Olimel N12E 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/d over 5 days.
The pooled data from clinical trials and the postmarketing experience indicate the following adverse drug reactions (ADRs) related to OLIMEL. (See Table 5.)

Click on icon to see table/diagram/image

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: Cholestasis, Hepatomegaly, Jaundice.
Immune System Disorders: Hypersensitivity.
Injury, poisoning and procedural complications: Parenteral nutrition associated liver disease (see Precautions).
Investigations: Blood alkaline phosphatase increased, Transaminases increased, Blood bilirubin increased, Elevated liver enzymes.
Renal and Urinary Disorders: Azotemia.
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 N12E 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 characterised by findings such as fever, anemia, leukopenia, 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.
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 via the relevant national reporting system.