Daivobet

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Betamethasone dipropionate 643 µg/g equivalent to 500 µg/g betamethasone;  ; Calcipotriol 50 µg/g (as calcipotriol hydrate 52.2µg/g)

Fáanlegur frá:

LEO Pharma Limited

INN (Alþjóðlegt nafn):

Betamethasone dipropionate 643 µg/g (equivalent to 500 µg/g betamethasone)

Skammtar:

50µg/500µg/g

Lyfjaform:

Topical ointment

Samsetning:

Active: Betamethasone dipropionate 643 µg/g equivalent to 500 µg/g betamethasone   Calcipotriol 50 µg/g (as calcipotriol hydrate 52.2µg/g) Excipient: Ceteareth-15 dl-Alpha tocopherol Liquid paraffin White soft paraffin

Einingar í pakka:

Tube, aluminium, sample pack (not marketed), 3 g

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Crystal Pharma SA

Vörulýsing:

Package - Contents - Shelf Life: Tube, aluminium, sample pack - 3 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 15 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 30 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 60 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 100 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 120 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C

Leyfisdagur:

2004-01-29

Upplýsingar fylgiseðill

DAIVOBET
®
50/500
OINTMENT
1
DAIVOBET

50/500 OINTMENT
_Dye-vo-bet _
Calcipotriol
_(Kal-sippo-try-all)/ _
Betamethasone
_(Beet-ah-meth-ah sown ) _
CONSUMER MEDICINE INFORMATION (CMI)
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START YOUR TREATMENT.
Daivobet
®
50/500 ointment is the
brand name. Calcipotriol and
betamethasone are the generic
names of the combination product,
which is Daivobet
®
ointment.
KEEP THIS LEAFLET. You may want
to read it again.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about using the medicine
Daivobet
®
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 Daivobet
®
ointment
against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING
DAIVOBET
® OINTMENT
, TALK TO
YOUR DOCTOR OR PHARMACIST.
WHAT DAIVOBET
®
OINTMENT IS USED FOR
Daivobet
®
ointment is an anti-
psoriasis medicine. Daivobet
®
ointment contains two active
ingredients:
•
calcipotriol [as monohydrate]
(related to Vitamin D)
•
betamethasone dipropionate (a
corticosteroid).
Daivobet
®
ointment is used only on
skin affected by plaque-type
psoriasis. Psoriasis is a skin
disorder in which skin cells are
overactive. The calcipotriol in
Daivobet
®
ointment treats the
overactive skin cells. The
betamethasone dipropionate
relieves redness, swelling, itching
and irritation of the skin.
Daivobet
®
ointment is used in the
type of psoriasis, where “plaques”
form in the skin. Plaques are
raised, rough, reddened areas
covered with fine, dry silvery
scales. Plaques are usually about
one to two centimetres across.
_ _
Daivobet
®
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.
BEFORE YOU USE
DAIVOBET
® OINTMENT
_WHEN YOU MUST NOT USE _
_DAIVOBET_
_®_
_ OINTMENT_
_ _
DO NOT U

Vara einkenni

Page 1 of 12
NEW ZEALAND DATA SHEET
1
DAIVOBET
® 50/500 OINTMENT
Daivobet
®
50/500 calcipotriol 50 microgram/g and betamethasone 500 microgram/g
(as dipropionate)
ointment
2
QUANTITATIVE AND QUALITATIVE COMPOSITION
One gram of Daivobet
®
ointment contains 50 micrograms of calcipotriol (as monohydrate) and
500
micrograms of betamethasone (as dipropionate).
3
PHARMACEUTICAL FORM
Ointment
Off-white to yellow ointment.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Daivobet
®
ointment is indicated for the once daily topical treatment of
plaque-type psoriasis vulgaris
amenable to topical therapy in adult patients 18 years and older.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Daivobet
®
ointment is indicated FOR TOPICAL USE ONLY and NOT FOR OPHTHALMIC USE.
All psoriasis-affected areas treated with Daivobet
®
should be, where possible, protected from direct
sunlight and UV-light with items of clothing. Topical calcipotriol
should only be used with UV radiation if
the physician and patient consider that the potential benefits
outweigh the potential risks. The potential
phototoxic effects of Daivobet
®
over long term exposure have not been fully investigated.
ADULTS:
Daivobet
®
ointment should be applied topically to the affected area once daily.
The maximum daily
dose should not exceed 15 grams.
THE MAXIMUM RECOMMENDED WEEKLY DOSE OF DAIVOBET
® OINTMENT IS 100 G/WEEK.
The treated area should not be more than 30% of the body surface.
THE RECOMMENDED TREATMENT PERIOD OF DAIVOBET
® OINTMENT IS 4 WEEKS. At the completion of the
treatment period, repeated treatment with Daivobet
®
ointment can be initiated under medical
supervision. There is no clinical experience with Daivobet
®
Ointment beyond 52 weeks.
CHILDREN:
Daivobet
®
ointment is not recommended for use in children and adolescents below
the age of 18 years.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Patients with known disorders of calcium metabolism (see section 4.4).
eDoc-000637271