Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
CALCITRIOL
Galderma (UK) Ltd
CALCITRIOL
0.003 %w/w
Ointment
Withdrawn
2008-05-19
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Silkis micrograms per g ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 3 micrograms of calcitriol (INN). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Ointment White, translucent ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 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. There is no experience of the use of Silkis in children (see 4.4. Special Warnings and Precautions for Use). Patients with kidney or liver dysfunction should not use Silkis (see also 4.3. Contra-indications). 4.3 CONTRAINDICATIONS 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. Silkis must not be used in patients known to be hypersensitive to the active substance or to any of the excipients. 4.4 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 in order to avoid unintentional application to non lesional areas. Izlasiet visu dokumentu