PRESCRIBING INFORMATIONVinorelbine Injection USP

VINORELBINE TARTRATE- vinorelbine tartrate injection 
Jiangsu Hengrui Medicine Co., Ltd.

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PRESCRIBING INFORMATION
Vinorelbine Injection USP

Warning

WARNING

Vinorelbine Injection USP should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous (IV) use only. Intrathecal administration of other vinca alkaloids has resulted in death. Syringes containing this product should be labeled "WARNING – FOR IV USE ONLY. FATAL if given intrathecally.”

Severe granulocytopenia resulting in increased susceptibility to infection may occur. Granulocyte counts should be ≥1,000 cells/mm3 prior to the administration of Vinorelbine Injection USP. The dosage should be adjusted according to complete blood counts with differentials obtained on the day of treatment.

Caution - It is extremely important that the intravenous needle or catheter be properly positioned before Vinorelbine Injection USP is injected. Administration of Vinorelbine Injection USP may result in extravasation causing local tissue necrosis and/or thrombophlebitis (see DOSAGE AND ADMINISTRATION: Administration Precautions).

Principal Display Panel – 1mL Vial Label

Virtual Label - We will be using a PLD to market this product

NDC 57884-3003-1

1 mL Single-Use Vial

VINORELBINE INJECTION
USP, 10mg/mL

Principal Display Panel – 1mL Vial Label

Principal Display Panel – 1mL Carton Label

Virtual Label - We will be using a PLD to market this product

NDC 57884-3003-1

1 mL Single-Use Vial

VINORELBINE INJECTION
USP, 10mg/mL

Principal Display Panel – 1mL Carton Label

Principal Display Panel – 5mL Vial Label

Virtual Label - We will be using a PLD to market this product

NDC 57884-3003-2

5 mL Single-Use Vial

VINORELBINE INJECTION
USP, 50mg/5mL

Principal Display Panel – 5mL Vial Label

Principal Display Panel – 5mL Carton Label

Virtual Label - We will be using a PLD to market this product

NDC 57884-3003-2

5 mL Single-Use Vial

VINORELBINE INJECTION
USP, 50mg/5mL

Principal Display Panel – 5mL Carton Label
VINORELBINE TARTRATE 
vinorelbine tartrate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:57884-3003
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VINORELBINE TARTRATE (VINORELBINE) VINORELBINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57884-3003-110 in 1 BOX
11 in 1 CARTON
11 mL in 1 VIAL
2NDC:57884-3003-210 in 1 BOX
21 in 1 CARTON
25 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09110609/26/201203/21/2014
Labeler - Jiangsu Hengrui Medicine Co., Ltd. (654147255)

Revised: 3/2014
 
Jiangsu Hengrui Medicine Co., Ltd.