Product Dossier

AMINOVEN

Product Dossier for AMINOVEN (alanine, arginine, glycine, histidine, isoleucine, leucine, lysine acetate, lysine, methionine, phenylalanine, proline,…

What it is

Aminoven is a clear, colourless to slightly yellow solution. It contains alanine, arginine, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, and valine. Aminoven is an injection for intravenous infusion. Each litre of Aminoven 10% contains 100 g total amino acids, 16.2 g total nitrogen, and 1680 kJ (400 kcal) total energy.

Approved indications

— To supply amino acids as part of a composite admixture of total parenteral nutrition.

Dosing overview

A daily dose of 1.0–1.5 g amino acids per kg body weight per day is commonly used, but recommendations from current professional nutritional guidelines should be consulted. For adults, the dosage is 10–20 mL of Aminoven 10% per kg body weight (equivalent to 1.0–2.0 g amino acids per kg body weight per day), for example 700–1400 mL Aminoven 10% at 70 kg body weight per day. The maximum infusion rate is 1.0 mL of Aminoven 10% per kg body weight per hour (equivalent to 0.1 g amino acids per kg body weight per hour). For children and adolescents aged 2–18 years, the dose should be adjusted to hydration status, biological development, and body weight; a dose of 10–20 mL per kg per day equivalent to 1.0–2.0 g amino acid per kg per day should meet the needs of most paediatric patients. Aminoven is administered via a central vein as a continuous infusion.

Key safety warnings

Serum electrolytes, fluid balance, and renal function should be properly monitored during administration. Laboratory tests for monitoring should include blood and urine glucose, serum proteins, kidney and liver function tests, serum electrolytes, haemogram, serum and urine osmolarities, and blood urea. Care should be exercised in the administration of large volume infusion fluids to patients with cardiac insufficiency to avoid risk of development of pulmonary oedema. Amino acid solutions may precipitate acute folate deficiency, so folic acid should be given daily. All total parenteral nutrition regimens are hypertonic, which will result in development of thrombophlebitis as a result of duration of infusion and osmolarity. Central venous catheters may result in central complications like thrombosis with a potential risk of embolism. Extravasation of total parenteral nutrition admixtures may cause tissue damage, with severity dependent on the osmolarity of the fluid, the amount extravasated before stopping the infusion, and the location of extravasation. Areas with a thin subcutaneous layer between the skin and underlying bone are more vulnerable.

Contraindications

The administration of Aminoven is contraindicated in disturbances of amino acid metabolism, metabolic acidosis, renal insufficiency without haemodialysis or haemofiltration treatment, advanced liver insufficiency, fluid overload, shock, hypoxia, and decompensated heart failure. Aminoven 10% is contraindicated in children less than 2 years of age; for children under 2 years, paediatric amino acid preparations should be used, which are formulated to meet their different metabolic needs.

Regulatory history

Aminoven 10% solution for infusion in 500 mL and 1000 mL bottles was first listed on the Australian Register of Therapeutic Goods on 22 October 2007.