TRAVOCORT CREAM

Страна: Малайзия

Език: английски

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

Активна съставка:

ISOCONAZOLE NITRATE; DIFLUCORTOLONE VALERATE

Предлага се от:

DKSH MALAYSIA SDN BHD

INN (Международно Name):

ISOCONAZOLE NITRATE; DIFLUCORTOLONE VALERATE

Броя в опаковка:

10gm mcg/mL

Произведено от:

LEO PHARMA MANUFACTURING ITALY S.R.L

Листовка

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TRAVOCORT
®
CREAM
Diflucortolone valerate/Isoconazole nitrate
(1mg/10mg)
1
WHAT IS IN THIS LEAFLET
1.
What Travocort
®
Cream is used for
2.
How Travocort
®
Cream works
3.
Before you use Travocort
®
Cream
4.
How to use Travocort
®
Cream
5.
While you are using it
6.
Possible side effects
7.
Storage and Disposal of Travocort
®
Cream
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
KEEP THIS LEAFLET.
You may need to read
it again.
WHAT TRAVOCORT
® CREAM IS USED FOR
•
This medicine is used to treat fungal
infections
of
the
skin
where
inflammation
(redness,
swelling,
soreness) is also a problem.
HOW TRAVOCORT
® CREAM WORKS
•
This medicine contains two active
substances, isoconazole nitrate and
diflucortolone valerate. Isoconazole
nitrate treats fungal diseases of the
skin
and
diflucortolone
valerate
suppresses inflammation of the skin
and
soothes
complaints
such
as
itching, burning and pain.
BEFORE YOU USE TRAVOCORT
® CREAM
-
_When you must not use it_
_ _
Do not use Travocort
®
Cream if you:
•
are
allergic
(hypersensitive)
to
isoconazole nitrate or diflucortolone-
valerate or any of the other ingredients
of this medicine (listed in section 8),
•
have skin lesions in the area to be
treated which are associated with a
tuberculosis or syphilis infection,
•
have
a
viral
infection
e.g.
herpes,
shingles
or
chicken-pox
(varicella,
herpes zoster),
•
have a chronic skin inflammation of
the face (rosacea), skin inflammation
around the mouth (perioral dermatitis)
or
a
skin
reaction
following
vaccination in the area to be treated.
-
_Before you start to use it_
_ _
•
Talk to your doctor, pharmacist or
nurse before using Travocort.
-
_Taking other medicine _
•
Please
tell
your
doctor
or
pharmacist if you are taking or
have
recently
taken
any
other
medicines,
including
medicines
obtained without a prescription.
•
Interactions
of
Travocort
with
other medicines are not known so
far.
HOW TO USE TRAVOCORT
® CREAM
-

Данни за продукта

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.l.
Important information, please read carefully!
1. NAME OF THE MEDICINAL PRODUCT
Travocort 1 %/0.1 % cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g Travocort contains 10 mg (1 %) isoconazole nitrate and
1 mg (0.1 %) diflucortolone valerate.
3. PHARMACEUTICAL FORM
Travocort contains a white to slightly yellowish opaque
cream. 1 g Travocort cream contains 10 mg isoconazole
nitrate and 1 mg diflucortolone valerate in an easy-to-remove
low fat base (o/w emulsion).
4. CLINICAL PARTICULARS
4.1 INDICATION
Initial or interim treatment of those superficial fungal
infections of the skin which are accompanied by highly
inflammatory or eczematous skin conditions, e.g. in the
region of the hands, the interdigital spaces of the feet, and
the inguinal and genital regions.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Travocort should be applied twice daily to the diseased areas
of skin. The treatment with Travocort must be terminated
after regression of the inflammatory or eczematous skin
condition, at the latest, however, after 2 weeks, and the
therapy continued or followed up with the corticoid-free
preparation Travogen. This applies in particular for use in
the inguinal and genital regions.
4.3 CONTRAINDICATIONS
Tuberculous or syphilitic processes in the area to be treated;
virus diseases (e.g. varicella, herpes zoster), rosacea,
perioral dermatitis and postvaccination skin reactions in the
area to be treated.
Hypersensitivity to the active substances or to any of the
excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Specific additional therapy is required for bacterial
infections of the skin.
Travocort should not be allowed to come into contact with
the eyes when bei