DORIBAX 500 MG (Doripenem) for Injection

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

DORIPENEM MONOHYDRATE

Available from:

CELLTRION HEALTHCARE MALAYSIA SDN. BHD.

INN (International Name):

DORIPENEM MONOHYDRATE

Units in package:

10Units Units

Manufactured by:

Shionogi Pharma Co., Ltd.

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Doribax 500 mg (Doripenem for injection).
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains doripenem monohydrate equivalent to 500 mg
doripenem.
The medicinal product does not contain any excipients.
PHARMACEUTICAL FORM
Powder for solution for infusion (Powder for infusion).
A white to slightly yellowish off-white crystalline powder.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Doribax is indicated for the treatment of the following infections in
adults (see Special Warnings and
Precautions for Use and Pharmacodynamic Properties):
•
Nosocomial pneumonia (including ventilator–associated pneumonia)
•
Complicated intra-abdominal infections
•
Complicated urinary tract infections
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage and administration by infection is shown in the
following table:
Infection
Dosage
Frequency
Infusion Time
Nosocomial pneumonia including
ventilator–associated pneumonia
Complicated intra-abdominal infection
Complicated UTI, including pyelonephritis
500 mg
500 mg
500 mg
every 8 hours
every 8 hours
every 8 hours
1 or 4 hours*
1 hour
1 hour
*Based mainly on PK/PD considerations, a 4-hour infusion time may be
more suitable for infection with
less susceptible pathogens (see Pharmacodynamic Properties). This
dosing regimen should also be
considered in particularly severe infections.
For infusion solution shelf life see Shelf Life.
The usual treatment duration of doripenem therapy is 5-14 days and
should be guided by the severity,
site of the infection and the patient’s clinical response. Doripenem
was given for up to 14 days in
clinical studies and the
safety
of
longer durations of therapy
has not been established. After
commencing treatment with intravenous doripenem, a switch to
appropriate oral therapy to complete
the treatment course is possible once clinical improvement has been
establised.
2
Dosage in paediatric patients
Doribax is