SMOFlipid 20% Adverse Reactions

Undesirable effects observed during the administration of fat emulsion: See Table 1.

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Should these side effects occur or should the triglyceride level during infusion rise above 3 mmol/l, the infusion of SMOFlipid 20% should be stopped or, if necessary, continued at a reduced dosage.
SMOFlipid 20% should always be a part of a complete parenteral nutritional treatment including amino acids and glucose. Nausea, vomiting and hyperglycemia are symptoms related to conditions indicating parenteral nutrition and may sometimes be associated with parenteral nutrition.
Monitoring of triglycerides and blood glucose levels are recommended to avoid elevated levels, which may be harmful.
Fat overload syndrome: Impaired capacity to eliminate triglycerides can lead to "Fat overload syndrome" which may be caused by overdose. Possible signs of metabolic overload must be observed. The cause may be genetic (individually different metabolism) or the fat metabolism may be affected by ongoing or previous illnesses. This syndrome may also appear during severe hypertriglyceridemia, even at the recommended infusion rate, and in association with a sudden change in the patient's clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorder, hemolysis and reticulocytosis, abnormal liver function tests and coma. The symptoms are usually reversible if the infusion of the fat emulsion is discontinued. Should signs of a fat overload syndrome occur, the infusion of SMOFlipid 20% should be discontinued.