Possible early reactions on the administration of lipid emulsions are: slight increase in temperature, flush, cold feeling, shivering, loss of appetite, nausea, vomiting, respiratory distress, headache, pain in the back, bones, chest and lumbar region, fall or increase in blood pressure (hypotension, hypertension), hypersensitivity reactions (e.g. anaphylactic reactions, dermal eruptions).
Hot flushes or bluish discoloration of the skin due to reduced oxygen content of the blood (cyanosis) can occur as side effects.
If these side effects occur the infusion should be discontinued or, if appropriate, the infusion should be continued at a lower dose level.
Attention should be paid to the possibility of an overloading syndrome. This can occur as a result of individually varying, genetically determined metabolic conditions and can occur at different rates and after differing doses depending on previous disorders.
Overloading syndrome is associated with the following symptoms: enlargement of the liver (hepatomegaly) with and without jaundice (icterus), enlargement of the spleen (splenomegaly), fatty infiltration of the organs, pathological hepatic function parameters, anaemia, reduction of white cell count (leucopenia), reduction of platelet count (thrombocytopenia), a tendency to haemorrhage and haemorrhages, alterations or reduction in the blood coagulation factors (bleeding time, coagulation time, prothrombin time etc.), fever, hyperlipaemia, headache, stomache ache, fatigue.
If signs of vein wall irritation, phlebitis, or thrombophlebitis occur, change of the infusion site should be considered.
Please inform the doctor or pharmacist if the patient notices any undesirable effect that is not mentioned.
Nutriflex Omega Special:
The following listing includes a number of systemic reactions that may be associated with the use of Nutriflex Omega special. Under conditions of correct use, in terms of dosing monitoring, observation of safety restrictions and instructions, most of them are rare (≥ 1/10,000 to < 1/1,000).
Blood and lymphatic system disorders:
Very rare (< 1/10,000): Hypercoagulation.
Immune system disorders:
Rare (≥ 1/10,000 to < 1/1,000): Allergic reactions (e.g. anaphylactic reactions, dermal eruptions, laryngeal, oral and facial oedema).
Metabolism and nutrition disorders:
Very rare (< 1/10,000): Hyperlipidaemia, hyperglycaemia, metabolic acidosis, ketoacidosis.
The frequency of these undesirable effects is dose-dependent and may be higher under the conditions of absolute or relative lipid overdose.
Nervous system disorders:
Rare (≥ 1/10,000 to < 1/1,000): Drowsiness.
Rare (≥ 1/10,000 to < 1/1,000): Hypertension or hypotension, flush.
Respiratory, thoracic and mediastinal disorders:
Rare (≥ 1/10,000 to < 1/1,000): Dyspnoea, cyanosis.
Uncommon (≥ 1/1,000 to < 1/100): Nausea, vomiting, loss of appetite.
Skin and subcutaneous tissue disorders:
Rare (≥ 1/10,000 to < 1/1,000): Erythema.
General disorders and administration site conditions:
Rare (≥ 1/10,000 to < 1/1,000): Headache, elevated body temperature, sweating, feeling cold, chills, pain in the back, bones, chest and lumbar region.
Very rare (< 1/10,000): Fat overload syndrome (see details as follows).
Should adverse reactions occur or should the triglyceride level rise above 3 mmol/l during infusion, the infusion of Nutriflex Omega special should be stopped or, if necessary, continued at a reduced dosage.
If the infusion is restarted, the patient should be carefully monitored, especially at the beginning, and serum triglycerides should be determined at short intervals.
Triglycerides that contain omega-3 fatty acids may increase bleeding time and inhibit platelet aggregation. In patients with aspirin-induced asthma, pulmonary function may deteriorate as well.
Nausea, vomiting, lack of appetite and hyperglycaemia are symptoms often related to conditions indicating parenteral nutrition or may be associated with parenteral nutrition.
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, anemia, leukopenia, thrombocytopenia, coagulation disorder, hemolysis 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 Nutriflex Omega special should be discontinued immediately.
Note: Patients should inform their doctor or pharmacist if they notice any side effect not mentioned.