Diprosalic ointment

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

betamethasone (betamethasone dipropionate), salicylic acid

Tersedia dari:

Schering-Plough Labo N.V.

Kode ATC:

D07XC01

INN (Nama Internasional):

betamethasone (betamethasone dipropionate), salicylic acid

Dosis:

0,5mg/g+ 30mg/g

Bentuk farmasi:

ointment

Unit dalam paket:

30g aluminium tube

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2021-06-16

Karakteristik produk

2
1.
NAME OF THE MEDICINAL PRODUCT
DIPROSALIC
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_GENERAL CHARACTERISTIC: _
_MAIN PHYSICAL/CHEMICAL PROPERTIES_: soft, homogeneous, white ointment
without foreign inclusions.
_COMPOSITION: _1 g of ointment contains betamethasone 0.5 mg (as
dipropionate) and salicylic acid 30
mg;
_EXCIPIENTS_: liquid paraffin, white soft paraffin.
3.
PHARMACEUTICAL FORM
Ointment.
PHARMACOTHERAPEUTIC GROUP. Dermatological corticosteroids. Highly
active corticosteroids in
combination with other agents. ATC code: D07X C01.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
To relieve inflammations in the uninfected subacute and chronic
hyperkeratotic and dry dermatoses
that
are
normally
responsive
to
corticosteroid
therapy:
psoriasis,
chronic
atopic
dermatitis,
neurodermatitis (lichen simplex chronicus), lichen planus, eczema
(including nummular eczema,
grocers
itch,
eczematoid
dermatitis),
dyshidrosis
(dropsy),
seborrheic
dermatitis
of
the
scalp,
ichthyosis vulgaris and other ichthyotic conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and children_: a thin film should be applied to cover the
affected area twice daily – in the
morning and in the evening. For some patients adequate maintenance
therapy may be achieved with
less frequent application. Duration of therapy varies depending upon
the severity and state of the
disease.
_Maximum daily dose_: the dose should be adjusted to have daily
control of symptoms.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to any of components of the preparation.
-
Bacterial and viral infections of skin (herpes, varicella, herpes
zoster, molluscum contagiosum) or
fungal infection; tuberculosis, syphilis, skin post-vaccinal
reactions.
-
Acne vulgaris, acne, rosacea, perioral dermatitis.
Avoid contact with wounds, ulcers or mucosa.
Do not use Diprosalic in ophthalmology; do not use under occlusive
dressing.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation or sensitization develops with the use of the drug,
treatment should be discontinued.