מדינה: דרום אפריקה
שפה: אנגלית
מקור: South African Health Products Regulatory Authority (SAHPRA)
Pharmaco Distribution (Pty) Ltd
See ingredients
CAPSULES
EACH CAPSULE CONTAINS CALCITRIOL 0,25 ug
Registered
1980-07-06
Page 1 of 7 SCHEDULING STATUS S4 PROPRIETARY NAME, STRENGTH AND DOSAGE FORM ROCALTROL ® 0,25 ΜG (calcitriol 0,25 µg capsule) ROCALTROL ® 0,50 ΜG (calcitriol 0,50 µg capsule) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ROCALTROL • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • ROCALTROL has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. 1. WHAT DOES ROCALTROL CONTAIN? The active substance is calcitriol. The other ingredients are: butylhydroxyanisole, butylhydroxytoluene, medium-chain triglycerides. Composition of capsule shell: gelatin, glycerol, mannitol, sorbitol, starch, red and yellow iron oxide E172, titanium dioxide E171. 2. WHAT ROCALTROL IS USED FOR? ROCALTROL contains a medicine called calcitriol. This belongs to a group of medicines called ‘vitamin D metabolites’. ROCALTROL is used to treat the following: Bone disease in people with kidney problems (renal osteodystrophy). Weakening of the bones in women after the menopause (change of life). This is also known as post-menopausal osteoporosis. ROCALTROL works by making your body absorb more calcium from your diet. This helps to form healthy bones and reduce bone damage. Page 2 of 7 3. BEFORE TAKING ROCALTROL DO NOT TAKE ROCALTROL IF: • You are allergic (hypersensitive) to calcitriol or any of the other ingredients of ROCALTROL (listed in Section 1 above), or to other ‘vitamin D metabolite’ medicines (used to treat bone disease). These include alfacalcidol and colecalciferol. • You have extra deposits of calcium in your body (metastatic calcification). • You have high levels of calcium in your blood (hypercalcaemia). • You are unwell because of high levels of vitamin D in your body. TAKE SPECIAL CARE WITH ROCALTROL: • If you are finding it difficult to move about (for example, after an operation). TAKING ROCALTROL WITH FOOD AND DRINK: קרא את המסמך השלם
Page 1 of 10 SCHEDULING STATUS S4 PROPRIETARY NAME AND DOSAGE FORM ROCALTROL ® 0,25 µg (capsules) ROCALTROL ® 0,50 µg (capsules) COMPOSITION Each ROCALTROL ® 0,25 µg capsule contains 0,25 µg calcitriol. Each ROCALTROL ® 0,50 µg capsule contains 0,50 µg calcitriol. Excipients of capsule contents: butylhydroxyanisole, butylhydroxytoluene, medium-chain triglycerides. Composition of capsule shell: gelatin, glycerol, sorbitol, mannitol, starch, titanium dioxide E171, red and yellow iron oxide E172. PHARMACOLOGICAL CLASSIFICATION A 22.1.4 Vitamin. PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Calcitriol is the most active known form of vitamin D 3 in stimulating intestinal calcium transport and osteoblastic activity in the skeleton. The biological effects of calcitriol are mediated via the vitamin D receptor. The two known sites of action of calcitriol are the intestine and bone, but additional evidence suggests that it also acts on the kidney and the parathyroid gland. PHARMACOKINETIC PROPERTIES _Absorption: _ Peak plasma concentrations following a single oral dose of 0,25 to 1,0 µg of calcitriol were reached within 2 to 6 hours. Page 2 of 10 _Metabolism: _ Calcitriol is hydroxylated and oxidised in the kidney and in the liver by specific cytochrome P450 isoenzyme, CYP24A1. Several metabolites with different degrees of vitamin D activity have been identified. _Elimination: _ The elimination half-life of calcitriol in plasma ranges between 5 to 8 hours. The elimination and absorption kinetics of calcitriol remain linear. Calcitriol is excreted in the bile and may undergo an enterohepatic circulation. _Pharmacokinetics in special clinical situations: _ In patients with nephrotic syndrome or in those undergoing haemodialysis, serum levels of calcitriol were reduced and time to peak levels was prolonged. INDICATIONS • As an adjunct treatment of established post-menopausal osteoporosis where hormones or bisphosphonates cannot be used. • Renal bone disease (renal osteodystrophy) such as in chronic renal f קרא את המסמך השלם