IMBRUVICA CAPSULES 140 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

IBRUTINIB

متاح من:

J-C HEALTH CARE LTD

الشكل الصيدلاني:

CAPSULES

تركيب:

IBRUTINIB 140 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CILAG GMBH INTERNATIONAL, SWITZERLAND

الخصائص العلاجية:

• Mantle Cell Lymphoma:Imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma :Imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)• Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) with 17p deletion:Imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) with 17p deletion.• Waldenström’s MacroglobulinemiaImbruvica is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).• Marginal Zone LymphomaIMBRUVICA is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.• Chronic Graft versus Host DiseaseIMBRUVICA is indicated for the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

تاريخ الترخيص:

2019-04-30

نشرة المعلومات

CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC ـب قلعتت
ةيفاضإ ةيبناج ضارعأ
:LYMPHOMA )CLL/SLL)
مسجلا يف زاهج
يبناجلا ضرعلا
ءاعملأا يفو ةدعملا يف تابارطضإ
نايثغ
كاسمإ
مفلا يف باهتلإ
تاؤيقت
نطبلا يف ملأ
مضه رسع
تافآو تاثولت
ةيولعلا ةيسفنتلا قرطلا يف ثولت
بويجلا باهتلإ
دلجلا يف تاثولت
نيتئرلا يف باهتلإ
ةيلوبلا كلاسملا يف ثولت
ةيئاوهلا تابصقلا باهتلإ
موعلبلاو فنلأا باهتلإ
نيعلا ةمحتلم باهتلإ
ءاطعلإا ةقطنم فورظو ةماع تابارطضإ
ةعفترم ةنوخس
ةيطيحم ةمذو
فعض
ةريرعشق
ملأ
دلجلا تحت ةجسنلأا يفو دلجلا يف
تابارطضإ
ةفزنأ
دلجلا يف ةفيفط ةفزنأ
يردصلا صفقلا فوج يفو سفنتلا يف
تابارطضإ
لاعس
موعلبلا يف ملاآ
سفنتلا يف قيض
ةجسنلأا يفو يمظعلا لكيهلا تلاضع يف
تابارطضإ
ةماضلا
لصافملا يف ملاآ
ةيلضع تاصلقت
يبصعلا زاهجلا يف تابارطضإ
راود
عادص
يطيحم يبصع للاتعإ
ةيئاذغو ةيبلاقتسإ تابارطضإ
ماعطلل ةيهشلا ةلق
ببسي دق يذلا ،مدلا يف لوبلا ضمح ةبسن
عافترإ
سرقنلا
ةفرعم ريغ وأ ةثيبخ ،ةديمح ماروأ
*ةيوناث ةثيبخ ماروأ
ةيومدلا ةيعولأا يف تابارطضإ
مدلا طغض عافترإ
فزن
تايومدلا صوحف جئاتن يف ذوذش
ةيومدلا تاحيفصلا ةبسن يف ضافخنإ
تلادعلا ةبسن يف ضافخنإ
نيبولغوميهلا ةبسن يف ضافخنإ
ةيئارجإ تاطلاتخإو ةيمس ،تاباصإ
بيرستلا ءاطعإ ةقطنمب قلعتي لعف در
نينيعلا يف تابارطضإ
ةيؤرلا شوشت
ن

خصائص المنتج

Page 1 of 56
Imbruvica_Capsules_Tablets_SmPC_Dec2023_ref_USPI_May2022, EU SmPC
Jun2022 & CCDS V.33
FULL PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
IMBRUVICA 140mg Capsules
IMBRUVICA 140mg TABLETS
IMBRUVICA 280mg TABLETS
IMBRUVICA 420mg TABLETS
IMBRUVICA 560mg TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 140 mg of
ibrutinib
Tablets:
IMBRUVICA 140mg
TABLETS
IMBRUVICA 280mg
TABLETS
IMBRUVICA 420mg
TABLETS
IMBRUVICA 560mg
TABLETS
Ibrutinib 140mg
Ibrutinib 280 mg
Ibrutinib 420mg
Ibrutinib 560mg
3
PHARMACEUTICAL FORM
Capsules; size 0, white opaque hard gelatin capsule with black
printing "ibr 140 mg", containing off-white to
white powder.
Tablets:
140 mg tablets: Yellow green to green round tablets debossed with
“ibr” on one side and
“140” on the other side.
280 mg tablets: Purple oblong tablets debossed with “ibr” on one
side and “280” on the
other side.
420 mg tablets: Yellow green to green oblong tablets debossed with
“ibr” on one side and
“420” on the other side.
560 mg tablets: Yellow to orange oblong tablets debossed with
“ibr” on one side and
“560” on the other side.
4
INDICATIONS AND USAGE
4.1
Mantle Cell Lymphoma
IMBRUVICA is indicated for the treatment of adult patients with mantle
cell lymphoma (MCL) who have
received at least one prior therapy.
Page 2 of 56
Imbruvica_Capsules_Tablets_SmPC_Dec2023_ref_USPI_May2022, EU SmPC
Jun2022 & CCDS V.33
4.2
CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
IMBRUVICA is indicated for the treatment of adult patients with
chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL).
4.3
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p
deletion
IMBRUVICA is indicated for the treatment of adult patients with
chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL) with 17p deletion.
4.4
Waldenström’s Macroglobulinemia
IMBRUVICA is indicated for the treatment of adult patients with
Waldenström’s macroglobulinemia (WM).
4.5 Marginal Zone Lymphoma
IMBRUVICA is