Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALENDRONATE SODIUM; Vitamin D3 100,000 I.U./g, Ph. Eur.
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
ALENDRONATE SODIUM; Vitamin D3 100,000 I.U./g, Ph. Eur.
4Tablet Tablets
Rovi Pharma Industrial Services S.A
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ FOSAMAX ® PLUS Alendronate Sodium/Cholecalciferol (70mg/2800I.U., 70mg/5600I.U.) 1 WHAT IS IN THIS LEAFLET 1. What FOSAMAX PLUS is used for 2. How FOSAMAX PLUS works 3. Before you use FOSAMAX PLUS 4. How to use FOSAMAX PLUS once weekly 5. While you are using FOSAMAX PLUS 6. Side effects 7. Storage and Disposal of FOSAMAX PLUS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT FOSAMAX PLUS IS USED FOR _WHY HAS MY DOCTOR PRESCRIBED _ _FOSAMAX PLUS? _ Your doctor has prescribed FOSAMAX PLUS to treat your osteoporosis and to help make sure you get enough vitamin D. This will help prevent you from developing fractures. absorb calcium properly unless you have enough vitamin D. Too little vitamin D may lead to bone loss and osteoporosis, and severe vitamin D deficiency may cause muscle weakness which can lead to falls, and greater risk of fracture. _WHAT SHOULD I KNOW ABOUT _ _VITAMIN D? _ Vitamin D is an essential nutrient, required for calcium absorption and healthy bones. The main source of Vitamin D is through exposure to summer sunlight, which makes vitamin D in our skin. Clothing or sun block can prevent from getting enough sunlight. In addition, as people age, their skin becomes less able to make vitamin D. Very few foods are natural sources of vitamin D. Too little vitamin D leads to inadequate calcium absorption and low phosphate – the minerals that make bones strong. Even if you are eating a diet rich in calcium or taking a calcium supplement, your body cannot HOW IS NORMAL BONE MAINTAINED? Bone undergoes a normal process of rebuilding that occurs continuously throughout your skeleton. First, old bone is removed (resorbed), then new bone is laid down (formed). This balanced process of resorbing and forming bone keeps your skeleton healthy and strong. WHAT IS OSTEOPOROSIS AND WHY SHOULD IT BE TREATED? Osteoporosis is thinning and weakening of the bones. It is common in women after menopause and may also occur in Prečítajte si celý dokument
1 FOSAMAX PLUS LPC-MK0217A-T-052015c-Malaysia (alendronate sodium/cholecalciferol, MSD) LOCAL PRODUCT CIRCULAR FOSAMAX PLUS ® 70/2800 (alendronate sodium 70 mg/cholecalciferol 2800 IU) FOSAMAX PLUS ® 70/5600 (alendronate sodium 70 mg/cholecalciferol 5600 IU) I. THERAPEUTIC CLASS FOSAMAX PLUS contains alendronate sodium and cholecalciferol (vitamin D 3 ). Alendronate Sodium Alendronate sodium is a bisphosphonate that acts as a potent, specific inhibitor of osteoclast- mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Cholecalciferol Cholecalciferol (vitamin D 3 ) is a secosterol that is the natural precursor of the calcium-regulating hormone calcitriol (1,25-dihydroxyvitamin D 3 ) II. INDICATIONS FOSAMAX PLUS is indicated • For the treatment of osteoporosis in postmenopausal women to increase bone mass, prevent fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass or by the presence or history of osteoporotic fracture. • Treatment of osteoporosis in men to prevent fractures. 2 III. CLINICAL PHARMACOLOGY IIIa. Mechanism of Action Alendronate Sodium Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [ 3 H] alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [ 3 H] alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix, where it is no lo Prečítajte si celý dokument