DERMOVATE

País: Indonesia

Idioma: indonesio

Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ficha técnica Ficha técnica (SPC)
01-01-2017

Ingredientes activos:

CLOBETASOL PROPIONATE

Disponible desde:

GLAXO WELLCOME INDONESIA - Indonesia

Designación común internacional (DCI):

CLOBETASOL PROPIONATE

Dosis:

0,05 % B/B

formulario farmacéutico:

SALEP

Unidades en paquete:

DUS, TUBE @ 10 G

Fabricado por:

GLAXO WELLCOME INDONESIA - Indonesia

Fecha de autorización:

2016-02-09

Ficha técnica

                                ERS_leaDERCre&Oint_PI Update to GDS16/IPI09_circ1_2Jun2021
Page 1 of 6
DERMOVATE CREAM AND OINTMENT
CLOBETASOL PROPIONATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_DERMOVATE_ Cream and Ointment contains Clobetasol propionate 0.05%
w/w.
CLINICAL INFORMATION
INDICATIONS
_DERMOVATE_ is a very active topical corticosteroid which is of
particular value when used in short
courses for the treatment of the more resistant dermatoses such as
psoriasis (excluding
widespread plaque psoriasis), recalcitrant eczema, lichen planus,
discoid lupus erythematosus and
other conditions which do not respond satisfactorily to less active
steroids.
DOSAGE AND ADMINISTRATION_ _
PHARMACEUTICAL FORM
Cream and Ointment.
OINTMENT
Ointments are especially appropriate for dry, lichenified or scaly
lesions.
CREAM
Creams are especially appropriate for moist or weeping surfaces.
ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR
Apply sparingly to the affected area once or twice daily until
improvement occurs and discontinue
when control is achieved. In the more responsive conditions this may
be within a few days.
Treatment should not be continued for more than four weeks without the
patient’s condition being
reviewed. Repeated short courses of _DERMOVATE _may be used to control
exacerbations. If
continuous steroid treatment is necessary, a less potent preparation
should be used.
In very resistant lesions, especially where there is hyperkeratosis,
the effect of _DERMOVATE _can
be enhanced, if necessary, by occluding the treatment area with
polythene film.
Overnight occlusion only is usually adequate to bring about a
satisfactory response. Thereafter
improvement can usually be maintained by application without
occlusion.
CONTRAINDICATIONS
The following conditions should not be treated with _DERMOVATE: _
-
Untreated cutaneous infections
-
Rosacea
-
Acne vulgaris
-
Pruritus without inflammation
-
Perianal and genital pruritus
-
Perioral dermatitis.
_DERMOVATE_ is contraindicated in dermatoses in children under one
year of age, including
dermatitis.
WARNINGS
                                
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