BINDOZEF INJECTION 1g

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Cefepime

Tillgänglig från:

Aurobindo Pharma Australia Pty Ltd

Klass:

Medicine Registered

Bipacksedel

BINDOZEF INJECTION 1 G AND 2 G 
CONSUMER MEDICINE INFORMATION 
Ver 1.1 
BINDOZEF INJECTION 1 G AND 2 G 
CEFEPIME (AS CEFEPIME HYDROCHLORIDE) 
CONSUMER MEDICINE INFORMATION 

_ _
BINDOZEF INJECTION 1 g & 2 g                    

                  Page 1 of 3 
WHAT IS IN THIS LEAFLET? 

The medicine which your doctor has 
prescribed for you is called 
BINDOZEF INJECTION. The 
information in this leaflet answers 
some questions you may have about 
BINDOZEF INJECTION.  

This leaflet does not contain all the 
information about BINDOZEF 
INJECTION. Your doctor or 
pharmacist has been provided with 
full information, and can answer any 
questions you may have. Follow your 
doctor's advice, even if it differs from 
what is in this leaflet.  

You should read this leaflet carefully 
before BINDOZEF INJECTION is 
given to you. Keep this leaflet in a 
safe place, you may need to read it 
again.  

WHAT BINDOZEF 
INJECTION IS USED FOR: 

BINDOZEF INJECTION contains 
cefepime which belongs to a group of 
antibiotics called cephalosporins. 
These antibiotics work by killing the 
bacteria that are causing the 
infection.  
BINDOZEF INJECTION is an 
injectable antibiotic used for serious 
infections in adults caused by 
bacteria in the lungs (pneumonia and 
bronchitis), in the kidney and bladder 
(urinary tract infections), in the skin, 
inside the abdomen (peritonitis and 
biliary tract infections), in the womb 
or vagina, or in the blood 
(septicaemia). It may be

given before 
surgery or if you have a lack of white 
blood cells with fever.  
BINDOZEF INJECTION is also used 
for serious infections in children over 
2 months of age caused by bacteria in 
the lungs (pneumonia), in the kidney 
and bladder (urinary tra

Produktens egenskaper

 
Product Information:   
BINDOZEF INJECTION (Cefepime for Injection 1 g and 2 g)    

    Ver 1.4 

Page 1 of 15 

PRODUCT INFORMATION 

BINDOZEF INJECTION 1G (1 G CEFEPIME AS CEFEPIME HYDROCHLORIDE) 
POWDER FOR INJECTION 

BINDOZEF INJECTION 2G (2 G CEFEPIME AS CEFEPIME HYDROCHLORIDE) 
POWDER FOR INJECTION 

NAME OF THE MEDICINE 
Cefepime as Cefepime hydrochloride  

DESCRIPTION

Cefepime hydrochloride is a semi-synthetic
broad-spectrum cephalosporin antibiotic for parenteral 
administration.  The chemical name is Pyrrolidinium,
1-[[7-[[(2-amino-4-
thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-
yl]methyl]-1-methyl-,chloride, monohydrochloride, monohydrate,
[6R-[6α,7ß(Z)]], which 
corresponds to the following structural formula: 

Cefepime hydrochloride is a white to pale yellow powder, which is
highly soluble in water. 

MOLECULAR FORMULA: C
19
H
25
ClN
6
O
5
S
2
•HCl•H
2
O 
MOLECULAR WEIGHT: 571.50 
CAS REGISTRY NUMBER: 123171-59-5 

BINDOZEF INJECTION contains Arginine as an excipient. 

PHARMACOLOGY 
_PHARMACOKINETICS (IN ADULTS) _
Average plasma concentrations of cefepime observed in normal adult
males at various times 
following single 30-minute infusions of 500 mg, 1 g and 2 g are
summarised in Table 1. Following 
intramuscular administration, cefepime is completely absorbed. The
average plasma concentrations 
of cefepime at various times following a single IM injection are
summarised in Table 1.  

TABLE 1 

Product Information:   
BINDOZEF INJECTION (Cefepime for Injection 1 g and 2 g)    

    Ver 1.4 

Page 2 of 15 

MEAN PLASMA CONCENTRATIONS OF CEFEPIME (MICROGRAM/ML) IN  
MALE SUBJECTS WITH NORMAL RENAL FUNCTION  

TIME AFTER DOSE (HOURS) 
DOSE 
0.5 1 2 4 8 12 
INTRAVENOUS 
INFUSION        
500 
mg 
33.6 18.9 11.3  4.6  1.0  0.6 
1�