TRAVOCORT CREAM

Quốc gia: Nam Phi

Ngôn ngữ: Tiếng Anh

Nguồn: South African Health Products Regulatory Authority (SAHPRA)

Sẵn có từ:

Adcock Ingram Limited

Liều dùng:

See ingredients

Dạng dược phẩm:

CREAM

Thành phần:

EACH 1 g CREAM CONTAINS DIFLUCORTOLONE VALERATE 1 mg ISOCONAZOLE NITRATE 10 mg

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

1982-04-11

Tờ rơi thông tin

PATIENT INFORMATION LEAFLET FOR TRAVOCORT
09 May 2023
SCHEDULING STATUS
S4
TRAVOCORT, 10 MG / 1 MG, CREAM
ISOCONAZOLE NITRATE / DIFLUCORTOLONE VALERATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING TRAVOCORT
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
TRAVOCORT has been prescribed for you personally and you should not
share your
medicine with other people. It
may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What TRAVOCORT is and what it is used for
2. What you need to know before you use TRAVOCORT
3. How to use TRAVOCORT
4. Possible side effects
5. How to store TRAVOCORT
6. Contents of the pack and other information
1. WHAT TRAVOCORT IS AND WHAT IT IS USED FOR
1 g TRAVOCORT contains isoconazole nitrate 10 mg and 1 mg
diflucortolone valerate in an easy to
remove low fat base emulsion.
The active substances in TRAVOCORT are isoconazole nitrate and
diflucortolone valerate. Other
excipients include:
White soft paraffin, liquid paraffin, cetostearyl alcohol, polysorbate
60, sorbitan stearate, disodium
edetate dihydrate, purified water.
PATIENT INFORMATION LEAFLET FOR TRAVOCORT
09 May 2023
TRAVOCORT is an anti-fungal medicine (an antimycotic) and an
anti-inflammatory medicine (a
corticosteroid) formulated as a cream to be used on the skin.
One of TRAVOCORT's active ingredients, isoconazole nitrate, is
effective against dermatophytes
and yeasts, yeast-like fungi (including the causative organism of
pityriasis versicolor) and moulds,
as well as against the causative organism of erythrasma. The other
active ingredient, diflucortolone
valerate, suppresses inflammatory and allergic skin reactions.
TRAVOCORT is used for the 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 in t

Đặc tính sản phẩm

PROFESSIONAL INFORMATION FOR TRAVOCORT
09 May 2023
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
TRAVOCORT, 10 MG / 1 MG, CREAM
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g TRAVOCORT contains isoconazole nitrate -imidazole, nitrate) 10 mg
and diflucortolone valerate
1 mg in an easy-to-remove low fat base oil water emulsion.
Excipients with known effect: cetostearyl alcohol
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream.
White to slightly yellowish opaque cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fungal infections of hairless and hairy skin, e.g. in the region of
the hands, the interdigital spaces of
the feet, and in the inguinal and genital regions.
Because of the addition of diflucortolone valerate, TRAVOCORT is
indicated for the initial or
intermediate treatment of those fungal diseases which are accompanied
by highly inflammatory or
eczematous skin conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
TRAVOCORT should be applied twice daily to the diseased areas of skin.
In infections of the
interdigital spaces it is often advisable to place a strip of gauze
smeared with TRAVOCORT between
_ _
09 May 2023
the toes or fingers.
The treatment with TRAVOCORT must be terminated after regression of
the inflammatory or
eczematous skin condition and the therapy continued or followed up
with the isoconazole nitrate
preparation without corticoid additive. This applies in particular for
use in inguinal and genital
regions.
If a secondary microbial skin infection is present suitable
concomitant anti-microbial therapy should
be instituted. If fungal infections are present, a topically active
antimycotic should be applied.
_PAEDIATRIC POPULATION_
No data are available.
METHOD OF ADMINISTRATION
Cutaneous use.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
•
Tuberculous or syphilitic processes in the area to be treated; virus
diseases (e.g. varicella,
herpes zoster), rosacea, perioral dermatitis and