Country: Իսրայել
language: անգլերեն
source: Ministry of Health
MESALAZINE
FERRING PHARMACEUTICALS LTD
A07EC02
TABLETS SLOW RELEASE
MESALAZINE 1 G
PER OS
Required
FERRING INTERNATIONAL CENTER SA, SWITZERLAND
MESALAZINE
MESALAZINE
Mild to moderate ulcerative colitis. Crohn's disease.
2016-12-31
-يئوض س ّ سحت( يجسفنبلا قوف ءوضلا هاجتو سمشلا هاجت ةطرفم ةيدلج ةيساسح (Photosensitivity نم دحاو لمعتسم نم لقأ ىدل رهظت ضارعأ - ادج ةردان نايحأ يف رهظت ةيبناج ضارعأ : 10,000 لصأ افيزن ببست دق يتلاو ،مدلا ايلاخ عاونأ ضعب يف ضافخنا( ىرخأ مد تابارطضاو مدلا رقف )قلحلا يف ملاآو ىمح ،تامدك ،ببسلا لوهجم زارب وأ/و )نينيعلا وأ/و دلجلا رارفصا( ناقري ضارعلأا نمضتت( دبكلا يف تابارطضا )نوللا حتاف مكارت ببسب مروت( ةمذو وأ/و ،لوبلا يف مد ضارعلأا نمضتت( ىلكلا يف تابارطضا ))لئاوسلا زخو ضارعلأا نمضتت .نيقاسلاو نيديلا باصعأ يف رثؤت ةلاح( يطيحم يبصع للاتعا )ساسحلإا صقنو نمضتت( ةئرلا بدنت وأ ةئرلاب طيحملا ءاشغلا باهتلا ،ةئرلا يف ف ّ يلتو ةيسسحت لعف دودر يف ملأ وأ ةحار مدع ،) bronchospasm ( ةيسفنتلا كلاسملا جنشت ،لاعس ضارعلأا )ديازتم وأ/و يومد مغلب ،سفنتلا ءانثأ ردصلا ةقبطلا لكب اررض قحلي يذلا ) IBD ( يباهتللاا يعملا ضرم نم عون( نولوقلل يلك باهتلا )ةظيلغلا ءاعملأا نم ةيلخادلا )ساكعنلال لباق( رعشلا طقاست لصافملا يف وأ تلاضعلا يف ملأ امو بلقلا ،ىلكلا ،دلجلا ،لصافملا لثم مسجلا نم ةفلتخم قطانم بيصي نأ نكمي باهتلا لاثم( رربم ريغو يعيبط ريغ فيزن ،ىمح ،بعت ،لصافملا ملاآ ضارعلأا لمشت( كلذ ىلإ ةديدشلا روثبلاو ةديدشلا تافلآا كلذ يف امب( دلجلا ىلع ةيناوجرأ عقب ،تامدك ،)فنلأا في read_full_document
Page 1 of 9 1. NAME OF THE MEDICINAL PRODUCT Pentasa® slow release tablets, 500 mg Pentasa® slow release tablets, 1 g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Mesalazine Each Pentasa slow release, 500mg tablet contains: 500 mg mesalazine. Each Pentasa slow release, 1g tablet contains: 1000 mg mesalazine. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pentasa slow release tablets 500 mg. White-grey to pale-brown, specked round tablets, scored and marked 500mg on one side and ‘PENTASA’ on the reverse side. Pentasa slow release tablets 1 g. White-grey to pale-brown, specked oval tablets, and marked with ‘PENTASA’ on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of mild to moderate ulcerative colitis and Crohn’s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ULCERATIVE COLITIS _Adults: _ Active treatment: Individual dosage, up to 4 g mesalazine once daily or in two or three divided doses. Maintenance treatment: Recommended dosage, 2 g mesalazine once daily. CROHN’S DISEASE _Adults: _ Active treatment: Individual dosage, up to 4 g mesalazine daily in two or three divided doses. Maintenance treatment: Individual dosage, up to 4 g mesalazine daily in two or three divided doses. PAEDIATRIC POPULATION The safety and efficacy in children below 6 years have not been established. There is only limited documentation for an effect in children (age 6-18 years) ULCERATIVE COLITIS Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose). _ _ Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose). It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg: and the normal adult dose to those above 40 kg._ _ C read_full_document