DERMOVATE CREAM

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

CLOBETASOL 17- PROPIONATE

Disponible des:

GLAXO SMITH KLINE (ISRAEL) LTD

Codi ATC:

D07AD01

formulario farmacéutico:

CREAM

Composición:

CLOBETASOL 17- PROPIONATE 0.05 %W/W

Vía de administración:

TOPICAL

tipo de receta:

Required

Fabricat per:

GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND

Grupo terapéutico:

CLOBETASOL

Área terapéutica:

CLOBETASOL

indicaciones terapéuticas:

Clobetasol is a very potent topical corticosteroid indicated for adults, elderly and children over 1 year for the short term treatment only of more resistant inflammatory and pruritic manifestations of steroid responsive dermatoses unresponsive to less potent corticosteroids. 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.

Data d'autorització:

2023-02-28

Informació per a l'usuari

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician's prescription only
Dermovate Cream
Clobetasol 17-propionate 0.05% w/w
Each gram contains 0.5 mg of clobetasol 17-propionate.
For the list of the inactive and allergenic ingredients in the
medicine, see section
2 – “Important information about some of the ingredients in the
medicine” and
section 6 – “Additional information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
The medicine is not intended for children under 1 year of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
Dermovate Cream is used to reduce redness and itchiness of certain
skin
problems. These skin problems include:
∙
Recurrent eczema.
∙
Psoriasis (thickened patches of inflamed, red skin, often covered by
silvery
scales), excluding widespread plaque psoriasis.
∙
Lichen planus (a skin disease that causes itchy, reddish-purple, flat
bump on
the wrists, forearms or lower legs).
∙
Discoid lupus erythematosus (a disease of the skin most often
affecting the
face, ears and scalp, and causing scarring and increased sensitivity
of the
skin to sunlight).
∙
Dermatitis and other skin conditions that do not respond to milder
steroid
ointments or creams.
Therapeutic group: Corticosteroids.
A group of medicines called steroids that help reduce swelling and
irritation.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
∙
If you are sensitive (allergic) to clobetasol 17-propionate or to any
of the
additional ingredients contained in this medicine (as listed in
section 6).
∙
In children under 1 year of age
∙
To treat any of the following skin problems; it could make them worse:
- acne
- sever

Fitxa tècnica

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1.
NAME OF THE MEDICINAL PRODUCT
Dermovate Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clobetasol 17-propionate 0.05% w/w
Excipients with known effect:
Cetosteryl alcohol
Clorocresol
Propylene glycol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clobetasol is a very potent topical corticosteroid indicated for
adults, elderly
and children over 1 year for the short term treatment only of more
resistant
inflammatory and pruritic manifestations of steroid responsive
dermatoses
unresponsive to less potent corticosteroids. 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
POSOLOGY AND METHOD OF ADMINISTRATION
CLOBETASOL PROPIONATE BELONGS TO THE MOST POTENT CLASS OF TOPICAL
CORTICOSTEROIDS (GROUP IV) AND PROLONGED USE MAY RESULT IN SERIOUS
UNDESIRABLE EFFECTS (SEE SECTION 4.4). IF TREATMENT WITH A LOCAL
CORTICOSTEROID
IS CLINICALLY JUSTIFIED BEYOND 4 WEEKS, A LESS POTENT CORTICOSTEROID
PREPARATION SHOULD BE CONSIDERED. REPEATED BUT SHORT COURSES OF
CLOBETASOL
PROPIONATE MAY BE USED TO CONTROL EXACERBATIONS (SEE DETAILS BELOW).
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Route of administration: Cutaneous
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 until improvement occurs (in the more
responsive
conditions this may be within a few days),
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 clobetasol propionate may be used to control
exacerbations.
In more resistant lesions, especially where there is hyperkeratosis,
the effect of
clobetasol can