Label and Approval History
Drug Name(s) KABIVEN AND PERIKABIVEN
FDA Application No. (NDA) 200656
Active Ingredient(s) AMINO ACIDS;ELECTROLYTES;DEXTROSE;LIPID
Company FRESENIUS KABI
Kabiven
Supply: 2053ml / bag << IKABH >>
Description: Kabiven consists of a three chamber bag and an overpouch. An oxygen absorber is placed between the inner bag and the overpouch. The inner bag is separated into three chambers by peelable seals. The components(glucose 19%含1053ml, Vamin 18含600ml and intralipid 20%含400ml) have to be mixed before use, by opening of the peelable seals. Total energy 1900Kcal.
Indication:靜脈營養注射適用於無法由口腔進食或經由腸道獲取足夠營養，或禁止由口腔及腸道進食之病患
Dosage and Administration:
pH 5.6
Osmolarity: 1060 mosm/L
Kabiven is recommended to be infused only into a central vein
Total energy: 25-35 kcal/kg/day
The maximum infusion rate for glucose : 0.25g/kg/h
Amino acid < 0.1g/kg/h
Fat < 0.15g/kg/h
The infusion rate : < 2.6 ml/kg/hr (corresponding to 0.25 g glucose, 0.09 g amino acid, 0.1g fat/kg)
The recommended infusion period for individual bags of Kabiven is 12 – 24hrs
Contraindication: Contraindicated use in patient have hypersensitivity to egg or soy protein, severe hyperlipidemia or with severe liver / renal insufficiency, severe blood coagulation disorders, acute shock, hyperglycemia (which requires more than 6 units insulin/h, metabolic acidosis, severe sepsis and coma, Infants & children < 2 years.
Caution：Caution use in patient with impaired lipid metabolism, pancreatitis, impaired renal and liver function, sepsis
Note :1. in order to minimize the risk of thrombophlebitis, daily rotation of infusion site is recommended.
2. Watch out for fat-overload syndrome as hyperlipiaemia, fever, fat infiltration, hepatomegaly, splenomegaly etc
Storage & Stability:
1. The contents of the three separate chambers have to be mixed before use. After breaking the seals, chemical and physical in use stabilility of the mixed three chamber bag has been demonstrated for 24hrs at 25℃
2. The mixed emulsion may be stored up to 6 days at 2-8℃before being used. After removal from storage at 2-8℃, the admixture should be infused within 24 hrs.
Reference: Drug package Insert. |
