TRAVOGEN CREAM 1%

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

ISOCONAZOLE NITRATE

Tilgjengelig fra:

DKSH SINGAPORE PTE. LTD.

ATC-kode:

D01AC05

Dosering :

10 mg/g

Legemiddelform:

CREAM

Sammensetning:

ISOCONAZOLE NITRATE 10 mg/g

Administreringsrute:

TOPICAL

Resept typen:

Pharmacy Only

Produsert av:

LEO Pharma Manufacturing Italy S.r.I

Autorisasjon status:

ACTIVE

Autorisasjon dato:

1991-01-14

Informasjon til brukeren

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
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g Travogen Cream contains 10 mg Isoconazole nitrate (equivalent to
1% (w/w) isoconazole nitrate).
PHARMACEUTICAL FORM
White to slightly yellowish opaque cream.
INDICATIONS
Superficial fungal infections of the skin, e.g. in the region of the
hands, the interdigital spaces of the feet, and in the inguinal
and genital regions.
DOSAGE AND ADMINISTRATION
Cutaneous use. Travogen should be applied once daily to the affected
areas of skin.
A general rule for fungal infections is that topical therapy be
continued for a period of two to three weeks, and for four weeks
in refractory infections (particularly infections of the interdigital
spaces). Longer period of treatment are also possible.
To avoid recurrence, treatment should be continued for at least
another two weeks after clinical healing.
CONTRAINDICATIONS
None so far known.
INTERACTION WITH OTHER MEDICAMENT
No interaction studies have been performed.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Travogen should not be allowed to come into contact with the eyes when
being applied to the face.
The physican should advise the patients on hygienic measures and skin
care, if applicable, during the treatment.
If Travogen cream is applied to the genital region, the excipients
liquid paraffin and soft paraffin may cause damage of latex
products for barrier methods such as condoms and diaphragms used
concomitantly, thus impairing their effectiveness.
FERTILITY, PREGNANCY AND LACTATION
It has been shown in animal studies that there were no adverse effects
on birth and lactation, and on the fertility and
reproductive functions. Hence base

Preparatomtale

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
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g Travogen Cream contains 10 mg Isoconazole nitrate (equivalent to
1% (w/w) isoconazole nitrate).
PHARMACEUTICAL FORM
White to slightly yellowish opaque cream.
INDICATIONS
Superficial fungal infections of the skin, e.g. in the region of the
hands, the interdigital spaces of the feet, and in the inguinal
and genital regions.
DOSAGE AND ADMINISTRATION
Cutaneous use. Travogen should be applied once daily to the affected
areas of skin.
A general rule for fungal infections is that topical therapy be
continued for a period of two to three weeks, and for four weeks
in refractory infections (particularly infections of the interdigital
spaces). Longer period of treatment are also possible.
To avoid recurrence, treatment should be continued for at least
another two weeks after clinical healing.
CONTRAINDICATIONS
None so far known.
INTERACTION WITH OTHER MEDICAMENT
No interaction studies have been performed.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Travogen should not be allowed to come into contact with the eyes when
being applied to the face.
The physican should advise the patients on hygienic measures and skin
care, if applicable, during the treatment.
If Travogen cream is applied to the genital region, the excipients
liquid paraffin and soft paraffin may cause damage of latex
products for barrier methods such as condoms and diaphragms used
concomitantly, thus impairing their effectiveness.
FERTILITY, PREGNANCY AND LACTATION
It has been shown in animal studies that there were no adverse effects
on birth and lactation, and on the fertility and
reproductive functions. Hence base