Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
RISANKIZUMAB
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
L04AC18
SOLUTION FOR INJECTION
RISANKIZUMAB 150 MG/ML
S.C
Required
ABBVIE INC., USA
RISANKIZUMAB
Skyrizi is indicated for the treatment of patients 16 years and older with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable.
2023-02-20
رغصأ يلفس فرط ةشوطرخلل ربكأ يولع ءزج ب2 ةشوطرخلا صحفإ .ةيكيتسلاپلا ةينيصلا نم ةيانعب ةشوطرخلا جارخإب مق هعزن وأ ةشوطرخلا نم يولعلا ءزجلا ريودت زوجي لا ● ةشوطرخلا صحفإ ىلع يوتحي دقو رفصأ ىتح ً اقئار لئاسلا ودبي نأ بجي ● ىرت نأ ميلس رمأ اذه .ةفافش وأ ءاضيب ةريغص تائيزج رثكأ وأ ةدحاو ةعاقف وأ ،هنول ر ّ يغت ، ً اركع لئاسلا ادب اذإ لامعتسلإا زوجي لا ● ةريبك تائيزج وأ تاتف ىلع يوتحي وأ ةققشتم ريغ فافشلا كيتسلاپلاو ةشوطرخلا ءازجأ ● ةروسكم نإو ىتح( ً ادمجتم لئاسلا ناك اذإ لامعتسلإا زوجي لا ● .)باذ نأ تفشتكإ ،اهتطقسأ اذإ ةشوطرخلا لامعتسإ زوجي لا ● .ةبوطعم تناك اذإ وأ ،ةصقان ءازجأ كلانه ج2 يلفس فرط رغصأ زكرم ف ّ ظن يلفسلا فرطلا رغصلأا ةشوطرخلل رغصلأا يلفسلا فرطلا ف ّ ظن ةشوطرخلل رغصلأا يلفسلا فرطلا عقوم ددح ةطساوب ةشوطرخلا نم رغصلأا يلفسلا فرطلا ف ّ ظن ● ةيلوحك ةدامض لامعتسإ ىلع صرحإ .ةيلوحك ةدامض ةشوطرخلا نم رغصلأا يلفسلا فرطلا زكرم فيظنتل دعب ةشوطرخلا نم رغصلأا يلفسلا فرطلا سمل زوجي لا ● فيظنتلا يدومع لكشب ل ِ خدأ د2 "ةقط" نقحلا ةادأ لخاد يف ةفيظنلا ةشوطرخلا ل ّ مح هعزن وأ ةشوطرخلا نم يولعلا ءزجلا ريودت زوجي لا ● لخاد يف ةشوطرخلا نم رغصلأا يلفسلا فرطلا لخدأ ً لاوأ ● نقحلا ةادأ ىتح ،لفسلأل ةشوطرخلا نم يولعلا ءزجلا ةوقب عفدإ ● Belgenin tamamını okuyun
SKY 360-600 JAN24_SPC_clean Page 1 of 16 1 NAME OF THE MEDICINAL PRODUCT Skyrizi ® 600 mg concentrate for solution for infusion Skyrizi ® 360 mg solution for injection in Pre-filled cartridge 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Skyrizi 600 mg concentrate for solution for infusion Each vial contains 600 mg of risankizumab in 10.0 mL of solution (60mg/mL). Skyrizi 360 mg solution for injection in Pre-filled cartridge Each Pre-filed cartridge contains 360 mg of risankizumab in 2.4 mL solution (150 mg/mL). Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody selective to the interleukin (IL)-23 protein produced in Chinese Hamster Ovary cells using recombinant DNA technology. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Skyrizi 600 mg concentrate for solution for infusion (infusion) The solution is colourless to slightly yellow and clear to slightly opalescent Skyrizi 360 mg solution for injection (injection) The solution is colourless to yellow and clear to slightly opalescent. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Risankizumab is indicated for the treatment of patients 16 years and older with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable. 4.2 Posology and method of administration Skyrizi is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Skyrizi is indicated. Posology SKY 360-600 JAN24_SPC_clean Page 2 of 16 The recommended dose is 600 mg administered by intravenous infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Missed dose If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time. Special populations Elderly (aged 65 years and ove Belgenin tamamını okuyun