Dermovate ointment

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Descargar Fitxa tècnica (SPC)
21-11-2022

ingredients actius:

clobetasol (clobetasol propionate)

Disponible des:

GlaxoSmithKline Pharmaceuticals S.A.

Codi ATC:

D07AD01

Designació comuna internacional (DCI):

clobetasol (clobetasol propionate)

Dosis:

0,5mg/g

formulario farmacéutico:

ointment

Unidades en paquete:

aluminium tube 25g

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2018-12-24

Informació per a l'usuari

                                DERMOVATE
CLOBETASOL PROPIONATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_DERMOVATE_ Cream and Ointment contains Clobetasol propionate 0.05 %
w/w.
CLINICAL INFORMATION
INDICATIONS
_DERMOVATE_ is a very potent topical corticosteroid indicated for
adults, elderly and
children over 1 year for the relief of the inflammatory and pruritic
manifestations of
steroid responsive dermatoses.
These include the following:
-
Psoriasis (excluding widespread plaque psoriasis).
-
Recalcitrant dermatoses
-
Lichen planus
-
Discoid lupus erythematosus
-
Other skin conditions which do not respond satisfactorily to less
potent 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 thinly and gently rub in using only enough to cover the entire
affected area once
or twice a day for up to 4 weeks until improvement occurs, then reduce
the frequency of
application or change the treatment to a less potent preparation.
Allow adequate time
for absorption after each application before applying an emollient.
Repeated short courses of _DERMOVATE_ may be used to control
exacerbations.
In more 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.
If the condition worsens or does not improve within 2-4 weeks,
treatment and diagnosis
should be re-evaluated.
Treatment should not be continued for more than 4 weeks. If continuous
treatment is
necessary, a less potent preparation should be used.
The maximum weekly dose should not exceed 50 gms/week.
ATOPIC DERMATITIS (ECZEMA)
Therapy with _DERMOVATE_ cream and ointment should be gradually
discont
                                
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Fitxa tècnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DERMOVATE, CLOBETASOL PROPIONATE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_DERMOVATE _Cream and Ointment contains Clobetasol propionate 0.05 %
w/w.
3.
PHARMACEUTICAL FORM
Cream and Ointment.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
_DERMOVATE _is a very potent topical corticosteroid indicated for
adults, elderly and children over
1 year for the relief of the inflammatory and pruritic manifestations
of steroid responsive
dermatoses.
These include the following:
-
Psoriasis (excluding widespread plaque psoriasis).
-
Recalcitrant dermatoses
-
Lichen planus
-
Discoid lupus erythematosus
-
Other skin conditions which do not respond satisfactorily to less
potent steroids
4.2
DOSAGE AND ADMINISTRATION
_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 thinly and gently rub in using only enough to cover the entire
affected area once or twice a
day for up to 4 weeks until improvement occurs, then reduce the
frequency of application or
change the treatment to a less potent preparation. Allow adequate time
for absorption after each
application before applying an emollient.
Repeated short courses of _DERMOVATE _may be used to control
exacerbations.
In more 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.
If the condition worsens or does not improve within 2-4 weeks,
treatment and diagnosis should be
re-evaluated.
Treatment should not be continued for more than 4 weeks. If continuous
treatment is necessary, a
less potent preparation should be used.
The maximum weekly dose should not exceed 50gms/week.
ATOPIC D
                                
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