AURO-CEFAZOLIN 0.5g cefazolin (as sodium) 0.5g powder for injection vial

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

cefazolin sodium, Quantity: 524 mg

Boleh didapati daripada:

Strides Pharma Science Pty Ltd

INN (Nama Antarabangsa):

cefazolin sodium

Borang farmaseutikal:

Injection, powder for

Komposisi:

Excipient Ingredients:

Laluan pentadbiran:

Intramuscular, Intravenous

Unit dalam pakej:

1, 10, 5

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Cefazolin is indicated in the treatment of the following serious infections due to susceptible organisms:,Respiratory tract infections due to S. pneumoniae, Klebsiella species, H. influenzae, Staph. aureus (penicillin-sensitive and penicillin- resistant), and Group A beta-haemolytic streptococci.,Injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.,Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin in the subsequent prevention of rheumatic fever are not available at present.,Genitourinary tract infections due to Esch. coli, Pr. mirabilis, Klebsiella species, and some strains of Enterobacter and enterococci.,Skin and skin structure infections due to Staph. aureus (penicillin-sensitive and penicillin- resistant), and Group A beta-haemolytic streptococci and other strains of streptococci.,Bone and joint infections due to Staph. aureus.,Septicaemia due to S. pneumoniae, Staph. aureus (penicillin-sensitive and penicillin-resistant), Pr. mirabilis, Esch. coli and Klebsiella species.,Endocarditis due to Staph. aureus (penicillin-sensitive and penicillin-resistant), and Group A beta-haemolytic streptococci.,Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

Ringkasan produk:

Visual Identification: White or almost white powder filled in 10 ml clear glass vials with grey rubber stoppers sealed with aluminium seal having light rose PP disc; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store below 30 degrees Celsius

Status kebenaran:

Registered

Tarikh kebenaran:

2011-12-23

Risalah maklumat

AURO-CEFAZOLIN
CONSUMER MEDICINE INFORMATION
Ver 1.3
Page 1 of 3
AURO-CEFAZOLIN 0.5G, 1G & 2G
Cephazolin (as sodium)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
AURO-
CEFAZOLIN. It does not contain all
the available information and 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
AURO-
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 WITH THE MEDICINE.
You may need to read it again.
WHAT
AURO-CEFAZOLIN IS
USED FOR
AURO-CEFAZOLIN
contains
cephazolin (as cephazolin sodium) as
the
active
ingredient.
Cephazolin
belongs
to
a
group
of
antibiotics
called cephalosporins.
AURO-CEFAZOLIN is used to treat
serious
infections,
caused
by
bacteria,
in
different
parts
of
the
body. It works by killing the bacteria
that
are
causing
your
infection,
including infections of the:
•
respiratory tract (throat, tonsils,
chest and lungs)
•
nose
•
skin and soft tissue
•
genitourinary tract (kidney and
bladder)
•
bone and joint
•
blood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
AURO-
CEFAZOLIN HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another purpose
.
AURO-CEFAZOLIN
is
not
recommended for use in premature
infants
and
in
infants
under
one
month.
This medicine is only available with
a doctor’s prescription.
There
is
no
evidence
that
it
is
addictive.
BEFORE YOU TAKE
AURO-CEFAZOLIN
_ _
_WHEN _
_YOU _
_MUST _
_NOT _
_BE _
_GIVEN _
_AURO-CEFAZOLIN _
YOU
MUST
NOT
BE
GIVEN
AURO-
CEFAZOLIN IF YOU HAVE A KNOWN
ALLERGY TO:
•
cephazolin
•
any
other
cephalosporin
antibiotic
•
or a major allergy to penicillin.
Signs
of
an
allergic
reaction
may
include
shortness
of
breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue or
other parts of the body; rash, itching
or hives on the skin.
YOU
MUST
NOT
B

Ciri produk

Product Information:
AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)
Ver 1.4
Page 1 of 9
PRODUCT INFORMATION
AURO-CEFAZOLIN 0.5G (0.5 G CEPHAZOLIN AS CEPHAZOLIN SODIUM) POWDER FOR
INJECTION
AURO-CEFAZOLIN 1G (1 G CEPHAZOLIN AS CEPHAZOLIN SODIUM) POWDER FOR
INJECTION
AURO-CEFAZOLIN 2G (2 G CEPHAZOLIN AS CEPHAZOLIN SODIUM)
POWDER FOR INJECTION
NAME OF THE MEDICINE
The name of the medicine is cephazolin as cephazolin 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 REGISTRY NUMBER: _[27164-46-1]_
DESCRIPTION
AURO-CEFAZOLIN is a semisynthetic cephalosporin antibiotic for
parenteral administration
only. It is a white or almost white powder, very hygroscopic. It is
freely soluble in water and
very slightly soluble in ethanol. It contains approximately 48 mg (2.1
mEq) of sodium per g of
cephazolin sodium
Microbiology: In vitro tests demonstrate that the bactericidal action
of cephalosporins results
from inhibition of cell-wall synthesis. Cephazolin 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 _
_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 cephazolin.
Product Information:
AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)
Ver 1.4
Page 2 of 9
Pharmacology: The following table demonst