Doribax

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Doripenem 500mg ( as doripenem monohydrate)

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Doripenem 500 mg ( as doripenem monohydrate)

Dosage:

500 mg

Pharmaceutical form:

Powder for infusion

Composition:

Active: Doripenem 500mg ( as doripenem monohydrate)

Units in package:

Vial, glass, Type I clear 20 mL with fluororesin/elastomer stopper , alu seal and flip off cap. 10 per carton, 10 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Shionogi & Co Ltd

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I clear 20 mL with fluororesin/elastomer stopper , alu seal and flip off cap. 10 per carton - 10 dose units - 3 years from date of manufacture stored at or below 25°C 12 hours reconstituted stored at or below 25°C. In normal saline 4 hours reconstituted stored at or below 25°C. In 5% dextrose 72 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). In normal saline 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). In 5% dextrose

Authorization date:

2008-11-20

Patient Information leaflet

DORIBAX
®

500MG POWDER FOR INTRAVENOUS INFUSION 
_Doripenem monohydrate _
_ _
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about 
DORIBAX.  It does not contain all the available 
information.  It does not take the place of talking to 
your doctor or pharmacist. 
All medicines have risks and benefits.  Your doctor has 
weighed the risks of you being given DORIBAX 
against the benefits this medicine is expected to have 
for you. 
If you have any concerns about being given this 
medicine, ask your doctor. 
Keep this leaflet while being treated. You may need to 
read it again. 
WHAT DORIBAX IS USED FOR 
DORIBAX is an antibiotic. It works by killing the 
bacteria (germs) that cause infections in various parts 
of the body. 
These infections include: 
•  pneumonia (a serious type of chest or lung 
infection) that you catch in a hospital or 
similar setting, including pneumonia that you 
catch when on a machine that helps you 
breathe 
•  complicated infections of the area around 
your stomach (abdominal infections) 
•  complicated urinary tract infections, including 
kidney infections and cases that have spread 
to the bloodstream. 
Your doctor may have prescribed this medicine for 
another reason. 
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT 
WHY IT HAS BEEN PRESCRIBED FOR YOU. 
THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR’S 
PRESCRIPTION. 

BEFORE DORIBAX IS GIVEN 
WHEN DORIBAX MUST NOT BE GIVEN 
YOU MUST NOT BE GIVEN THE MEDICINE IF YOU HAVE AN 
ALLERGY TO: 
•  doripenem, the active ingredient in the medicine  
•  other antibiotics such as penicillins, 
cephalosporins or carbapenems (which are used to 
treat various infections) as you may also be 
allergic to DORIBAX. 

Symptoms of an allergic reaction may include rash, 
itching or hives on the skin, shortness of breath, 
wheezing or difficulty breathing, swelling of

Summary of Product characteristics

1 DORIBAX(120113)ADS 
CCDS(101111) 

DORIBAX
®

DATA SHEET 
NAME OF THE MEDICINAL PRODUCT 

DORIBAX
®
 500 mg doripenem (as monohydrate) powder for intravenous infusion 

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 infusion (Powder for intravenous 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 TABLE 1: 

TABLE 1: DOSAGE OF DORIBAX
®
 BY INFECTION 

INFECTION DOSAGE 
FREQUENCY 
INFUSION 
TIME 
Nosocomial pneumonia including ventilator–
associated pneumonia 
500 mg 
every 
8 hours 
1 or 4 hours* 
Complicated intra-abdominal infection 
500 mg 
every 
8 hours 
1 hour 
Complicated UTI, including pyelonephritis 
500 mg 
every 
8 hours 
1 hour 
2 DORIBAX(120113)ADS 
CCDS(101111) 

*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�