Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CALCIPOTRIOL
DKSH MALAYSIA SDN BHD
CALCIPOTRIOL
100gm mcg/mL; 30gm mcg/mL
LEO Laboratories Ltd
PLEASE REFER TO SECTION E12 Baca dokumen lengkap
Daivonex® Ointment Daivonex® ointment contains 50μg/g (0.005% w/w) calcipotriol. O ff white to yellowish white translucent ointment. Pack sizes: 15 g, 30 g and 100 g. Not all pack sizes are marketed in the country. Properties Daivonex® ointment is a topical formulation of the vitamin D derivative, calcipotriol, which induces differentiation and suppresses proliferation of skin cells (keratinocytes). Daivonex ® ointment thus normalises abnormal cell proliferation and differentiation in psoriatic skin. Indications Psoriasis vulgaris. Dosage and administration Adults: Daivonex® ointment should be applied to the affected area twice daily. For some patients adequate maintenance therapy may be achieved with less frequent application. The maximum amount used by an adult in one week should not exceed 100 g (equivalent to 5 mg of calcipotriol) . If using other calcipotriol containing medicinal products concomitantly, the total weekly dose of all calcipotriol containing medical products, including Daivonex® ointment, should not exceed 5 mg of calcipotriol . Contra indications Hypersensitivity to the active substance or to any of the excipients . Due to the content of calcipotriol, Daivonex® ointment is contraindicate d in patients with known disorder s of calcium metabolism (see Special warnings and precautions for use) . Fertility, pregnancy and l actation Pregnancy Safety for use of calcipotriol during human pregnancy has not been established. When calcipotriol was administered orally in animals, reproductive toxicity has been shown. Calcipotriol should not be used during pregnancy unless clearly necessary. Breast-feeding It is unknown whether calcipotriol is excreted in human milk. Caution should be exercised when prescribing Daivonex® ointment to women who breast -feed. The pati ent should be instructed not to use Daivonex® ointment on the breast when breast -feeding. Fertility Studies in rats with oral doses of calcipotriol demonstrated no impairment of male and female fertility. Use in Children Safety and e Baca dokumen lengkap