Elidel 10mg/g cream

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Letöltés Termékjellemzők (SPC)
06-04-2020

Aktív összetevők:

pimecrolimus

Beszerezhető a:

MEDA Manufacturing

ATC-kód:

D11AH02

INN (nemzetközi neve):

pimecrolimus

Adagolás:

10mg/g

Gyógyszerészeti forma:

cream

db csomag:

15g aluminium tube

Recept típusa:

Prescription

Engedélyezési státusz:

Registered

Engedély dátuma:

2015-08-03

Termékjellemzők

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Elidel 10 mg/g cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains 10 mg of pimecrolimus.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
Whitish or almost white homogeneous cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients aged 2 years and over with mild or moderate
atopic dermatitis where treatment
with topical corticosteroids is either inadvisable or not possible.
This may include:

Intolerance to topical corticosteroids

Lack of effect of topical corticosteroids

Use on the face and neck where prolonged intermittent treatment with
topical corticosteroids
may be inappropriate
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Elidel should be initiated by physicians with experience in the
diagnosis and treatment of atopic
dermatitis.
Elidel can be used in the short term for the treatment of the signs
and symptoms of atopic eczema and
intermittently in the long term for the prevention of progression to
flares.
Elidel treatment should begin at the first appearance of signs and
symptoms of atopic dermatitis. Elidel
should only be applied to areas affected with atopic dermatitis.
Elidel should be used for as short
period as possible during flares of disease. The patient or caregiver
should stop using Elidel when
signs and symptoms resolve. Treatment should be intermittent,
short-term and not continuous. Elidel
should be applied thinly to the affected areas twice daily.
Data from clinical studies support intermittent treatment with Elidel
for up to 12 months.
If no improvement occurs after 6 weeks, or in case of disease
exacerbation, Elidel should be stopped.
The diagnosis of atopic dermatitis should be re-evaluated and further
therapeutic options considered.
Adults
Apply a thin layer of Elidel to the affected skin twice daily and rub
in gently and completely. Each
affected region of the skin should be treated with Elidel until
clearance occurs and then treatment
shoul
                                
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