Betamethasone ointment for topical use

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

betamethasone (betamethasone valerate)

Dostopno od:

Arpimed LLC

Koda artikla:

D07AC01

INN (mednarodno ime):

betamethasone (betamethasone valerate)

Odmerek:

1mg/g

Farmacevtska oblika:

ointment for topical use

Enote v paketu:

15g aluminium tube

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2018-10-27

Lastnosti izdelka

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