OZCEF cefaclor 375mg (as monohydrate) modified release tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

cefaclor monohydrate

Dostupné z:

Sun Pharma ANZ Pty Ltd

INN (Medzinárodný Name):

cefaclor monohydrate

Príbalový leták

OZCEF Tabs CMI V3 June 2013
1
OZCEF
CEFACLOR MODIFIED RELEASE TABLETS
CONSUMER MEDICINE INFORMATION
_ _
_WHAT IS IN THIS LEAFLET _
This
leaflet
answers
some
common questions about
OZCEF
.
It
does
not
contain
all
the
available information.
It
does
not
take
the
place
of
talking
to
your
doctor
and
pharmacist.
This leaflet was last updated on
the date at the end of this leaflet.
More recent information may be
available. The latest Consumer
Medicine Information is available
from
https://www.ebs.tga.gov.au/
and may contain important
information about the medicine
and its use of which you should be
aware.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the risks of you taking
OZCEF
against the benefits it 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.
OZCEF
tablets
contain
cefaclor
monohydrate
as
the
active
ingredient.
_ _
_WHAT OZCEF IS USED FOR _
_ _
OZCEF
is an antibiotic used to
treat infections in different parts of
the
body
caused
by
bacteria,
including infections of the:
•
ears, nose, throat and tonsils
(upper respiratory tract)
•
chest
and
lungs
(lower
respiratory tract)
•
bladder
and
kidneys
(lower
urinary tract)
•
skin
OZCEF
will
not
work
against
infections caused by viruses such
as colds or the flu.
OZCEF
belongs
to
a
group
of
antibiotics called cephalosporins,
which
are
closely
related
to
penicillins.
OZCEF
works
by
killing
the
bacteria causing your infection or
by stopping its growth.
Your doctor may have prescribed
OZCEF
for another reason. Ask
your
doctor
if
you
have
any
questions about why
OZCEF
has
been prescribed for you.
This
medicine
is
available
only
with a doctor’s prescription.
There is no evidence that
OZCEF
is addictive.
There is not enough information to
recommend
the
use
of
this
medicine
for
children
under
the
age of 12 years.
_ _
_BEFORE YOU START USING _
_OZCEF TABLETS _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE OZCEF TABLETS IF:
•
YO

Súhrn charakteristických

OZCEF Tabs P1 V4 Jun 2013
Page 1 of 6
OZCEF
_PRODUCT INFORMATION _
NAME OF THE MEDICINE
Cefaclor monohydrate
Structural formula:
H
2
N H
O
N
H
N
S
O
Cl
HO
O
H
2
O
.
H
H
Molecular formula:
C
15
H
14
CIN
3
O
4
S.H
2
O
Chemical name:
3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid
monohydrate
CAS number:
70356-03-5
DESCRIPTION
Cefaclor (monohydrate) is a white to off-white crystalline powder,
slightly soluble in water, but is insoluble in
alcohol and chloroform.
OZCEF tablets contain 375 mg cefaclor as cefaclor monohydrate,
hypromellose, hydroxypropylcellulose,
lactose, colloidal anhydrous silica, magnesium stearate and purified
talc. The film coating materials are
hypromellose, titanium dioxide, Macrogol 400 and indigo carmine
CI73015. The printing ink contains purified
water, iron oxide black, propylene glycol, hypromellose and isopropyl
alcohol. _ _
_ _
PHARMACOLOGY
MICROBIOLOGY
_In vitro_ tests demonstrate that the bactericidal action of the
cephalosporins results from inhibition of cell wall
synthesis. Cefaclor is stable in the presence of bacterial
β
-lactamases; consequently,
β
-lactamase producing
organisms resistant to penicillins and some cephalosporins may be
susceptible to cefaclor. Cefaclor may have
useful activity against the following organisms _in vitro_ and in
clinical infections.
_Gram-positive organisms: Staphylococcus aureus, Staphylococcus
saprophyticus, Streptococcus pneumoniae _
_and Streptococcus pyrogenes _ (group A Streptococci). Note that
cefaclor is not active against methicillin
resistant Staphylococci.
_Gram-negative organisms: Haemophilus influenzae, Moraxella
(Branhamella) catarrhalis, Escherichia coli. _
_Klebsiella pneumoniae and Proteus mirabilis. _
_ _
_Note: _
_The _
_pseudomonas _
_sp. _
_Acinetobacter _
_calcoaceticus, _
Enterococci,
Enterobacter sp.,
indole-positive
Proteus, and Serratia sp. are resistant to cefaclor.
_ _
_Susceptibility testing. _Dilution or diffusion techniques – either
quantitative (MIC) or breakpoint, should be used
following a regularly