Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Calcitriol 0.5ug;
AFT Pharmaceuticals Ltd
Calcitriol 0.5 µg
0.5 mcg
Liquid filled capsule
Active: Calcitriol 0.5ug Excipient: Ascorbyl palmitate Butylated hydroxyanisole Gelatin Glycerol Iron oxide red Iron oxide yellow Medium-chain triglycerides Sodium ethyl hydroxybenzoate Sodium propyl hydroxybenzoate Sorbitol Titanium dioxide
Bottle, glass, Amber, 100 capsules
Prescription
Prescription
Cerbios-Pharma SA
- Established postmenopausal osteoporosis.
Package - Contents - Shelf Life: Bottle, glass, Amber - 100 capsules - 24 months from date of manufacture stored at or below 25°C
2002-09-26
CALCITRIOL-AFT CALCITRIOL 0.25ΜG AND 0.5ΜG SOFT GEL CAPSULES WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Calcitriol-AFT soft gel capsules. 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 your taking Calcitriol-AFT 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 CALCITRIOL-AFT IS USED FOR Calcitriol occurs naturally in humans and is a biologically active form of vitamin D. Calcitriol-AFT is used to treat people with postmenopausal osteoporosis (bone- thinning) and to prevent osteoporosis in people taking oral corticosteroids. Calcitriol- AFT is also for the treatment of low blood calcium in patients with renal osteodystrophy (a form of bone disease due to failure of the kidneys), hypoparathyroidism from various causes (reduced function of the parathyroid glands), hyperparathyroidism (excessive levels of the parathyroid hormone in the body) and rickets (Vitamin D deficiency). Calcitriol-AFT works by improving absorption of calcium from the intestine and by stimulating growth of healthy bones. This medicine is available only with a doctor's prescription. Your doctor may have prescribed Calcitriol-AFT for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY CALCITRIOL-AFT HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE CALCITRIOL-AFT _WHEN YOU MUST NOT TAKE IT_ _ _ Do not take Calcitriol-AFT if: • you have had an allergic reaction to calcitriol or any other Vitamin D-like substances, or any ingredients listed in the Ingredients section of this leaflet • you have high levels of calcium in your blood (called hypercalcaemia) • you have high levels of vitamin D in your blood • the package is torn or shows signs of tampering • the expiry date printed on the pack has pas Прочитать полный документ
Page 1 of 8 NEW ZEALAND DATA SHEET 1. CALCITRIOL – AFT Calcitriol – AFT capsules 0.25 μg Calcitriol – AFT capsules 0.5 μg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Calcitriol – AFT 0.25 μg: Each capsule contains 0.25μg of synthetic calcitriol, a biologically active form of vitamin D3. Calcitriol – AFT 0.5 μg: Each capsule contains 0.5μg of synthetic calcitriol, a biologically active form of vitamin D3. Excipients with known effect: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, liquid filled. Calcitriol - AFT are oval, orange soft-gel capsules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Established postmenopausal osteoporosis. • Renal osteodystrophy in patients with chronic renal failure, particularly those undergoing haemodialysis. • Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre- dialysis). • Postsurgical hypoparathyroidism. • Idiopathic hypoparathyroidism. • Pseudohypoparathyroidism. • Vitamin D-dependent rickets. • Hypophosphataemic vitamin D-resistant rickets. • Prevention of corticosteroid induced osteoporosis 4.2 DOSE AND METHOD OF ADMINISTRATION Standard dosage The optimal daily dose of Calcitriol-AFT must be carefully determined for each patient on the basis of the serum calcium level. Calcitriol-AFT therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium (see Patient monitoring). Page 2 of 8 A prerequisite for optimal efficacy of Calcitriol-AFT is adequate but not excessive calcium intake (in adults: approximately 800mg daily) at the beginning of therapy. Calcium supplements may be necessary. Because of improved calcium absorption from the gastrointestinal tract, some patients on Calcitriol- AFT may be maintained on a lower calcium intake. Patients who tend to develop hypercalcaemia may require only low doses of calcium or no supplementation at all. The total daily calcium intake (i.e. from food, and, Прочитать полный документ