Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
calcitriol
Apotex Pty Ltd
Calcitriol
Registered
APO-CALCITRIOL CAPSULES _Contains the active ingredient calcitriol_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Calcitriol. It contains the active ingredient, calcitriol. It is used to treat people with osteoporosis and to prevent osteoporosis in people taking oral corticosteroids. It is also prescribed by doctors for the treatment of low blood calcium in patients with osteodystrophy (a form of bone disease), hypoparathyroidism (reduced function of the parathyroid glands) and rickets. _HOW IT WORKS_ It works by improving absorption of calcium from the intestine and by stimulating growth of healthy bones. Calcitriol occurs naturally in humans and is a biologically active form of vitamin D. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • calcitriol or any other medicine containing vitamin D compounds • any of the ingredients listed at the end of this leaflet Symptoms of an allergic reaction may include: • cough, shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the ski Կարդացեք ամբողջական փաստաթուղթը
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 Կարդացեք ամբողջական փաստաթուղթը