LABORATOIRES GALDERMA (FRANCE)🇸🇬 Health Sciences Authority
Approval Date
Dec 30, 2002
Approval ID
2dc78d821e287cd8
Company
LABORATOIRES GALDERMA (FRANCE)
Type
Therapeutic
Approval Details
Approval Id
2dc78d821e287cd8
Drug Name
SILKIS OINTMENT 3 mcg/g
Product Name
SILKIS OINTMENT 3 mcg/g
Approval Number
SIN12160P
Approval Date
2002-12-30
Registrant
GALDERMA SINGAPORE PRIVATE LIMITED
Licence Holder
GALDERMA SINGAPORE PRIVATE LIMITED
Drug Type
Therapeutic
Forensic Classification
Prescription Only
Dosage Form
OINTMENT
Dosage
<p><strong>4.2. Posology and method of administration</strong></p>
<p><u>Posology</u><br>
Silkis Ointment should be applied to the psoriasis affected areas twice per day, once in the morning and once in the evening before retiring and after washing. It is recommended that not more than 35% of the body surface be exposed to daily treatment. Not more than 30 g of ointment should be used per day. There is limited clinical experience available for the use of this dosage regimen of more than 6 weeks.</p>
<p><u>Paediatric population</u><br>
There is no experience of the use of Silkis in children (see 4.4. Special warnings and precautions for use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Special population</u><br>
Patients with kidney or liver dysfunction should not use Silkis (see also 4.3. Contra-indications).</p>
Route Of Administration
TOPICAL
Indication Info
<p><strong>4.1. Therapeutic indications</strong></p>
<p>Silkis is indicated in topical treatment of mild to moderately severe plaque psoriasis (psoriasis vulgaris) with up to 35% of body surface area involvement.</p>
Contraindications
<p><strong>4.3. Contra-indications</strong></p>
<p>Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
Patients on systemic treatment of calcium homeostasis.<br>
Patients with kidney or liver dysfunction.<br>
Patients with hypercalcaemia and patients known to suffer from abnormal calcium metabolism.</p>
