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SPC, UK: Dovonex Ointment (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Leo Laboratories Limited
Διεύθυνση :
Longwick Road, Princes Risborough, Bucks., HP27 9RR
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Name of the medicinal product

Dovonex Ointment.

Qualitative and quantitative composition

Calcipotriol 50 micrograms per g. For full list of excipients, see section 6.1

Pharmaceutical form

Ointment. Off white to yellowish white translucent ointment.

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 ...

Contraindications

Dovonex Ointment is contraindicated in patients with known disorders of calcium metabolism and patients with severe liver and kidney disease. As with other topical preparations, Dovonex Ointment is contra-indicated ...

Special warnings and precautions for use

Dovonex Ointment should not be used on the face. Patients should be advised to wash their hands after applying the ointment and to avoid inadvertent transfer to other body areas, especially the face. ...

Interaction with other medicinal products and other forms of interaction

There is no experience of concomitant therapy with other antipsoriatic products applied to the same skin area at the same time.

Fertility, pregnancy and lactation

Pregnancy The safety of the use of calcipotriol during human pregnancy has not been established, and studies in animals have shown reproductive toxicity when calcipotriol was administered orally. Calcipotriol ...

Effects on ability to drive and use machines

Calcipotriol has no or negligible influence on the ability to drive and to use machines.

Undesirable effects

Very common >1/10 Common >1/100 and <1/10 Uncommon >1/1,000 and <1/100 Rare >1/10,000 and <1/1,000 Very rare <1/10,000 Approximately 25% of the patients treated with Dovonex Ointment could experience an ...

Overdose

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

Pharmacodynamic properties

Pharmacotherapeutic group: Antipsoriatics for topical use ATC Code: D05AX02 Calcipotriol is a vitamin D derivative. In vitro data suggest that calcipotriol induces differentiation and suppresses proliferation ...

Pharmacokinetic properties

Data from a single study containing 5 evaluable patients with psoriasis treated with 0.3‑1.7 g of a 50 micrograms/g tritium labelled calcipotriol ointment suggested that less than 1% of the dose was absorbed. ...

Preclinical safety data

The effect on calcium metabolism is approximately 100 times less than that of the hormonally active form of vitamin D3. Calcipotriol has shown maternal and foetal toxicity in rats and rabbits when given ...

List of excipients

Disodium edetate Disodium phosphate dihydrate DL-α-tocopherol Liquid paraffin Macrogol (2) stearyl ether Propylene glycol Purified water White soft paraffin

Incompatibilities

Should not be mixed with other medicinal products.

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 ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

LEO Laboratories Limited Longwick Road Princes Risborough Bucks HP27 9RR UK

Marketing authorization number(s)

PL 00043/0177

Date of first authorization / renewal of the authorization

10 January 1991

Date of revision of the text

August 2011