Posology : מינונים

4.2 Posology and method of administration

The choice of the specific sodium chloride and dextrose (glucose) concentration, dosage, volume, rate and duration of administration depends on the age, weight, clinical condition of the patient and concomitant therapy. It should be determined by a physician. For patients with electrolyte and glucose abnormalities and for paediatric patients, consult a physician experienced in intravenous fluid therapy.

Fluid balance, serum glucose, serum sodium and other electrolytes should 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. Dextrose 4.3 % w/v and sodium chloride 0.18 % w/v solution may become extremely hypotonic after administration due to dextrose (glucose) metabolisation in the body (see sections 4.4, 4.5 and 4.8).

Rapid correction of hyponatraemia and hypernatraemia is potentially dangerous (risk of serious neurologic complications).

Electrolyte supplementation may be indicated according to the clinical needs of the patient.

Adults, older patients and adolescents (age 12 years and over): 
The recommended dosage is 500 ml to 3 L/24h

Administration rate
The infusion rate is usually 40 ml/kg/24h and should not exceed the patient’s dextrose (glucose) oxidation capacities to avoid hyperglycaemia. Therefore, the maximum acute administration rate is 5 mg/kg/min.

Paediatric Population

Use of dextrose 4.3 % w/v and sodium chloride 0.18 % w/v should be restricted to specialist paediatric settings such as renal, hepatic and cardiac units, high dependency units and intensive care units.

The dosage varies with weight:
0-10 kg body weight:        100 ml/kg/24h
10-20 kg body weight:       1000 ml + (50 ml/kg over 10 kg)/24h > 20 kg body weight:        1500 ml + (20 ml/kg over 20 kg)/24h 
The administration rate varies with weight:
0-10 kg body weight:          6-8 ml/kg/h
10-20 kg body weight:         4-6 ml/kg/h
> 20 kg body weight:          2-4 ml/kg/h

The infusion rate should not exceed the patient’s dextrose (glucose) oxidation capacities to avoid hyperglycaemia. Therefore, the maximum acute administration rate is 10-18 mg/kg/min, depending on the total body mass.

For all patients, a gradual increase of flow rate should be considered when starting administration of dextrose (glucose) containing products.

Method of administration

The administration is performed by intravenous infusion.
Dextrose 4.3 % w/v and sodium chloride 0.18 % w/v solution is hypotonic and hyperosmolar, due to the dextrose (glucose) content.

Precautions to be taken before manipulating or administering the product 
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not administer unless the solution is clear, and the seal is intact. Administer immediately following the insertion of infusion set.
The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution to prevent air entering the system.

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

Additives may be introduced before or during infusion through the injection site.
When additive is used, verify isotonicity prior to parenteral administration.
Hyperosmolar solutions may cause venous irritation and phlebitis. Thus, any hyperosmolar solution is recommended to be administered through a large central vein, for rapid dilution of the hyperosmotic solution.

For further information on the product with additives, please see sections 6.2, 6.3 and 6.6.