TRAVOGEN CREAM

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ISOCONAZOLE NITRATE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

ISOCONAZOLE NITRATE

Unit dalam pakej:

20gm mcg/mL

Dikeluarkan oleh:

LEO PHARMA MANUFACTURING ITALY S.R.L

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TRAVOGEN
®
CREAM
Isoconazole nitrate
(10mg/g)
1
WHAT IS IN THIS LEAFLET
1.
What Travogen
®
Cream is used for
2.
How Travogen
®
Cream works
3.
Before you use Travogen
®
Cream
4.
How to use Travogen
®
Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Travogen
®
Cream
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TRAVOGEN
® CREAM IS USED FOR
Travogen Cream is a medicine used to
treat fungal infection of the skin, such as
those between the toes, on the hands and
in the genital region.
HOW TRAVOGEN
® CREAM WORKS
Travogen
Cream
contain
isoconazole
nitrate. It displays a very broad spectrum
of antimicrobial action. Travogen Cream
is effective against all major types of
fungus and yeast that occur on human
skin.
BEFORE YOU USE TRAVOGEN
® CREAM
-
_When you must not use it_
_ _
Do not use Travogen Cream:
•
if you are allergic to isoconazole
nitrate
or
any
of
the
other
ingredients of this medicine (listed
in section product description).
-
_Before you start to use it_
_ _
_Pregnancy and breast-feeding _
•
If
you
are
pregnant
or
breast-
feeding,
think
you
may
be
pregnant or are planning to have a
baby,
ask
your
doctor
or
pharmacist
for
advice
before
using this medicine.
•
Do not use Travogen Cream in the
breast
area
if
you
are
breast-
feeding
-
_Taking other medicine _
•
Tell your doctor or pharmacist if
you are using any other medicines,
including any that you buy without
a prescription from a pharmacy,
supermarket or health food shop.
•
There are no known interactions.
HOW TO USE TRAVOGEN
® CREAM
-
_How much to use _
•
Always use this medicine exactly
your doctor or pharmacist has told
you
as this may differ from the
information
in
leaflet.
Please
consult a doctor or pharmacist if
you
do
not
understand
the
instructions
on
the
medication
label.
-
_When to use it _
•
Apply Travogen Cream once
daily to the infected parts of the
skin.
_ _
_ _
-
_How long to use it _
•
A general

Ciri produk

IIT004-00 - Page 1 + 2 - 148 x 210 mm – DRA_90040
IIT004-00 - 29/01/2019 - OMA: Updated for CI project (CAPA 173674)
Insert
148 x 210 mm
IIT004-00
29/01/2019
OMA
100%
All products
Used for:
Segrate keyline DRA_90040
Comments:
Approval:
Date:
Production site approval:
Graphic approval:
Revision info:
Manufactured by
LEO Pharma Manufacturing Italy S.r.I.
Important information, please read
carefully
COMPOSITION
Travogen contains a white to slightly
yellowish, opaque cream.
1 g Travogen Cream contains
10 mg Isoconazole nitrate.
PHARMACODYNAMIC PROPERTIES
Isoconazole nitrate is for use in the treatment
of superficial fungal diseases of the skin.
It displays a very broad spectrum of
antimicrobial action. It is effective against
dermatophytes and yeasts, yeast-like fungi
(including the causative organism of pityriasis
versicolor) and molds, as well as against the
causative organism of erythrasma.
PHARMACOKINETIC PROPERTIES
Isoconazole penetrates rapidly into the
skin from Travogen cream. Maximum drug
levels in the skin were already reached after
1 hour and were maintained for at least
7 hours (horny layer: approx. 3500 µg/ml ±
7 mmol/l, living epidermis approx. 20 µg/ml
± 40 µmol/l, dermis approx. 3 µg/ml ± 6
µmol/l). Removal of the horny layer prior to
the application increased isoconazole levels
in the living skin approximately by a factor
of 2. Drug levels in the horny layer and the
epidermis exceeded minimum inhibitory
and biocidal antimycotic concentrations of
most important pathogens (dermatophytes,
molds and yeasts) several-fold and reached
those values in the dermis.
Isoconazole is not metabolically inactivated
in the skin. Systemic load due to
percutaneous absorption is low. Even after
removal of the horny layer less than 1% of
the applied dose has reached the systemic
circulation within 4 hours exposure time.
The percutaneously absorbed portion was
too low to permit investigating the fate
of isoconazole nitrate within the human
organism.
Investigation of metabolism after
intravenous administration
0.