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.
- 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.
NeoProfen may alter signs of infection. Patients’ caregivers should be informed to monitor the infant for any signs of infection.
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.
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.
3 x 2 mL Single Use Vials
(ibuprofen lysine) injection
Sterile Solution for IV Use Only
RECORDATI RARE DISEASES GROUP
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
|NEOPROFEN ibuprofen lysine solution|
|Labeler — Recordati Rare Diseases Inc. (181699406)|
|Alcami Carolinas Corporation||832394733||MANUFACTURE (55292-122)|
Revised: 06/2022 Recordati Rare Diseases Inc.
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