XAMIOL

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

BETAMETHASONE AS DIPROPIONATE; CALCIPOTRIOL AS HYDRATE

Beschikbaar vanaf:

DEXCEL LTD, ISRAEL

ATC-code:

D07AC01

farmaceutische vorm:

GEL

Samenstelling:

BETAMETHASONE AS DIPROPIONATE 0.5 MG / 1 G; CALCIPOTRIOL AS HYDRATE 50 MCG / 1 G

Toedieningsweg:

TOPICAL

Prescription-type:

Required

Geproduceerd door:

LEO PHARMA A/S , DENMARK

Therapeutische categorie:

BETAMETHASONE

Therapeutisch gebied:

BETAMETHASONE

therapeutische indicaties:

Topical treatment of psoriasis vulgaris on the scalp and topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults 18 years of age and older.

Autorisatie datum:

2015-08-31

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Xamiol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains: 50 microgram of calcipotriol (as hydrate)
and 0.5 mg of
betamethasone (as dipropionate).
Excipient with known effect:
Butylhydroxytoluene (E321) 160 microgram/g gel.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gel.
An almost clear, colourless to slightly off-white gel.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of psoriasis vulgaris on the scalp and topical
treatment of mild to
moderate “non-scalp” plaque psoriasis vulgaris in adults 18 years
of age and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Xamiol gel should be applied to affected areas once daily. The
recommended treatment
period is 4 weeks for scalp areas and 8 weeks for “non-scalp”
areas. If it is necessary to
continue or restart treatment after this period, treatment should be
continued after
medical review and under regular medical supervision.
When using calcipotriol containing
medicinal products, the maximum daily dose should
not exceed 15 g. The body surface area treated with calcipotriol
containing medicinal
products should not exceed 30% (see section 4.4).
_ _
_If used on the scalp _
All the affected scalp areas may be treated with Xamiol gel. Usually
an amount between
1 g and 4 g per day is sufficient for treatment of the scalp (4 g
corresponds to one
teaspoon).
Special populations
_Renal and hepatic impairment_
The safety and efficacy of Xamiol gel in patients with severe renal
insufficiency or
severe hepatic disorders have not been evaluated.
_ _
_Paediatric population _
The safety and efficacy of Xamiol gel in children below 18 years have
not been
established. Currently available data in children aged 12 to 17 years
are described in
section 4.8 and 5.1, but no recommendation on a posology can be made.
Method of administration
Xamiol gel should not be applied directly to the face or eyes. In
order to achieve optimal
effect, i