Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
RISEDRONIC ACID AS SODIUM
ABIC MARKETING LTD, ISRAEL
M05BA07
FILM COATED TABLETS
RISEDRONIC ACID AS SODIUM 150 MG
PER OS
Required
WARNER CHILCOTT DEUTSCHLAND GMBH, GERMANY
RISEDRONIC ACID
RISEDRONIC ACID
Treatment of postmenopausal osteoporosis.Prevention of postmenopausal osteoporosis.
2015-04-30
١٩٨6 - )تار َ ضحتسم( ةلدايصلا ةمظنأ بجومب كلهتسملل ةرشن طقف بيبط ةفصو قفو ءاودلا ق ّ وس ُ ي غلم ١5٠ رهشلا يف ةرم لينوتكأ ف ّ لغم صرق :ىلع يوتحي صرق ّ لك - ةلا ّ عف ة ّ دام غلم ١٥٠ (مويدوص ـك) تانوردسير ضمح .Risedronic Acid (as Sodium) 150 mg ."ةيفاضإ تامولعم" ٦ دنبلا رظن ُ ا :ة ّ يساسحلل ةريثمو ةلا ّ عف ريغ داوم هذه يوتحت .ءاودلا لامعتساب ءدبلا لبق كلذو اهتياهن ىتح ن ّ عمتب ةرشنلا أرق ِ إ ىلإ ه ّ جوتف ةيفاضإ ةلئسأ كيدل تناك اذإ .ءاودلا نع ةزجوم تامولعم ىلع ةرشنلا . ّ يلديصلا ىلإ وأ بيبطلا ّ رضي دق ه ّ نلأ ؛نيرخلآا لامعتسلا ه ِ طعت لا .كضرم جلاعل كل فصو ءاودلا اذه .مهضرمو كضرم نيب هباشت كل ادب ول ىتح ،مهب ءارجإ متي مل .ا ً ماع ١٨ ليج تحت نيقهارملل وأ لافطلأل لينوتكأ ءاطعإ عونمم .رمعلا نم ةئفلا هذه ىلع ءاودلا تاريثأت لوح ثاحبأ ١ . ؟ءاو ّ دلا اذه ّ دعأ َ مل ءاسنلا ىدل (ماظعلا ةشاشه) ماظعلا لخلخت ضرم عنمو جلاعل صصخم ءاو ّ دلا .ة ّ يرهشلا ةرودلا عاطقنا دعب :ة ّ يجلاعلا ةليصفلا . تانوفسوفسيب اهلامتحا نم فيفختلل يلاتلابو اهتيوقتل كماظع ىلع ةرشابم لمعي لينوتكأ .راسكنلال ؟ماظعلا يه ام ماظعلا ،ةايحلا للاخ .ىرخأ نداعمو مويسلكلا نم ن ّ وكم يح جيسن يه ماظعلا .ةديدج ماظعب لدبتستو ت ّ تفتت ةميدقلا ىلع مسجلا ةردق نم ربكأ ةعرسب لصحي نأ نكمم ماظعلا نادقف ،٣٥ ليج دعب ةلباق نو Citiți documentul complet
_ _ _Page 1 _ THE FORMAT OF THIS INSERT WAS DETERMINED BY THE MINISTRY OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED ON SEPTEMBER 2015 PRODUCT INFORMATION ACTONEL ® ONCE A MONTH 150 MG NAME OF THE MEDICINE ACTONEL ONCE A MONTH 150 MG NON-PROPRIETARY NAME Each Actonel tablet contains the equivalent of 150 mg 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. . 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, colloidal anhydrous silica, indigo carmine 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 turnover seen in pre-menopausal women. Decreases in biochemical markers of bo Citiți documentul complet