TRAVOCORT CREAM

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DIFLUCORTOLONE VALERATE; ISOCONAZOLE NITRATE

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

D01AC20

Dosage:

1 mg/g

Pharmaceutical form:

CREAM

Composition:

DIFLUCORTOLONE VALERATE 1 mg/g; ISOCONAZOLE NITRATE 10 mg/g

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

LEO Pharma Manufacturing Italy S.r.I

Authorization status:

ACTIVE

Authorization date:

1990-05-31

Patient Information leaflet

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:
TRAVOCORT
®
Cream
Broad-spectrum antimycotic with a corticoid additive
063581
Manufactured by: LEO Pharma Manufacturing Italy S.r.l.
Important information, please read carefully!
COMPOSITION
Travocort contains a white to slightly yellowish opaque
cream. 1 g Travocort contains 10 mg (1%)isoconazole
nitrate and 1 mg (0.1%) diflucortolone valerate in an easy-
to-remove low fat base (o/w emulsion).
PHARMACODYNAMICS
Pharmacotherapeutic group:Imidazole and triazole
derivatives, combinations
ATC Code:D01AC20
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 gram-positive bacteria in-vitro and against
the causative organism of erythrasma. Diflucortolone
valerate suppresses inflammation in inflammatory and
allergic skin conditions and alleviates the subjective
complaints such as pruritus, burning and pain.
PHARMACOKINETICS
R Isoconazole nitrate
Isoconazole penetrates rapidly into human skin from
Travocort cream and reaches maximum drug concentrations
in the horny layer and in the living skin already 1 hour
after application. High concentrations were maintained
for at least 7 hours (horny layer: approx. 3500 μg/ml
(corresponding to 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 concentrations in the living skin
approximately by a factor of 2, based on a study done on
guinea pig skin. Drug concentrations in the horny layer and
the epidermis exceeded

Summary of Product characteristics

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:
Font updated to Univers Next
000000-YY
TRAVOCORT® Cream
Broad-spectrum antimycotic with a corticoid additive
Manufactured by: LEO Pharma Manufacturing Italy S.r.l.
Important information, please read carefully!
COMPOSITION
Travocort contains a white to slightly yellowish opaque
cream. 1 g Travocort contains 10 mg (1%)isoconazole nitrate
and 1 mg (0.1%) diflucortolone valerate in an easy-to-remove
low fat base (o/w emulsion).
PHARMACODYNAMICS
Pharmacotherapeutic group:Imidazole and triazole
derivatives, combinations
ATC Code:D01AC20
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
gram-positive bacteria in-vitro and against the causative
organism of erythrasma. Diflucortolone valerate suppresses
inflammation in inflammatory and allergic skin conditions
and alleviates the subjective complaints such as pruritus,
burning and pain.
PHARMACOKINETICS
• Isoconazole nitrate
Isoconazole penetrates rapidly into human skin from
Travocort cream and reaches maximum drug concentrations
in the horny layer and in the living skin already 1 hour after
application. High concentrations were maintained for at least
7 hours (horny layer: approx. 3500 μg/ml (corresponding to
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 concentrations
in the living skin approximately by a factor of 2, based on
a study done on guinea pig skin. Drug concentrations in
the horny l