Daivonex

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Calcipotriol 50 µg/g

Disponible depuis:

LEO Pharma Limited

DCI (Dénomination commune internationale):

Calcipotriol 50 µg/g

Dosage:

50 mcg/g

forme pharmaceutique:

Topical ointment

Composition:

Active: Calcipotriol 50 µg/g Excipient: Dibasic sodium phosphate dihydrate Disodium edetate dihydrate dl-Alpha tocopherol Liquid paraffin Polyoxyethylene stearyl ether Propylene glycol Purified water White soft paraffin

Unités en paquet:

Tube, aluminium, 15g Physician sample pack, 15 g

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Leo Pharma A/S

Descriptif du produit:

Package - Contents - Shelf Life: Tube, aluminium, 15g Physician sample pack - 15 g - 24 months from date of manufacture stored at or below 25°C 6 months opened stored at or below 25°C - Tube, aluminium, 30g - 30 g - 24 months from date of manufacture stored at or below 25°C 6 months opened stored at or below 25°C - Tube, aluminium, 100g - 100 g - 6 months opened stored at or below 25°C 24 months from date of manufacture stored at or below 25°C - Tube, aluminium, 120g - 120 g - 6 months opened stored at or below 25°C 24 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

1990-07-10

Notice patient

CONSUMER MEDICINE INFORMATION
DAIVONEX
® OINTMENT
_CALCIPOTRIOL (KAL-SIPPO-TRY-ALL)_
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
®
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 Daivonex
®
ointment against the benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING DAIVONEX
®
OINTMENT, TALK TO YOUR DOCTOR
OR PHARMACIST.
WHAT DAIVONEX
®
OINTMENT IS USED FOR
Daivonex
®
ointment is an anti-psoriasis medicine. Daivonex
®
ointment contains
calcipotriol (related to Vitamin D). DAIVONEX
®
OINTMENT DOES NOT CONTAIN
STEROIDS.
Daivonex
®
ointment is used only on skin affected by psoriasis. Psoriasis is a
skin
disorder in which skin cells are overactive. The calcipotriol in
Daivonex
®
ointment
treats the overactive skin cells.
Daivonex
®
ointment is used in the commonest type of psoriasis, where "plaques"
form in the skin. Plaques are raised, rough, reddened areas covered
with fine, dry
silvery scales. Plaques are usually a centimetre or two across.
Daivonex
®
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.
eDoc-000806160 - Version
1. 0
BEFORE YOU USE DAIVONEX
®
OINTMENT
_WHEN YOU MUST NOT USE DAIVONEX_
_®_
_ OINTMENT_
DO NOT USE DAIVONEX
® OINTMENT 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
® OINT

Résumé des caractéristiques du produit

NEW ZEALAND DATA SHEET
1
DAIVONEX
®
50 MICROGRAM/GRAM TOPICAL OINTMENT _ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Daivonex
®
ointment contains calcipotriol 50 microgram per gram
Daivonex
®
ointment contains the anhydrous form of calcipotriol.
For full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Daivonex
®
is a topical ointment. It is a smooth, white preservative free
ointment base.
4
CLINICAL PARTICULARS
4.1
INDICATIONS
Daivonex
®
ointment is indicated for the topical treatment of psoriasis vulgaris,
including
plaque psoriasis in adults and children (see section 4.4 Special
warnings and precautions for
use - paediatric population). In adult patients, Daivonex
®
ointment may also be used in
combination with systemic acitretin or cyclosporin.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
Adults
_DAIVONEX_
_®_
_ OINTMENT THERAPY:_
Daivonex
®
ointment should be applied topically to the affected area once or
twice daily (i.e.
in the morning and/or in the evening). Initially, twice daily
application of the ointment is
usually preferred. Application may then be reduced to once daily,
provided individual clinical
response is satisfactory. After satisfactory improvement has occurred,
treatment should be
discontinued.
If recurrence develops after reduction in frequency of application or
after discontinuation, the
treatment may be reinstituted at the initial dosage. Experience is
lacking in the use of
calcipotriol for periods longer than 1 year.
THE MAXIMUM RECOMMENDED WEEKLY DOSE OF DAIVONEX
® OINTMENT IS 100 G/WEEK.
When using a combination of ointment and cream the total maximum dose
should not exceed
100 g per week.
eDoc-000783454 - Version
1. 0
It should be noted that there are no long-term clinical studies
assessing the safety of using
Daivonex
®
ointment during exposure to sunlight. Therefore, all
psoriasis-affected areas
treated with calcipotriol should be, where possible, protected from
direct sunlight and UV-
light with items of clothing. Furthermore, topical calcipotriol