מדינה: סינגפור
שפה: אנגלית
מקור: HSA (Health Sciences Authority)
CALCITRIOL
GALDERMA SINGAPORE PRIVATE LIMITED
D05AX03
3 mcg/g
OINTMENT
CALCITRIOL 3 mcg/g
TOPICAL
Prescription Only
LABORATOIRES GALDERMA
ACTIVE
2002-12-30
OINTMENT CALCITRIOL COMPOSITION SILKIS OINTMENT contains 3µg/g calcitriol (BAN, USAN and INN) as the active ingredient and white soft paraffin, liquid paraffin and D,L-·-tocopherol as excipients. PHARMACEUTICAL FORM SILKIS OINTMENT is for cutaneous use. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES: Calcitriol inhibits the proliferation and stimulates differentiation of keratinocytes. Calcitriol inhibits proliferation of T-cells and normalises the production of various inflammation factors. Topical administration of SILKIS OINTMENT to patients with plaque psoriasis results in an improvement of the skin lesions.This effect is noted from 4 weeks after the start of treatment. PHARMACOKINETIC PROPERTIES: The mean absorption of calcitriol is estimated at around 10%. Following absorption, both unchanged calcitriol and metabolites have been demonstrated in plasma. The effect of the metabolites on calcium homeostasis is negligible. In most patients, circulating levels of exogenous calcitriol are below the level of detection (2pg/ml). In clinical trials, no relevant increase in plasma calcitriol levels after treatment of large body surface areas of up to 6,000 cm2 (35% body surface area) was noted. INDICATIONS AND USAGE Topical treatment of mild to moderately severe plaque psoriasis (_psoriasis vulgaris_) with up to 35% of body surface area involvement. CONTRA-INDICATIONS Patients on systemic treatment of calcium deficiency. Patients with kidney or liver/biliary dysfunction. Patients with hypercalcaemia or patients with calcium metabolism problems. SILKIS OINTMENT must not be used in patients known to be sensitive to any of the ingredients of the ointment. UNDESIRABLE EFFECTS A low incidence of skin irritation (reddening, itching) has been reported following the use of SILKIS OINTMENT. Such irri- tation is usually of a temporary nature. If sensitivity or severe irritation occurs, treatment should be discontinued tempo- rarily or discontinued altogether. During clinical studies, no hypercalcaemia was o קרא את המסמך השלם
O I N T M E N T c a l c i t r i o l Product code: MOCK UP Product description: SILKIS POM 30 Market: EX2 Article: Leaflet Flat size: 180x315 Fold size: 180x26,25 PMS 432U DIELINES Artwork approved by: Date: Signature: WHOLE TEXT , including barcodes, pre-printed mentions and legal or special labelling constraints. PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT. Font size: 8 pt Pharmacode: TBD _GRAPHIC DESIGNER: Guillaume ANDRÉ_ _LAUNCHING DEPARTMENT - Z.I. Galderma - 74540 ALBY-SUR-CHERAN - FRANCE_ 1. NAME OF THE MEDICINAL PRODUCT Silkis 3 µg/g ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 3 µg of calcitriol (INN). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Ointment White, translucent ointment 4.CLINICAL PARTICULARS 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). 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. 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. 4.4. SPECIAL WARNINGS AND PR קרא את המסמך השלם