Land: Israel
Språk: engelska
Källa: Ministry of Health
RASAGILINE AS MESYLATE
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
N04BD02
TABLETS
RASAGILINE AS MESYLATE 1 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
RASAGILINE
Azilect is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa)or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
2014-12-31
صيخشت بجي !ةمتعلا يف ةيودأ لوانت زوجي لا ةيئاودلا ةعرجلا نم دكأتلاو ءاودلا عباط تاراظنلا عض .ءاود اهيف لوانتت ةرم لك يف .كلذ رملأا مزل اذإ ةيبطلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا وأ بيبطلا رشتسإ ،ءاودلا اذه ةيبناجلا ضارعلأا )4 ببسي دق ءاودلا اذه لامعتسإ نإ ،ءاود لكب امك نم شهدنت لا .نيلمعتسملا ضعب دنع ةيبناج ً اضارعأ .اهنم ً ايأ يناعت لاأ زئاجلا نم .ةيبناجلا ضارعلأا ةمئاق :اذإ بيبطلل ً لااح هجوتلا بجي ،يرسق كولس لثم ةذاش تايكولس كيدل تروطت ∙ وأ قافنلإا ،رامقلا ىلع نامدلإا ،ةيساوسو راكفأ عفاد نع مجان كولس ،هيف غلابم لكشب ءارشلا راكفأ وأ داتعملا نع ةدئاز ةيسنج ةبغرو )ةيعافدنإ( )عفاودلا يف مكحتلا تابارطضإ( ةديازتم ةيسنج .)»ءاودلا لامعتسإ لبق« ـ 2 ةرقفلا رظنأ( .)نايذه( ةدوجوم ريغ ءايشأ عمست وأ ىرت تنك ∙ مدع ،ةنوخس ،نايذه نم جيزم يأ كيدل دجو ∙ .)نينوتوريسلا ةمزلاتم( قرعت وأ فاجترإ ،ةحار ةيدلج تاريغت تظحلا اذإ بيبطلل هجوتلا بجي ةدئاز ةروطخ كلانه نوكت دق هنلأ كشلل ةريثم اذه لامعتسإ دنع )امونلايم( دلجلا ناطرس ثودحل .)"ءاودلا لامعتسإ لبق" ـ 2 ةرقفلا رظنأ( ءاودلا ةيفاضإ ةيبناج ضارعأ رهظت ضارعأ ـ ً ادج ةعئاش ةيبناج ضارعأ :ةرشع نيب نم دحاو لمعتسم نم رثكأ ىدل ) dyskinesia ( ةيدارإ لا تاكرح ∙ عادص ∙ ىدل رهظت ضارعأ ـ ةعئاش ةيبناج Läs hela dokumentet
1 Azilect- Tablets_SPC- Notif _11-2020_NS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT AZILECT 1 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AZILECT is indicated for the treatment of idiopathic Parkinson’s disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of rasagiline is 1 mg (one tablet of AZILECT) once daily, to be taken with or without levodopa. _Elderly_ No change in dose is required for elderly patients (see section 5.2). _Hepatic impairment_ Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3). Rasagiline use in patients with moderate hepatic impairment should be avoided. Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment. In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4 and 5.2). _Renal impairment_ No special precautions are required in patients with renal impairment. _ _ _Paediatric population_ The safety and efficacy of AZILECT in children and adolescents have not been established. There is no relevant use of AZILECT in the paediatric population in the indication Parkinson’s disease. Method of administration For oral use. AZILECT may be taken with or without food. 2 Azilect- Tablets_SPC- Notif _11-2020_NS 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St Läs hela dokumentet