DAIVOBET

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

BETAMETHASONE AS DIPROPIONATE; CALCIPOTRIOL AS HYDRATE

Fáanlegur frá:

DEXCEL LTD, ISRAEL

ATC númer:

D05AX52

Lyfjaform:

OINTMENT

Samsetning:

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

Stjórnsýsluleið:

DERMAL

Gerð lyfseðils:

Required

Framleitt af:

LEO PHARMA A/S , DENMARK

Meðferðarhópur:

CALCIPOTRIOL, COMBINATIONS

Lækningarsvæði:

CALCIPOTRIOL, COMBINATIONS

Ábendingar:

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

Leyfisdagur:

2023-01-31

Vara einkenni

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