Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
calcitriol
Apotex Pty Ltd
Calcitriol
Registered
1 AUSTRALIAN PRODUCT INFORMATION APO-CALCITRIOL (CALCITRIOL) CAPSULES 1 NAME OF THE MEDICINE Calcitriol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each APO-Calcitriol capsule contains 0.25 μg of calcitriol as active ingredient. EXCIPIENTS WITH KNOWN EFFECT Gelatin For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Red coloured, oval soft gelatin capsules containing a clear oily liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO-Calcitriol is indicated for the: • treatment of established osteoporosis diagnosed by objective measuring techniques, such as densitometry, or by radiographic evidence of a traumatic fracture • prevention of corticosteroid-induced osteoporosis in patients commencing oral steroid therapy in a dose and regimen expected to result in a significant bone loss • treatment of hypocalcaemia in patients with uraemic osteodystrophy, hypoparathyroidism and in hypophosphataemic rickets. 2 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Calcitriol capsules are intended for oral administration. DOSAGE GENERAL The optimal daily dose of calcitriol must be carefully determined for each patient and indication. Dosage optimisation should be accompanied by regular monitoring of serum calcium concentration. When the optimal dosage of calcitriol has been determined, the serum calcium levels should be checked regularly. As soon as serum calcium nears hypercalcaemic levels (1 mg per 100 mL [0.25 mmol/L] above normal 9-11 mg per 100 mL [2.25-2.75 mmol/L] on average), the dosage of calcitriol should be substantially reduced or treatment stopped altogether until normocalcaemia ensues. If hypercalcaemia occurs, the drug should be immediately discontinued until normocalcaemia ensues. Withdrawal of additional doses of calcium can also be of benefit in bringing about rapid normalisation of serum calcium levels. Careful consideration should also be given to lowering the dietary calcium intake. Should hypercalcaemia occur, calcitriol should be suspended immediately and se Pročitajte cijeli dokument