Daivonex

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Calcipotriol 50 µg/g

可用日期:

LEO Pharma Limited

INN（国际名称）:

Calcipotriol 50 µg/g

剂量:

50 mcg/g

药物剂型:

Topical cream

组成:

Active: Calcipotriol 50 µg/g Excipient: Cetomacrogol 1000 Cetostearyl alcohol Dibasic sodium phosphate dihydrate Disodium edetate dihydrate Glycerol Liquid paraffin N-(3-chloroallyl)hexaminium chloride Purified water White soft paraffin

每包单位数:

Tube, Physician sample, 15 g

类:

Prescription

处方类型:

Prescription

厂商:

Leo Pharma A/S

產品總結:

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

授权日期:

1993-05-31

资料单张

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

产品特点

NEW ZEALAND DATA SHEET
DAIVONEX
® CREAM
_Calcipotriol 50 microgram/g Cream_
PHYSICAL AND CHEMICAL PROPERTIES
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
macrogol cetostearyl ether, 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, as less tha