Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Dosage** **_Must be diluted before use. Adults and children age 11 years and above_.** One ampoule (10 ml) of Vitalipid N Adult is added to 500 ml Intralipid 10% or 20%. After mixing by gentle agitation the emulsion is infused as described for Intralipid. The daily maintenance dosage of the vitamins A, D2, E and K1 are thereby supplied. Vitalipid N Adult should be added aseptically within one hour before the start of the infusion and should be used within 24 hours. Vitalipid N Adult can be used to reconstitute Soluvit™ N. The contents of one vial of Soluvit N (the daily maintenance dosages of water-soluble vitamins) are dissolved by the aseptic addition of 10 ml of Vitalipid N Adult and added to Intralipid.
INTRAVENOUS
Medical Information
**Indications** Vitalipid N Adult is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D2, E and K1.
**Contraindications** Known hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients.
B05XC
维生素类
Manufacturer Information
FRESENIUS KABI (SINGAPORE) PTE LTD
FRESENIUS KABI AB
Active Ingredients
Documents
Package Inserts
Vitalipid N Adult Injection PIL.pdf
Approved: July 2, 2010