SMOFlipid 20%

SMOFlipid 20%

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 1,000 mL Refined soya bean oil 60 g, medium-chain triglycerides 60 g, refined olive oil 50 g, fish oil (rich in omega-3 acids) 30 g. Total energy: 2,000 kCal/L. Osmolality: Approx 380 mOsmol/kg·H2O
Indications/Uses
Supply of energy & essential & omega-3 fatty acids as part of parenteral nutrition regimen when oral or enteral nutrition is impossible, insufficient or contraindicated.
Dosage/Direction for Use
IV Infuse into a peripheral or central vein. Adult 1-2 g fat/kg daily, corresponding to 5-10 mL/kg daily. Infusion rate: 0.125 g fat/kg/hr, corresponding to 0.63 mL SMOFlipid/kg/hr. Max: 0.15 g fat/kg/hr corresponding to 0.75 mL SMOFlipid/kg/hr. Childn Max daily dose: 3 g fat/kg, corresponding to 15 mL SMOFlipid/kg, gradually increased during 1st wk of administration. Max infusion rate: 0.15 g fat/kg/hr. Neonate & infant Initially 0.5-1 g fat/kg daily followed by successive increase by 0.5-1 g fat/kg daily up to 3 g fat/kg daily. Max daily dose: 3 g fat/kg, corresponding to 15 mL SMOFlipid/kg. Max infusion rate: 0.125 g fat/kg/hr. Premature & low birth wt neonate Infuse continuously over about 24 hr.
Contraindications
Hypersensitivity to fish, egg, soy or peanut protein. Severe hyperlipidemia, liver insufficiency, blood coagulation disorders; acute shock; acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency; unstable conditions eg, severe post-traumatic conditions, uncomplicated DM, acute MI, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration. Severe renal insufficiency w/o access to hemofiltration or dialysis.
Special Precautions
Interrupt infusion immediately if any signs or symptoms of anaphylactic reaction eg, fever, shivering, rash or dyspnoea occur. Cross allergic reaction between soyabean & peanut. Not to exceed 3 mmol/L serum triglyceride conc during infusion. Fat overload syndrome; metabolic acidosis. Patients w/ marked risk for hyperlipidemia (eg, patients w/ high lipid dosage, severe sepsis & extremely low birth wt infants). Impaired lipid metabolism in patients w/ renal failure, DM, pancreatitis, liver function impairment, hypothyroidism, sepsis. Monitor capacity to eliminate fat; blood platelet counts, LFTs & serum triglycerides in premature neonates on long term parenteral nutrition. Regularly check lab tests monitoring IV nutrition eg, blood glucose levels, LFTs, acid base metabolism, fluid balance, full blood count & electrolytes. High levels of plasma lipids may interfere w/ some lab blood tests eg, Hb. Avoid addition of other medicaments or substances. Pregnancy & lactation. Neonates & premature neonates w/ hyperbilirubinemia & pulmonary HTN.
Adverse Reactions
Drug Interactions
Transient increase in lipoprotein lipase release into circulation initially resulting in increased plasma lipolysis, followed by a transient decrease in triglyceride clearance w/ heparin.
MIMS Class
Parenteral Nutritional Products
ATC Classification
V06DX - Other combinations of nutrients ; Used as general nutrients.
Presentation/Packing
Form
SMOFlipid 20% emulsion for infusion
Packing/Price
100 mL x 1's;250 mL x 1's
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