Under conditions of correct use, in terms of dosing monitoring, observation of safety restrictions and instructions, undesirable effects may still occur. The following listing includes a number of systemic reactions that may be associated with the use of Omeflex special.
g. anaphylactic reactions, dermal eruptions, laryngeal, oral and facial oedema) Metabolism and nutrition disorders Uncommon: Loss of appetite Very rare: Hyperlipidaemia, hyperglycaemia, metabolic acidosis The frequency of these undesirable effects is dose-dependent and may be higher under the condition of absolute or relative lipid overdose.
Nervous system disorders Rare:
Headache, drowsiness Vascular disorders Rare: Hypertension or hypotension, flush Respiratory, thoracic and mediastinal disorders Rare: Dyspnoea, cyanosis Gastrointestinal disorders Uncommon: Nausea, vomiting Hepatobiliary disorders Not known: Cholestasis Skin and subcutaneous tissue disorders Rare: Erythema, sweating Musculoskeletal and connective tissue disorders Rare: Pain in the back, bones, chest and lumbar region General disorders and administration site conditions Rare: Elevated body temperature, feeling cold, chills Very rare: Fat overload syndrome (details see below) Should adverse reactions occur, the infusion must be stopped.
4 mmol/l (1000 mg/dl) during infusion, the infusion must be stopped. 4). If the infusion is restarted, the patient should be carefully monitored, especially at the beginning, and serum triglycerides should be determined at short intervals.
Information on particular undesirable effects Nausea, vomiting and lack of appetite are symptoms often related to conditions for which parenteral nutrition is indicated, and may be associated with parenteral nutrition at the same time.
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 fat metabolism may be affected by ongoing or previous illnesses.
This syndrome may also appear during severe hypertriglyceridaemia, 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 hyperlipidaemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anaemia, leucopenia, thrombocytopenia, coagulation disorder, haemolysis and reticulocytosis, abnormal liver function tests and coma.
The symptoms are usually reversible if the infusion of the fat emulsion is discontinued. Should signs of a fat overload syndrome occur, the infusion of Omeflex special should be discontinued immediately. 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. uk/yellowcard.