SRATOP 0.5g cefazolin (as sodium) 0.5g powder for injection vial

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

cefazolin sodium, Quantity: 524 mg

Mevcut itibaren:

Strides Pharma Science Pty Ltd

INN (International Adı):

cefazolin sodium

Farmasötik formu:

Injection, powder for

Kompozisyon:

Excipient Ingredients:

Uygulama yolu:

Intramuscular, Intravenous

Paketteki üniteler:

10, 5, 1

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

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.

Ürün özeti:

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

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2011-12-23

Bilgilendirme broşürü

SRATOP
CONSUMER MEDICINE INFORMATION
Ver 1.3
Page 1 of 3
SRATOP 0.5G, 1G & 2G
Cephazolin (as sodium)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
SRATOP.
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
SRATOP
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 SRATOP IS USED FOR
SRATOP
contains
cephazolin
(as
cephazolin
sodium)
as
the
active
ingredient. Cephazolin belongs to a
group
of
antibiotics
called
cephalosporins.
SRATOP
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 SRATOP HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose
.
SRATOP
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 SRATOP
_ _
_WHEN _
_YOU _
_MUST _
_NOT _
_BE _
_GIVEN _
_SRATOP _
YOU MUST NOT BE GIVEN SRATOP 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 BE GIVEN SRATOP IF
THE
PACKAGING
IS
TORN
OR
SHOWS
SIGNS OF TAMPERING.
YOU MUST NOT BE GIVEN SRATOP
AF

Ürün özellikleri

Product Information:
SRATOP (Cephazolin for Injection 0.5g, 1g & 2g)
Ver 1.4
Page 1 of 9
PRODUCT INFORMATION
SRATOP 0.5G (0.5 G CEPHAZOLIN AS CEPHAZOLIN SODIUM) POWDER FOR
INJECTION
SRATOP 1G (1 G CEPHAZOLIN AS CEPHAZOLIN SODIUM) POWDER FOR INJECTION
SRATOP 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
SRATOP 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:
SRATOP (Cephazolin for Injection 0.5g, 1g & 2g)
Ver 1.4
Page 2 of 9
Pharmacology: The following table demonstrates the blood levels and
duration of cephazoli