Posology : מינונים

4.2     Posology and method of administration

Posology
The dosage and infusion rate should be within the ranges recommended below and should be governed by the patient’s ability to utilise fat.
1.      Adults and school-age children
1-2 g fat per kg body weight per day, corresponding to 10-20 ml of Lipofundin MCT/LCT 10% or 5-10 ml of Lipofundin MCT/LCT 20% per kg body weight per day.
2.      Neonates, infants and pre-school children.
Dosage is governed by the maturity and birth-weight of the infant. Neonates 2.5-3 g (up to 4 g) of fat per kg body weight per day, corresponding to 25-
30 ml (up to 40 ml) of Lipofundin MCT/LCT 10% or 12.5-15 ml (up to 20 ml) of Lipofundin MCT/LCT 20% per kg body weight per day.
Especially in preterm infants and low-birth-weight neonates, the ability to eliminate infused lipids is not yet fully developed. Therefore maximum fat doses should not be administered to these patients. The infant’s ability to eliminate infused fat from the circulation should be checked daily. Measuring serum triglycerides is the only reliable method. If lipaemia is present re-testing should be carried out after an interval of four hours.
At the end of the daily fat-free interval, the fat must have been cleared from the serum.
Infants and pre-school children
0.5-3 g of fat per kg body weight per day, corresponding to 5-30 ml of Lipofundin MCT/LCT 10% or 2.5-15 ml of Lipofundin MCT/LCT 20% per kg body weight per day.
3.      Elderly
Age per se requires no adjustment of the adult dosage. However, caution should be exercised in the “frail” and indeed in all patients with poor renal, cardiac or liver function, where smaller volumes should be used depending on the individual’s requirements and condition.

Infusion rates
In general, fat emulsions should be infused at as low a rate as possible. During the first 15 minutes the infusion rate should not exceed 0.05-0.1 g of fat per kg body weight and hour, corresponding to 0.5-1.0 ml of Lipofundin MCT/LCT 10% or 0.25- 0.5 ml of Lipofundin MCT/LCT 20% per kg body weight and hour. If no adverse reactions are observed during this initial phase, the infusion rate may be increased to 0.15-0.2 g fat per kg body weight per hour, corresponding to 1.5-2.0 ml of Lipofundin MCT/LCT 10% or 0.75-1.0 ml of Lipofundin MCT/LCT 20% per kg body weight and hour. The daily fat infusions should be administered over not less than 16 hours, preferably as continuous infusion over 24 hours.
To premature and low birth-weight infants Lipofundin MCT/LCT should be administered continuously during 24 hours/day. The dose can only be increased up to a maximum of 4.0 g/kg/24 hours by concomittant careful monitoring by following the triglyceride levels, liver function tests and oxygen saturation. The rates given are maximum rates and no attempt should be made to exceed these in order to compensate for missed doses.

Duration of use
In total parenteral nutrition, Lipofundin MCT/LCT is normally administered over 1-2 weeks. If fat infusions are further indicated and appropriate monitoring is instituted, the period of use of Lipofundin MCT/LCT may be extended.
Method of administration

Lipofundin MCT/LCT should be administered by intravenous infusion as part of a total parenteral nutrition regimen via a peripheral vein or central venous catheter.
Lipofundin MCT/LCT can be infused into the same central or peripheral vein as the carbohydrate and amino acid solutions by means of a short Y-connector near the infusion site. This allows for mixing of the solutions immediately before entering the vein. Flow rates for each solution should be controlled separately by infusion pumps, if these are used.
For safe administration of intravenous fluids from non-collapsible containers a giving set with an integral airway is recommended.
Infusion sets with in-line filters are not to be used for administration of fat emulsions.