Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Calcitriol
Alphapharm Pty Ltd
Medicine Registered
SICAL ® _contains the active ingredient calcitriol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sical 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 Sical 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 YOUR MEDICINE. You may need to read it again. WHAT SICAL IS USED FOR Sical contains the active ingredient calcitriol, one of the naturally occurring and biologically active forms of Vitamin D. Calcitriol acts in the body in a similar manner to Vitamin D. Sical is used to treat people with osteoporosis, a disease where the bones of the body weaken, and in the prevention of osteoporosis in people taking oral corticosteroids. Sical capsules are also prescribed for patients who have low blood calcium levels due to osteodystrophy (a type of bone disease), hypoparathyroidism (a condition where the parathyroid glands have decreased function) and rickets. Sical increases calcium absorption in the intestine and stimulates healthy bone growth. There are many different types of medicines used to treat bone conditions. Sical belongs to a group of medicines known as vitamin D compounds. Your doctor may have prescribed Sical for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY SICAL HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Sical is not addictive. BEFORE YOU TAKE SICAL _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SICAL IF: • YOU HAVE HAD AN ALLERGIC REACTION TO SICAL, CALCITRIOL OR ANY INGREDIENTS LISTED IN THE INGREDIENTS SECTION OF THIS LEAFLET • YOU HAVE HIGH BLOOD CALCIUM LEVELS (HYPERCALCAEMIA) • YOU HAVE VITAMIN D TOXICITY • YOU ARE BREASTFEEDING OR WISH TO BREASTFEED. Sical may pass into the bre Prečítajte si celý dokument
SICAL _Calcitriol _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE Active ingredient: Calcitriol Chemical name: 1,25-dihydroxycholecalciferol Structural formula: Molecular formula: C 27 H 44 O 3 Molecular weight: 416.65. CAS Registry no.: 32222-06-3 DESCRIPTION Calcitriol is a white, crystalline compound, which occurs naturally in humans. It is soluble in organic solvents but practically insoluble in water. Calcitriol is available as soft gelatin capsules containing 0.25 micrograms of calcitriol. Each capsule also contains butylated hydroxyanisole, butylated hydroxytoluene, coconut oil - fractionated, gelatin, glycerol, sorbitol solution (70 percent, non-crystallising), iron oxide red, iron oxide yellow and purified water. PHARMACOLOGY PHARMACODYNAMICS Calcitriol is the most important active metabolite of vitamin D3. It is normally formed in the kidney from its precursor 25-hydroxycholecalciferol (25-HCC). Physiological daily production is normally 0.5 - 1.0 g and is somewhat higher during periods of increased bone synthesis (eg growth or pregnancy). Sical - Product Information 3 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 D3 (cholecalciferol). Vitamin D 3 must be metabolically activated in the liver and the kidney before it is fully active as a regulator of calcium and phosphorus metabolism at target tissues. The initial transformation of vitamin D 3 is catalysed by a vitamin D 3 -25-hydroxylase enzyme (25-OHase) present in the liver, and the product of this reaction is 25-hydroxyvitamin D 3 [25-(OH) D 3 ]. Hydroxylation of 25-(OH) D 3 occurs in the mitochondria of kidney tissue, activated by the renal 25-hydroxyvitamin D 3 -1 alpha- hydroxylase (alpha-OHase), to produce 1,25-(OH)2 D 3 (calcitriol), the Prečítajte si celý dokument