SYNTHAMIN

What it is

SYNTHAMIN is indicated for parenteral nutrition in adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated. It is an emulsion for intravenous infusion. Each bag contains a sterile non-pyrogenic combination of a 10% amino acid solution with electrolytes, a 20% lipid emulsion and 42% glucose solution.

Approved indications

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

Dosing overview

The dosage should be individualised depending on energy expenditure, the patient's clinical status, body weight, and ability to metabolise constituents of SYNTHAMIN. The bag size should be chosen accordingly. The dosage range of 13–31 ml/kg bw/day will provide 0.7–1.6 g amino acids/kg bw/day and 14–33 kcal/kg bw/day of total energy. The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acids 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h. The infusion rate should not exceed 2.0 ml/kg bw/h. The recommended infusion period is 14–24 hours. The flow rate should be increased gradually during the first hour.

Key safety warnings

Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition, and in some cases fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Fat overload syndrome has been reported with similar products and may be caused by inappropriate administration or when the product is given according to instructions if the patient has reduced or limited ability to metabolise lipids. The syndrome is characterised by fever, anaemia, leucopoenia, thrombocytopenia, coagulation disorders, hyperlipidaemia, liver fatty infiltration, deteriorating liver function, and central nervous system manifestations. Refeeding severely undernourished patients may result in refeeding syndrome, characterised by shift of potassium, phosphorus, and magnesium intracellularly. In malnourished patients, initiation of parenteral nutrition can precipitate pulmonary oedema and congestive heart failure as well as decrease serum concentration of potassium, phosphorus, magnesium and water-soluble vitamins. These changes can occur within 24 to 48 hours, therefore careful and slow initiation is recommended with close monitoring and appropriate adjustment of fluid, electrolytes, minerals and vitamins. Patients on parenteral nutrition may experience hepatic complications including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis, and should be monitored accordingly. The infusion must be stopped immediately if any signs or symptoms of an allergic reaction develop. SYNTHAMIN contains soya oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soybean and peanut.

Contraindications

The use of SYNTHAMIN is contraindicated in hypersensitivity or known allergy to corn or corn products, fish, egg, soya, or peanut proteins or to any of the active substances or excipients; severe hyperlipidaemia; severe hepatic impairment; severe blood coagulation disorders; congenital abnormalities of amino acid metabolism; severe renal impairment without access to haemofiltration or dialysis; uncontrolled hyperglycaemia; pathologically elevated serum levels of any of the included electrolytes; general contraindications to infusion therapy including acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency; and unstable conditions such as severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma.

Regulatory history

SYNTHAMIN was first registered on the ARTG on 30 September 1991, with six variant presentations registered under licence category RE, sponsored by Baxter Healthcare.