Dovonex Ointment (2011)
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