CEFTRIAXONE AND DEXTROSE (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

CefTRIaxONE for Injection

and Dextrose Injection

2g

REF 3155-11

NDC 0264-3155-11

DUPLEX® CONTAINER

50 mL

Use only after mixing contents of both chambers.

For IV Use Only Iso-osmotic Single-Dose Sterile/Nonpyrogenic

Reconstitution: Hold container with set port in a downward direction and fold the diluent chamber just below the solution meniscus. To activate seal, squeeze folded diluent chamber until seal between diluent and drug chamber opens, releasing diluent into drug chamber. Agitate the reconstituted solution until the drug powder is completely dissolved. Fold the container a second time and squeeze until seal between drug chamber and set port opens.

After reconstitution each 50 mL single dose unit contains: Ceftriaxone for Injection (equivalent to 2 g ceftriaxone) with approx. 1.11 g Hydrous Dextrose USP in Water for Injection USP

Approximate osmolality: 290 mOsmol/kg

Prior to Reconstitution: Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Use only if container and seals are intact. Do not peel foil strip until ready for use. After foil strip removal, product must be used within 7 days, but not beyond the labeled expiration date. Protect from light after removal of foil strip.

After Reconstitution: Use only if prepared solution is clear and free from particulate matter. Use within 24 hours if stored at room temperature or within 7 days if stored under refrigeration. Do not use in a series connection. Do not introduce additives into this container. Prior to administration check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired. Do not freeze.

Not made with natural rubber latex, PVC or DEHP.

B. Braun Medical Inc.

Bethlehem, PA 18018-3524

Rx only

Prepared in USA. API from USA and Italy.

Y37-002-570

LD-207-5

EXP

3155-11 Container Label
(click image for full-size original)

PEEL HERE

Drug Chamber

Discard unit if foil strip is damaged. Peel foil strip only when ready for use. Visually inspect drug prior to reconstitution. See package insert for complete directions for reconstitution and administration.

LD-336-1 X27-001-485

Drug Chamber Label
(click image for full-size original)
CEFTRIAXONE AND DEXTROSE ceftriaxone injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-3153
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 1 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE 1.87 g in 50 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0264-3153-11 24 CONTAINER in 1 CASE contains a CONTAINER
1 50 mL in 1 CONTAINER This package is contained within the CASE (0264-3153-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050796 04/20/2005
CEFTRIAXONE AND DEXTROSE ceftriaxone injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-3155
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 2 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE 1.11 g in 50 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0264-3155-11 24 CONTAINER in 1 CASE contains a CONTAINER
1 50 mL in 1 CONTAINER This package is contained within the CASE (0264-3155-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050796 04/20/2005
Labeler — B. Braun Medical Inc. (002397347)

Revised: 01/2022 B. Braun Medical Inc.

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