DBL CEFEPIME FOR INJECTION cefepime (as hydrochloride) 2g powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Cefepime

Disponível em:

Hospira Australia Pty Ltd

Classe:

Medicine Listed (Export Only)

Características técnicas

Product Information - Australia 

Version 2.0 

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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,