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:

Pfizer Australia Pty Ltd

DCI (Denominação Comum Internacional):

Cefepime

Status de autorização:

Registered

Folheto informativo - Bula

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
™
Cefepime Powder for
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 tract infections),
•
in the skin;
•
in the blood; or
•
if the child has a lack of white
blood cells with fever.
DBL
™
Cefepime Powder for
Injection will not wo

Características técnicas

Product Information - Australia
Version 3.0
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

, 7

(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, cefepime is completely
absorbed. The average
plasma concentrations of cefepime at various times following a single
IM injection are
summarised in Table 1.
Product Information - Australia
Version 3.0
Page 2 of 14
TABLE 1: MEAN PLASMA CONCE