Liposyn II (Page 3 of 3)

HOW SUPPLIED

Liposyn II (Intravenous Fat Emulsion) 10% and 20% is a white to slightly off-white emulsion with no evidence of oiling out of the emulsion.

Liposyn II 10% (List No. 9786) is supplied in 200, 250 and 500 mL single-dose containers.

Liposyn II 20% (List No. 9789) is supplied in 200, 250 and 500 mL single-dose containers.

Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing.

References

  1. Levene M, Wigglesworth J, Desai R. Pulmonary fat accumulation after Intralipid infusion in the preterm infant. Lancet II: 815-818, (Oct. 18), 1980.
  2. Dahms B, Halpin T. Pulmonary arterial lipid deposit in newborn infants receiving intravenous lipid infusion. J. Pediatrics: 97:800-805, (Nov.), 1980.

Revised: August, 2005

©Hospira 2005 EN-1011 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

RL-2186

label ndc 0409-9786-02
(click image for full-size original)

RL-2262

label ndc 0409-9789-02
(click image for full-size original)
LIPOSYN II
safflower oil, soybean oil, and egg phospholipids injection, emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9786
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAFFLOWER OIL (SAFFLOWER OIL) SAFFLOWER OIL 5 g in 100 mL
SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 5 g in 100 mL
EGG PHOSPHOLIPIDS (EGG PHOSPHOLIPIDS) EGG PHOSPHOLIPIDS 1.2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM HYDROXIDE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-9786-03 12 BOTTLE, GLASS in 1 CASE contains a BOTTLE, GLASS
1 500 mL in 1 BOTTLE, GLASS This package is contained within the CASE (0409-9786-03)
2 NDC:0409-9786-02 12 BOTTLE, GLASS in 1 CASE contains a BOTTLE, GLASS
2 250 mL in 1 BOTTLE, GLASS This package is contained within the CASE (0409-9786-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018997 08/27/1984
LIPOSYN II
safflower oil, soybean oil, and egg phospholipids injection, emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9789
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAFFLOWER OIL (SAFFLOWER OIL) SAFFLOWER OIL 10 g in 100 mL
SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 5 g in 100 mL
EGG PHOSPHOLIPIDS (EGG PHOSPHOLIPIDS) EGG PHOSPHOLIPIDS 1.2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM HYDROXIDE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-9789-03 12 BOTTLE, GLASS in 1 CASE contains a BOTTLE, GLASS
1 500 mL in 1 BOTTLE, GLASS This package is contained within the CASE (0409-9789-03)
2 NDC:0409-9789-02 12 BOTTLE, GLASS in 1 CASE contains a BOTTLE, GLASS
2 250 mL in 1 BOTTLE, GLASS This package is contained within the CASE (0409-9789-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018991 08/27/1984
Labeler — Hospira, Inc. (141588017)

Revised: 07/2012 Hospira, Inc.

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