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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ostram 1.2 g.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 3.30 g of Tricalcium Phosphate Ph. Eur. equivalent to 1.2 g of calcium in a formulation as
described in the application.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To correct calcium deficiency states and maintain appropriate balance in such disorders as osteoporosis, osteomalacia,
rickets, tetany, malabsorption states. This may be used if necessary provided expert advice is sought in pregnancy and
lactation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral
Recommended dosage: 1 sachet a day.
4.3 CONTRAINDICATIONS
Use in patients with hypercalcaemia and hypercalciuria such as hyperparathyroidism, hypervitaminosis D, neoplastic
diseases with decalcification of bone, immobilisation osteoporosis, sarcoidosis.
Use in patients with renal insufficiency.
Use in the milk-alkali syndrome.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Calcium salts should be used with caution in patients with impaired renal function,or with nephrocalcinosis.
The use of calcium salts should be accompanied by a careful surveillance to ensure maintenance of correct calcium
balance.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
The effects of digoxin and other cardiac glycosides may be accentuated by calcium and toxicity may be produced.
Calcium salts should not be administered simultaneously with tetracycline because of reduced absorption of anti-
infective.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/09/2008_
_CRN 2056138_
_page number: 1_
4.6 PREGNANCY AND LACTATION
_See section 4.1, Therapeutic
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