- Approval Id
- 680ee10863a05bcf
- Drug Name
- DAIVOBET OINTMENT
- Product Name
- DAIVOBET OINTMENT
- Approval Number
- SIN12241P
- Approval Date
- 2003-03-27
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- OINTMENT
- Dosage
- <p><strong>Posology and method of administration</strong><br>
<u>Posology</u><br>
Daivobet® Ointment should be applied to the affected area once daily. The recommended treatment period is 4 weeks. There is experience with repeated courses of Daivobet® Ointment up to 52 weeks. If it is necessary to continue or restart treatment after 4 weeks, treatment should be continued after medical review and under regular medical supervision.</p>
<p>When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g, the maximum weekly dose should not exceed 100 g, and the body surface area treated with calcipotriol containing medicinal products should not exceed 30%.</p>
<p><u>Special Populations</u><br>
<em>Renal and hepatic impairment</em><br>
The safety and efficacy of Daivobet® Ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.</p>
<p><u>Paediatric population</u><br>
The safety and efficacy of Daivobet® Ointment in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in sections "Undesirable effects and Pharmacodynamics properties" – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>, but no recommendation on a posology can be made.</p>
<p><u>Method of Administration</u><br>
Daivobet® Ointment should be applied to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Daivobet® Ointment.</p>
- Route Of Administration
- TOPICAL
- Indication Info
- <p><strong>Indications</strong><br>
Initial topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
Hypersensitivity to the active substances or to any of the excipients.<br>
Due to the content of calcipotriol, Daivobet® Ointment is contraindicated in patients with known disorders of calcium metabolism.<br>
Due to the content of corticosteroid, Daivobet® Ointment 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, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers, wounds and perianal and genital pruritus.</p>
<p>Daivobet® is contraindicated in erythrodermic, exfoliative and pustular psoriasis.</p>
- Atc Code
- D05AX52
- Atc Item Name
- calcipotriol, combinations
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
