SILKIS Ointment (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Silkis 3 micrograms per g ointment.
Qualitative and quantitative composition
One gram of ointment contains 3 micrograms of calcitriol (INN). For the full list of excipients, see section 6.1.
Pharmaceutical form
Ointment. White, translucent ointment.
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.
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 ...
Contraindications
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 ...
Special warnings and precautions for use
The ointment can be applied to the face with caution, as there is an increased risk of irritation in this area. Contact with the eyes should be avoided. The hands should be washed after applying the ointment ...
Interaction with other medicinal products and other forms of interaction
Silkis must be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics or medications with pharmacological effects impacted by a change ...
Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of Calcitriol in pregnant women. Studies in animals have shown developmental toxicity at doses which caused maternal toxicity (see section ...
Effects on ability to drive and use machines
Silkis has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Between 10% and 20% of patients can be expected to experience adverse reactions. Adverse reactions are usually localised to the application site and mild to moderate in nature. Very common adverse reactions: ...
Overdose
The most common symptoms which may occur after accidental administration are anorexia, nausea, vomiting, constipation, hypotonia and depression. Lethargy and coma are occasionally observed. If hypercalcaemia ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antipsoriatics for topical use ATC code: D05AX03 Mechanism of action Calcitriol inhibits the proliferation and stimulates differentiation of keratinocytes. Calcitriol inhibits ...
Pharmacokinetic properties
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 ...
Preclinical safety data
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. ...
List of excipients
Liquid paraffin White soft paraffin Alpha-tocopherol
Incompatibilities
There are no relevant data on the compatibility of Silkis with other medicinal products. Therefore, Silkis should be used according to the posology and method of administration provided above (Section ...
Shelf life
3 years. Shelf life after first opening: 8 weeks.
Special precautions for storage
No special precautions for storage.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK
Marketing authorization number(s)
PL 10590/0047
Date of first authorization / renewal of the authorization
10.07.1995/09.02.2004
Date of revision of the text
April 2017
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