Regulatory Information
GALDERMA SINGAPORE PRIVATE LIMITED
GALDERMA SINGAPORE PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
OINTMENT
**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).
TOPICAL
Medical Information
**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.
**4.3. 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.
D05AX03
calcitriol
Manufacturer Information
GALDERMA SINGAPORE PRIVATE LIMITED
LABORATOIRES GALDERMA
Active Ingredients
Documents
Package Inserts
SILKIS_PI.pdf
Approved: January 15, 2018