topiderm Hydrocortisone acetate 1% Cream

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Hydrocortisone acetate 10 mg/g

Tilgængelig fra:

AFT Pharmaceuticals Ltd

Dosering:

1% w/w

Lægemiddelform:

Topical cream

Sammensætning:

Active: Hydrocortisone acetate 10 mg/g Excipient: Ceteareth-10 Cetostearyl alcohol Liquid paraffin Phenoxyethanol Purified water White soft paraffin

Recept type:

Restricted

Terapeutiske indikationer:

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 pruritis and sunburn.

Produkt oversigt:

Package - Contents - Shelf Life: Tube, aluminium, Printed white, inner surface lacquer HOLAC. White PE cap - 30 g - 24 months from date of manufacture stored at or below 30°C

Autorisation dato:

2018-01-10

Produktets egenskaber

Page 1 of 6
NEW ZEALAND DATA SHEET
1.
TOPIDERM® HYDROCORTISONE ACETATE 1% CREAM
Hydrocortisone acetate 1% w/w cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone acetate 1% w/w
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Opaque off-white viscous topical cream.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
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, (such as
rashes due to cosmetics and jewellery), psoriasis, anogenital
pruritus, and sunburn.
4.2.
Dose and method of administration
Adults and children 2 years of age and older:
Apply to affected area not more than 3 – 4 times daily.
Children under 2 years of age:
Do not use, consult a doctor.
Reduce the number of applications as symptoms subside.
Rebound of pre-existing dermatoses can occur with abrupt
discontinuation of topical corticosteroid
preparations.
topiderm® Hydrocortisone acetate 1% Cream should not be used under
bandages or dressings except
on medical advice.
4.3.
Contraindications
Hypersensitivity to hydrocortisone acetate or to any of the excipients
listed in SECTION 6.1 LIST OF
EXCIPIENTS.
•
Do not use on acne
•
Hypersensitivity to any of the ingredients
•
Do not use in the eye
Like all other topical corticosteroids, topiderm® Hydrocortisone
acetate 1% Cream is contraindicated
in skin infections and infestations such as chicken pox, herpes and
other viral infections.
Page 2 of 6
Hydrocortisone may mask signs of infection. If any infection is
present, an appropriate anti-infective
agent should be used first. topiderm® Hydrocortisone acetate 1% Cream
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 treate