DAIVOBET OINTMENT

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CALCIPOTRIOL; BETAMETHASONE DIPROPIONATE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

CALCIPOTRIOL; BETAMETHASONE DIPROPIONATE

Unit dalam pakej:

30gm mcg/mL; 15gm mcg/mL; 60gm mcg/mL; 3gm mcg/mL

Dikeluarkan oleh:

LEO LABS LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
DAIVOBET® OINTMENT
Calcipotriol/betamethasone Diproprionate (50mcg/0.5mg per gram)
__________________________________________________________________________________________________
_________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What Daivobet Ointment is used
for
2. How Daivobet Ointment works
3. Before you use Daivobet Ointment
4. How to use Daivobet Ointment
5. While you are using it
6. Side effects
7. Storage and Disposal of Daivobet
Ointment
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT DAIVOBET OINTMENT IS USED
FOR
Daivobet Ointment is used on the
skin to treat plaque psoriasis
(psoriasis vulgaris) which is
amenable to topical therapy. Psoriasis
is caused by your skin cells being
produced too quickly. This causes
redness, scaling and thickness of your
skin.
HOW DAIVOBET OINTMENT WORKS
Calcipotriol is a vitamin D analogue
that helps to bring the rate of skin cell
growth back to normal.
Betamethasone is a steroid that acts to
reduce inflammation.
BEFORE YOU USE DAIVOBET OINTMENT
_-When you must not use it _
-
If you are allergic
(hypersensitive) to
calcipotriol, betamethasone,
or any of the other inactive
ingredients of Daivobet.
-
If you have problems with
calcium levels in your body
(ask your doctor)
-
If you have certain types of
psoriasis that is inflamed
with intense redness, peeling
and/or blister.
-
If you want to use for
children below 18 years old
-
As Daivobet contains a
strong steroid do NOT use
on skin affected by
-
Skin infections caused
by viruses, fungus,
bacteria or parasites
-
Perioral dermatitis (red
rash around the mouth)
-
Thin skin, easily
damaged veins, stretch
marks
-
Ichthyosis (inherited
dry, thickened, scaly
skin)
-
Acne
-
Rosacea (redness on
face)
-
Ulcers or broken skin
_Pregnancy and lactation _
Do not use Daivobet if you are
pregnant (or might be pregnant) or if
you are breast-feeding, unless you
have agre

Ciri produk

Daivobet ® Ointment
Composition
Active Ingredients: Calcipotriol 50 micrograms/g (as hydrate), betamethasone 0.5 mg/g (as dipropionate).
Excipients: Liquid paraffin (contains all -rac -α-tocopherol), polyoxypropylene stearyl ether (contains
butylhydroxytoluene (E321)), all -rac -α-tocopherol, white soft paraffin (contains all -rac -α-tocopherol)
Presentation
Off -white to yellow ointment.
Pack sizes: 3g, 15g, 30g and 60g. Not all pack sizes are marketed in the country.
Indications
Initial topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.
Posology and method of administration
Daivobet® should be applied to affected areas once daily. The recommended treatment period is 4 weeks.
There is experi ence with repeated courses of D aivobet® up to 52weeks. If it is necessary to continue
or restart treatment after 4 weeks, treatment should be continued after medical review and under regular
medical supervision.
When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g
The body surface area treated with calcipotriol containing medicinal products should not exceed 30%
Special populations
Renal and hepatic impairment
The safety and efficacy of Daivobet ointment in patients with severe renal insufficiency or severe hepatic
disorders have not been evaluated.
Paediatric population
The safety and efficacy of Daivobet ointment in children below 18 years have not been estab lished.
Currently available data in children aged 12 to 17 years are described in section s on Undesirable effects and
Pharmacodynamics properties but no recommendation on a posology can be made.
Method of administration
Daivobet ointment should be applied to the affected area. In order to achieve optimal effect, it is not
recommended to take a shower or bath immediately after application of Daivobet ointment.
Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Due to the content of calcipotriol, Daivobet® is contraindicated in patients with kno