Ceftaroline labels and packages

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Ceftaroline fosamil
TEFLARO® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Clinical Studies
Labels and Packages

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

Teflaro®(ceftaroline fosamil) for injection

Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045, USA

Manufactured by: Facta Farmaceutici S.p.A. Nucleo Industriale S. Atto–S. Nicolò a Tordino 64020 Teramo, Italy

Teflaro® is a registered trademark of Forest Laboratories, Inc.

IF95USCFR08 ©2010-2013 Forest Laboratories, Inc. All rights reserved.

Principal Display Panel – 400 mg Vial Label

Rx only NDC 0456-0400-01

Teflaro® ceftaroline fosamil for injection 400 mg/vial

For Intravenous Infusion Only.

See package insert for dosage information.

Single use vial – Discard after use

Principal Display Panel – 400 mg Carton Label

NDC 0456-0400-10 Rx only 10 Single-Use Vials

Teflaro® (ceftaroline fosamil) for injection

400 mg/vial

FOR INTRAVENOUS INFUSION ONLY CONSTITUTED SOLUTION MUST BE FURTHER DILUTED FOR INTRAVENOUS INFUSION

Principal Display Panel – 600 mg Vial Label

Rx only NDC 0456-0600-01

Teflaro® ceftaroline fosamil for injection 600 mg/vial

For Intravenous Infusion Only.

See package insert for dosage information.

Single use vial – Discard after use

Principal Display Panel – 600 mg Carton Label

NDC 0456-0600-10 Rx only 10 Single-Use Vials

Teflaro® (ceftaroline fosamil) for injection

600 mg/vial

FOR INTRAVENOUS INFUSION ONLY CONSTITUTED SOLUTION MUST BE FURTHER DILUTED FOR INTRAVENOUS INFUSION

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s001lbl.pdf