BOCATRIOL Capsule 0.5 Millilitre
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
CALCITRIOL
Available from:
Leo Laboratories Limited
Dosage:
0.5 Millilitre
Pharmaceutical form:
Capsule
Authorization date:
2000-02-04
Summary of Product characteristics
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
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