Daivonex Scalp Solution

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Calcipotriol 50 µg/mL

Beszerezhető a:

LEO Pharma Limited

INN (nemzetközi neve):

Calcipotriol 50 µg/mL

Adagolás:

50 mcg/g

Gyógyszerészeti forma:

Topical solution

Összetétel:

Active: Calcipotriol 50 µg/mL Excipient: Hyprolose Isopropyl alcohol Levomenthol Propylene glycol Purified water Sodium citrate dihydrate

db csomag:

Bottle, plastic, PEbottle&cap 30mL sample pack, 30 mL

Osztály:

Prescription

Recept típusa:

Prescription

Gyártó:

Leo Pharma A/S

Termék összefoglaló:

Package - Contents - Shelf Life: Bottle, plastic, PEbottle&cap 30mL sample pack - 30 mL - 24 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C - Bottle, plastic, PE bottle &cap 30mL - 30 mL - 24 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C - Bottle, plastic, PE bottle &cap 60mL - 60 mL - 24 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C - Bottle, plastic, PE bottle &cap 100mL - 100 mL - 24 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C

Engedély dátuma:

1993-11-29

Betegtájékoztató

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

Termékjellemzők

NEW ZEALAND DATA SHEET
DAIVONEX
® SCALP SOLUTION
_Calcipotriol 50 microgram/mL_
PHYSICAL AND CHEMICAL PROPERTIES
Calcipotriol is a white or almost white crystalline substance.
Calcipotriol 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
®
scalp solution contains the hydrated form of calcipotriol. It also
contains menthol, hydroxypropylcellulose, sodium citrate, propylene
glycol, isopropyl
alcohol 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, as less than 5% of the
administered
radioactivity was excreted at th