DermAssist

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Hydrocortisone 1%{relative}

זמין מ:

Teva Pharma (New Zealand) Limited

INN (שם בינלאומי):

Hydrocortisone 1% w/w

כמות:

1% w/w

טופס פרצבטיות:

Topical cream

הרכב:

Active: Hydrocortisone 1%{relative} Excipient: Cetomacrogol 1000 Cetostearyl alcohol Chlorocresol Liquid paraffin Purified water White soft paraffin

סוג מרשם:

Restricted

תוצרת:

Pharmacia & Upjohn Company LLC

סממני תרפויטית:

For topical application for the temporary relief of symptoms associated with acute and chronic corticosteroid responsive conditions including, minor skin irritations, itching and rashes due to eczema, dermatitis, contact dermatitis (such as rashes due to cosmetics and jewellery), psoriasis, anogenital pruritus and sunburn.

leaflet_short:

Package - Contents - Shelf Life: Tube, Aluminium with HDPE cap - 15 g - 24 months from date of manufacture stored at or below 25°C - Tube, Aluminium with HDPE cap - 30 g - 24 months from date of manufacture stored at or below 25°C

תאריך אישור:

2016-02-12

מאפייני מוצר

Version 1.0
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NEW ZEALAND DATA SHEET
1 NAME OF THE MEDICINE
DermAssist
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
DermAssist Cream contains hydrocortisone 1% w/w.
Excipients with known effect:
cetostearyl alcohol, chlorocresol
For the full list of excipients, see Section 6.1 List of excipients
.
3 PHARMACEUTICAL FORM
Topical cream
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DermAssist Cream is indicated for topical application for the
temporary relief of symptoms associated
with acute and chronic corticosteroid responsive conditions including,
minor skin irritations, itching
and rashes due to eczema, dermatitis, contact dermatitis (such as
rashes due to cosmetics and
jewellery), psoriasis, anogenital pruritus and sunburn.
4.2
DOSE AND METHOD OF ADMINISTRATION
Apply a thin layer to the affected skin three to four times a day as
required. Once the inflammation
has subsided the frequency of use may be reduced.
DermAssist should not be used under bandages or dressings except on
medical advice.
4.3
CONTRAINDICATIONS
Acne.
Hypersensitivity to any of the ingredients.
Do not use in the eye.
Like all other topical corticosteroids, DermAssist is contraindicated
in skin infections and infestations
such as chicken pox, herpes and other viral infections.
Hydrocortisone may mask signs of infection. If any infection is
present, an appropriate anti-infective
agent should be used first. DermAssist may be used to reduce
inflammation but if a favourable
response does not occur promptly then use of the product should be
discontinued until the infection
has been adequately controlled.
If any skin irritation develops discontinue use and treat
appropriately. If extensive areas are treated, or
if occlusive dressings are used, the possibility also exists for
increased systemic absorption and this
could in turn lead to the depression of the
hypothalamo-pituitary-adrenal axis. In all such patients it is
essential to monitor adrenal function at regular intervals.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term contin