Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
CALCIPOTRIOL
PCO Manufacturing
50 mcg/g Micrograms/g
Ointment
2004-06-11
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dovonex 50 micrograms/g Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains 50 micrograms calcipotriol. Excipient: Propylene glycol (E1520) _For full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Ointment. _Product sourced from the UK and Greece:_ A faint, translucent white to yellowish ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dovonex Ointment is indicated for the topical treatment of plaque psoriasis (psoriasis vulgaris). Dovonex ointment may also be used in combination with phototherapy, acitretin, cyclosporin or topical corticosteroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _The ointment should be applied to the affected area once to twice daily. Twice daily application of the ointment is often preferred initially. Application of the ointment can be reduced to once daily when appropriate. Maximum weekly dose should not exceed 100g. Twice daily application of Dovonex in combination with phototherapy, cyclosporin or acitretin and once daily application of Dovonex in combination with corticosteroids (e.g. administration of Dovonex in the morning and steroid in the evening) is effective and well tolerated. The addition of Dovonex twice daily will enhance the efficacy and reduce the dosage of cyclosporin, acitretin and phototherapy. _Children: Over 12 years: _Dovonex Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75g. _Aged 6 to 12 years: _Dovonex Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 50g. _Under 6 years: _There is limited experience of the use of Dovonex Ointment in this age group. A maximum safe dose has not been esta Preberite celoten dokument