Betamethasone cream cream for external use

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

betamethasone (betamethasone valerate)

Sẵn có từ:

Arpimed LLC

Mã ATC:

D07AC01

INN (Tên quốc tế):

betamethasone (betamethasone valerate)

Liều dùng:

1mg/g

Dạng dược phẩm:

cream for external use

Các đơn vị trong gói:

aluminium tube 15g

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2019-12-17

Đặc tính sản phẩm

SUMMARY PRODUCT CHARACTERISTIC (SPC)
BETAMETHASONE
0.1 % CREAM FOR TOPICAL USE
1.1 BRAND NAME – BETAMETHASONE
1.2 INTERNATIONAL NON-PROPERTY NAME - BETAMETHASONE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Betamethasone cream for topical use contains:
active ingredient: betamethasone [as valerate] – 1 mg;
_For a full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM
White homogenous odorless cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betamethasone valerate is a 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:
Atopic dermatitis (including infantile atopic dermatitis)
Nummular dermatitis (discoid eczema)
Prurigo nodularis
Psoriasis (excluding widespread plaque psoriasis)
Lichen simplex chronicus (neurodermatitis) and lichen planus
Seborrhoeic dermatitis
Irritant or allergic contact dermatitis
Discoid lupus erythematosus
Adjunct to systemic steroid therapy in generalised erythroderma
Insect bite reactions
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Cutaneous
Creams are especially appropriate for moist or weeping surfaces.
Apply thinly and gently rub in using only enough to cover the entire
affected area once or twice daily
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.
In the more resistant lesions, such as the thickened plaques of
psoriasis on elbows and knees, the effect
of betamethasone valerate 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 in
such lesions; thereafter, improvement can usually be maintained by
regular application without
occlusion.
If the condition worsens or does not improve