Intralipid (Page 3 of 3)

HOW SUPPLIED

Intralipid ® 20% is supplied as a sterile emulsion in the following fill sizes: 100 mL, 250 mL and 500 mL.
100 mL: 0338-0519-58
250 mL: 0338-0519-09
500 mL: 0338 0519-13

Intralipid ® 20% is also available as Pharmacy Bulk Package in the following fill size.

1000 mL: 0338-0519-14

STORAGE

Intralipid ® 20% should not be stored above 25°C (77°F). Do not freeze Intralipid ® 20%. If accidentally frozen, discard the bag.

REFERENCES

  1. Padley FB: “Major Vegetable Fats,” The Lipid Handbook (Gunstone FD, Harwood JL, Padley FB, eds.), Chapman and Hall Ltd., Cambridge, UK (1986), pp. 88-9.
  2. Levene MI, Wigglesworth JS, Desai R: Pulmonary fat accumulation after Intralipid ® infusion in the preterm infant. Lancet 1980; 2(8199):815-8.
  3. American Academy of Pediatrics: Use of intravenous fat emulsion in pediatric patients. Pediatrics 1981; 68:5(Nov) 738-43.

(Rev September 2016)

Manufactured for
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Manufactured by
Fresenius Kabi,
Uppsala, Sweden

Intralipid ® is a registered trademark of Fresenius Kabi AB.

Instruction for Use — Intralipid ® 20% Container

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PACKAGE LABEL — PRINCIPAL DISPLAY — Intralipid 250 mL Container Label

NDC 0338-0519-09

Intralipid ® 20%

A 20% I.V. Fat Emulsion

250 mL For Intravenous Use

Rx only

bag 20
(click image for full-size original)
INTRALIPID i.v. fat emulsion emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0519
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 20 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
EGG PHOSPHOLIPIDS
GLYCERIN
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0519-58 100 mL in 1 BAG None
2 NDC:0338-0519-09 250 mL in 1 BAG None
3 NDC:0338-0519-13 500 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018449 04/01/2004
Labeler — Baxter Healthcare Corporation (005083209)
Registrant — Fresenius Kabi Deutschland GmbH (506719546)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi AB Uppsala 559785113 analysis (0338-0519), manufacture (0338-0519)

Revised: 01/2019 Baxter Healthcare Corporation

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