Држава: Израел
Језик: Енглески
Извор: Ministry of Health
RISANKIZUMAB
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
L04AC18
SOLUTION FOR INJECTION
RISANKIZUMAB 150 MG / 1 ML
S.C
Required
ABBVIE DEUTSCHLAND GMBH & CO. KG, GERMANY
RISANKIZUMAB
Plaque PsoriasisSkyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who arecandidates for systemic therapy.Psoriatic ArthritisSkyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of activepsoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
2022-05-31
1986 -)تارضحتسم( ةلديصلا ةمظنأ بجومب كلهتسملل ةرشن طقف بيبط ةفصو بسح ءاودلا اذه ق ّ وسي غلم 150 TM يزيرياكس نقحلل زهاج ملق نمض نقحلل لولحم يف غلم 150 باموزيكناسير ىلع يوتحي نقحلل زهاج ملق لك :اهزيكرتو ةلاعفلا ةداملا Risankizumab 150 mg/1 mL ،للم 1 "ةيفاضإ تامولعم" 6 ةرقفلا رظنأ ءاجرلا ـ ةيساسحلا تادلومو ةلاعفلا ريغ داوملا ةمئاقل .ةرشنلا هذه يف تامولعم ىلع ةرشنلا هذه يوتحت .ءاودلل كلامعتسإ لبق اهتياهن ىتح نعمتب ةرشنلا أرقإ .يلديصلا وأ بيبطلا عجار ،ةيفاضإ ةلئسأ كيدل ترفوت اذإ .ءاودلا نع ةزجوم نأ كل ادب ولو ىتح مهرضي دق وهف .نيرخلآل هيطعت لا .كلجأ نم جلاعلل ءاودلا اذه فص ُ و .كتلاحل ةهباشم ةيبطلا مهتلاح ؟ءاودلا صصخم ضرغ يلأ .1 ةيحيوللا ةيفدصلا ىدل ،ةديدشلا ىتح ةطسوتملا ةيحيوللا )psoriasis( ةيفدصلا جلاعل صصخم يزيرياكس .يزاهج جلاعل نيحشرملا رابكلا يفدصلا لصافملا باهتلإ لصافملا باهتلإ جلاعل صصخم ،) MTX ( تاسكيرتوتيم ةكراشمب وأ هدرفمب ،يزيرياكس رثكأ وأ دحاو ءاودب قباس جلاعل ةيفاك ريغ ةباجتسإ نم اوساق نيذلا رابكلا ىدل طشنلا يفدصلا .جلاعلا لمحت مهناكمإب نكي مل وأ DMARDs ةعومجم نم مزيتامورلل داضم :ةيجلاعلا ةليصفلا .نيكولرتنإ تاطبثم نم ،يعانملا زاهجلا تاطبثم نم .باهتللإا ببسي يذلا ،'IL-23' ىمسملا مسجلا يف نيتورپ بجح قيرط نع يزيرياكس لمعي ةيحيوللا ةيفدصلا ةط Прочитајте комплетан документ
Page 1 of 20 SKY 150 75 API APR23_CL 1. NAME OF THE MEDICINAL PRODUCT Skyrizi ® 150 mg solution for injection in pre-filled pen Skyrizi ® 150 mg solution for injection in pre-filled syringe Skyrizi ® 75 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Skyrizi 150 mg solution for injection in pre-filled pen Each pre-filled pen contains 150 mg risankizumab in 1 -mL solution. Skyrizi 150 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 150 mg risankizumab in 1 -mL solution. Skyrizi 75 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 75 mg risankizumab in 0.83 -mL solution. Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese Hamster Ovary cells using recombinant DNA technology. Excipients with known effect (75 mg solution for injection only) This medicinal product contains 68.0 mg sorbitol per 150 mg dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Skyrizi 150 mg solution for injection in pre-filled pen and in pre-filled syringe The solution is colourless to yellow and clear to slightly opalescent Skyrizi 75 mg solution for injection in pre-filled syringe The solution is colourless to slightly yellow and clear to slightly opalescent. The liquid may contain tiny white or clear particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Plaque Psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic Arthritis Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product is intended for use under the guidance and supervision of a physician experienced in the d Прочитајте комплетан документ