CELESTONE-M betamethasone 0.2mg/g (as valerate) cream tube

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

betamethasone valerate, Quantity: 0.244 mg/g

متاح من:

ORGANON PHARMA PTY LTD

INN (الاسم الدولي):

Betamethasone valerate

الشكل الصيدلاني:

Cream

تركيب:

Excipient Ingredients: purified water; sodium hydroxide; chlorocresol; cetostearyl alcohol; cetomacrogol 1000; phosphoric acid; white soft paraffin; liquid paraffin; monobasic sodium phosphate dihydrate

طريقة التعاطي:

Topical

الوحدات في الحزمة:

5g (sample), 100g

الفئة:

Medicine Registered

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

INDICATIONS AS AT 30 APRIL 1991: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as atopic eczema, infantile eczema, nummular eczema, anogenital and senile pruritus, contact dermatitis, seborrhoeic dermatitis, neurodermatitis, solar dermatitis, stasis dermatitis and psoriasis. Celestone -M is indicated for maintenance therapy.

ملخص المنتج:

Visual Identification: White Cream; Container Type: Tube; Container Material: Al; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

1991-10-08

نشرة المعلومات

CELESTONE
® - M
_Betamethasone valerate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Celestone M.
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 this medicine
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 CELESTONE M IS
USED FOR
Celestone M contains the active
ingredient called betamethasone
valerate.
It is a type of cortisone and belongs
to the group of medicines called
corticosteroids. Celestone M is
classified as a moderately strong
topical corticosteroid.
Celestone M 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
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
CELESTONE M
_WHEN YOU MUST NOT USE IT_
DO NOT USE CELESTONE M IF YOU HAVE
AN ALLERGY TO:
•
OTHER MEDICINES CONTAINING
BETAMETHASONE VALERATE
•
ANY OTHER CORTICOSTEROID(S)
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
SOME SYMPTOMS OF AN ALLERGIC
REACTION INCLUDE WHEEZING, SKIN
RASH AND HIVES.
DO NOT USE CELESTONE M 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 ROSACEA
•
INFLAMMATION AROUND THE
MOUTH
•
SKIN CONDITIONS WI

خصائص المنتج

S-CCDS-MK1745-MTL-082017
AUSTRALIAN PRODUCT INFORMATION –
CELESTONE
®
-M (BETAMETHASONE VALERATE) CREAM
1
NAME OF THE MEDICINE
Betamethasone valerate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Celestone-M Cream contains betamethasone valerate equivalent to
betamethasone 0.2mg/g.
EXCIPIENTS WITH KNOWN EFFECT
Celestone-M Cream contains cetostearyl alcohol and chlorocresol.
For the full list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Celestone-M is indicated for the relief of the inflammatory and
pruritic manifestations of
corticosteroid-responsive dermatoses such as atopic eczema, infantile
eczema, nummular
eczema, anogenital and senile pruritus, contact dermatitis,
seborrhoeic dermatitis,
neurodermatitis, solar dermatitis, stasis dermatitis and psoriasis.
Celestone-M is indicated for the maintenance therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
Apply a small amount to the affected area two or three times daily.
Refractory lesions of psoriasis and other deep seated dermatoses, such
as chronic lichen
simplex, hypertrophic lichen planus, atopic dermatitis, chronic
eczematous and lichenified hand
eruptions, recalcitrant pustular eruptions of the palms and soles,
respond better if occlusive
dressings are used.
_ _
OCCLUSIVE DRESSINGS
Apply a layer of medication over the entire lesion under a light gauze
dressing, cover with a
pliable transparent, impermeable plastic material well beyond the
edges of the treated area.
Seal the edges to normal skin by adhesive tape or other means. Leave
the dressing in place for
1 to 3 days and repeat the procedure three or four times as needed.
Occasionally, a miliary
eruption or folliculitis develops in the skin beneath the dressing and
should be treated by
removing the plastic covering and applying a topical antibiotic.
4.3 CONTRAINDICATIONS
Hypersensitivity to betamethasone valerate, other corticosteroids or
any components in
Celestone-M. Like other topical corticosteriods, Celestone-M is
contr