Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
Calcitriol
Roche Products Pty Ltd
Medicine Registered
ROCALTROL ® _contains the active ingredient calcitriol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ROCALTROL 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 you taking ROCALTROL capsules 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 ROCALTROL IS USED FOR ROCALTROL is used to treat people with osteoporosis and to prevent osteoporosis in people taking oral corticosteroids. ROCALTROL capsules are 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. ROCALTROL works by improving absorption of calcium from the intestine and by stimulating growth of healthy bones. ROCALTROL contains calcitriol which occurs naturally in humans and is a biologically active form of vitamin D. There are many different types of medicines used to treat bone conditions. ROCALTROL belongs to a group of medicines known as vitamin D compounds. Your doctor, may have prescribed ROCALTROL for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY ROCALTROL HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. ROCALTROL is not addictive. BEFORE YOU TAKE ROCALTROL _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ROCALTROL IF: 1. YOU HAVE HAD AN ALLERGIC REACTION TO ROCALTROL, CALCITRIOL, OTHER VITAMIN D COMPOUNDS, OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET 2. YOU HAVE HIGH LEVELS OF CALCIUM IN YOUR BLOOD (CALLED HYPERCALCAEMIA) 3. YOU HAVE VITAMIN D TOXICITY 4. YOU ARE BREAST-FEEDING OR INTEND TO BREAST-FEED ROCALTROL may pass into breast milk and have unwanted e Lestu allt skjalið
Rocaltrol PI 111107 _ _ _ _ 1 of 13 CDS 3.0 NAME OF THE MEDICINE ROCALTROL (calcitriol) CAS 32222-06-3 The chemical name for calcitriol is (5_Z_,7_E_)-9,10-secocholesta-5,7,10(19)-triene-1 α,3β,25-triol (calcitriol), the molecular formula is C 27 H 44 O 3 . Calcitriol has a molecular weight of 416.65. DESCRIPTION Calcitriol is a white, crystalline compound, which occurs naturally in humans. It is soluble in organic solvents but practically insoluble in water. ROCALTROL is available as soft gelatin capsules containing 0.25 micrograms of calcitriol. Each capsule also contains butylated hydroxyanisole, butylated hydroxytoluene and medium chain triglycerides. The capsule shell contains gelatin, glycerol, Karion 83, titanium dioxide, iron oxide red and iron oxide yellow. PHARMACOLOGY PHARMACODYNAMICS _MECHANISM OF ACTION _ The biological effects of calcitriol are mediated by the vitamin D receptor, a nuclear hormone receptor expressed in most cell types and functioning as a ligand-activated transcription factor that binds to specific DNA sites to modify the expression of target genes. Calcitriol is one of the most important active metabolites of vitamin D 3 . It is normally formed in the kidney from its precursor 25-hydroxycholecalciferol (25-HCC). Physiological daily production is normally 0.5 - 1.0 µg and is somewhat higher during periods of increased bone synthesis (eg growth or pregnancy). Rocaltrol PI 111107 _ _ _ _ _ _ 2 of 13 CDS 3.0 The natural supply of vitamin D in humans depends mainly on exposure to ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin D 3 (cholecalciferol). Vitamin D 3 must be metabolically activated in the liver and Lestu allt skjalið