País: Israel
Idioma: inglés
Fuente: Ministry of Health
TISAGENLECLEUCEL
NOVARTIS ISRAEL LTD
DISPERSION FOR INFUSION
TISAGENLECLEUCEL
I.V
Required
NOVARTIS PHARMACEUTICALS CORPORATION, USA
Kymriah is indicated for the treatment of: - Paediatric and young adult patients up to and including 25 years of age with CD19+ B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse. - Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Limitation of Use: KYMRIAH is not indicated for treatment of patients with primary or secondary central nervous system lymphoma- Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
2019-11-27
ايرميك زيهجت متي يذلا تقولا يف ناطرسلا جلاع نأش نمو كيدل مدلا ضاضيبإ وأ اموفمللا يف مقافت ثدحي دق ،ايرميك جاتنإ اهيف متي يتلا ةرتفلا للاخ فاقيإ قيرط نع كيدل ناطرسلا رقتسيل )"يريسجت جلاع" ىمسي( يفاضإ جلاع لامعتسإ ررقي نأ كبيبط ارطخ لكشت وأ ةريطخ نوكت دقو ةيبناج ضارعأ ىلإ جلاعلا اذه يدؤي دق .ةديدج ناطرس ايلاخ روطت .جلاعلا اذهل ةلمتحملا ةيبناجلا ضارعلأا نع كبيبط كل حرشي فوس .ةايحلا ىلع ايرميك ـب جلاعلا لبق ةرشابم ىطعت ىرخأ ةيودأ رملأا اذه .ةيفاضإ ةيودأ كل ىطعت نأ زئاجلا نم ايرميك يقلت قبست يتلا ةقيقد 60 ىتح 30 للاخ :لمشت نأ اهنأش نم ةيفاضلإا ةيودلأا هذه .ةنوخسو بيرستلا ةجيتن لعف دودر ثودح عنمل صصخم لوماتيساراپ ∙ .نيمارديهنيفيد لثم ،نيماتسيهلا تاداضم عون نم ةيودأ ∙ ايرميك ىطعي فيك سيك رهظ ىلع رهظت يتلاو كنع فرعت يتلا ةيصخشلا جلاعملا ليصافت نأ نم دكأتلاب كبيبط موقي ∙ .كليصافت قباطت ايرميك بيرست .كديرو ىلإ اهلاخدإ متي ةبوبنأ ربع طيقنتلاب ىطعي ،يأ ،بيرستلا ةطساوب ايرميك كبيبط كيطعي ∙ تنك اذإ اميف كبيبط صحفيس بيرستلا ةيلمع للاخ .ةدحاو ةعاس نم لقأ ةداع ءارجلإا اذه رمتسي .)يسسحت لعف درل ةلمتحم ضارعأ( راود وأ سفنتلا يف تابوعص نم يساقت .ةدحاو ةرمل جلاع وه ايرميك ∙ ايرميك يقلت دعب ىلع عيباسأ 4 ةدمل ،جلاعلا هيف تيقلت يذلا ىفشتسملا ن Leer el documento completo
KYM API DEC23 V9.0 EU SmPC 26 April 2023 1 1. NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 ×10 6 - 6 ×10 8 cells dispersion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description Kymriah (tisagenlecleucel) is a genetically modified autologous cell-based product containing T cells transduced _ex vivo_ using a lentiviral vector expressing an anti-CD19 chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked via a human CD8 hinge and transmembrane region to an intracellular signalling chain of human 4-1BB (CD137) co-stimulatory domain and CD3-zeta signalling domain. 2.2 Qualitative and quantitative composition Each patient-specific infusion bag of Kymriah contains tisagenlecleucel at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells) The medicinal product is packaged in one or more infusion bags overall containing a cell dispersion of 1.2 × 10 6 to 6 × 10 8 CAR-positive viable T cells in a cryopreservative solution. The cellular composition and the final cell number varies between individual patient batches. In addition to T cells, natural killer (NK) cells may be present. Each infusion bag contains 10-30 mL or 30-50 mL of cell dispersion. The quantitative information of medicinal product, including the number of infusion bags (see section 6) to be administered, is presented on the batch specific documentation accompanying the medicinal product for treatment. Excipient with known effect This medicinal product contains 2.43 mg sodium per mL and 24.3 to 121.5 mg sodium per dose. Each bag contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersion for intravenous infusion. A colourless to slightly yellow dispersion in infusion bag/s. 4. CLINICAL PARTICULARS Patient Information Brochure and Patient Alert Card The marketing of Kymriah is subject to Leer el documento completo