Omegaflex Peri/Omegaflex Special Adverse Reactions

Under conditions of correct use, adherence to dosage and 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 OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion.
Undesirable effects are listed according to their frequencies as follows: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data).
Blood and lymphatic system disorders: Rare: Hypercoagulation.
Not known: Leucopenia, thrombocytopenia.
Immune system disorders: Rare: Allergic reactions (e.g. anaphylactic reactions, dermal eruptions, laryngeal, oral and facial oedema).
Metabolism and nutrition disorders: Very rare: Hyperlipidaemia, hyperglycaemia, metabolic acidosis. The frequency of these undesirable effects is dose-dependent and may be higher in cases 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.
Metabolism and nutrition disorders: Uncommon: Loss of appetite.
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 (see details as follows).
Should adverse reactions occur, the infusion must be stopped.
Should the triglyceride level rise to above 11.4 mmol/L (1000 mg/dL) during infusion, the infusion must be stopped. With levels above 4.6 mmol/L (400 mg/dL), the infusion may be continued at a reduced dosage (see Precautions).
If the infusion is restarted, the patient should be carefully monitored, especially at the beginning, and serum triglycerides should be determined at short intervals.
Omegaflex Peri: General disorders and administration site conditions: Common: After a few days, vein irritation, phlebitis or thrombophlebitis may occur. If signs of vein wall irritation, phlebitis or thrombophlebitis occur, change of the infusion site should be considered.
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. 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 OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion 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. Healthcare professionals are asked to report any suspected adverse reactions.