国家: 以色列
语言: 英文
来源: Ministry of Health
MESALAZINE
FERRING PHARMACEUTICALS LTD
A07EC02
TABLETS SLOW RELEASE
MESALAZINE 500 MG
PER OS
Required
FERRING INTERNATIONAL CENTER SA, SWITZERLAND
MESALAZINE
MESALAZINE
Mild to moderate ulcerative colitis.Crohn's disease
2014-06-30
-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 阅读完整的文件
Page 1 of 8 1. NAME OF THE MEDICINAL PRODUCT Pentasa® Suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Pentasa suppository contains: 1g mesalazine For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suppositories. Oblong, compressed white to light tan, speckled suppositories 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Ulcerative Proctitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 1 suppository 1-2 times daily. Method of administration For rectal use. A visit to the toilet is recommended before administration of suppositories. See separate instructions for use. 4.3 CONTRAINDICATIONS PENTASA is contraindicated in: - patients with known hypersensitivity to mesalazine, salicylates or any of the excipients , listed in section 6.1 - patients with severe liver and/or renal impairment 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is recommended when treating patients allergic to sulphasalazine (risk of allergy to salicylates). Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. In case of acute symptoms of intolerance i.e. abdominal cramps, abdominal pain, fever and severe headache and/or the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other signs of hypersensitivity, the treatment should be discontinued immediately. Caution is recommended in patients with impaired liver function. Liver function parameters like ALT or AST should be assessed prior to and during treatment, at the discretion of the treating physician . The drug is not recommended for use in patients with impaired renal function and in patients with haemorrhagic diathesis. Baseline renal function measurement is required in all patients initiating treatment with mesalazine. Urinary status (dip sticks) should be determined prior to and during t 阅读完整的文件