DORIBAX™ Powder for Injection 500mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Doripenem monohydrate

Available from:

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

Dosage:

500 mg

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

Composition:

Doripenem monohydrate 500 mg

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Shionogi Pharma Co., Ltd.

Authorization status:

ACTIVE

Authorization date:

2009-03-13

Patient Information leaflet

1

NAME OF THE MEDICINAL PRODUCT  
DORIBAX™ Powder for Injection 500mg 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
DORIBAX™, doripenem monohydrate for injection vials contain 500 mg of doripenem on 
an anhydrous basis. All references to doripenem activity are expressed in terms of the active 
doripenem moiety. DORIBAX™ is not formulated with any inactive ingredients. 

PHARMACEUTICAL FORM 
DORIBAX™ vials contain 500 mg of doripenem, a white to slightly yellowish off-white 
crystalline powder. The powder is constituted for intravenous infusion. The pH of the 
infusion solution is between 4.5 and 5.5. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
DORIBAX™ is a carbapenem antibiotic indicated as a single agent for the treatment of the 
following infections caused by susceptible bacteria:
(See _Microbiology._) 
•  Complicated intra-abdominal infections 
•  Complicated  urinary  tract  infections,  including  complicated  and  uncomplicated 
pyelonephritis and cases with concurrent bacteremia_ _
Doribax  is  also  indicated  for  the  treatment  of  nosocomial  pneumonia,  including  ventilator-
associated pneumonia, caused by susceptible bacteria. In the nosocomial pneumonia clinical 
studies, adjunctive use of an aminoglycoside was permitted.  _ _
Because  of  its  broad  spectrum  of  bactericidal  activity  against  gram-positive  and  gram-
negative  aerobic  and  anaerobic  bacteria,  DORIBAX™  can  be  considered  for  treatment  of 
complicated  and  mixed  infections.  Appropriate  specimens  for  bacteriological  examination 
should be obtained in order to isolate and identify causative organisms and to determine their 
susceptibility  to  doripenem.  In  the  absence  of  such  data,  local  epidemiology 

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
DORIBAX™ Powder for Injection 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
DORIBAX™, doripenem monohydrate for injection vials contain 500 mg
of doripenem on
an anhydrous basis. All references to doripenem activity are expressed
in terms of the active
doripenem moiety. DORIBAX™ is not formulated with any inactive
ingredients.
PHARMACEUTICAL FORM
DORIBAX™ vials contain 500 mg of doripenem, a white to slightly
yellowish off-white
crystalline powder. The powder is constituted for intravenous
infusion. The pH of the
infusion solution is between 4.5 and 5.5.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
DORIBAX™ is a carbapenem antibiotic indicated as a single agent for
the treatment of the
following infections caused by susceptible bacteria: (See
_Microbiology._
)
•
Complicated intra-abdominal infections
•
Complicated urinary tract infections, including complicated and
uncomplicated
pyelonephritis and cases with concurrent bacteremia
_ _
Doribax is also indicated for the treatment of nosocomial pneumonia,
including ventilator-
associated pneumonia, caused by susceptible bacteria. In the
nosocomial pneumonia clinical
studies, adjunctive use of an aminoglycoside was permitted.
_ _
Because of its broad spectrum of bactericidal activity against
gram-positive and gram-
negative aerobic and anaerobic bacteria, DORIBAX™ can be considered
for treatment of
complicated and mixed infections. Appropriate specimens for
bacteriological examination
should be obtained in order to isolate and identify causative
organisms and to determine their
susceptibility
to
doripenem.
In
the
absence
of
such
data,
local
epidemiology
and
susceptibility patterns may contribute to the empiric selection of
therapy.
POSOLOGY AND METHOD OF ADMINISTRATION
The
recommended
dose
of
DORIBAX™
is
500
mg
administered
every
8
hours
by
intravenous infusion. The recommended dosage and administration by
infection is described
in Table 1:
2
TABLE 1:
DOSAGE OF DORIBAX™ BY INFECTION_ _
_INFECTION _
_DOSAGE _
_FREQUE