NEOPROFEN (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

NeoProfen (ibuprofen lysine) Injection is dispensed in treated 1 clear glass single-use vials, each containing 2 mL of sterile solution (NDC 55292-122-52). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP. NeoProfen is supplied in a carton containing 3 single-use vials.


1
NeoProfen (ibuprofen lysine) Injection is dispensed in a glass vial having a silicon dioxide coating or polymer coating that inhibits the formation of particulates that result from the interaction of the ibuprofen lysine with untreated glass.

Storage and Handling

Store at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.

17 PATIENT COUNSELING INFORMATION

Infection

NeoProfen may alter signs of infection. Patients’ caregivers should be informed to monitor the infant for any signs of infection.

Platelet Aggregation

Patients’ caregivers should be informed that like other NSAIDS, NeoProfen can inhibit clot formation therefore their infant should be monitored for any signs of bleeding.

Administration

Patients’ caregivers should be informed that the infants’ skin and tissues should be monitored as leakage from administration may be irritating to tissue.

Manufactured by: Alcami Carolinas Corporation, Charleston, SC 29405, U.S.A.

For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.

® Trademark of Recordati Rare Diseases Inc.

Revised: 03/2021

PRINCIPAL DISPLAY PANEL

NDC 55292-122-52
3 x 2 mL Single Use Vials
NeoProfen ®
(ibuprofen lysine) injection
20mg/2mL

(10mg/mL)
Sterile Solution for IV Use Only
RECORDATI RARE DISEASES GROUP
Rx only
Each mL contains:
Ibuprofen 10 mg (as ibuprofen lysine) in Water for Injection, USP.
Dilute to an appropriate volume with dextrose or saline. Please refer to the Package Insert for full prescribing information.
Store at 20-25ºC (68-77ºF); excursions permitted 15-30ºC (59-86ºF). Store vials in carton until use.
Manufactured by: Alcami Carolinas Corporation
Charleston, SC 29405, U.S.A.
For: Recordati Rare Diseases Inc.
Lebanon, NJ 08833, U.S.A.
® Trademark of Recordati Rare Diseases Inc. PC-4478E

3VialCarton
(click image for full-size original)
NEOPROFEN ibuprofen lysine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55292-122
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen lysine (ibuprofen) ibuprofen 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55292-122-52 3 VIAL in 1 CARTON contains a VIAL
1 2 mL in 1 VIAL This package is contained within the CARTON (55292-122-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021903 04/13/2006
Labeler — Recordati Rare Diseases Inc. (181699406)
Establishment
Name Address ID/FEI Operations
Alcami Carolinas Corporation 832394733 MANUFACTURE (55292-122)

Revised: 06/2022 Recordati Rare Diseases Inc.

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