Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
Risedronic acid 139.2mg equivalent to Risedronate Sodium
ZUELLIG PHARMA PTE. LTD.
M05BA07
150mg
TABLET, FILM COATED
Risedronic acid 139.2mg equivalent to Risedronate Sodium 150mg
ORAL
Prescription Only
Balkanpharma-Dupnitsa AD
ACTIVE
2011-04-18
_ _ _Page _ _1 _ ACTONEL ® ONCE-A-MONTH 150MG TABLET _Risedronate _ Tablet [sanofi logo] NAME OF THE MEDICINE NON-PROPRIETARY NAME Risedronate Each Actonel tablet contains 150mg of risedronate sodium equivalent to 139.2mg of risedronic acid. The empirical formula for risedronate sodium is C 7 H 10 NO 7 P 2 Na. The chemical name of risedronate sodium is [1-hydroxy-2-(3- pyridinyl)ethylidene]bis(phosphonic acid) monosodium salt. CHEMICAL STRUCTURE The chemical structure of risedronate sodium is the following: Molecular Weight: 305.10 The CAS registry number is 115436-72-1 DESCRIPTION Risedronate sodium is a fine, white to off-white, odourless, crystalline powder. It is soluble in water and in aqueous solutions and essentially insoluble in common organic solvents. Each Actonel tablet contains risedronate sodium 150 mg, crospovidone, magnesium stearate, microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, macrogol 400, macrogol 8000, silicon dioxide, indigo carmine CI73015 and titanium dioxide. PHARMACOLOGY Risedronate is a potent pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. Risedronate is a third generation bisphosphonate. In preclinical studies risedronate demonstrated potent anti-osteoclast and anti-resorptive activity, increasing bone mass and biomechanical strength dose-dependently. The activity of risedronate was confirmed by bone marker measurements during pharmacodynamic and clinical studies. With risedronate 5 mg daily, decreases in biochemical markers of bone turnover were observed within 1 month of treatment and reached a maximum decrease in 3-6 months, remaining stable during the course of therapy. This data demonstrates that risedronate causes a moderate reduction in bone resorption and bone turnover. The new steady state approximates the rate of bone Soma hati kamili
AAAA09817-RISE IR THE 150-SG/L 4129247 190x600 Black 126774 Magenta 4129247 AAAA09817-RISE IR THE 150-SG/L № Parameter PIL 1 Paper weight g/m 2 45 2 Pack line type C80 3 Old AW ID AAAK2724 4 New AW ID AAAA09817 5 Old item code 4128424 6 New item code 4129247 7 Pharmcode 126774 8 Note SUPPLIER INFORMATION TABLE AAAA09817-RISE IR THE 150-SG/L 4129247 190x600 Black Magenta 4129247 AAAA09817-RISE IR THE 150-SG/L Soma hati kamili