Omegaflex Peri/Omegaflex Special Special Precautions

Caution should be exercised in cases of increased serum osmolarity.
Disturbances of the fluid, electrolyte or acid-base balance must be corrected before the start of infusion.
Too rapid infusion can lead to fluid overload with pathological serum electrolyte concentrations, hyperhydration and pulmonary oedema.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
The serum triglyceride concentration should be monitored when infusing OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion.
Depending on the patient's metabolic condition, occasional hypertriglyceridaemia may occur. If the plasma triglyceride concentration exceeds 4.6 mmol/L (400 mg/dL) during administration of lipids, it is recommended to reduce the infusion rate. The infusion must be interrupted if the plasma triglyceride concentration exceeds 11.4 mmol/L (1000 mg/dL), as these levels have been associated with acute pancreatitis.
Like all solutions containing carbohydrates, the administration of OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion can lead to hyperglycaemia. The blood glucose level should be monitored. If there is hyperglycaemia, the rate of infusion should be reduced or insulin should be administered. If the patient is receiving other intravenous glucose solutions concurrently, the amount of additionally administered glucose has to be taken into account.
An interruption of administration of the emulsion may be indicated if the blood glucose concentration rises to above 14 mmol/L (250 mg/dL) during administration.
Commencing or recommencing nutrition therapy in malnourished or depleted patients may cause hypokalaemia, hypophosphataemia and hypomagnesaemia. Close monitoring of serum electrolytes is mandatory. Adequate supplementation of electrolytes according to deviations from normal values is necessary.
Controls of the serum electrolytes, the water balance, the acid-base balance, and of blood cell counts, coagulation status, hepatic and renal function are necessary.
Substitution of electrolytes, vitamins and trace elements may be necessary as required. As OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion contains zinc, magnesium, calcium and phosphate, care should be taken when it is co-administered with solutions containing these substances.
OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion is a preparation of complex composition. It is, therefore, strongly advisable not to add other solutions (as long as compatibility is not proven - see Incompatibilities under Cautions for Usage). For OMEGAFLEX Peri Emulsion for Infusion, additions can increase the overall osmolarity of the emulsion; consider with regard to peripheral administration and monitor the injection site.
OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination (see also Interactions).
As with all intravenous solutions, especially for parenteral nutrition, strict aseptic precautions are necessary for the infusion of OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion.
OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion is high in sodium. This should be particularly taken into account for those on a sodium-controlled (low sodium/low salt) diet.
Patients with impaired lipid metabolism: OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion should be administered cautiously to patients with disturbances of lipid metabolism with increased serum triglycerides, e.g. renal insufficiency, diabetes mellitus, pancreatitis, impaired hepatic function, hypothyroidism (with hypertriglyceridaemia), sepsis, and metabolic syndrome. If OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion is given to patients with these conditions, more frequent monitoring of serum triglycerides is necessary to assure triglyceride elimination and stable triglyceride levels below 11.4 mmol/L (1000 mg/dL).
In combined hyperlipidaemias and in metabolic syndrome, triglyceride levels react to glucose, lipids and overnutrition. Adjust dose accordingly. Determine and monitor other lipid and glucose sources, and drugs interfering with their metabolism.
The presence of hypertriglyceridaemia 12 hours after lipid administration also indicates a disturbance of lipid metabolism.
Patients with diabetes mellitus, impaired cardiac or renal function: Like all large-volume infusion solutions, OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion should be administered with caution to patients with impaired cardiac or renal function.
There is only limited experience of its use in patients with diabetes mellitus or renal failure.
Interference with laboratory tests: The fat content may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation) if blood is sampled before fat has been adequately cleared from the blood stream.
Effects on ability to drive and use machines: OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion has no or negligible influence on the ability to drive and use machines.
Use in Children: There is as yet no clinical experience of the use of OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion in children and adolescents.
Use in the Elderly: Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.
Omegaflex Peri: Infusion in peripheral veins may cause thrombophlebitis. Monitor infusion site daily for signs of thrombophlebitis.
This medicinal product contains 1150 mg sodium per 1250 mL bag, equivalent to 58% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
The maximum daily dose of this product for a 70 kg adult is equivalent to 129% of the WHO recommended maximum daily intake for sodium.
Omegaflex Special: This medicinal product contains 771 mg sodium per 625 mL bag, equivalent to 39% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
The maximum daily dose of this product for a 70 kg adult is equivalent to 151% of the WHO recommended maximum daily intake for sodium.