SMOFlipid 20% Special Precautions

The capacity to eliminate fat is individual and should therefore be monitored according to the routines of the clinician. This is in general done by checking the triglyceride levels. Special caution should be taken in patients with a marked risk for hyperlipidemia (e.g. patients with high lipid dosage, severe sepsis and extremely low birth weight infants).
The concentration of triglycerides in serum should in general not exceed 3 mmol/l during infusion. An overdose may lead to fat overload syndrome.
This medicinal product contains soya bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross-allergic reaction has been observed between soya bean and peanut.
SMOFlipid should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis.
Clinical data in patients with diabetes mellitus or renal failure are limited.
Administration of medium-chain fatty acids alone can result in metabolic acidosis. This risk is to a great extent eliminated by the simultaneous infusion of the long chain fatty acids included in SMOFlipid. Concomitant administration of carbohydrates will further eliminate this risk. Hence, simultaneous infusion of carbohydrate or a carbohydrate-containing amino acid solution is recommended. Laboratory test generally associated with monitoring of intravenous nutrition should be checked regularly. These include blood glucose levels, liver functions tests, acid base metabolism, fluid balance, full blood count and electrolytes.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
SMOFlipid should be given with caution to neonates and premature neonates with hyperbilirubinemia and cases with pulmonary hypertension. In neonates, particularly premature neonates on long term parenteral nutrition, blood platelet counts, liver function tests and serum triglycerides should be monitored.
High levels of lipids in plasma may interfere with some laboratory blood tests, e.g. haemoglobin.
The addition of other medicaments or substances to SMOFlipid 20% should generally be avoided unless compatibility is known.
Driving and using machines: No effects on the ability to drive and operate machines are to be expected.