Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INFUSION, SOLUTION
**Posology and method of administration** For administration via a central vein as a continuous infusion. Dosage depends on the severity of the catabolic state and on the amino acid requirement. A maximum daily dosage of 2 g amino acids/kg body weight should not be exceeded in parenteral nutrition. **Daily dose:** 6.7 – 13.3 ml of **Aminoven 15%** per kg body weight (equivalent to 1.0 – 2.0 g amino acids per kg body weight) corresponding to 470 – 930 ml **Aminoven 15 %** at 70 kg body weight. **Maximum infusion rate:** 0.67 ml of **Aminoven 15%** per kg body weight per hour (equivalent to 0.1 g amino acids per kg body weight and hour). The recommended infusion period is to provide a continuous infusion for at least 14 hours up to 24 hours, depending on the clinical situation. Bolus administration is not recommended. **Maximum daily dose:** 13.3 ml of **Aminoven 15%** per kg body weight (equivalent to 2.0 g amino acids per kg body weight) corresponding to 140 g amino acids at 70 kg body weight. The solution is administered as long as parenteral nutrition is required.
INTRAVENOUS
Medical Information
**Therapeutic indications** For supply of amino acids, as part of a parenteral nutrition regimen. **Aminoven 15%** is mainly indicated if during parenteral nutrition therapy the fluid volume has to be restricted. Amino acid solutions should be administered generally in combination with adequate amount of energy supplements.
**Contraindications** As for all amino acid solutions, the administration of **Aminoven 15%** is contraindicated in the following conditions: Disturbances of amino acid metabolism, metabolic acidosis, renal insufficiency without haemodialysis or haemofiltration treatment, advanced liver insufficiency, fluid overload, shock, hypoxia, decompensated heart failure. The administration of **Aminoven 15%** is contraindicated in children. For parenteral nutrition of infants and children paediatric amino acid preparations should be used, which are formulated to meet the different metabolic needs of children. No clinical studies have been conducted with **Aminoven 15%** solution in newborns, infants or children.
B05BA01
amino acids
Manufacturer Information
FRESENIUS KABI (SINGAPORE) PTE LTD
Fresenius Kabi Austria GmbH (Graz)
Active Ingredients
Documents
Package Inserts
Aminoven Solution for Infusion PI.pdf
Approved: September 30, 2021