Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
EMICIZUMAB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
B02BX06
SOLUTION FOR INJECTION
EMICIZUMAB 150 MG / 1 ML
S.C
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
EMICIZUMAB
Hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.
2023-11-30
• نوكي نأ بجي .نوللا يف رييغتل وأ تايئيزج دوجول لولحملا صحفا ،ءاودلا لامعتسا لبق اذإ ،ركعتم هنأ تظحلا اذإ ءاودلا لامعتسا عنم ُ ي .رفصلأل لئام نول ىتح نوللا ميدع لولحملا .نيعلل ةرهاظ تايئيزج ىلع يوتحي ناك اذإ وأ ،هنول رييغت • ة ّ لس يف وأ ةيودلأا ءاقلإ عنم ُ ي .هلامعتسا م ّ تي مل اذإ ةمئلام ةروصب لولحم لك يمرب مق ص ّ لختلا ةيفيك ىلإ ةبسنلاب ّ يلديصلا لأسا . ّ ي ّ حصلا فرصلا هايم يف وأ تيبلا يف تلامهملا .ةئيبلا ىلع ظافحلا يف دعاستس تاوطخلا هذه ّ نإ .اهل ةجاحب دعت مل يتلا ةيودلأا نم ة ّ يفاضإ تامولعم ( 6 غلم 30 ىلع اربيلميه نم ةروراق لك يوتحت .(emicizumab) باموزيسيمإ ةلا ّ عفلا ةداملا 0.7 ( غلم 105 ،)للم/غلم 150 زيكرتب للم 0.4 ( غلم 60 ،)للم/غلم 30 زيكرتب للم 1 ) .*باموزيسيمإ نم )للم/غلم 150 زيكرتب للم 1 ( غلم 150 وأ )للم/غلم 150 زيكرتب للم .ءاودلا زيكارت لك قيوست م ّ تي لا دق * :ىلع ا ً ضيأ ءاودلا يوتحي ،ةلا ّ عفلا ةداملا ىلإ ةفاضلإاب L-arginine, L-histidine, Poloxamer 188, L-aspartic acid and water for injection. ؟ة ّ وبعلا يوحت اذامو ءاودلا ودبي فيك .رفصلأل لئام نول ىتح نوللا ميدع لولحملا .نقحلل لولحم وه اربيلميه .ةدحاو ةيجاجز ةروراق ىلع اربيلميه نم ة ّ وبع لك يوتحت ة ّ وبعلا هذه يف لومشم ريغ وهو اربيلميه نقح لجأ نم بولطم اذام تحت هنقحو ةنقحملا ىلإ ةروراقلا نم اربيلميه لولحم لقن لجأ نم نقح ةربإو ل Aqra d-dokument sħiħ
Page 1 of 30 Hemlibra PI_Version 8 HEMLIBRA ® EMICIZUMAB Solution for injection 1. NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection Hemlibra 150 mg/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hemlibra 30 mg/mL solution for injection Each mL of solution contains 30 mg of emicizumab* Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL. Hemlibra 150 mg/mL solution for injection Each mL of solution contains 150 mg of emicizumab* Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL. Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration of 150 mg/mL. Each vial of 1 mL contains 150 mg of emicizumab at a concentration of 150 mg/mL. * Emicizumab is a humanised monoclonal modified immunoglobulin G4 (IgG4) antibody produced using recombinant DNA technology in mammalian Chinese Hamster Ovary (CHO) cells For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. _ _ Colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. Page 2 of 30 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders. Posology Treatment (including routine prophylaxis) with bypassing agents (e.g. activated prothrombin complex concentrate [aPCC] and activated recombinant human FVII [rFVIIa]) should be discontinued the day before starting Hemlibra therapy (see section 4.4). Factor VIII (FVIII) prophylaxis may be continued for the first 7 days of Hemlibra treatment. The recommended dose is 3 mg/kg once weekly for the first 4 weeks (loading dose), followed by a maintenance dose from week 5, of either 1.5 mg/kg once weekly, 3 mg/kg every t Aqra d-dokument sħiħ