OliClinomel N4-550E/OliClinomel N7-1000E Adverse Reactions

Undesirable effects may occur as a result of inappropriate use (for example overdose, too fast administration rate (see "Precautions" and "Overdosage").
On initiating an intravenous infusion, the appearance of signs or symptoms of an allergic reaction (such as perspiration, fever, chills, headache, skin rash, dyspnoea, bronchospasm) must result in its immediate discontinuation.
OLICLINOMEL N4-550E, N7-1000E, and N8-800 have been used in four (4) clinical studies. Three (3) studies evaluated the ease of use and the safety, and the nutritional efficiency of the product with 2 of the 3 studies in patients undergoing gastrointestinal surgery for gastric cancer. The third study was in hospitalized patients with various diagnoses requiring parenteral nutrition (31% surgery, 23% trauma, 51% medical patients). The medical patients had a variety of disorders that included cardiac, respiratory, gastrointestinal, metabolic, nervous system, infectious, renal, and neoplastic disease. The last study was to assess the safety and efficacy of OLICLINOMEL and was in patients admitted to a surgical service. Of those, 86.3% underwent surgery (most were abdominal surgery for gastrointestinal disease).
The data collected (286 patients) from these 4 clinical trials and in addition from post-marketing experience indicate the following adverse reactions to a medicinal product related to OliClinomel. (See Table 10.)

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Fat overload syndrome (very rare): "Fat overload syndrome" may be caused by inappropriate administration e.g. overdose and/or infusion rate higher than recommended; 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 in OliClinomel, accompanied by prolonged plasma clearance may result in a "fat overload syndrome". This syndrome is associated with a sudden change in the patient's clinical condition, and is characterised by findings such as HYPERlipidaemia, fever, fatty infiltration of the liver, hepatomegaly, deteriorating liver function, anaemia, leukopenia, thrombocytopenia, coagulation disorders and central nervous system manifestations (e.g. coma), requiring hospitalisation. These symptoms are reversible if the lipid emulsion is discontinued.
Paediatric population: Thrombocytopenia has been reported in children receiving lipid infusions.
Post-Marketing Adverse Reactions: In addition, the following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity.
IMMUNE SYSTEM DISORDERS: Bronchospasm (as part of an allergic reaction).
METABOLISM AND NUTRITION DISORDERS: Fat overload syndrome.
NERVOUS SYSTEM DISORDERS: Tremor.
HEPATOBILIARY DISORDERS: Cholestasis, Jaundice.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Erythema, Hyperhidrosis.
MUSCULOSKELETAL, CONNECTIVE TISSUE AND BONE DISORDERS: Musculoskeletal pain, Back pain, Muscle spasm.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Catheter site phlebitis, Infusion site oedema, Chest pain/discomfort, Feeling hot.
INVESTIGATIONS: Blood bilirubin increased, Hepatic enzymes abnormal.
Other (Class) Reactions: The following has been reported with other similar products: Pulmonary vascular precipitates (Pulmonary vascular emboli and Pulmonary distress) (see Precautions).