- Approval Id
- 700560207a310987
- Drug Name
- AMINOVEN SOLUTION FOR INFUSION 15%
- Product Name
- AMINOVEN SOLUTION FOR INFUSION 15%
- Approval Number
- SIN16337P
- Approval Date
- 2021-09-30
- Registrant
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Licence Holder
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INFUSION, SOLUTION
- Dosage
- <p><strong>Posology and method of administration</strong><br>
For administration via a central vein as a continuous infusion.</p>
<p>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.</p>
<p><strong>Daily dose:</strong><br>
6.7 – 13.3 ml of <strong>Aminoven 15%</strong> per kg body weight (equivalent to 1.0 – 2.0 g amino acids per kg body weight) corresponding to 470 – 930 ml <strong>Aminoven 15 %</strong> at 70 kg body weight.</p>
<p><strong>Maximum infusion rate:</strong><br>
0,67 ml of <strong>Aminoven 15%</strong> per kg body weight per hour (equivalent to 0.1 g amino acids per kg body weight and hour).</p>
<p>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.</p>
<p><strong>Maximum daily dose:</strong><br>
13.3 ml of <strong>Aminoven 15%</strong> 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.</p>
<p>The solution is administered as long as a parenteral nutrition is required.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
For supply of amino acids as part of a parenteral nutrition regimen. <strong>Aminoven 15%</strong> is mainly indicated if during parenteral nutrition therapy the fluid volume has to be restricted.</p>
<p>Amino acid solutions should be administered generally in combination with adequate amount of energy supplements.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
As for all amino acid solutions the administration of <strong>Aminoven 15%</strong> is contraindicated in the following conditions:<br>
Disturbances of amino acid metabolism, metabolic acidosis, renal insufficiency without haemodialysis or haemofiltration treatment, advanced liver insufficiency, fluid overload, shock, hypoxia, decompensated heart failure.</p>
<p>The administration of <strong>Aminoven 15%</strong> is contraindicated in children.</p>
<p>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.</p>
<p>No clinical studies have been conducted with <strong>Aminoven 15%</strong> solution in newborns, infants or children.</p>
- Atc Code
- B05BA01
- Atc Item Name
- amino acids
- Pharma Manufacturer Name
- FRESENIUS KABI (SINGAPORE) PTE LTD