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SMOFLIPID 20% [SIN13246P]
Active ingredients: SMOFLIPID 20%
Last updated 26 October 2025
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Product Info
SMOFLIPID 20%
[SIN13246P]
Product information
Active Ingredient and Strength | MEDIUM CHAIN TRIGLYCERIDES - 60 G PER 1,000 ML |
Dosage Form | INJECTION, EMULSION |
Manufacturer and Country | FRESENIUS KABI AUSTRIA GMBH - AUSTRIA |
Registration Number | SIN13246P |
Licence Holder | FRESENIUS KABI (SINGAPORE) PTE LTD |
Forensic Classification | GENERAL SALE LIST |
Anatomical Therapeutic Chemical (ATC) code | B05BA02 |
Indications
Supply of energy and essential fatty acids and omega-3 fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.
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.
Contraindications
Hypersensitivity to fish-, egg-, soya or peanut protein or to any of the active substances or excipients.
Severe hyperlipidemia.
Severe liver insufficiency.
Severe blood coagulation disorders.
Severe renal insufficiency without access to hemofiltration or dialysis.
Acute shock.
General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency.
Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis and severe sepsis and hypotonic dehydration).