DAIVOBET 50/500 calcipotriol 50 microgram/g and betamethasone (as dipropionate) 500 microgram/g ointment tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcipotriol, Quantity: 50 microgram/g; betamethasone dipropionate, Quantity: 643 microgram/g (Equivalent: betamethasone, Qty 500 microgram/g)

Available from:

LEO Pharma Pty Ltd

INN (International Name):

Betamethasone dipropionate,Calcipotriol

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: liquid paraffin; polyoxypropylene-11 stearyl ether; dl-alpha-tocopherol; white soft paraffin; butylated hydroxytoluene

Administration route:

Topical

Units in package:

100g, 15g, 120g, 60g, 30g, 3g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Daivobet ointment is indicated for the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy.

Product summary:

Visual Identification: Off-white to yellow ointment; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-08-26

Patient Information leaflet

DAIVOBET
®
50/500
OINTMENT
1
DAIVOBET

50/500 OINTMENT
_Dye-vo-bet _
Calcipotriol
_(Kal-sippo-try-all)/ _
Betamethasone
_(Beet-ah-meth-ah sown ) _
CONSUMER MEDICINE INFORMATION (CMI)
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START YOUR TREATMENT.
Daivobet
®
50/500 ointment is the
brand name. Calcipotriol and
betamethasone are the generic
names of the combination product,
which is Daivobet
®
ointment.
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
Daivobet
®
ointment. 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 Daivobet
®
ointment
against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING
DAIVOBET
® OINTMENT
, TALK TO
YOUR DOCTOR OR PHARMACIST.
WHAT DAIVOBET
®
OINTMENT IS USED FOR
Daivobet
®
ointment is an anti-
psoriasis medicine. Daivobet
®
ointment contains two active
ingredients:
•
calcipotriol [as monohydrate]
(related to Vitamin D)
•
betamethasone dipropionate (a
corticosteroid).
Daivobet
®
ointment is used only on
skin affected by plaque-type
psoriasis. Psoriasis is a skin
disorder in which skin cells are
overactive. The calcipotriol in
Daivobet
®
ointment treats the
overactive skin cells. The
betamethasone dipropionate
relieves redness, swelling, itching
and irritation of the skin.
Daivobet
®
ointment is used in the
type of psoriasis, where “plaques”
form in the skin. Plaques are
raised, rough, reddened areas
covered with fine, dry silvery
scales. Plaques are usually about
one to two centimetres across.
_ _
Daivobet
®
ointment is available
only with a doctor’s prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
This medicine is not addictive.
BEFORE YOU USE
DAIVOBET
® OINTMENT
_WHEN YOU MUST NOT USE _
_DAIVOBET_
_®_
_ OINTMENT_
_ _
DO NOT U

Summary of Product characteristics

Daivobet
®
50/500 Ointment – Australian PI
1
AUSTRALIAN PRODUCT INFORMATION – DAIVOBET
® 50/500 (CALCIPOTRIOL
[AS MONOHYDRATE] AND BETAMETHASONE [AS DIPROPIONATE]) OINTMENT
1
NAME OF THE MEDICINE
Calcipotriol monohydrate
Betamethasone dipropionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of Daivobet
®
ointment contains 50 micrograms of calcipotriol (as monohydrate) and
500
microgram of betamethasone (as dipropionate).
Excipients with known effect: butylated hydroxytoluene.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ointment.
Off-white to yellow.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Daivobet
®
ointment is indicated for the once daily topical treatment of
plaque-type psoriasis vulgaris
amenable to topical therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Daivobet
®
ointment is indicated FOR TOPICAL USE ONLY. Daivobet
®
ointment is NOT FOR
OPHTHALMIC USE. Do not use if the pack shows signs of damage or
tampering.
The phototoxic effects of Daivobet
®
ointment have not been studied in psoriasis patients. All psoriasis-
affected areas treated with Daivobet
®
ointment should be, where possible, protected from direct
sunlight and UV-light with items of clothing.
ADULTS:
Daivobet
®
ointment should be applied topically to the affected area once daily.
The maximum daily
dose should not exceed 15 grams. If using other topical products
containing Calcipotriol in addition to
Daivobet® ointment, the total dose of all Calcipotriol containing
products should not exceed 15 g per
day.
eDoc-000764277 - Version
2. 0
Daivobet
®
50/500 Ointment – Australian PI
2
THE MAXIMUM RECOMMENDED WEEKLY DOSE OF DAIVOBET
®
OINTMENT IS 100 GRAMS/WEEK.
The treated area should not be more than 30% of the body surface.
THE USE OF DAIVOBET
® 50/500 OINTMENT SHOULD BE INTERMITTENT FOR UP TO ONE YEAR UNDER CLOSE
MEDICAL SUPERVISION. TREATMENT SHOULD BE LIMITED TO FOUR WEEK PERIODS
WITH CALCIPOTRIOL USED
ALONE FOR ONE MONTH BETWEEN PERIODS OF USE OF DAIVOBET
®
50/5