Dovonex Ointment Ref.[2602] Active ingredients: Calcipotriol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2011  Publisher: LEO Laboratories Limited Longwick Road Princes Risborough Bucks HP27 9RR UK

Therapeutic indications

Dovonex Ointment is indicated for the topical treatment of plaque psoriasis (psoriasis vulgaris) amenable to topical therapy.

Posology and method of administration

Adults

Dovonex Ointment should be applied to the affected area once or twice daily. For maximum benefit use the ointment twice daily. Maximum weekly dose should not exceed 100 g.

Children over 12 years

Dovonex Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75 g.

Children aged 6 to 12 years

Dovonex Ointment 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 Dovonex Ointment in this age group. A maximum safe dose has not been established.

These dose recommendations are based on extensive experience in adults. In respect of children, clinical experience in children has shown Dovonex to be safe and effective over eight weeks at a mean dose of 15 g per week but with wide variability in dose among patients. Individual dose requirement depends on the extent of psoriasis but should not exceed the above recommendations. There is no experience of use of Dovonex in combination with other therapies in children.

Overdose

Use above the recommended dose may cause elevated serum calcium which quickly subsides when treatment is discontinued.

Shelf life

Unopened container: 2 years.

After first opening of container: 6 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Lacquered aluminium tube with polypropylene screw cap.

Pack sizes: 30 g, 60 g, 100 g and 120 g.

Sample packs of 5 g and 15 g.

Polyethylene – aluminium laminate tube with screw cap.

Pack size: 240 g.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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