Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
RISEDRONATE SODIUM
ZUELLIG PHARMA PTE. LTD.
M05BA07
35 mg
TABLET, FILM COATED
RISEDRONATE SODIUM 35 mg
ORAL
Prescription Only
Balkanpharma-Dupnitsa AD
ACTIVE
2003-04-30
ACTONEL ® 35MG ONCE-A -WEEK (risedronate sodium) film-coated tablets [sanofi logo] NAME OF THE DRUG Actonel is risedronate sodium. Each Actonel tablet contains the equivalent of 35mg of risedronate sodium. 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. The chemical structure of risedronate sodium is the following: Molecular Weight: 305.10 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 (Once-a-Week 35mg) tablet contains risedronate sodium, lactose, crospovidone, magnesium stearate, microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, macrogol 400, macrogol 8000, silicon dioxide, iron oxide yellow E172, iron oxide red E172 and titanium oxide E171. PHARMACOLOGY Actonel is a potent pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. Actonel is a third generation bisphosphonate. In preclinical studies Actonel demonstrated potent anti-osteoclast and anti-resorptive activity, increasing bone mass and biomechanical strength dose-dependently. The activity of Actonel was confirmed by bone marker measurements during pharmacodynamic and clinical studies. With Actonel 5mg 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 Actonel causes a moderate reduction in bone resorption and bone turnover. The new steady state approximates the rate of bone turnover seen in pre-men Đọc toàn bộ tài liệu
AAAA09813-RISE IR THE 35-SG/L 4129243 190x600 Black 126778 Magenta 4129243 AAAA09813-RISE IR THE 35-SG/L № Parameter PIL 1 Paper weight g/m 2 45 2 Pack line type C80 3 Old AW ID AAAK0351 4 New AW ID AAAA09813 5 Old item code 4128775 6 New item code 4129243 7 Pharmcode 126778 8 Note SUPPLIER INFORMATION TABLE AAAA09813-RISE IR THE 35-SG/L 4129243 190x600 Black Magenta 4129243 AAAA09813-RISE IR THE 35-SG/L Đọc toàn bộ tài liệu