Cefuroxime labels and packages

Cefuroxime

ZINACEF®,CEFUROXIME® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Compatibility and Stability
Direction For Use
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

Principal Display Panel

NDC 0173-0352-10

Zinacef®

(cefuroxime for injection)

750 mg

Equivalent to 750 mg of Cefuroxime Activity

For IM or IV use.

Rx only

STORE UPRIGHT.

See accompanying prescribing information for Dosage and Administration.

Store between 15o and 30oC (59o and 86oF). Protect from light.

To prepare IM suspension, add 3.0 mL of Sterile Water for Injection. Shake gently to disperse and withdraw completely the resulting suspension for injection. The resulting concentration is approximately 225 mg/mL

To prepare IV solution, add 8.3 mL of Sterile Water for Injection. Shake until dissolved and withdraw completely the resulting solution for injection.

After constitution, the suspension and solution maintain potency for 24 hours at room temperature or 48 hours under refrigeration (5oC). Color changes do not affect potency.

GlaxoSmithKline, RTP, NC 27709

Made in England

Rev. 12/09

10000000076134

Principal Display Panel

NDC 0173-0354-10

Zinacef®

(cefuroxime for injection)

1.5 g

Equivalent to 1.5 g of Cefuroxime Activity.

For IV use.

Rx only

See prescribing information for Dosage and Administration.

Store between 15o and 30oC (59o and 86oF). Protect from light.

To prepare IV solution, add 16.0 mL of Sterile Water for Injection. Shake until dissolved and withdraw completely for injection.

After constitution, the solution maintains potency for 24 hours at room temperature or 48 hours under refrigeration (5oC). Color changes in solution do not affect potency.

GlaxoSmithKline, RTP, NC 27709

Made in England

Rev. 12/09

10000000076137

Principal Display Panel

NDC 0173-0400-00

Zinacef®

(cefuroxime for injection)

7.5 g

Equivalent to 7.5 g of Cefuroxime Activity.

Pharmacy Bulk Package – Not for Direct Infusion

Rx only

See accompanying prescribing information for Dosage and Administration.

Store between 15o and 30oC (59o and 86oF). Protect from light.

To prepare solution, add 77 mL of Sterile Water for Injection. Shake well to dissolve. The constituted solution occupies a volume of about 82.5 mL and contains approximately 750 mg of cefuroxime activity per 8 mL.

After constitution, the solution maintains potency for 24 hours at room temperature or 7 days under refrigeration (5°C). Dispense aliquots from the vial via a suitable dispensing device into infusion fluids under a laminar flow hood using aseptic technique.

DISCARD VIAL WITHIN 24 HOURS AFTER INITIAL WITHDRAWAL.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in England

Rev. 12/09

10000000076190

Principal Display Panel

NDC 0173-0436-00

Zinacef®

(cefuroxime for injection)

ADD-Vantage® Vial

750 mg

Equivalent to 750 mg of Cefuroxime Activity.

For IV use.

Rx only

See accompanying prescribing information for Dosage and Administration and Instructions for Constitution.

Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

Color changes do not affect potency.

GlaxoSmithKline

RTP, NC 27709

Made in England

* ADD-Vantage® is a trademark of Hospira, Inc.

Rev. 9/10

10000000084188

Principal Display Panel

NDC 0173-0437-00

Zinacef®

(cefuroxime for injection)

ADD-Vantage® Vial

1.5 g

Equivalent to 1.5 g of Cefuroxime Activity.

For IV use. Rx only

See accompanying prescribing information for Dosage and Administration and Instructions for Constitution.

Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

Color changes do not affect potency.

GlaxoSmithKline

RTP, NC 27709

Made in England

* ADD-Vantage® is a trademark of Hospira, Inc.

Rev. 9/10

10000000084262

Principal Display Panel

NDC 0173-0424-00

Zinacef®

(cefuroxime injection)

750 mg Galaxy

Single-Dose Container

50 mL

Iso-osmotic

Code 2G3546

Sterile, Nonpyrogenic

Each 50 mL contains: cefuroxime sodium equivalent to 750 mg of cefuroxime with approx. 1.4 g of dextrose hydrous, USP added to adjust osmolality and 300 mg of sodium citrate hydrous, USP added as a buffer. pH adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. pH 5.0 to 7.5.

Dosage: Intravenously as directed by a physician. See accompanying prescribing information.

Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity.

Rx only

Do not store above -20oC. Thaw at room temperature (25oC) or under refrigeration (5oC). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution is stable for 28 days under refrigeration or 24 hours at room temperature. Do not refreeze.

Zinacef is a registered trademark of GlaxoSmithKline

Galaxy is a registered trademark of Baxter International Inc.

Manufactured for GlaxoSmithKline

Research Triangle Park, NC 27709

By Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Made in England

PL 2040 Plastic

7-34-61-893

Rev. 1/10

10000000076245

Principal Display Panel

NDC 0173-0425-00

Zinacef®

(cefuroxime injection)

1.5 g

Galaxy

Single-Dose Container

50 mL

Iso-osmotic

Code 2G3547

Sterile, Nonpyrogenic

Each 50 mL contains: cefuroxime sodium equivalent to 1.5 g of cefuroxime with 600 mg of sodium citrate hydrous, USP added as a buffer. pH adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. pH 5.0 to 7.5.

Dosage: Intravenously as directed by a physician. See accompanying prescribing information.

Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity.

Rx only

Do not store above -20oC. Thaw at room temperature (25oC) or under refrigeration (5oC). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution is stable for 28 days under refrigeration or 24 hours at room temperature. Do not refreeze.

Zinacef is a registered trademark of GlaxoSmithKline

Galaxy is a registered trademark of Baxter International Inc.

Manufactured for GlaxoSmithKline

Research Triangle Park, NC 27709

By Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Made in England

PL 2040 Plastic

7-34-61-894

Rev. 1/10

10000000076247

## References

[edit | edit source]

http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50643s11lbl.pdf