Vancomycin labels and packages

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

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

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

LAB-0494-2.0 January 2013

PRINCIPAL DISPLAY PANEL - 10 g Bottle Carton

NDC 0069-2599-99 Rx only

VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP (Formerly: Sterile Vancomycin Hydrochloride)

PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION

10 grams* per Pharmacy Bulk Package

Sterile LYOPHILIZED For IV Infusion After Dilution

AFTER RECONSTITUTION MUST BE FURTHER DILUTED. NOT TO BE DISPENSED AS A UNIT.

One Pharmacy Bulk Package bottle

Pfizer Injectables

Hospira, Inc., Lake Forest, IL 60045 USA

RL-3426

RL-3423

RL-3427

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050671s014lbl.pdf