Vancomycin labels and packages: Difference between revisions
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Revision as of 20:58, 6 January 2014
| Vancomycin |
|---|
| VANCOMYCIN HYDROCHLORIDE® FDA Package Insert |
| Description |
| Clinical Pharmacology |
| Microbiology |
| Indications and Usage |
| Contraindications |
| Warnings |
| Precautions |
| Adverse Reactions |
| Overdosage |
| Dosage and Administration |
| Directions For Use |
| How Supplied |
| Labels and Packages |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA
Baxter and Galaxy are registered trademarks of Baxter International Inc.
07-19-66-566
Revised, October 2011
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
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Baxter
Vancomycin Injection, USP
750 mg
GALAXY Single-Dose Container
150 mL Iso-osmotic
NDC 0338-3580-48 Code 2G3580 Sterile Nonpyrogenic
Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose
Hydrous, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. pH range 3.0 to 5.0.
Dosage: Intravenously as directed by a physician. See package insert.
Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity.
Rx Only
Store at or below -20°C (-4°F). Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.
Baxter and GALAXY are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
PL 2040 Plastic
07-34-61-824
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Baxter Logo
Vancomycin Injection, USP
3 - 150 mL Single Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze.
750 mg Baxter Healthcare Corporation Deerfield, IL 60015 USA
NDC 0338-3580-48 Code 2G3580
- FOR BAR CODE POSITION ONLY
(01) 20303383580485
GALAXY Container
Sterile Nonpyrogenic
Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. pH range 3.0 to 5.0
Dosage: Intravenously as directed by a physician. See package insert.
Cautions: DO NOT ADD SUPPLEMENTARY MEDICATION. Must not be used in series connections. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Rx Only.
Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.
Handle frozen product containers with care. Product containers may be fragile in the frozen state.
Baxter and Galaxy are registered trademarks of Baxter International Inc.
PL 2040 Plastic
07-04-66-117
References
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050671s014lbl.pdf