Numeta G13%E/Numeta G16%E/Numeta G19%E Adverse Reactions

The safety and administration of Numeta was assessed in a single phase III study. One hundred and fifty nine (159) paediatric patients were included in the study and received Numeta.
The following table summarizes the Adverse Reactions seen in this study. (See Table 20.)

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The following adverse reactions have been reported with other parenteral nutrition admixtures: Fat overload syndrome: 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 when the product is administered according to instructions. The reduced or limited ability to metabolize the lipids contained in Numeta 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 hyperlipidemia, fever, liver fatty infiltration (hepatomegaly), deteriorating liver function, anemia, leukopenia, thrombocytopenia, coagulation disorders and central nervous system manifestations (e.g. coma). The syndrome is usually reversible when the infusion of the lipid emulsion is stopped.
Pulmonary vascular precipitates (pulmonary vascular embolism and respiratory distress) (see Precautions).
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.