ENSTILAR® CUTANEOUS FOAM 50mcgg + 0.5mgg

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

Betamethasone dipropionate eqv. Betamethasone; Calcipotriol monohydrate eqv. Calcipotriol

Beschikbaar vanaf:

DKSH SINGAPORE PTE. LTD.

ATC-code:

D05AX52

farmaceutische vorm:

AEROSOL, FOAM

Samenstelling:

Betamethasone dipropionate eqv. Betamethasone 0.5mg/g; Calcipotriol monohydrate eqv. Calcipotriol 52.2mcg/g

Toedieningsweg:

TOPICAL, CUTANEOUS

Prescription-type:

Prescription Only

Geproduceerd door:

LEO Laboratories Ltd

Autorisatie-status:

ACTIVE

Autorisatie datum:

2020-02-27

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Enstilar® 50 micrograms/g + 0.5 mg/g cutaneous foam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cutaneous foam contains 50 micrograms of calcipotriol (as
monohydrate)
and 0.5 mg of betamethasone (as dipropionate).
Excipient with known effect:
Butylhydroxytoluene (E321) 50 micrograms/g cutaneous foam.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cutaneous foam.
After spraying, a white to off-white foam is formed.
The foam has the appearance of a non-expanding foam that gradually
collapses after
spraying.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of psoriasis vulgaris in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Flare treatment_
Enstilar® foam should be applied to the affected area once daily. The
recommended
treatment period is 4 weeks. If it is necessary to continue or restart
treatment after this
period, treatment should be continued after medical review and under
regular
supervision.
_Long-term maintenance treatment_
Patients who have responded at 4 weeks’ treatment using Enstilar®
once daily are
suitable for long-term maintenance treatment. Enstilar® should be
applied twice
weekly on two non-consecutive days to areas previously affected by
psoriasis
vulgaris. Between applications there should be 2-3 days without
Enstilar® treatment.
If signs of a relapse occur, flare treatment, as described above,
should be re-initiated.
_Maximum dose_
The daily maximum dose of Enstilar® should not exceed 15 g, i.e. one
60 g can
should last for at least 4 days. 15 g corresponds to the amount
administered from the
can if the actuator is fully depressed for approximately one minute. A
two-second
application delivers approximately 0.5 g. As a guide, 0.5 g of foam
should cover an
area of skin roughly corresponding to the surface area of an adult
hand.
1
The maximum weekly dose of Enstilar® should not exceed 100g.
If using other topical products containing calcipotriol in ad