VERCEF MR TABLET 375MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CEFACLOR

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CEFACLOR

Unit dalam pakej:

100Tablet Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

VERCEF MR
Page 1
VERCEF MR
(Cefaclor Modified Release Tablets 375 mg)
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What
VERCEF MR
is used for
2.
How
VERCEF MR
works
3.
Before you use
VERCEF MR
4.
How to use
VERCEF MR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
VERCEF
MR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
This leaflet answers some common
questions about
VERCEF MR
.
It does not contain all of 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
VERCEF MR
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.
WHAT VERCEF MR IS USED FOR
VERCEF
MR
is
used
to
treat
the
infections
caused
by
the
susceptible
organisms:
-
Upper respiratory tract infections
(throat and tonsils).
-
Lower respiratory tract infections
(chest and lungs).
-
Urinary tract infections.
-
Skin and soft tissue infections.
HOW VERCEF MR WORKS
VERCEF MR
contains C
efaclor which
is
a
type
of
antibiotic
called
cephalosporin. Cefaclor is used to treat
infections caused by bacteria.
Ask
your
doctor
if
you
have
any
questions why it has been prescribed
for you.
This medicine is only available with a
doctor’s prescription.
There
is
not
enough
information
to
recommend the use of this medicine
for children.
BEFORE YOU USE VERCEF MR
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE VERCEF MR IF YOU:

are
allergic
to
cefaclor,
other
cephalosporins or any of the other
ingredients of this medicine (see
product description at the end of
this leaflet).
An
allergic
reaction
may
include
skin rash, itching, swelling of the
face,
lips,
tongue
and
throat
or
difficulty in breathing.
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK HAS
EXPIRED OR IF THE PACKAGING IS TORN

Ciri produk

_“For the use only of a Registered Medical Practitioner” _
VERCEF MR
(CEFACLOR MODIFIED RELEASE TABLETS 375 MG)
COMPOSITION
Each modified release film coated tablet contains:
Cefaclor USP
equivalent to anhydrous Cefaclor………………………375 mg
Excipients: Sunset Yellow Lake, Purified Talc, Macrogol 400, Titanium
Dioxide, Hydropropyl Methyl
Celulose (2910/2208) Colloidal Anhydrous Silica, Lactose, Magnesium
Sterate, Hydropropyl
Cellulose.
DESCRIPTION
VERCEF MR TABLETS (Cefaclor Modified release Tablets 375 mg) contain
cefaclor. Cefaclor is a
cephalosporin antibiotic intended for oral administration. It is
chemically designated as 3-Chloro-7-
D
-
(2-phenylglycinamido)-3-cephem-4-carboxylic
acid
monohydrate..
Its
empirical
formula
is
C
15
H
14
ClN
3
O
4
S.H
2
O and the molecular weight is 385.8. Its chemical structure is as
given below:
.H
2
O
CEFACLOR
STRUCTURAL FORMULA
PRODUCT DESCRIPTION:
Capsule shaped biconvex, peach coloured, film coated tablets imprinted
‘VERCEF MR 375’ in red
edible ink.
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
_ _
Cefaclor has been shown to be active _ in vitro_ against most strains
of the following organisms,
although clinical efficacy has not been established:
_GRAM NEGATIVE ORGANISMS: _
_Citrobacter diversus _
_Neisseria gonorrhoeae _
_ _
_ANAEROBIC ORGANISMS: _
_Propionibacterium acnes _
_Bacteroides_ species (excluding Bacteroides fragilis)
_Peptococci _
_Peptostreptococci _
_ _
Note:_ Pseudomonas _ sp_, Acinetobacter calcoaceticus, _ most strains
of enterococci,_ Enterobacter _ sp_, _
indole-positive_ Proteus _and_ Serratia _sp are resistant to cefaclor.
Cefaclor is inactive against methicillin
resistant staphylococci.
_ _
Using the NCCLS recommended methods for sensitivity testing, the
criteria for dilution methods are:
MIC ≤ 8 micrograms/ml
susceptible
MIC = 16 micrograms/ml
moderately susceptible
MIC ≥ 32 micrograms/ml
resistant
and for the standard disc test, using a 30 microgram cefaclor disc
(zone diameters)
MIC ≥ 18 mm
suscepti