DOVOBET Ointment 50/500 Micrograms/g
Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Karatteristiċi tal-prodott
(SPC)
28-04-2024
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
CALCIPOTRIOL BETAMETHASONE
Disponibbli minn:
PCO Manufacturing
Dożaġġ:
50/500 Micrograms/g
Għamla farmaċewtika:
Ointment
Data ta 'l-awtorizzazzjoni:
2008-10-10
Karatteristiċi tal-prodott
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dovobet® 50 microgram/g + 0.5 mg/g ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcipotriol 50 microgram/g (as hydrate), betamethasone 0.5 mg/g (as dipropionate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
_Product imported from the UK:_
Off-white to yellow, ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dovobet should be applied to the affected area once daily. The recommended treatment period is 4 weeks. After this period
repeated treatment with Dovobet can be initiated under medical supervision.
The maximum daily dose should not exceed 15 g, the maximum weekly dose should not exceed 100 g, and the treated area should
not be more than 30% of the body surface.
Dovobet is not recommended for the use in children and adolescents below the age of 18 years.
4.3 CONTRAINDICATIONS
Due to the content of calcipotriol Dovobet is contra-indicated in patients with known disorders of calcium metabolism.
Due to the content of corticosteroid, Dovobet is contraindicated in the following conditions: Viral (e.g. herpes or
varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to
tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin
veins, ichthyosis, acne rosacea, ulcers, wounds, perianal and genital pruritus.
Dovobet is contraindicated in guttate, erythrodermic, exfoliative and pustular psoriasis.
Dovobet is contraindicated in patients with severe renal insufficiency or severe hepatic disorders.
4.4 SPECIAL WARNINGS AN
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