DiproSalic 0.05% w/w + 2% w/w Scalp Application

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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13-10-2017
Download 제품 특성 요약 (SPC)
13-10-2017

유효 성분:

BETAMETHASONE DIPROPIONATE; Salicylic acid

제공처:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC 코드:

D07XC; D07XC01

INN (International Name):

BETAMETHASONE DIPROPIONATE; Salicylic acid

복용량:

0.05 %w/w+2 percent weight/weight

약제 형태:

Cutaneous solution

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Corticosteroids, potent, other combinations; betamethasone

승인 상태:

Not marketed

승인 날짜:

1983-10-27

환자 정보 전단

                                1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPROSALIC® 0.05% W/W + 2% W/W SCALP APPLICATION
Betamethasone (as dipropionate)/Salicylic acid_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Diprosalic Scalp Application is and what it is used for
2.
Before you use Diprosalic Scalp Application
3.
How to use Diprosalic Scalp Application
4.
Possible side effects
5.
How to store Diprosalic Scalp Application
6.
Further information
1.
WHAT DIPROSALIC SCALP APPLICATION IS AND WHAT IT IS USED FOR
Diprosalic Scalp Application contains two active ingredients,
betamethasone dipropionate and salicylic acid.
Betamethasone dipropionate is one of a group of medicines called
topical corticosteroids. It is classified as a
“potent corticosteroid”. These medicines are put on the surface of
the skin to reduce the redness and itchiness
caused by certain skin problems. Salicylic acid softens the top layer
of scales on the surface of the skin,
which are caused by your skin problem. This allows the betamethasone
dipropionate to reach the diseased
skin underneath to help heal it.
In adults and children, Diprosalic Scalp Application is used to treat
skin conditions where the outer surface
of the skin is covered by a layer of scales. Your scalp application
will remove the layer of scales and reduce
the redness and itchiness caused by your skin problem.
2.
BEFORE YOU USE DIPROSALIC SCALP APPLICATION
DO NOT USE DIPROSALIC SCALP APPLICATION
-
if you are allergic (hypersensitive) to betamethasone dipropionate,
salicylic acid or any of the other
ingredients in Diprosalic Scalp Application.
-
on a
                                
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제품 특성 요약

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DiproSalic 0.05% w/w + 2% w/w Scalp Application
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A colourless, translucent viscous cutaneous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betamethasone Dipropionate is a synthetic fluorinated corticosteroid.
In combination with salicylic acid it is indicated
for the treatment of chronic lichenified eczema, lichen planus, lichen
simplex and non bullous ichthyosiform
erythroderma. It is also effective in the less responsive conditions
such as psoriasis of the scalp and chronic plaque
psoriasis of the hands and feet but excluding widespread plaque
psoriasis.
Topical salicylic acid softens keratin, loosens cornified epithelium
and desquamates the epidermis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
In most cases a few drops should be applied to the affected areas once
or twice daily and massaged gently and
thoroughly into the skin.
For some patients adequate maintenance therapy may be achieved with
less frequent application.
It is recommended that DiproSalic preparations are prescribed for two
weeks, and that treatment is reviewed at that
time. The maximum weekly dose should not exceed 60g.
Children:
Dosage in children should be limited to 5 days.
4.3 CONTRAINDICATIONS
Rosacea, acne, perioral dermatitis, perianal and genital pruritus.
Hypersensitivity to any of the ingredients of the
DiproSalic preparations contra-indicates their use as does tuberculous
and most viral lesions of the skin, particularly
herpes simplex, vaccinia, varicella. DiproSalic should not be used in
napkin eruptions, fungal or bacterial skin
infections without suitable concomitant anti-infective therapy.
0.05
% w/w
Betamethasone (as dipropionate)
2.00
% w/w
Salicylic Acid.
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