DAIVONEX CREAM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CALCIPOTRIOL AS HYDRATE

Available from:

DEXCEL LTD, ISRAEL

ATC code:

D05AX02

Pharmaceutical form:

CREAM

Composition:

CALCIPOTRIOL AS HYDRATE 50 MCG/G

Administration route:

DERMAL

Prescription type:

Required

Manufactured by:

LEO PHARMA A/S , DENMARK

Therapeutic group:

CALCIPOTRIOL

Therapeutic area:

CALCIPOTRIOL

Therapeutic indications:

Psoriasis vulgaris, mild to moderate plaque affecting up to 40 % of skin area.

Authorization date:

2011-01-31

Summary of Product characteristics

DAIVONEX
® CREAM
1. NAME OF THE MEDICINAL PRODUCT
DAIVONEX Cream.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcipotriol 50 mcg/g (as hydrate).
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Soft white cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Psoriasis Vulgaris, mild to moderate plaque affecting up to 40% of
skin area.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Daivonex Cream should be applied to the affected area once to twice
daily.
Twice daily application of the cream is often preferred initially.
Application of the
cream can be reduced to once daily when appropriate. Maximum weekly
dose
should not exceed 100 g.
When used together with Daivonex Ointment or Daivonex Scalp Solution,
the total
dose of calcipotriol should not exceed 5 mg in any week, equivalent to
100 gram
Daivonex Cream (1 gram cream equivalent to 1 gram ointment or 1 ml
scalp
solution).
Daivonex Cream in combination with corticosteroids (e.g.
administration of Daivonex
in the morning and steroid in the evening) is effective and well
tolerated.
Children over 12 years:
Daivonex Cream should be applied to the affected area
twice daily. Maximum weekly dose should not exceed 75 g.
Children aged 6 to 12 years:
Daivonex Cream should be applied to the affected
area twice daily. Maximum weekly dose should not exceed 50 g.
Children under 6 years:
There is limited experience of the use of Daivonex Cream
in this age group. A maximum safe dose has not been established.
There is no experience of use of Daivonex in combination with other
psoriatic
therapies in children.
4.3 CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients.
Due to the content of calcipotriol, Daivonex is contraindicated in
patients with known
disorders of calcium metabolism.
PHYSICIAN’S INSERT
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Daivonex Cream should not be used in the face. The patient must be
instructed
in correct use of the product to avoid application and accidental
transfer to the
face. Hands must be washed after each applic