DAIVONEX calcipotriol (as monohydrate) 50 microgram/g cream tube

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

Calcipotriol

Beschikbaar vanaf:

LEO Pharma Pty Ltd

INN (Algemene Internationale Benaming):

Calcipotriol

Bijsluiter

DAIVONEX
®
CREAM
1
DAIVONEX

CREAM
Calcipotriol
_(Kal-sippo-try-all) _
CONSUMER MEDICINE INFORMATION
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 Daivonex
®
.
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 Daivonex
®
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING
DAIVONEX
®
, TALK TO YOUR
DOCTOR OR PHARMACIST.
WHAT DAIVONEX
® IS
USED FOR
Daivonex
®
is an anti-psoriasis
medicine. Daivonex
®
contains
calcipotriol (related to Vitamin D).
Daivonex
®
does NOT contain
steroids.
Daivonex
®
is used only on skin
affected by psoriasis. Psoriasis is a
skin disorder in which skin cells are
overactive. The calcipotriol in
Daivonex
®
treats the overactive
skin cells.
Daivonex
®
is used in the
commonest type of psoriasis,
where “plaques” form on the skin.
Plaques are raised, rough,
reddened areas covered with fine,
dry silvery scales.
_ _
Daivonex
®
cream 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
DAIVONEX
®
_WHEN YOU MUST NOT USE _
_DAIVONEX_
_®_
_ _
_ _
DO NOT USE DAIVONEX
® IF YOU HAVE
AN ALLERGY TO:

any medicine containing
calcipotriol

any of the ingredients listed at
the end of this leaflet (see
PRODUCT DESCRIPTION).
Some of the symptoms of an
allergic reaction include shortness
of breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or ”hives” on the skin.
DO NOT USE DAIVONEX
®
FOR SEVERE
WIDESPREAD PSORIASIS, OR THE
TYPES OF PSORIASIS KNOWN AS
GUTTATE, GENERALISED PUSTULAR OR
ERYTHRODERMIC EXFOLIATIVE
PSORIASIS. Your doctor will ide

Productkenmerken

1
PRODUCT INFORMATION
DAIVONEX
® CREAM
AUST R 57354
_Calcipotriol 50 microgram/g_
NAME OF THE MEDICINE: CALCIPOTRIOL
DESCRIPTION
Calcipotriol is a white or almost white crystalline substance. It is a
vitamin D derivative and behaves in
a similar manner to vitamin D, forming a reversible
temperature-dependent equilibrium between
calcipotriol and pre-calcipotriol.
Chemical structure of calcipotriol
Chemical name: (1S, 3R, 5Z, 7E, 22E, 24S) -24-Cyclopropyl-9,
10-secochola-5,7,10(19), 22-tetraene-
1,3,24-triol. CAS 112965-21-6
Daivonex
®
cream contains the hydrated form of calcipotriol. It also contains
cetomacrogol 1000,
cetostearyl alcohol, quaternium-15, disodium edetate, sodium phosphate
- dibasic dihydrate, glycerol,
liquid paraffin, soft white paraffin and purified water.
PHARMACOLOGY
Calcipotriol is a non-steroidal antipsoriatic agent, derived from
vitamin D. Calcipotriol exhibits a
vitamin D-like effect by competing for the 1,25(OH)
2
D
3
receptor. Calcipotriol is as potent as
1,25(OH)
2
D
3
, the naturally occurring active form of vitamin D, in regulating cell
proliferation and cell
differentiation, but much less active than 1,25(OH)
2
D
3
in its effect on calcium metabolism. Calcipotriol
induces differentiation and suppresses proliferation (without any
evidence of a cytotoxic effect) of
keratinocytes, thus reversing the abnormal keratinocyte changes in
psoriasis. The therapeutic goal
envisaged with calcipotriol is thus a normalisation of epidermal
growth.
PHARMACOKINETICS :
Pharmacokinetic studies with
3
H-calcipotriol have been performed in rats and minipigs. Oral
absorption of calcipotriol was approximately 60% in rats and 40% in
minipigs. The half-life of
calcipotriol was 12 minutes in rats and 60 minutes in minipigs. The
major metabolite of calcipotriol,
MC1080, was present in the first plasma sample at 5 minutes; its half
life was 54 minutes in rats and
1.8 hours in minipigs. Drug-related radioactivity was excreted in
urine and faeces, and clearance was
considered to be almost exclusively metabolic,