FOBAN OINTMENT

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
12-09-2022
Ciri produk Ciri produk (SPC)
12-09-2022

Bahan aktif:

SODIUM FUSIDATE

Boleh didapati daripada:

HOE PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

SODIUM FUSIDATE

Unit dalam pakej:

15gm mcg/mL; 5gm mcg/mL

Dikeluarkan oleh:

HOE PHARMACEUTICALS SDN. BHD.

Risalah maklumat

                                _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
FOBAN OINTMENT
Sodium Fusidate (2% w/w)
_ _
WHAT IS IN THIS LEAFLET
1.
What Foban Ointment is used
for
2.
How Foban Ointment works
3.
Before you use Foban Ointment
4.
How to use Foban Ointment
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Foban
Ointment
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
This leaflet answers some common
questions about Foban Ointment. It
does
not
contain
all
the
available
information.
It
does
not
take
the
place of talking to your pharmacist
or doctor.
Keep
this
leaflet
with
the
medication. You may need to read it
again.
WHAT FOBAN OINTMENT
IS USED FOR
Foban
Ointment
is
used
for
skin
lesions
primarily
or
secondarily
infected
by
skin
germs
(bacteria)
such
as
Staphylococcus
or
Streptococcus.
HOW FOBAN OINTMENT
WORKS
Foban Ointment contains the active
ingredient
sodium
fusidate.
Every
gram of ointment contains 20 mg of
sodium fusidate.
SODIUM FUSIDATE
is an antibiotic that
provides antibacterial activity against
most germs (bacteria) on skin.
Ask your pharmacist or doctor if you
have
any
questions
about
this
medicine.
BEFORE YOU USE FOBAN OINTMENT
_ _
_When you must not use it _
DO NOT APPLY FOBAN OINTMENT IF:
•
You are hypersensitive to Fusidic
acid and its salts or to any of this
medicine’s ingredients.
_Before you start to use it _
TELL YOUR PHARMACIST OR DOCTOR:
•
If you have an infection on your
skin and specify the infected area.
•
If
you
are
using
any
other
prescription
or
non-prescription
medicines or skin products.
PREGNANCY AND BREAST FEEDING:
•
Ask your doctor or pharmacist for
advice before taking this medicine
if
you
are
pregnant
or
breast-
feeding.
•
Safety of usage during pregnancy
and
lactation
has
not
been
established.
•
Fusidic acid has been detected in
breast milk, but with topical use
the possible amount of medicine
present
is
unlikely
to
affect
the
infant.
_Taking other medicines _
Tell your pharmacist or doctor if you
are taking any o
                                
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Ciri produk

                                Est. 1979
FOBAN CREAM AND OINTMENT
NAME AND STRENGTH OF ACTIVE SUBSTANCES :
CREAM: Fusidic Acid 2% w/w.
OINTMENT: Sodium Fusidate 2% w/w.
PRODUCT DESCRIPTION :
CREAM: A white cream.
Other ingredients: Propyl Paraben, Methyl Paraben, White Soft
Paraffin, Cetostearyl Alcohol,
Cetomacrogol 1000 (Macrogol Cetostearyl Ether), Propylene Glycol,
Liquid Paraffin and Purified
Water.
OINTMENT: A colourless ointment.
Other ingredients: Liquid Paraffin and White Soft Paraffin.
PHARMACODYNAMICS : Fusidic acid and its salts exert antibacterial
activity against most
Gram positive organisms; in particular, they are effective against
pathogenic Staphylococci,
including the penicillinase-producing strains. They have slight or no
activity against Gram
negative organisms and fungi.
PHARMACOKINETICS : Fusidic acid and its salts are widely distributed
into tissues and body
fluids, including bone, pus, and synovial fluid; they penetrate
cerebral abscesses but do not enter
cerebrospinal fluid in appreciable amounts. They have been found in
foetal circulation and in
breast milk. About 95% or more of Fusidic acid or Sodium fusidate in
the circulation is bound to
plasma protein. Fusidic acid or Sodium fusidate is excreted in the
bile, almost entirely as
metabolites, some of which have weak antimicrobial activity.
About 2% appears unchanged in the faeces. Little is excreted in the
urine or removed by
haemodialysis.
INDICATIONS
:
Skin
lesions
primarily
or
secondarily
infected
with
_Staphylococcus_
or
_Streptococcus._
CONTRAINDICATIONS : Known hypersensitivity to Fusidic acid, it salts
and propylene glycol.
DRUG INTERACTIONS : No synergy has been demonstrated in vitro in most
studies between
Fusidic acid and rifampicin or vancomycin, and antagonism of the
effects of ciprofloxacin has
been reported. Interactions with the penicillins are complex, with
either antagonism of the effect
of one or both agents, or lack of any efffect. However, the
combination of an antistaphylococcal
penicillin with Fusidic acid may prevent the emergence of Fusidic
a
                                
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