DBL CEFEPIME FOR INJECTION cefepime (as hydrochloride) 1g powder for injection vial

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

Cefepime

Boleh didapati daripada:

Hospira Australia Pty Ltd

Kelas:

Medicine Listed (Export Only)

Risalah maklumat

 
DBL
™
 Cefepime cmi 

page 1 
DBL
™ 
CEFEPIME POWDER FOR 
INJECTION

_Cefepime dihydrochloride (SEF-eh-pim) _

CONSUMER MEDICINE INFORMATION 
_Date of dispensing_ 
_Patient Name  _
_Pharmacist Name _
_Patient address _
_Pharmacist Address _

WHAT IS IN THIS LEAFLET 

This leaflet answers some 
common questions about DBL
™

Cefepime Powder for Injection.  It 
does not contain all the available 
information. 

It does not take the place of 
talking to your doctor and 
pharmacist. 

All medicines have risks and 
benefits.  Your doctor has 
weighed the risks of you taking 
DBL
™
 Cefepime Powder for 
Injection against the benefits this 
medicine is expected to have for 
you. 

IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 

KEEP THIS LEAFLET WITH THE 
MEDICINE. 
You may need to read it again. 

WHAT DBL
™
 CEFEPIME 
POWDER FOR INJECTION IS 
USED FOR 

DBL
™
 Cefepime Powder for 
Injection belongs to a group of 
antibiotics called cephalosporins.  

It is used to treat infections in 
different parts of the body caused 
by bacteria. These antibiotics 
work by killing the bacteria that 
are causing your infection. 

DBL
™
 Cefepime Powder for 
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).  

DBL
™
 Cefepime Powder for 
Injection is also used to prevent 
infections before, during and after 
surgery. It may be given before 
surgery or if you have a lack of 
white blood cells with fever. 

DBL
™
�

Ciri produk

Product Information - Australia 

Version 2.0 

         Page  1 of 14 

DBL
™
 CEFEPIME POWDER FOR INJECTION  

NAME OF THE MEDICINE 
Cefepime (as hydrochloride monohydrate) powder for solution for
injection  

Molecular Formula:  C
19
H
25
N
6
O
5
S
2
Cl.HCl.H
2
O 
Molecular Weight: 
571.5 
CAS Registry No.: 
123171-59-5 
ARC code:    
J01DE01 

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-
[6
α, 7β(Z)]].  

Cefepime hydrochloride is a white to pale yellow powder. It is
highly soluble in water. It has 
a pH of between 4.0 and 6.0. 

DBL
™
 Cefepime Powder for Injection is a sterile lyophilised powder for
injection containing 
the inactive ingredient L-arginine to control the pH of the
reconstituted solution at 4.0 to 6.0. 
Following reconstitution with Water for Injection as directed in
labelling, it results in a pale 
yellow to amber coloured, clear solution. 

Each 20 mL vial contains either 1.914 g or 3.828 g of sterile
cefepime – L-arginine powder, 
which is equivalent to 1 g or 2 g of cefepime and approximately 725
mg of arginine per gram 
of cefepime. It contains no antimicrobial preservative and is for use
in one patient only. 

PHARMACOLOGY 
MECHANISM OF ACTION  
Cephalosporins act by interfering with bacterial cell-wall synthesis,
leading to lysis of the 
infectious organism. 

PHARMACOKINETICS  
_In Adults _
_ _
Average plasma concentrations of cefepime observed in normal
adult males at various 
times following single 30-minute infusions of 1 g and 2 g are
summarised in Table 1. 
Following intramuscular (IM) administration,