Doribax powder, for solution

Ingredients and appearance - Product information

Doribax powder, for solution- Doripenem

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 59630-320
Route of Administration Intravenous

Active Ingredient/Active Moiety

Ingredient Name Strength
Doripenem ( UNII: BHV525JOBH)( Doripenem - UNII: BHV525JOBH ) 500 mgin 10 mL

Product Characteristics

Color white (white to slightly-yellowish off white)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA022106 USA

Doribax powder, for solution- Doripenem

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 59630-309
Route of Administration Intravenous

Active Ingredient/Active Moiety

Ingredient Name Strength
Doripenem ( UNII: BHV525JOBH)( Doripenem - UNII: BHV525JOBH ) 250 mgin 10 mL

Product Characteristics

Color white (white to slighly-yellowish off-white)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA022106 USA

Labeler - Shionogi Inc.( 098241610)

Establishment

Name ID/FEI Business Operations
Shionogi Inc. 098241610 manufacture( 59630-320, 59630-309), api manufacture( 59630-320, 59630-309), analysis( 59630-320, 59630-309)
Duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated.
Duration can be extended up to 14 days for patients with concurrent bacteremia.
[see Preparation of 250 mg DORIBAX ® dose using the 250 mg vial and Preparation of 250 mg DORIBAX ® dose using the 500 mg vial ( 2.3)]
Comparators include piperacillin/tazobactam (4.5g every 8hours) and imipenem (500mg every 6hours or 1g every 8hours)
including preferred terms ( alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, and transaminases increased) and laboratory test values (ALT or AST ULN at baseline and >5 x ULN at End of Treatment (EOT))
Unless stated otherwise, only one sample was collected per subject;
Time from start of infusion;
Serial samples were collected; maximum concentrations reported;
Tmax range;
BQL (Below Quantifiable Limits) in 6 subjects;
BQL in 1 subject;
Median (range)
The current absence of resistant isolates precludes defining any results other than "Susceptible". Isolates yielding MIC or disk diffusion results suggestive of "Nonsusceptible" should be subjected to additional testing.
This organism may be used for validation of susceptibility test results when testing organisms of the Streptococcus anginosus group
500mg administered over 1hour every 8hours
n= number of patients in the designated population who were cured; N = number of patients in the designated population
1g administered over 35minutes every 8hours
= confidence interval
ME = microbiologically evaluable patients
mMITT = microbiological modified intent-to-treat patients
N = number of unique baseline isolates
n = number of pathogens assessed as cured
500mg administered over 1 hour every 8hours
n=number of patients in the designated population who were cured; N=number of patients in the designated population
250mg administered intravenously every 24hours
CI=confidence interval
ME=microbiologically evaluable patients
mMITT=microbiological modified intent-to-treat patients
data from comparative and non-comparative studies
N = number of unique baseline isolates
n = number of pathogens with a favorable outcome (eradication)