SODIUM CHLORIDE 0.45% AND GLUCOSE 2.5% INTRAVENOUS INFUSION BP [SIN07991P]

Product Info

SODIUM CHLORIDE 0.45% AND GLUCOSE 2.5% INTRAVENOUS INFUSION BP

[SIN07991P]

Indication

4.1 Therapeutic Indications

• Isotonic dehydration

• Hypertonic dehydration,

• Vehicle solution for compatible medicinal products

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 patients' 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. Sodium Chloride 0.45% and Glucose 2.5% Solution for Infusion 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).

Maximum daily dose:
Up to 40 ml/kg body weight per day.
Any additional losses (due to e.g. fever, diarrhoea, vomiting, etc.) should be substituted according to the volume and composition of the lost fluids.

Maximum infusion rate:
Up to 5 ml per kg body weight per hour.

In the treatment of hypertonic dehydration, the correction of sodium levels must not exceed 0.5 mmol/l/hour. Faster decrease of serum sodium level can cause brain oedema.

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.

As children are at a higher risk of developing hyponatraemia, this solution should be used with caution and close monitoring of fluid balance and serum electrolytes (especially the serum sodium level) in paediatric patients.

Any additional losses (due to e.g. fever, diarrhoea, vomiting) should be substituted according to the volume and composition of the lost fluids.

The dose should be calculated based on the severity of the dehydration and the clinical condition of the patient.

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. Close monitoring of blood glucose levels is recommended in order to prevent hyperglycaemia. 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.
This solution is not generally suitable for fluid and electrolyte supply over extended periods of time without additional administration of sodium containing medicinal products or infusions in the setting of the complete therapy scheme. Long-term administration of this solution alone may provoke disorders of fluid and electrolyte balance, dependent on kidney function.

Contraindications

4.3 Contraindications

• Hyperhydration

• Hypotonic dehydration

• Head trauma (first 24 hours)

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

• Hyponatraemia

• Severe renal insufficiency with oligo- or anuria

• Acute congestive heart failure

Due to the risk of hyponatraemia the product must not be used in paediatric patients with the non-osmotic secretion of ADH (in pain, anxiety, the post-operative state, nausea, vomiting, pyrexia, sepsis, reduced circulating volume, respiratory disorders, CNS infections, and metabolic and endocrine disorders).