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HSA Approval

AMINOVEN SOLUTION FOR INFUSION 15%

SIN16337P

AMINOVEN SOLUTION FOR INFUSION 15%

AMINOVEN SOLUTION FOR INFUSION 15%

September 30, 2021

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD
Licence HolderFRESENIUS KABI (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

L-Valine

5.5g/L

Valine

L-Serine

9.6g/L

Serine

L-Tryptophan

1.6g/L

Tryptophan

Glycine

18.5g/L

Glycine

L-lysine acetate eqv. L-lysine

11.1g/L

Lysine

Taurine

2g/L

Taurine

L-Phenylalanine

5.5g/L

Phenylalanine

L-Methionine

3.8g/L

Methionine

L-Tyrosine

0.4g/L

Tyrosine

L-Isoleucine

5.2g/L

Isoleucine

L-Threonine

8.6g/L

Threonine

L-Histidine

7.3g/L

Histidine

L-Alanine

25g/L

Alanine

L-Leucine

8.9g/L

Leucine

L-Arginine

20g/L

L-arginine

L-Proline

17g/L

Proline

Documents

Package Inserts

Aminoven Solution for Infusion PI.pdf

Approved: September 30, 2021

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