Cefoxitin labels and packages
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
DUPLEX is a registered trademark of B. Braun Medical Inc.
ATCC is a registered trademark of American Type Culture Collection.
Clinitest is a registered trademark of Siemens Healthcare Diagnostics Inc.
B. Braun Medical Inc. Irvine, CA 92614-5895 USA 1-800-227-2862 www.bbraun.com Made in USA
Y36-002-814 LD-100-3
PRINCIPAL DISPLAY PANEL - 50 mL Container Label
Cefoxitin for Injection and Dextrose Injection
1g*
REF 3123-11 NDC 0264-3123-11
DUPLEX® DRUG DELIVERY SYSTEM
50 mL
Use only after mixing contents of both chambers. For IV Use Only Iso-osmotic Single Dose Sterile/Nonpyrogenic
- Contains cefoxitin sodium equivalent to 1 g cefoxitin.
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: Cefoxitin Sodium USP (equivalent to 1 g cefoxitin) with approx. 2 g (4% w/v) Hydrous Dextrose USP in Water for Injection USP. Sodium content is 53.8 mg (2.3 mEq) per gram of cefoxitin. 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 12 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.
The DUPLEX Container is Latex-free, PVC-free, and DEHP-free. Rx only
B. Braun Medical Inc.
Y37-002-402 LD-204-2
Made in USA
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
 |
PRINCIPAL DISPLAY PANEL - 50 mL Container Label
Cefoxitin for Injection and Dextrose Injection
2g*
REF 3125-11 NDC 0264-3125-11
DUPLEX® DRUG DELIVERY SYSTEM
50 mL
Use only after mixing contents of both chambers. For IV Use Only Iso-osmotic Single Dose Sterile/Nonpyrogenic
- Contains cefoxitin sodium equivalent to 2 g cefoxitin.
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: Cefoxitin Sodium USP (equivalent to 2 g cefoxitin) with approx. 1.1 g (2.2% w/v) Hydrous Dextrose USP in Water for Injection USP. Sodium content is 53.8 mg (2.3 mEq) per gram of cefoxitin. 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 12 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.
The DUPLEX Container is Latex-free, PVC-free, and DEHP-free. Rx only
B. Braun Medical Inc.
Y37-002-403 LD-205-2
Made in USA
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
| File:Cefoxitin15.jgp |
References
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065214s013lbl.pdf