Elidel cream for external use

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

pimecrolimus

Prieinama:

MEDA Manufacturing

ATC kodas:

D11AH02

INN (Tarptautinis Pavadinimas):

pimecrolimus

Dozė:

10mg/g

Vaisto forma:

cream for external use

Vienetai pakuotėje:

aluminium tube 15g

Recepto tipas:

Prescription

Autorizacija statusas:

Registered

Leidimo data:

2020-08-04

Prekės savybės

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
Excipients with known effect
10 mg benzyl alcohol, 40 mg cetyl alcohol, 40 mg stearyl alcohol, and
50 mg propylene glycol (E 1520) in
1 g of cream.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
Whitish and homogeneous.
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
Posology
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.
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.
3
_Adults _
Apply a thin layer of Elidel to the affected skin twice daily and rub
in gently and completely. Each affected
region of the s