What are the ingredients in JEVTANA?

Active ingredient: cabazitaxel

Inactive ingredient: polysorbate 80

sanofi-aventis U.S. LLCBridgewater, NJ 08807

Issued June 2010

JEVTANAis a registered trademark of sanofi-aventis

©2010 sanofi-aventis U.S. LLC

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PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 0024-5824-11

JEVTANA (cabazitaxel)Injection

60 mg/1.5 mL Before First Dilution*

This carton contains: 1 JEVTANA vial and 1 Diluent vial*Requires two dilutions before administration-See back panel for detailsFOR INTRAVENOUS INFUSION ONLY AFTER SECOND DILUTION

CYTOTOXIC AGENT

RX ONLY

sanofi aventis

PRINCIPAL DISPLAY PANEL - 5.7 mL Label

JEVTANA (cabazitaxel) Injection NDC 0024-5823-15 60 mg/1.5 mL Before First Dilution*

* FOR INTRAVENOUS INFUSION ONLY AFTER SECOND DILUTION

CAUTION: Reconstitute this vial using the entire contents of the diluent vial (approx 5.7 mL). Following this first dilution, the resultant solution contains a concentration of 10mg/mL. Withdraw only the required amount of the first dilution to prepare the final infusion solution prior to administration. See package insert for full dilution information.

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).Do not refrigerate. Single-dose vial.    CYTOTOXIC AGENT sanofi-aventis U.S. LLC/ Origin: United Kingdom 50093662

Manufacturer
sanofi-aventis U.S. LLC

Active Ingredients
Source
U.S. National Library of Medicine
DailyMed
Last Updated: 2nd of March 2011