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DORIBAX- doripenem powder, for solution


  1. Patient Information
  2. Manufactured By:
  3. Manufactured For:
  4. Revised: 5/2019document Id:

Patient Information 

  • Patients should be advised that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. They should report any previous hypersensitivity reactions to DORIBAX, other carbapenems, beta-lactams or other allergens.
  • Patients should be counseled that anti-bacterial drugs including DORIBAXshould only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When DORIBAXis prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by DORIBAXor other antibacterial drugs in the future.
  • Patients should be counseled to inform their physician
    • if they have central nervous system disorders such as stroke or history of seizures. Seizures have been reported during treatment with DORIBAXand with closely related antibiotics
    • if they are taking valproic acid or sodium valproate. Valproic acid concentrations in the blood will drop below the therapeutic range upon co-administration with DORIBAX. If treatment with DORIBAXis necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed.
  • Keep out of the reach of children.

MINI-BAG Plus is a trademark of Baxter International Inc.

Product of Japan

Manufactured By: 


Shionogi & Co. Ltd.
Osaka 541-0045, Japan

Manufactured For: 


Shionogi Inc.
Florham Park, NJ 07932

Rev. 08/2015

PRINCIPAL DISPLAY PANEL

NDC 59630-320-10

DORIBAX

(doripenem for injection)

500 mg/vial

Contains 10 vials

Rx only

NDC 59630-320-10 DORIBAX   (doripenem for injection) 500 mg/vial Contains 10 vials Rx only

PRINCIPAL DISPLAY PANEL

NDC 59630-309-10

DORIBAX

(doripenem for injection)

250 mg/vial

Contains 10 vials

Rx only

NDC 59630-309-10 DORIBAX   (doripenem for injection) 250 mg/vial Contains 10 vials Rx only

DORIBAX
doripenem powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59630-320
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DORIPENEM(UNII: BHV525JOBH) (DORIPENEM - UNII:BHV525JOBH)DORIPENEM500 mg in 10 mL
Product Characteristics
Colorwhite (white to slightly-yellowish off white)Score
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59630-320-1010 in 1 CARTON10/12/200702/28/2020
1NDC:59630-320-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02210610/12/200702/28/2020
DORIBAX
doripenem powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59630-309
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DORIPENEM(UNII: BHV525JOBH) (DORIPENEM - UNII:BHV525JOBH)DORIPENEM250 mg in 10 mL
Product Characteristics
Colorwhite (white to slighly-yellowish off-white)Score
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59630-309-1010 in 1 CARTON10/15/201002/28/2020
1NDC:59630-309-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02210610/15/201002/28/2020
Labeler -Shionogi Inc. (098241610)
Establishment
NameAddressID/FEIBusiness Operations
Shionogi Pharma Co., Ltd.717959195manufacture(59630-320, 59630-309) , api manufacture(59630-320, 59630-309) , analysis(59630-320, 59630-309)

Revised: 5/2019document Id: 

8879a2d9-9310-b59a-e053-2a95a90ab1c2Set id: 974cac49-7d08-4c2a-9c24-ce75f66d9d75Version: 12Effective Time: 20190513Shionogi Inc.



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