IFEX (Page 6 of 6)
PACKAGE LABEL — PRINCIPLE DISPLAY PANEL
Vial Label
NDC 0338-3991-01
IFEX
IFOSFAMIDE FOR INJECTION, USP
1 g/vial
Rx only
SINGLE-DOSE VIAL
This vial contains 1g ifosfamide.
Add 20 mL Sterile Water for
Injection, USP, or Sterile
Bacteriostatic Water for Injection,
USP, (benzyl alcohol or parabens
preserved), shaking to dissolve,
for a reconstituted concentration
of 50 mg per mL.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F)
Protect from temperatures
above 30° C (86° F).
FOR IV USE
READ ACCOMPANYING
PACKAGE INSERT for detailed
indications, dosage, and
precautions.
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
USA HA-65-01-561
C130
Bar Code
N(01)1 03 0338 3991 01 7
Lot:/Exp.:
JMXXXJJJJ — MM
Carton Label
1 vial
NDC 0338-3991-01
IFEX
(ifosfamide for injection, USP)
Single-Dose Vial
FOR IV USE
Rx only
1 g
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
See bottom panel for lot
number and expiration date.
Bar Code
N3 0338399101 0
This vial contains 1 g ifosfamide. Add
20 mL Sterile Water for Injection, USP,
or Sterile Bacteriostatic Water for
Injection, USP, (benzyl alcohol or
parabens preserved), shaking to
dissolve, for a reconstituted
concentration of 50 mg per mL.
READ ACCOMPANYING PACKAGE
INSERT for detailed indications,
dosage, and precautions.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).
Constituted solutions should be
refrigerated and used within 24 hours.
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USAMade in Germany
Vial Label
NDC 0338-3993-01
IFEX
IFOSFAMIDE FOR INJECTION, USP
3 g/vial
Rx only
SINGLE-DOSE VIAL
This vial contains 3g ifosfamide.
Add 60 mL Sterile Water for
Injection, USP, or Sterile
Bacteriostatic Water for Injection,
USP, (benzyl alcohol or parabens
preserved), shaking to dissolve,
for a reconstituted concentration
of 50 mg per mL.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F)
Protect from temperatures
above 30° C (86° F).
FOR IV USE
READ ACCOMPANYING
PACKAGE INSERT for detailed
indications, dosage, and
precautions.
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
USA HA-65-01-564
C 132
Bar CodeN(01)1 03 0338 3993 01 1
Lot:/Exp.:
JMXXX
JJJJ — MM
Carton Label
1 vial
NDC 0338-3993-01
IFEX
(ifosfamide for injection, USP)
Single-Dose Vial
FOR IV USE
Rx only
3 g /vial
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
HA-80-02-154
USA
See bottom panel for lot
number and expiration date.
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
C
837
(01) 0030338993014
(21) XXXXXXXXXXXX
(17) JJMMTT
(10)JMXXXA
1 vial NDC 0338-3993-01
IFEX
(Ifosfamide for injection, USP)
Single Dose Vial
Rx only
FOR IV USE
3 g /vial
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Lot/Exp.:
JMXXXA
JJJJ — MM
2617B5079
Barcode
FOLDING BOX
CAN BE RECYCLED symbol
This vial contains 3 g ifosfamide.
Add 60 mL Sterile Water for
Injection, USP, or Sterile
Bacteriostatic Water for Injection,
USP, (benzyl alcohol or parabens
preserved), shaking to dissolve,
for a reconstituted concentration
of 50 mg per mL.
READ ACCOMPANYING PACKAGE
INSERT for detailed indications,
dosage, and precautions.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).
Constituted solutions should be
refrigerated and used within 24 hours.
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USAMade in Germany
IFEX ifosfamide injection, powder, for solution | |||||||||||||||||
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IFEX ifosfamide injection, powder, for solution | |||||||||||||||||
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Labeler — Baxter Healthcare Corporation (005083209) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Baxter Deutschland GmbH | 312520353 | API MANUFACTURE (0338-3991), API MANUFACTURE (0338-3993) |
Revised: 07/2018 Baxter Healthcare Corporation
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