Advantan
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
25-08-2004
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Active ingredient:
Methylprednisolone aceponate 0.1%
Available from:
Schering (NZ) Limited
INN (International Name):
Methylprednisolone aceponate 0.1%
Dosage:
0.1 %
Pharmaceutical form:
Topical ointment
Composition:
Active: Methylprednisolone aceponate 0.1% Excipient: Hydrogenated castor oil Liquid paraffin Microcrystalline wax White soft paraffin
Units in package:
Tube, aluminium, epoxide coating, screw cap, 15 g
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Bayer AG
Product summary:
Package - Contents - Shelf Life: Tube, aluminium, epoxide coating, screw cap - 15 g - 60 months from date of manufacture stored at or below 30°C
Authorization date:
1997-11-05
Summary of Product characteristics
NEW ZEALAND DATA SHEET
Page 1 of 8
1 ADVANTAN®
Cream: ADVANTAN® methylprednisolone aceponate 0.1% cream
Ointment: ADVANTAN® methylprednisolone aceponate 0.1% ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream or ointment contains 1 mg (0.1%) methylprednisolone
aceponate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Topical cream.
Topical ointment.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Atopic dermatitis (endogenous eczema, neurodermatitis), contact
eczema, degenerative,
dyshidrotic, vulgar eczema, eczema in children.
4.2
Dose and method of administration
ADVANTAN® is for EXTERNAL TOPICAL USE ONLY and NOT FOR OPTHALMIC USE.
In general, the ADVANTAN® formulation appropriate to the skin
condition is applied thinly once per
day to the diseased areas of skin.
In general, the duration of use should not exceed 12 weeks in adults
and 4 weeks in children.
4.3
Contraindications
ADVANTAN® is contraindicated in most viral diseases (e.g. vaccinia,
varicella/herpes zoster) and
when tuberculous or syphilitic processes and post-vaccination skin
reactions are present in the area
to be treated. If rosacea, acne vulgaris, ulcera, atrophic skin
diseases, or perioral dermatitis are
present, ADVANTAN® must not be applied to the face.
Hypersensitivity to the active substance or to any of the excipients
listed in 6.1.
4.4
Special warnings and precautions for use
Care must be taken when using ADVANTAN® to avoid contact with the
eyes, deep open wounds and
mucosae.
Additional specific therapy is required in bacterially infected skin
diseases and/or in fungal
infections. Any spread of infection may require withdrawal of topical
corticosteroid therapy.
If the skin dries out excessively under protracted use of ADVANTAN®
Cream, a switch should be
made to ADVANTAN® ointment, a formulation which has a higher fat
content.
If signs of hypersensitivity develop, ADVANTAN® should be
discontinued and appropriate treatment
instituted.
eDoc-000782917 - Version
6. 0
NEW ZEALAND DATA SHEET
Page 2
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