XAMIOL

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

BETAMETHASONE AS DIPROPIONATE; CALCIPOTRIOL AS HYDRATE

제공처:

DEXCEL LTD, ISRAEL

ATC 코드:

D07AC01

약제 형태:

GEL

구성:

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

관리 경로:

TOPICAL

처방전 유형:

Required

Manufactured by:

LEO PHARMA A/S , DENMARK

치료 그룹:

BETAMETHASONE

치료 영역:

BETAMETHASONE

치료 징후:

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.

승인 날짜:

2015-08-31

제품 특성 요약

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