HOE GENTAMICIN CREAM 0.1% WW

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
19-02-2020
Ciri produk Ciri produk (SPC)
21-02-2020

Bahan aktif:

GENTAMICIN SULPHATE

Boleh didapati daripada:

HOE PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

GENTAMICIN SULPHATE

Unit dalam pakej:

15gm mcg/mL; 450 gm mcg/mL

Dikeluarkan oleh:

HOE PHARMACEUTICALS SDN. BHD.

Risalah maklumat

                                _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HOE GENTAMICIN CREAM
Gentamicin Sulphate (0.17%w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Hoe Gentamicin is used
for
2.
How Hoe Gentamicin works
3.
Before you use Hoe
Gentamicin
4.
How to use Hoe Gentamicin
5.
While you are using Hoe
Gentamicin Side effects
6.
Storage and Disposal of Hoe
Gentamicin Product
description
7.
Manufacturer and Product
Registration Holder
8.
Date of Revision
This leaflet answers some common
questions about Hoe Gentamicin. It
does not contain all the available
information.
It
does
not
take
the
place of talking to your pharmacist
or doctor.
All
medicines
have
risks
and
benefits. Your pharmacist or doctor
has weighed the risks of you taking
Hoe Gentamicin against the benefits
they expect it will have for you.
If
you
have
any
concerns
about
taking
this
medicine,
ask
your
pharmacist or doctor.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT HOE GENTAMICIN IS USED FOR
It
is
used
as
topical
treatment
to
treat various skin lesions infected by
common skin germs (bacteria).
Your
doctor
may
have
suggested
this medication for conditions other
than
those
listed
in
these
drug
information articles. If you have not
discussed this with your doctor or
are
not
sure
why
you
are
being
given this medication, speak to your
doctor.
HOW HOE GENTAMICIN WORKS
Hoe Gentamicin belongs to a group
of medicines called antibiotics. The
antibiotic in this product is called
Gentamicin
Sulphate
which
possesses
antibacterial
activity
against
most
germs
(bacteria)
on
skin.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT THIS
MEDICINE.
BEFORE YOU USE HOE GENTAMICIN
_-When you must not use it_
Do not use this medicine if

you have an allergy or have had an
adverse
reaction
to
any
of
this
medicine related ingredients.
Some
of
the
symptoms
of
an
allergic
reaction
may
include
shortness
of
breath,
wheezing
or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
_-Before you s
                                
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Ciri produk

                                -
(HOE)
EST. 1979
HOE GENTAMICIN CREAM 0.1% W/W
N A M E
A N D
S T R E N G T H
O F
A C T I V E
S U B S T A N C E :
Gentamicin
Sulphate
0 . 1 7 %
w/w
(equivalent to 0.1
% w/w Gentamicin).
PRODUCT
DESCRIPTION:
A white cream.
Other ingredients are
Phosphoric Acid,
Propyl
Paraben, Sodium
Edetate,
Methyl
Paraben,
Cetomacrogol
1 0 0 0 ,
Propylene
Glycol,
White
Soft
Paraffin,
Cetostearyl
Alcohol,
Sodium
Dihydrogen
Phosphate,
Liquid
Paraffin and
Purified Water.
P H A R M A C O D Y N A M I C S :
Gentamicin
s u l p h a t e
i s
a
b r o a d
s p e c t r u m
aminoglycoside
antibiotic which is bactericidal.
It acts directly on the bacterial ribosome , where they inhibit
protein synthesis and decrease the fidelity of translation of the
genetic code.
It is effective
against many strains of gram-negative bactericidal and staphylococcus
aureus.
P H A R M A C O K I N E T I C S :
Gentamicin sulphate
is
a bactericidal
antibiotic
which
is
active
against
a wide
v a r i e t y
o f
p a t h o g e n i c
gram-positive
and
gram-negative
b a c t e r i a .
When
applied
topically
to
large
areas
of
denuded
body
surface
as
the
case
of
burn
patients,
plasma concentrations can reach 1 mcg/ml, and 2% to 5% of the drug
used may appear in
the urine.
INDICATIONS: Treatment of impetigo, ery1hyma and other localised
primary bacterial skin
i n f e c t i o n
w i t h
a Gram-negative
c o m p o n e n t
a n d
a l s o
f o r
secondary
bacterial
infections
complicating other pre-existing dermatoses.
CONTRAINDICATION:
Hypersensitivity to gentamicin sulphate or any component in the base.
ADVERSE
EFFECT:
Ototoxicity and nephrotoxicity has been
reported
often in the topical
treatment of severe burns with gentamicin.
Hypersensitivity reactions have been reported
after local use.
P R E C A U T I O N S/W A R N I N G :
D i s c o n t i n u e
u s e
i f
h y p e r s e n s i t i v i t y
o r
i r r i t a t i o n ,
occurs.
PROLONG
USE
OF
A PREPARATION
CONTAINING
AN
A N T I B I O T I C
MAY RESULT
IN
O V E R G R O W T H
OF
NON
s u s c e p t i b l e
o r g a n i s m s
i n c l u d i n g
                                
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