Olimel N9E/PeriOlimel N4E Adverse Reactions

Potential undesirable effects may occur as a result of inappropriate use (for example: overdose, excessively fast infusion rate) (see Precautions and Overdosage).
At the beginning of the infusion, any of the following abnormal signs (sweating, fever, shivering, headache, skin rashes, dyspnoea) should be cause for immediate discontinuation of the infusion.
The following adverse drug reactions (ADRs) were reported with OLIMEL N9-840 in a randomised, double-blind, active-controlled, efficacy and safety study. Twenty-eight patients with various medical conditions (i.e. postsurgical fasting, severe malnutrition, enteral intake insufficient or forbidden) were included and treated; patients in the OLIMEL group received drug product up to 40 ml/kg/day over 5 days. (See Table 9.)

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The following class-like adverse drug reactions (ADRs) have been described in other sources in relation to similar parenteral nutrition products; the frequency of these events is not known.
Blood and lymphatic system disorders: thrombocytopenia.
Hepatobiliary disorders: cholestase, heptomegaly, jaundice.
Immune system disorders: hypersensitivity.
Investigations: Blood alkaline phosphatase increased, transaminases increased, blood bilirubin increased, elevated liver enzymes.
Renal and urinary disorders: azotaemia.
Vascular disorders: Pulmonary vascular precipitates (pulmonary vascular embolism and respiratory distress) (see Precautions).
Fat overload syndrome (very rare): Fat overload syndrome has been reported with similar products.
This may be caused by inappropriate administration (e.g. overdose and/or infusion rate higher than recommended, see Overdosage); however, the signs and symptoms of this syndrome may also occur at the start of an infusion when the product is administered according to instructions. The reduced or limited ability to metabolise the lipids contained in OLIMEL/PERIOLIMEL, accompanied by prolonged plasma clearance, may result in a "fat overload syndrome". This syndrome is associated with a sudden deterioration in the patient's clinical condition and is characterized by findings such as fever, anaemia, leukopoenia, thrombocytopenia, coagulation disorders, hyperlipidaemia, liver fatty infiltration (hepatomegaly), deteriorating liver function, and central nervous system manifestations (e.g. coma). The syndrome is usually reversible when infusion of the lipid emulsion is stopped.