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SILKIS OINTMENT 3 MCG/G [SIN12160P]
Active ingredients: SILKIS OINTMENT 3 MCG/G
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Product Info
SILKIS OINTMENT 3 MCG/G
[SIN12160P]
Product information
Active Ingredient and Strength | CALCITRIOL - 3 MCG/G |
Dosage Form | OINTMENT |
Manufacturer and Country | LABORATOIRES GALDERMA - FRANCE |
Registration Number | SIN12160P |
Licence Holder | GALDERMA SINGAPORE PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | D05AX03 |
4.1. Therapeutic indications
Silkis is indicated in topical treatment of mild to moderately severe plaque psoriasis (psoriasis vulgaris) with up to 35% of body surface area involvement.
4.2. Posology and method of administration
Posology
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.
Paediatric population
There is no experience of the use of Silkis in children (see 4.4. Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Special population
Patients with kidney or liver dysfunction should not use Silkis (see also 4.3. Contra-indications).
4.3. Contra-indications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Patients on systemic treatment of calcium homeostasis.
Patients with kidney or liver dysfunction.
Patients with hypercalcaemia and patients known to suffer from abnormal calcium metabolism.
