CLINOLEIC

What it is

ClinOleic is a sterile fat emulsion containing a mixture of refined olive oil (approximately 80%) and refined soya oil (approximately 20%). It is an emulsion for intravenous injection and is a milk-like homogeneous liquid. The formulation also contains egg lecithin (purified egg phospholipids), glycerol, sodium oleate, and water for injections, with a final pH between 6.0 and 8.0.

Approved indications

— Parenteral nutrition when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosing overview

Dosage depends on energy expenditure, the patient's clinical status, body weight, and ability to metabolise ClinOleic 20%, as well as additional energy given orally or enterally, and should be individualised with the bag size chosen accordingly. The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours, depending on the clinical situation.

Key safety warnings

Fat overload syndrome has been reported with similar products, which may be caused by inappropriate administration such as overdose or infusion rate higher than recommended, although signs and symptoms may also occur when the product is administered according to instructions and may result from reduced or limited ability to metabolise the lipids accompanied by prolonged plasma clearance. The syndrome is characterised by fever, anaemia, leukopaenia, thrombocytopaenia, coagulation disorders, hyperlipidaemia, liver fatty infiltration, deteriorating liver function and central nervous system manifestations such as coma, and is usually reversible when the infusion is stopped. Refeeding severely undernourished patients with parenteral nutrition may result in refeeding syndrome, characterised by intracellular shift of potassium, phosphorus and magnesium as the patient becomes anabolic, and thiamine deficiency and fluid retention may also develop, though careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. Light exposure of solutions for intravenous parenteral nutrition after admixture with trace elements or vitamins may have adverse effects on clinical outcome in neonates due to generation of peroxides and other degradation products, and when used in premature newborns, low birth weight infants and children, ClinOleic 20% should be protected from ambient light after admixture until administration is complete. Serious adverse reactions including acute respiratory distress and metabolic acidosis have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions.

Contraindications

Known hypersensitivity to egg, soybean or peanut proteins or to any of the ingredients, including the lipid emulsion and/or excipients. Severe hyperlipidaemia or severe disorders of lipid metabolism characterised by hypertriglyceridaemia and non-corrected metabolism disorders including lactic acidosis and uncompensated diabetes. Severe sepsis, severe liver disease, blood coagulation disorders, thrombophlebitis, acute and chronic renal failure, and myocardial infarction.

Regulatory history

ClinOleic 20% was first registered on the Australian Register of Therapeutic Goods on 19 February 2004, with two registrations: ARTG 97538 for the bottle formulation and ARTG 97537 for the bag formulation.