DAIVONEX OINTMENT

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CALCIPOTRIOL

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

CALCIPOTRIOL

Unit dalam pakej:

100gm mcg/mL; 30gm mcg/mL

Dikeluarkan oleh:

LEO Laboratories Ltd

Risalah maklumat

PLEASE REFER TO SECTION E12

Ciri produk

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