Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
CALCITRIOL
Leo Laboratories Limited
0.5 Millilitre
Capsule
2000-02-04
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bocatriol 0.5 micrograms Soft Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 micrograms calcitriol. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Capsule, soft. A pink/cream coloured, egg-shaped capsule containing an oily solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Renal Osteodystrophy_: Correction of calcium and phosphate metabolism abnormalities. _Postmenopausal osteoporosis_: Treatment of established postmenopausal osteoporosis. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Response to treatment is partly dependent on a sufficient intake of calcium. Dietary modification or supplements may be required. Bocatriol capsules are for oral administration only and should be swallowed with a little water. ADULTS _Renal osteodystrophy_ Hypercalcaemia can be avoided by carefully adjusting the dose of Bocatriol for each individual, according to the biological response to the medicine. Initially, a daily dose of 0.25 micrograms of Bocatriol is employed. A dose of 0.25 micrograms on alternative days may be adequate for those patients with normal or only slightly lowered calcium levels. This daily dose may be increased by 0.25 micrograms after 2-4 weeks if biochemical and clinical responses are considered inadequate. If necessary this dosage increment can be repeated at 2-4 weekly intervals. While the dose is being adjusted, serum calcium levels should be monitored at least twice each week. The majority of patients respond to a dose of between 0.5 micrograms and 1.0 micrograms per day. _Postmenopausal Osteoporosis_ The recommended dose of calcitriol is 0.25 micrograms twice daily. ELDERLY The same dose should be used as for other adults. CHILDREN The dose for children has not been established. IRISH MEDICINES BOARD ________________ Pročitajte cijeli dokument