Diprosalic ointment

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

betamethasone (betamethasone dipropionate), salicylic acid

MAH:

Schering-Plough Labo N.V.

ATC_code:

D07XC01

INN:

betamethasone (betamethasone dipropionate), salicylic acid

dosage:

0,5mg/g+ 30mg/g

pharmaceutical_form:

ointment

units_in_package:

30g aluminium tube

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2018-11-07

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
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 th