Posology : מינונים

4.2 Posology and method of administration

Posology
The choice of the specific sodium chloride and glucose concentration, dosage, volume, duration and rate of administration depend on the age, weight, clinical condition of the patient and concomitant therapy. These should be determined by a physician. For patients with electrolyte and glucose abnormalities and for pediatric 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 agonists due to the risk of hyponatremia.

Monitoring of serum sodium is particularly important when administering physiologically hypotonic solutions. Sodium chloride 0.33% and Glucose 5% Baxter may become extremely hypotonic after administration due to glucose metabolization in the body (see sections 4.4, 4.5 and 4.8).


Rapid correction of hyponatremia and hypernatremia 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 liters every 24 hours
Administration rate:

The infusion rate is usually 40 mL/kg/24 h and should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycemia. Therefore, the maximum dosage is 5 mg/kg/min.

Pediatric population
- The dosage varies with weight: from 0 to 10 kg body weight: 100 mL/kg/24 h - from 10 to 20 kg body weight: 1000 mL + (50 mL/kg over 10 kg)/24 h
- > 20 kg body weight: 1500 mL + (20 mL/kg over 20 kg)/24 h.

The infusion rate varies with weight:
- from 0 to 10 kg body weight: 6 – 8 mL/kg/h
- from 10 to 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 glucose oxidation capacities in order to avoid hyperglycemia. Therefore, the maximum dosage is 10-18 mg/kg/min, depending on the age and the total body mass.

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

Method of administration

The administration is performed by intravenous infusion.
Precautions to be taken into consideration before handling or administering the medicinal product.

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Do not administer unless the solution is clear and the container is intact. Administer immediately following the insertion of the infusion set.

Do not remove the bag from the overpouch until immediately prior to use. The inner bag maintains the sterility of the product.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order 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.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. This type of intravenous administration set with the vent in the open position should not be used with flexible plastic vessels.

Additives may be introduced before or during infusion through the injection port of the container.

When additives are used, verify tonicity of 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 medicinal product with additives, see sections 6.2, 6.3 and 6.6.