Posology : מינונים

4.2 Posology and method of administration
Adults
The dose is adjusted according to 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.

Maximum daily dose
40 ml/kg body weight (BW) per day, corresponding to 2 g glucose/kg BW per day and 6 mmol of sodium /kg BW per day.

Maximum Infusion rate:
5 ml/kg BW per hour, corresponding to 0.25 g glucose/kg BW per hour. Partial coverage of energy requirements, i. e. substitution of the obligatory daily glucose requirements, is only possible with the maximum dose stated above.

Pediatric patients
The dose is adjusted according to the individual requirements of fluid, electrolytes and energy.
Thus the patients age, weight, clinical and biological (acid-base balance) conditions and concomitant therapy should be taken into account.
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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 post- traumatic 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 ‘special warnings and precautions for use’.

Method of administration
Intravenous use
Hypertonic solutions should be administered in a large peripheral or central vein to diminish the risk of causing irritation.

Sodium chloride 0.9% and Glucose 5% solution is isotonic and hyperosmolar, due to the glucose content. It has an approximate osmolarity of 585 mOsmol/l.

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. Do not remove unit from overwrap until ready for 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. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Additives may be introduced before or during infusion through the resealable medication port.
When additive is used, verify tonicity 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.