Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
NILOTINIB AS HYDROCHLORIDE MONOHYDRATE
NOVARTIS ISRAEL LTD
L01XE08
CAPSULES
NILOTINIB AS HYDROCHLORIDE MONOHYDRATE 150 MG
PER OS
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
NILOTINIB
NILOTINIB
Treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.
2016-03-31
CML ـلا ضرم ةبقارم كبيبط لصاوي فوسف ،ﺎﻨﭽﯿﺳﺎت لوﺎﻨت نع فقوتلا كيلع نأب كل ليق اذإ لوﺎﻨت ةدوﺎعمب كدشري نأ زئﺎجلا نمو لوﺎﻨتلا نع فقوتلا دعبو للاخ ،لبق كلذو صرحب كيدل .كتلﺎحل ً ﺎقفو ،ةجﺎحلا تعد اذإ ﺎﻨﭽﯿﺳﺎت يئاودلا رادقملا نم دكأتلاو ءاودلا عباط صيخشت بجي !ةمتعلا يف ةيودأ لوانت زوجي لا .كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض .ءاود اهيف لوانتت ةرم لك يف .يلديصلا وأ بيبطلا رشتسإ ،ءاودلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ :ةيبناجلا ضارعلأا )4 شهدﻨت لا .نيلمعتسملا ضعب ىدل ةيبنﺎج ً ﺎضارعأ ببسي دق ﺎﻨﭽﯿﺳﺎت لﺎمعتﺳإ نإ ،ءاود لكب ﺎمك ةفيفط يه ةيبنﺎجلا ضارعلأا ةيبلﺎغ نإ .ﺎهﻨم ً ﺎيأ ينﺎعت لاأ زئﺎجلا نم .ةيبنﺎجلا ضارعلأا ةمئﺎق نم .جلاعلا ءدب نم عيبﺎﺳأ ةدع ىتح مﺎيأ ةدع دعب ةدﺎع لوزتو ،ةلدتعم ىتح .ةريطخ نوكت دق ةن ّ يعم ةيبناج ضارعأ نم دحاو لمعتسم نم رثكأ ىدل رهظت يتلا ضارعأ( ً ادج ةعئﺎش يه ةيبنﺎجلا ضارعلأا كلت رهظت ضارعأ( ةعئﺎش ريغ ،)100 نيب نم نيلمعتسم 1-10 ىدل رهظت ضارعأ( ةعئﺎش ،)ةرشع نيب نم نيلمعتسم 1-10 ىدل رهظت ضارعأ( ةردﺎن ،)1,000 نيب نم نيلمعتسم 1-10 ىدل .)دعب ددحي مل ﺎهعويش ضارعأ( فورعم ريغ عويشب ﺎهﻨع غ ِّ ل ُ ب وأ )10,000 ؛تلاضعلاو لصﺎفملا يف ملاآ :يمظعلا لكيهلاو لضعلا يف مللأ تﺎملاع ∙ ،ضفخﻨم وأ عفترم مد طغض ،ةحار م Lesen Sie das vollständige Dokument
1 TAS API SEP22 V14 EU SmPC 15JUN22 1. NAME OF THE MEDICINAL PRODUCT Tasigna 150 mg capsules Tasigna 200 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TASIGNA 150 MG CAPSULES One capsule contains 150 mg nilotinib (as hydrochloride monohydrate). Excipient with known effect One capsule contains 117.08 mg lactose monohydrate. TASIGNA 200 MG CAPSULES One capsule contains 200 mg nilotinib (as hydrochloride monohydrate). Excipient with known effect One capsule contains 156.11 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule TASIGNA 150MG CAPSULES White to yellowish powder in red opaque capsules, size 1 with black axial imprint “NVR/BCR”. TASIGNA 200MG CAPSULES White to yellowish powder in light yellow opaque capsules, size 0 with red axial imprint “NVR/TKI”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tasigna 150mg and 200mg are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic Myelogenous leukaemia (CML) in the chronic phase. Tasigna 200mg ONLY is indicated also for the treatment of Philadelphia chromosome positive chronic myeloid leukaemia (Ph+CML) in chronic phase or accelerated phase in patients resistant to or experiencing significant toxicity during treatment with imatinib. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML. Posology Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity 2 TAS API SEP22 V14 EU SmPC 15JUN22 occurs. If a dose is missed the patient should not take an additional dose, but take the usual prescribed next dose. _Posology for Philadelphia chromosome positive CML adult patients _ The recommended dose of Tasigna is: - 300 mg twice daily in newly diagnosed patients with CML in the chronic phase, - 400 mg twice daily in patients with chronic or accelerated phase CML with resistance or intolerance to prior the Lesen Sie das vollständige Dokument