Silkis

Absorption

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).

Distribution

In clinical trials, no relevant increase in plasma calcitriol levels after treatment of large body surface areas of up to 6000 cm² (35% body surface area) was noted.

Animal studies show that repeated excessive exposure to calcitriol leads to renal failure and tissue calcification due to hypervitaminosis D associated with hypercalciuria, hypercalcaemia, and hyperphosphataemia.

No indication of teratogenicity was observed in embryofoetal toxicity studies designed to assess the teratogenic potential of calcitriol. Some evidence of developmental toxicity was obtained in a cutaneous rabbit study at doses which caused maternal toxicity. No such effect was found in rats.

Local toxicity studies in animals with Calcitriol showed slight skin and eye irritation.

Liquid paraffin, white soft paraffin and alpha- tocopherol.

There are no relevant data on the compatibility of Silkis with other medicinal products.).

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

3 years

Shelf life after first opening: 8 weeks.

No special precautions for storage.

The product is packaged in collapsible aluminium tubes coated internally with an epoxy - phenolic resin and fitted with a white high density polyethylene or polypropylene screw cap.

Tubes contain either 15, 30 or 100g of ointment.

Not all pack sizes may be marketed.

Dispose of the medication in accordance with local regulations for medical waste.

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

PL 10590/0047

10.07.1995 / 09.02.2004

April 2017