SODIUM CHLORIDE 0.45% AND GLUCOSE 5% INTRAVENOUS INFUSION BP [SIN06426P]

Product Info

SODIUM CHLORIDE 0.45% AND GLUCOSE 5% INTRAVENOUS INFUSION BP

[SIN06426P]

4.1 Therapeutic Indications

• Isotonic dehydration

• Hypertonic dehydration

• Vehicle solution for compatible medicinal products

4.2 Posology and Method of Administration

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. Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP 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)

General guidelines
Daily dose:
Up to 40 ml/kg body weight per day, corresponding to 2 g glucose/kg body weight per day.
Infusion and drop rate:
Up to 5 ml/kg body weight per hour, corresponding to 0.25 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.

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.

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).