Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CALCIUM PHOSPHATE
Laboratoires Merck-Clevenot
1.2 Grams
Powder for Oral Solution
1993-09-21
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 Read the complete document