LOCATOP 0.1 %

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

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Vara einkenni Vara einkenni (SPC)
01-11-2016
Opinber matsskýrsla Opinber matsskýrsla (PAR)
17-08-2016

Virkt innihaldsefni:

DESONIDE

Fáanlegur frá:

PERRIGO ISRAEL AGENCIES LTD

ATC númer:

D07AB08

Lyfjaform:

CREAM

Samsetning:

DESONIDE 0.1 %

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

Required

Framleitt af:

PIERRE FABRE MEDICAMENT PRODUCTION, FRANCE

Meðferðarhópur:

DESONIDE

Lækningarsvæði:

DESONIDE

Ábendingar:

Treatment of dermatoses which require treatment with topical corticosteroids e.g. psoriasis, lichenipication, atopic dermatitis, contact dermatitis

Leyfisdagur:

2014-04-30

Vara einkenni

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
LOCATOP® 0.1
°/O,
CREAM
2
. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Desonide
.........................................................................0.100
g
for 100
g
of cream
Excipient with specific effect: sorbic acid.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
4. CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATION
Treatment of dermatoses which require treatment with topical
corticosteroids
e.g. psoriasis,
lichenipication,
atopic dermatitis, contact dermatitis
4.2.
P
OSOLOGY AND METHOD OF ADMINISTRATION
LOCATOP®
Cream should be applied to the affected areas as a thin film limited
to two times daily,
each
rubbed in gently.
An excessive increase in the number of applications per day risks
aggravating the adverse effects without improving the
therapeutic effects.
Treatment of large areas required monitoring of the number of tubes
used.
For rational use, it is advisable to apply the product as small
amounts spaced out, then spread with a plastic glove until fully
absorbed.
Gradual withdrawal is advisable in some dermatoses (psoriasis, atopic
dermatitis, etc.). This may be done by reducing the
frequency of applications and/or by using a less potent or less
concentrated corticoid.
As with other corticosteroids, therapy should be discontinued when
control is achieved. If no improvement
is
seen within 2 weeks, reassessment of diagnosis may be necessary.
LOCATOP®
Cream should not be used with occlusive dressings.
4.3 CONTRAINDICATIONS:
Hypersensitivity to any of the ingredient contained in this medicinal
product.
-
Primary bacterial, viral or fungal infections or parasitical
infections even if they include an inflammatory component.
-
Ulcerated lesions.
-
Acne.
-
Rosacea.
4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE
Special warnings
Prolonged use of highly active corticoids on the face leads to a risk
of corticoid-induced and paradoxically corticoid-sensitive
dermatitis with rebound after each withdrawal. Gradual wea
                                
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