TASIGNA 150 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

NILOTINIB AS HYDROCHLORIDE MONOHYDRATE

Commercializzato da:

NOVARTIS ISRAEL LTD

Codice ATC:

L01XE08

Forma farmaceutica:

CAPSULES

Composizione:

NILOTINIB AS HYDROCHLORIDE MONOHYDRATE 150 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Gruppo terapeutico:

NILOTINIB

Area terapeutica:

NILOTINIB

Indicazioni terapeutiche:

Treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

Data dell'autorizzazione:

2016-03-31

Foglio illustrativo

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�

Scheda tecnica

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