DAIVONEX Ointment (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
DAIVONEX 50 microgram/gram topical ointment.
2. Qualitative and quantitative composition
Daivonex ointment contains calcipotriol 50 microgram per gram. Daivonex ointment contains the anhydrous form of calcipotriol. For full list of excipients, see section 6.1 List of excipients.
3. Pharmaceutical form
Daivonex is a topical ointment. It is a smooth, white preservative free ointment base.
4.1. Therapeutic indications
Daivonex ointment is indicated for the topical treatment of psoriasis vulgaris, including plaque psoriasis in adults and children (see section 4.4 Special warnings and precautions for use paediatric population). ...
4.2. Posology and method of administration
Adults Daivonex ointment therapy Daivonex ointment should be applied topically to the affected area once or twice daily (i.e. in the morning and/or in the evening). Initially, twice daily application of ...
4.3. Contraindications
Allergic sensitisation to any constituent of Daivonex ointment. Patients with known disorders of calcium metabolism. NOT FOR OPHTHALMIC USE.
4.4. Special warnings and precautions for use
In view of the risk of hypercalcaemia secondary to excessive absorption of calcipotriol when there is extensive skin involvement, Daivonex ointment should not be used for severe extensive psoriasis. In ...
4.5. Interaction with other medicinal products and other forms of interaction
There is no experience of concomitant therapy with other topical antipsoriatic drugs applied to the same skin area. Daivonex ointment should not be used concurrently with calcium or vitamin D supplements, ...
4.6. Fertility, pregnancy and lactation
Pregnancy Category B1. Safety for use in pregnancy has not been established. Studies in animals have shown an increase in the incidence of skeletal variations in rats (wavy ribs, extra ribs, incomplete ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Adults In the clinical trial program conducted for Daivonex ointment, more than 1360 adult patients were evaluated for safety of calcipotriol. Adverse reactions following treatment with Daivonex ointment ...
4.9. Overdose
Hypercalcaemia has been reported rarely at the recommended dose of Daivonex ointment when used for the approved indication. Excessive use may cause elevated serum calcium, which rapidly subsides when treatment ...
5.1. Pharmacodynamic properties
Mechanism of action Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol exhibits a vitamin D-like effect by competing for the 1,25(OH)<sub>2</sub>D<sub>3</sub> receptor. ...
5.2. Pharmacokinetic properties
Pharmacokinetic studies with 3 H-calcipotriol have been performed in rats and minipigs. Oral absorption of calcipotriol was approximately 60% in rats and 40% in minipigs. The half-life of calcipotriol ...
5.3. Preclinical safety data
Carcinogenicity A dermal carcinogenicity study with calcipotriol in mice showed no indications of increased carcinogenic risks. Calcipotriol solution was applied topically for up to 24 months at doses ...
6.1. List of excipients
Dibasic sodium phosphate dihydrate Disodium edetate dihydrate dl-Alpha tocopherol Liquid paraffin Polyoxyethylene stearyl ether (also known as steareth-2) Propylene glycol Purified water White soft paraffin ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Unopened container: 2 years. After first opening of container: 6 months.
6.4. Special precautions for storage
Store below 25ºC. For ease of application, do not refrigerate.
6.5. Nature and contents of container
Daivonex ointment is available in aluminium tubes of 15 g, 30 g, 100 g or 120 g.
6.6. Special precautions for disposal and other handling
Any unused medicine or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
LEO Pharma Ltd, Auckland, New Zealand Toll Free No. 0800 497 456
9. Date of first authorization / renewal of the authorization
Date of first approval: 30 May 1991
10. Date of revision of the text
29 October 2019
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