HOSPIRA CEFAZOLIN SODIUM FOR INJECTION cefazolin (as sodium) 1 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefazolin sodium

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

cefazolin sodium

Authorization status:

Registered

Patient Information leaflet

________________________________________________________________________________
HOSPIRA™ Cefazolin Sodium Powder for Injection CMI
Page 1
HOSPIRA™
CEFAZOLIN SODIUM POWDER
FOR INJECTION
Cefazolin Sodium _(ke-fä-zö-lin)_
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Hospira™ Cefazolin Sodium
Powder for Injection. 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 being
given cefazolin against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET._ _
You may need to read it again.
WHAT HOSPIRA™
CEFAZOLIN SODIUM
POWDER FOR INJECTION IS
USED FOR
Cefazolin is an antibiotic used to
treat infections in different parts of
the body caused by bacteria.
Cefazolin will not work against
infections caused by viruses such
as colds or the flu.
This medicine belongs to a group
of antibiotics called
cephalosporins _(ke-fä-lö-spör-_
_ins)._
It works by killing the bacteria
causing your infection or by
stopping its growth.
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.
_ _
It is available only with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
HOSPIRA™
CEFAZOLIN
SODIUM POWDER FOR
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
HOSPIRA™ CEFAZOLIN SODIUM
POWDER FOR INJECTION IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
cefazolin
•
any other cephalosporin
antibiotics.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or

Summary of Product characteristics

Product Information - Australia_ _
Version 1.0
Page 1
HOSPIRA™ CEFAZOLIN SODIUM POWDER FOR INJECTION
NAME OF THE MEDICINE
Cefazolin sodium
Chemical Name: Sodium (6
_R, _
7
_R_
)-3-[[(5-methyl-1, 3, 4-thiadiazol-2-yl)sulphanyl]methyl]-8-oxo-7-
[(1
_H_
-tetrazol-1-ylacetyl) amino]-5-thia-1-azabicyclo[4.2.0]
oct-2-ene-2-carboxylate
Molecular formula: C
14
H
13
N
8
NaO
4
S
3
Molecular weight: 476.5
CAS: 27164-46-1
DESCRIPTION
Cefazolin sodium is a white to off white crystalline powder with a
solubility in water of greater than
or equal to 100 mg/mL. Hospira™ Cefazolin Sodium Powder for
Injection contains cefazolin sodium
as a single ingredient.
Hospira™ Cefazolin Sodium Powder for Injection is a powder for
parenteral administration following
reconstitution. Each vial contains 1.05
_ _
g of cefazolin sodium which is approximately equivalent to 1
_ _
g of cefazolin. Each gram of cefazolin sodium contains 48.3
_ _
mg of sodium.
PHARMACOLOGY
MICROBIOLOGY
_In vitro_
tests demonstrate that the bactericidal action of cephalosporins
results from inhibition of cell
wall synthesis. Cefazolin sodium is active against the following
organisms
_in vitro_
:
_Staphylococcus aureus_
(penicillin-sensitive and penicillin-resistant).
Group A beta-haemolytic streptococci and other strains of streptococci
(many strains of enterococci
are resistant).
_Streptococcus pneumoniae _
_ _
_Klebsiella species_
_Escherichia coli _
_ _
_ _
_Enterobacter aerogenes_
Product Information - Australia_ _
Version 1.0
Page 2
_Proteus mirabilis _
_ _
_ _
_Haemophilus influenzae _
Most strains of
_Enterobacter cloacae_
and indole-positive
_Proteus (Pr. vulgaris, Pr. morganii, Pr. _
_rettgeri)_
are resistant. Methicillin-resistant Staphylococci,
_Serratia, Pseudomonas, Acinetobacter _
_calcoaceticus _
(formerly
_Mima_
and
_Herellea_
species) are almost uniformly resistant to cefazolin.
_Disc Susceptibility tests _
Quantitative methods that require measurements of zone diameters give
the most precise estimates of
antibiotic susceptibility. One such proced