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BENDEKA- bendamustine hydrochloride injection, solution


  1. Patient Information
  2. Distributed By:
  3. Revised: 10/2018document Id:

Patient Information 

Allergic (Hypersensitivity) Reactions
Inform patients of the possibility of serious or mild allergic reactions and to immediately report rash, facial swelling, or difficulty breathing during or soon after infusion[see Warnings and Precautions (5.5)].

Myelosuppression
Inform patients of the likelihood that BENDEKA (bendamustine hydrochloride) injection will cause a decrease in white blood cells, platelets, and red blood cells. They will need frequent monitoring of these parameters. They should be instructed to report shortness of breath, significant fatigue, bleeding, fever, or other signs of infection[see Warnings and Precautions (5.1)].

Hepatotoxicity
Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their health care provider if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising[see Warnings and Precautions (5.6)].

Fatigue
Advise patients that BENDEKA (bendamustine hydrochloride) injection may cause tiredness and to avoid driving any vehicle or operating any dangerous tools or machinery if they experience this side effect[see Adverse Reactions (6.1)].

Nausea and Vomiting
Advise patients that BENDEKA (bendamustine hydrochloride) injection may cause nausea and/or vomiting. Patients should report nausea and vomiting so that symptomatic treatment may be provided[see Adverse Reactions (6.1)].

Diarrhea
Advise patients that BENDEKA (bendamustine hydrochloride) injection may cause diarrhea. Patients should report diarrhea to the physician so that symptomatic treatment may be provided[see Adverse Reactions (6.1)].

Rash
Advise patients that a mild rash or itching may occur during treatment with BENDEKA (bendamustine hydrochloride) injection. Advise patients to immediately report severe or worsening rash or itching[see Warnings and Precautions (5.5)].

Pregnancy and Nursing
BENDEKA (bendamustine hydrochloride) injection can cause fetal harm. Women should be advised to avoid becoming pregnant throughout treatment and for 3 months after bendamustine hydrochloride therapy has stopped. Men receiving BENDEKA (bendamustine hydrochloride) injection should use reliable contraception for the same time period. Advise patients to report pregnancy immediately. Advise patients to avoid nursing while receiving BENDEKA (bendamustine hydrochloride)[see Use in Specific Populations (8.1) and (8.3)].

BEN-006

Distributed By:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454


All rights reserved.

Principal Display Panel - Carton Label

NDC63459-348-04Rx Only

Sterile Multi-Dose Vial

BENDEKA
(bendamustine HCl)
Injection

100 mg/4 mL
(25 mg/mL)

For Intravenous Infusion Only

Must be diluted prior to
administration.

Distributed By: 

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Product of Italy

Principal Display Panel - Vial Label

Principal Display Panel - Vial Label

NDC63459-348-04 Multi-Dose Vial

Sterile Rx Only

BENDEKA
(bendamustine HCl) Injection

100 mg/4 mL
(25 mg/mL)

Must be diluted prior to administration.

For Intravenous Infusion Only

Principal Display Panel - Vial Label
BENDEKA
bendamustine hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63459-348
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bendamustine hydrochloride(UNII: 981Y8SX18M) (Bendamustine - UNII:9266D9P3PQ)bendamustine hydrochloride25 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
propylene glycol(UNII: 6DC9Q167V3)
monothioglycerol(UNII: AAO1P0WSXJ)
polyethylene glycol 400(UNII: B697894SGQ)
sodium hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63459-348-041 in 1 CARTON12/08/2015
14 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20819412/08/2015
Labeler -Teva Pharmaceuticals USA, Inc. (183236314)
Registrant -Eagle Pharmaceuticals, Inc. (849818161)
Establishment
NameAddressID/FEIBusiness Operations
Alidac Pharmaceuticals Limited650348852MANUFACTURE(63459-348)
Establishment
NameAddressID/FEIBusiness Operations
BSP Pharmaceuticals SpA857007830MANUFACTURE(63459-348)
Establishment
NameAddressID/FEIBusiness Operations
Olon SpA433371143API MANUFACTURE(63459-348)

Revised: 10/2018document Id: 

c67b9d93-8988-4833-bab9-7503f55a3f59Set id: ace9a43b-f9bd-4896-abfe-0ef4fec67ddfVersion: 12Effective Time: 20181004Teva Pharmaceuticals USA, Inc.



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