DERMAFIN CREAM

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

Terbinafine Hydrochloride

थमां उपलब्ध:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (इंटरनेशनल नाम):

Terbinafine Hydrochloride

पैकेज में यूनिट:

20gm mcg/mL; 20gm mcg/mL; 15gm mcg/mL; 10gm mcg/mL; 10gm mcg/mL; 15gm mcg/mL; 500 gm

द्वारा बनाया गया:

Y.S.P. INDUSTRIES (M) SDN BHD

सूचना पत्रक

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DERMAFIN
® CREAM
Terbinafine Hydrochloride (10mg/g)
1
WHAT IS IN THIS LEAFLET
This leaflet contains information below:
1.
What DERMAFIN
®
CREAM is used
for
2.
How DERMAFIN
®
CREAM works
3.
Before
you
use
DERMAFIN
®
CREAM
4.
How to use DERMAFIN
®
CREAM
5.
While
you
are
using
DERMAFIN
®
CREAM
6.
Side effects
7.
Storage and disposal of DERMAFIN
®
CREAM
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT DERMAFIN
® CREAM
IS USED FOR
DERMAFIN
®
CREAM is used for fungal
infections of the skin such as below:
•
athlete’s
foot
(tinea
pedis)
-
especially when it occurs between
the toes
•
jock itch (tinea cruris) - itchy rash
with
a
clear
border
which
often
occurs on the groin and inner thigh
area.
•
ringworm (tinea corporis) - circular
patches
of
red
rash
which
may
appear scaly.
•
pityriasis (tinea) versicolor - skin
infection caused by yeast, causing
scaly
patches
that
become
white
areas
due
to
loss
of
skin
pigmentation.
DERMAFIN
®
CREAM is for external use
only.
HOW DERMAFIN
® CREAM
WORKS
Terbinafine
is
a
fungicidal
medication
which kills certain dermatophytes, mould,
fungi
and
fungistatic
(inhibit
growth
of
fungi)
for
some
yeast
that
causes
the
infection.
BEFORE YOU USE DERMAFIN
® CREAM
_-When you must not use it _
DERMAFIN
®
CREAM is not recommended
for pregnant and breastfeeding women.
Do not use DERMAFIN
®
CREAM if you
have
allergy
towards
terbinafine
or
any
components in this cream preparation.
Do not use this medicine after the expiry
date or if the tube is leaking or tube nozzle
cover is broken.
_-Before you start to use it _
Tell your doctor or pharmacist if you are
allergic to terbinafine or any components of
this preparation.
_-Taking other medicines _
Seek advice from your doctor or pharmacist
if you intend to use DERMAFIN
®
CREAM
together with other medication.
HOW TO USE DERMAFIN
® CREAM
_-How much to use _
Apply a thin layer and rub lightly to the
affected skin and surrounding area once

उत्पाद विशेषताएं

ATTACHMENT 1
DERMAFIN
CREAM
INGREDIENT(S):
Each gram contains:
Terbinafine Hydrochloride .........................................
10mg
PRESERVATIVE(S):
Methyl
Paraben........................................................... 1mg
Propyl
Paraben............................................................
1mg
PHARMACOLOGY
(SUMMARY
OF
PHARMACODYNAMICS
AND
PHARMACOKINETICS):
Terbinafine is an allylamine with a range of antifungal activity
its action being fungicidal against dermatophytes, moulds and
certain dimorphic fungi, and either fungicidal or fungistatic
against yeast, depending on the species.
Terbinafine interferes with fungal ergosterol biosynthesis at
an early stage. This leads to a deficiency in ergosterol and to
intracellular accumulation of squalene, resulting in fungal cell
death.
Terbinafine
does
not
affect
the
metabolism
of
hormones or other drugs.
INDICATION(S):
Fungal infections of the skin caused by dermatophytes, eg.
_Tricophyton, _
_Microsporum _
_canis_
and
_Epidermophyton _
_floccosum_;
yeast
infections
of
the
skin,
principally
those
caused by the genus Candida; _Pityriasis (tinea) versicolor_ due
to _Pityrosporum orbiculare._
DOSAGE AND ADMINISTRATION:
Apply a thin layer and rub lightly to the affected skin and
surrounding
area
once
or
twice
daily.
In
the
case
of
intertriginous
infections
(submammary,
interdigital,
intergluteal, inguinal), the application may be covered with
gauze strip, especially at night.
Duration of treatment:
Tinea pedis, cruris, corporis: 1 week of treatment will normally
suffice if the cream is applied once daily.
Cutaneous Candidiasis: 1 -2 weeks
Pityriasis (tinea) versicolor: 2 weeks
CONTRAINDICATION(S):
Hypersensitivity to terbinafine.
PRECAUTION(S) / WARNING(S):
Terbinafine cream is for external use only. Contact with the
eyes should be avoided. It is not recommended for pregnant
and breastfeeding women
DRUG INTERACTION(S):
There are no known drug interactions involving terbinafine
cream.
SIDE EFFECT(S) / ADVERSE REACTION(S):
Occasional redness or itching.
SYMPTOMS