Posology : מינונים

4.2   Posology and method of administration
Posology

The patient’s ability to eliminate the fat infused, should govern the dosage and infusion rate, see section 4.4.

Adults
The standard dose is 1.0 – 2.0 g fat/kg body weight (b.w.)/day, corresponding to 5 – 10 ml/kg b.w./day.
The recommended infusion rate is 0.125 g fat/kg b.w./hour, corresponding to 0.63 ml Smoflipid/kg b.w./hour, and should not exceed 0.15 g fat/kg b.w./hour, corresponding to 0.75 ml Smoflipid/kg b.w./hour.


Paediatric population
Neonates and infants
The initial dose should be 0.5 – 1.0 g fat/kg b.w./day followed by a successive increase by 0.5 – 1.0 g fat/kg b.w./day up to 3.0 g fat/kg b.w./day.

It is recommended not to exceed a daily dose of 3 g fat/kg b.w./d, corresponding to 15 ml Smoflipid/kg b.w./day.

The rate of infusion should not exceed 0.125 g fat/kg b.w./hour.
In premature and low birthweight neonates, Smoflipid should be infused continuously over about 24 hours.
The duration of treatment should not exceed 30 days.


Children
It is recommended not to exceed a daily dose of 3 g fat/kg b.w./d, corresponding to 15 ml Smoflipid/kg b.w./day.

The daily dose should be increased gradually during the first week of administration.

The infusion rate should not exceed 0.15 g fat/kg b.w./hour.
The duration of treatment should not exceed 30 days.

Method of administration
Intravenous infusion into a peripheral or central vein.
When used in neonates and children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see section 4.4, 6.3 and 6.6).