ADVANTAN methylprednisolone aceponate 1mg/g cream tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methylprednisolone aceponate, Quantity: 1 mg/g

Available from:

LEO Pharma Pty Ltd

INN (International Name):

Methylprednisolone aceponate

Pharmaceutical form:

Cream

Composition:

Excipient Ingredients: butylated hydroxytoluene; purified water; Hard fat; cetostearyl alcohol; glyceryl monostearate; glycerol; disodium edetate; PEG-40 stearate; benzyl alcohol; decyl oleate; medium chain triglycerides

Administration route:

Topical

Units in package:

5g, 10g, 15g, 30g, 50g, 100g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Topical treatment of eczema and psoriasis.

Product summary:

Visual Identification: Opaque, white to yellowish cream.; Container Type: Tube; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1994-07-11

Patient Information leaflet

1
ADVANTAN
®
OINTMENT, FATTY OINTMENT, CREAM & LOTION
METHYLPREDNISOLONE ACEPONATE
_(meth’il-predd-niz-oh-lone ass-epp-on-eight)_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START YOUR TREATMENT.
KEEP THIS LEAFLET. You may want to
read it again.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about using the medicine
Advantan
®
. It does not contain all
the available information. It does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Advantan
®
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING ADVANTAN ®
, TALK TO YOUR
DOCTOR OR PHARMACIST.
WHAT ADVANTAN ® IS
USED FOR
The active ingredient in Advantan
®
belongs to the group of medicines
called corticosteroids. The
corticosteroid in Advantan
®
is
suitable to put on the skin. It is
therefore called a topical
corticosteroid, which is sometimes
shortened to topical steroid.
When Advantan
®
is put on the skin,
it relieves the redness, swelling,
itching and irritation of the skin in
ECZEMA AND PSORIASIS.
Advantan
®
preparations are
available only with a doctor's
prescription.
Advantan
®
is made up as four
different preparations. Each has a
distinct look and feel. They are:
•
ointment
•
fatty ointment
•
cream and
•
lotion
The most solid is the fatty ointment;
the most runny is the lotion. The
ointment and cream are in-between
in thickness.
Each preparation is especially
suitable in consistency for a
particular area of skin or skin
condition needing treatment. Your
doctor will prescribe the preparation
most suitable for you.
The Advantan
®
preparations are
medicines and should only be used
on skin affected by the conditions
described below.
All four Advantan
®
preparations
treat ECZEMA.
Advantan
®
ointment, fatty ointment
and cream (but NOT lotion) also
treat psoriasis.
ECZEMA is a skin condition with
redness, swelling, oozing of fluid,
crusting and l

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
– ADVANTAN
®
(METHYLPREDNISOLONE ACEPONATE)
1
NAME OF THE MEDICINE
Methylprednisolone aceponate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Advantan cream, lotion, ointment or fatty ointment contains
methylprednisolone aceponate 1
mg/g (0.1 %).
List of excipients with known effect: Advantan cream contains
cetostearyl alcohol and
butylated hydroxytoluene.
For a full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Advantan lotion is an oil-in-water emulsion containing 68% purified
water.
Advantan cream is an oil-in-water emulsion containing about 60%
purified water.
Advantan ointment is a water-in-oil emulsion containing 30% purified
water.
Advantan fatty ointment is a monophasic ointment with 96.9%
hydrocarbons.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Advantan cream, ointment and fatty ointment are indicated for the
topical treatment of
eczema and psoriasis in adults and children.
Advantan lotion is indicated for the topical treatment of eczema in
adults and children.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Advantan is FOR EXTERNAL TOPICAL USE ONLY and NOT FOR OPHTHALMIC USE.
The Advantan formulation most appropriate to the skin condition should
be used.
If the skin dries out excessively during treatment with Advantan cream
or lotion, a change
should be made to one of the formulations with a higher fat content
i.e. Advantan ointment or
fatty ointment.
The duration of use should be less than 12 weeks in adults and less
than 4 weeks in children.
INSTRUCTIONS FOR USE
Do not use beyond the expiry date on the package.
eDoc-000893198 - Version
2. 0
2
Do not use if the pack shows signs of damage or tampering.
ADVANTAN OINTMENT, FATTY OINTMENT & CREAM
Advantan ointment, fatty ointment or cream should usually be applied
as a thin coating once
per day to the affected areas. In the treatment of psoriasis, twice
daily application may be
required.
ADVANTAN LOTION
Advantan lotion should be applied sparingly once daily to the affected
areas and rubbed in