DAIVOBET

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

BETAMETHASONE AS DIPROPIONATE; CALCIPOTRIOL AS HYDRATE

제공처:

DEXCEL LTD, ISRAEL

ATC 코드:

D05AX52

약제 형태:

OINTMENT

구성:

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

관리 경로:

DERMAL

처방전 유형:

Required

Manufactured by:

LEO PHARMA A/S , DENMARK

치료 그룹:

CALCIPOTRIOL, COMBINATIONS

치료 영역:

CALCIPOTRIOL, COMBINATIONS

치료 징후:

Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.

승인 날짜:

2023-01-31

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Daivobet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 50 micrograms of calcipotriol (as
hydrate) and 0.5 mg of
betamethasone (as dipropionate).
Excipient with known effects:
Butylhydroxytoluene (E321) 50 micrograms/g ointment
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Ointment.
Off-white to yellow.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of stable plaque psoriasis vulgaris amenable to
topical therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Daivobet ointment should be applied to the affected area once daily.
The recommended treatment period is 4 weeks. There is experience with
repeated courses of Daivobet up to 52 weeks. If it is necessary to
continue or
restart treatment after 4 weeks, 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).
Special populations
_Renal and hepatic impairment _
The safety and efficacy of Daivobet ointment in patients with severe
renal insufficiency or
severe hepatic disorders have not been evaluated.
Paediatric population
The safety and efficacy of Daivobet ointment 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
Daivobet ointment should be applied to the affected area. In order to
achieve optimal effect,
it is not recommended to take a shower or bath immediately after
application of Daivobet
ointment.
4.3 CONTRAINDICATIONS
2
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Daivobet ointment is contraindicated in erythrodermic, exfoliative and
pustula