Betamethasone ointment for external use

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

betamethasone (betamethasone valerate)

Dostupné s:

Arpimed LLC

ATC kód:

D07AC01

INN (Mezinárodní Name):

betamethasone (betamethasone valerate)

Dávkování:

1mg/g

Léková forma:

ointment for external use

Jednotky v balení:

15g aluminium tube

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2023-10-12

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
BETAMETHASONE
0.1% OINTMENT FOR TOPICAL USE
1.1 BRAND NAME – BETAMETHASONE
1.2 INTERNATIONAL NON-PROPERTY NAME - BETAMETHASONE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 gram of ointment contains:
active ingredient: betamethasone valerate equivalent to 1mg
betamethasone.
_For a full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM
Ointment. White to yellowish white odorless
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
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Cutaneous
Ointments are especially appropriate for dry, lichenified or scaly
lesions.
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 within