SMOFlipid 20%

INJECTION, EMULSION

**Dosage and administration** The patient’s ability to eliminate the fat infused, should govern the dosage and infusion rate, see section “Special warning and precautions for use” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Safety and efficacy of SMOFlipid treatment have been investigated in two randomized, controlled clinical trials (n=101) up to 4 weeks of treatment. 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. 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. 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 Special warnings and precautions for use, Storage and Shelf life and Instruction for use and handling – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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.