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Cefepime Sandoz
CMI Version 01
1
CEFEPIME SANDOZ
CEFEPIME HYDROCHLORIDE POWDER FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Cefepime Sandoz.
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 taking this medicine
against the benefits they expect it will have for you.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CEFEPIME SANDOZ IS USED FOR
Cefepime Sandoz contains the active ingredient cefepime._ _
Cefepime belongs to a group of antibiotics called cephalosporins. It works by killing the bacteria that are
causing the infection.
This medicine is an injectable antibiotic used to treat serious infections in adults caused by bacteria in the:_ _
lung (pneumonia and bronchitis)
kidney and bladder (urinary tract infections)
skin
abdomen (peritonitis and biliary tract infections)
womb or vagina
blood (septicaemia).
It may also be given before surgery or if you have a lack of white blood cells with fever.
Cefepime Sandoz is also used for serious infections in children over 2 months of age caused by bacteria
in the:
lung (pneumonia)
kidney and bladder (urinary tract infections)
skin
blood (septicaemia).
It may also be given if the child has a lack of white blood cells with fever.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is
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제품 특성 요약
_Product Information _
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_ Page _
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_Cefepime Sandoz 500mg, 1g & 2g powder for injection _
_03/2012 _
Sandoz Pty Ltd
Version 01_ _
_1 _
PRODUCT INFORMATION
CEFEPIME SANDOZ
®
500MG,
1G & 2G POWDER FOR INJECTION
NAME OF THE MEDICINE
_ _
Generic name:
Cefepime (as hydrochloride)
Chemical name:
(6_R_,7_R_)-7-[[(2_Z_)-(2-Aminothiazol-4-yl)(methoxyimino)acetyl]
amino]-3-[(1-methylpyrrolidinio)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-
2-carboxylate dihydrochloride monohydrate
CAS : 123171-59-5
Empirical formula:
C
19
H
24
N
6
O
5
S
2
.2HCl.H
2
O
MW: 571.5
DESCRIPTION
Cefepime hydrochloride is a semi-synthetic broad spectrum cephalosporin antibiotic
for parenteral administration. Cefepime hydrochloride is a white to pale yellow
powder and is highly soluble in water.
Cefepime Sandoz is available as sterile vials containing cefepime hydrochloride
equivalent to 500mg, 1g or 2g of cefepime. It is an off-white to pale yellow
lyophilised powder. When reconstituted in water, it is a colourless faintly yellow to
brownish-yellow solution with a pH range of 4.0 to 6.0. Cefepime Sandoz powder for
injection also contains the inactive ingredient L-arginine.
_ _
PHARMACOLOGY
Pharmacokinetics (in adults)
Average plasma concentrations of cefepime observed in normal adult males at various
times following single 30-minute infusions of 500mg, 1g and 2g 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.
_Product Information _
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_Cefe
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