HIGHLIGHT
SmofKabiven/SmofKabiven Peripheral

SmofKabiven/SmofKabiven Peripheral Adverse Reactions

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
/
The Glory Medicina
Full Prescribing Info
Adverse Reactions

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Should these side-effects occur the infusion of SmofKabiven/SmofKabiven Peripheral should be stopped or, if necessary, continued at a reduced dosage.
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 lipid 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, lipid 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 lipid emulsion is discontinued.
Excess of amino acid infusion: As with other amino acid solutions, the amino acid content in SmofKabiven/SmofKabiven Peripheral may cause undesirable effects when the recommended infusion rate is exceeded. These effects are nausea, vomiting, shivering and sweating. Amino acid infusion may also cause a rise in body temperature. With an impaired renal function, increased levels of nitrogen containing metabolites (e.g. creatinine, urea) may occur.
Excess of glucose infusion: If the glucose clearance capacity of the patient is exceeded, hyperglycaemia will develop.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
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