per day.

Maximum infusion rate:
Up to 5 ml per kg body weight per hour, corresponding to approx. 0.25 g glucose/kg body weight per hour.

Paediatric population
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 specialist. When administering this solution the total daily fluid and glucose requirements should be taken into account.

Elderly patients
Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.

Other special patient groups
If the oxidative metabolism of glucose is impaired (e.g. in the early post-operative or posttraumatic period or in the presence of hypoxia or organ failure), the dosage should be adjusted to keep the blood glucose level close to normal values. See also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of administration
Intravenous use.
For instructions on dilution of the medicinal product before administration, see section 6.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

4.3 Contraindications

• Hyperhydration states

• Dehydration with hyponatraemia

• Head trauma (first 24 hours)

• Persistent hyperglycaemia not responding to insulin doses of up to 6 units/hour.

Paediatric population
This product should not be used in children except in paediatric specialist settings (such as renal, hepatic and cardiac units, high dependency units and intensive care units) under expert medical supervision. See also section 4.1.