DIPROSONE betamethasone 0.5 mg/g (as dipropionate) ointment tube

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

betamethasone dipropionate, Quantity: 0.64 mg/g (Equivalent: betamethasone, Qty 0.5 mg/g)

Commercializzato da:

ORGANON PHARMA PTY LTD

INN (Nome Internazionale):

Betamethasone dipropionate

Forma farmaceutica:

Ointment

Composizione:

Excipient Ingredients: white soft paraffin; liquid paraffin

Via di somministrazione:

Topical

Confezione:

5g(E), 15g, 50g

Classe:

Medicine Registered

Tipo di ricetta:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Indicazioni terapeutiche:

INDICATIONS AS AT 22 November 1995: Diprosone is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. These include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis.

Dettagli prodotto:

Visual Identification: A smooth uniform off-white ointment,free from foreign matter; Container Type: Tube; Container Material: Epoxy-coated Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2007-11-12

Foglio illustrativo

DIPROSONE
®
_Betamethasone dipropionate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DIPROSONE.
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 DIPROSONE
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DIPROSONE IS
USED FOR
The name of your medicine is
DIPROSONE. It contains the active
ingredient called betamethasone
dipropionate.
It is a type of cortisone and belongs
to the group of medicines called
corticosteroids. DIPROSONE is
classified as a high potency topical
corticosteroid.
There are three forms of
DIPROSONE: cream, ointment and
lotion.
DIPROSONE is used on the skin to
relieve the redness, swelling, itching
and discomfort of many skin
problems such as:
•
psoriasis (a stubborn skin
disorder with raised, rough,
reddened areas covered with dry,
fine silvery scales)
•
eczema (an often itchy skin
condition with redness, swelling,
oozing of fluid, crusting which
may lead to scaling)
•
other types of dermatitis
DIPROSONE Lotion is also used on
the scalp and hairy parts of the body.
Your doctor may have prescribed
DIPROSONE for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DIPROSONE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
DIPROSONE
_WHEN YOU MUST NOT USE IT_
DO NOT USE DIPROSONE IF YOU
HAVE HAD AN ALLERGIC REACTION, SUCH
AS WHEEZING, RASH OR HIVES, TO
DIPROSONE, ANY OTHER
CORTICOSTEROID, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT USE DIPROSONE IF YOU
HAVE:
•
A VIRAL SKIN INFECTION, SUCH AS
COLD SORES, SHINGLES OR CHICKEN
POX
•
A FUNGAL SKIN INFECTION, SUCH AS
THRUSH, TINEA OR RINGWORM
•
TUBERCULOSIS OF THE SKIN
•
ACNE ROSA

Scheda tecnica

Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
DIPROSONE
® (BETAMETHASONE DIPROPIONATE)
CREAM, OINTMENT AND LOTION
1
NAME OF THE MEDICINE
Betamethasone dipropionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone dipropionate equivalent to betamethasone 0.5 mg/g (0.05%
w/w).
DIPROSONE CREAM_ _(0.05% w/w): Each g contains betamethasone
dipropionate equivalent
to betamethasone 0.5 mg.
DIPROSONE OINTMENT_ _(0.05% w/w_)_: Each g contains betamethasone
dipropionate
equivalent to betamethasone 0.5 mg.
DIPROSONE LOTION_ _(0.05% w/w): Each mL contains betamethasone
dipropionate
equivalent to betamethasone 0.47 mg.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DIPROSONE is supplied as cream, ointment, lotion 0.05% w/w.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DIPROSONE is indicated for the relief of the inflammatory and pruritic
manifestations of
corticosteroid-responsive dermatoses. These include atopic eczema,
infantile eczema,
nummular eczema, contact dermatitis, neurodermatitis, anogenital and
senile pruritus, lichen
planus, intertrigo and psoriasis.
DIPROSONE Lotion is indicated wherever hair impedes access to the skin
in the treatment
of corticosteroid-responsive dermatoses particularly on the scalp,
chest and underarms, etc.
It is also indicated in the treatment of seborrhoea and psoriasis of
the scalp.
4.2
DOSE AND METHOD OF ADMINISTRATION
DIPROSONE Cream, Ointment: Apply a small amount to the affected area
twice daily. For
some patients adequate maintenance therapy may be achieved with once
daily application.
DIPROSONE Lotion: Apply twice daily. Part the hair with a comb, then
apply with nozzle
directly on the scalp. Squeeze bottle gently.
In most cases, 4 weeks continuous treatment should be considered the
maximum.
Children: Administration of topical corticosteroids to children should
be limited to the least
amount compatible with an effective therapeutic regimen.
4.3
CONTRAINDICATIONS
Hypersensitivity to betamethasone dipropionate, other corticosteroi