מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
CALCIUM GLUCONATE
Mercury Pharmaceuticals (Ireland) Ltd
CALCIUM GLUCONATE
10 %w/v, 1 Grams
Solution for Injection
Withdrawn
2008-06-23
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcium Gluconate Injection BP 10% w/v, 10ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml of solution contains 2.25 millimoles of Ca 2+ as calcium gluconate (975mg/10ml). Each ml of solution contains 0.225 millimoles of Ca 2+ as calcium gluconate (95.7 mg/ml). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless, sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Parenteral administration is indicated where the pharmacological action of a high calcium ion concentration is required, as in acute hypocalcaemia and hypocalcaemic tetany. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous or intramuscular injection. Adults: The usual dose is 5 - 10ml (1.125 - 2.25 mmol or 2.25 - 4.5 mEq Ca ++ ) by slow I.V. injection or by deep I.M. injection into the gluteal region. The dose can be repeated daily or every second day as required. Children: The usual dose is 2.5 - 5.0ml (0.562 - 1.125 mmol or 1.125 - 2.25 mEq Ca ++ ) by slow I.V. injection. The intramuscular route is not recommended for children. Elderly: As per adults, but elderly patients should be carefully supervised (See Warnings and Precautions). 4.3 CONTRAINDICATIONS Use in patients with hypercalcaemia and hypercalciuria (e.g. in hyperparathyroidism, hypervitaminosis D, neoplastic disease with decalcification of bone, immobilisation osteoporosis, sarcodiosis). Use in patients with renal insufficiency. Use in patients with 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, or in the elderly. Patients receiving calcium salts should be monitored, carefully, to ensure main קרא את המסמך השלם