Fusigen Ointment (Sodium Fusidate BP 2 % ww)

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

SODIUM FUSIDATE

Доступна з:

KOMEDIC SDN BHD

ІПН (Міжнародна Ім'я):

SODIUM FUSIDATE

Одиниць в упаковці:

15gm mcg/mL; 10gm mcg/mL; 10gm mcg/mL; 15gm mcg/mL; 3 gm mcg/mL

Виробник:

M/S Geno Pharmaceuticals Pvt. Ltd.

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FUSIGEN OINTMENT
Sodium Fusidate (2% w/w)
________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Fusigen ointment is used for
2.
How Fusigen ointment works
3.
Before you use Fusigen ointment
4.
How to use Fusigen ointment
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
Fusigen
ointment
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT FUSIGEN OINTMENT IS USED FOR
Fusigen ointment is used to treat bacterial
skin infection.
HOW FUSIGEN OINTMENT WORKS
Fusigen
ointment
contains
sodium
fusidate. It acts as a topical antibacterial
agent which penetrate skin tissue and
suppress bacteria growth.
BEFORE YOU USE FUSIGEN OINTMENT
_- When you must not use it _
Do not use Fusigen ointment if you:
•
are allergic to fusidic acid or sodium
fusidate, or any other ingredients in
Fusigen ointment (listed in Product
description).
_ _
_ _
_- Before you start to use it _
_Pregnancy and breast-feeding _
If you are pregnant or breastfeeding, or
think
you
may
be
pregnant
or
are
planning to have a baby, ask your doctor
pharmacist for advice before using this
medicine.
Fusigen
is
secreted
into
breastmilk,
but
with
topical
use,
the
possible
amount
of
drug
presents
is
unlikely to affect the infant.
_ _
_- Using other medicines _
Inform your doctor or your pharmacist if
you are using other medicines, including
any that you buy without a prescription
from a pharmacy, supermarket or health
food shop.
HOW TO USE FUSIGEN OINTMENT
_- How much to use _
A small quantity should be applied to the
infected area twice daily.
_ _
_- When to use it _
Uncovered wound-use it twice daily or as
directed by your doctor or pharmacist.
Covered
wound-less
frequent
applications may be adequate.
_ _
_- How long to use it _
Use Fusigen ointment for the duration
that the doctor recommends.
A
single
treatment
course
should
not
normally exceed 7 days.
Extended or recurrent ap

Характеристики продукта

FUSIGEN*
(SODIUM FUSIDATE OINTMENT BP)
NAME OF PRODUCT: FUSIGEN OINTMENT
NAME AND STRENGTH OF ACTIVE INGREDIENT:
Each g contains: Sodium Fusidate BP 20mg in a neutral ointment base
DOSAGE FORM: Topical Ointment
PRODUCT DESCRIPTION: Fusigen Ointment is a white to pale yellow, soft
and smooth greasy ointment
PHARMACODYNAMICS:
FUSIGEN is a topical antibacterial agent.
Fusidic acid and its salts show strong surface activity and are also
fat soluble. These properties facilitate its
diffusion between aqueous and lipid phases in complex media. This may
account in part for the tissue
penetrating properties exhibited by the antibiotic. (FUSIGEN has been
shown experimentally to penetrate
skin as effectively as the corticosteoids).
Concentrations of 0.03 – 0.12 mcg fusidic acid per ml inhibit nearly
all strains of _Staphylococcus aureus. _
Topical application of fusidic acid is also effective streptococci,
corynebacteria, nesseria and certain
clostridia.
PHARMACOKINETICS:
Fusidic acid is well absorbed from the gastrointestinal tract, highly
bound to plasma proteins (97% to
99.8%), distributed to many tissues, and metabolized in the liver to
inactive metabolites. The drug has a
serum half-life of 5 to 6 hours and is eliminated almost exclusively
in bile
INDICATIONS:
Indicated in the treatment of skin infections caused by Staphylococci
RECOMMENDED DOSAGE:
_Adults and children: _
Uncovered lesions – a small quantity should be applied to the
affected area twice daily until a satisfactory
response is obtained. A single treatment course should not normally
exceed 7 days
Covered lesions – less frequent applications may be adequate.
ROUTE OF ADMINISTRATION:
Topical application
CONTRAINDICATIONS:
Infection caused by non-susceptible organisms, in particular
_Pseudomonas aeruginosa_.
Hypersensitivity to fusidic acid and its salts. As with other topical
corticosteriod preparations, FUSIGEN
OINTMENT is contraindicated in primary bacterial, viral and fungal
skin infections, skin manifestations in
relation to tuberculosis or syphili