Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Dosage** Must be diluted before use _Preterms and Infants below 2.5 kg_ Vitalipid N Infant in a dosage of 4 ml/kg bodyweight/day. _Infants and children above 2.5 kg and under 11 years._ Vitalipid N Infant in a dosage of 10 ml/day. The daily dosage must not exceed 10 ml. The daily dosage is added to Intralipid 10% or 20%. After mixing by gentle agitation the emulsion is infused as described for Intralipid. The daily maintenance dosages of the vitamins A, D2, E and K1 are thereby supplied. Vitalipid N Infant should be added aseptically within one hour before the start of the infusion and should be used within 24 hours.
INTRAVENOUS
Medical Information
**Indications** Vitalipid N Infant is indicated in infants and children up to 11 years of age 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
Patient Information Leaflets
Vitalipid N Infant Injection PIL.pdf
Approved: December 31, 2009