EVETOR 10

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EVEROLIMUS

Available from:

UNIPHARM TRADING LTD, ISRAEL

ATC code:

L04AA18

Pharmaceutical form:

TABLETS

Composition:

EVEROLIMUS 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

IDIFARMA DESARROLLO FARMACÉUTICO, S.L., SPAIN

Therapeutic area:

EVEROLIMUS

Therapeutic indications:

Evetor is indicated for:- Treatment of patients with SEGA associated with tuberous sclerosis Complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of Evetor is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated. - Treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. The safety and effectiveness of EVETOR in the treatment of patients with carcinoid tumors have not been established. - Treatment of hormone receptor – positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non – steroidal aromatase inhibitor. - Treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of Evetor in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes. - Treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.- Treatment of unresectable, locally advanced or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

Authorization date:

2021-12-30

Patient Information leaflet

ءاودلا لوانت نع تفقوت اذإ
.بيبطلا ةراشتسإ نودب ءاودلاب جلاعلا نع
فقوتلا زوجي لا نم دكأتلاو ءاودلا عباط صيخشت بجي
!ةمتعلا يف ةيودأ لوانت زوجي لا اذإ ةيبطلا تاراظنلا عض .ءاود اهيف
لوانتت ةرم لك يف يئاودلا رادقملا
.كلذ رملأا مزل بيبطلا رشتسإ ،ءاودلا اذه لامعتسإ لوح
ةيفاضإ ةلئسأ كيدل ترفوت اذإ
.يلديصلا وأ
ةيبناجلا ضارعلأا )4
ضعب ىدل ةيبناج
ً
اضارعأ ببسي دق روتيڤيإ لامعتسإ نإف
،ءاود لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا
تيساق اذإ ،ةيبط ةدعاسم ىلع لوصحلل
ً
اروف هجوتو روتيڤيإ لوانت نع فقوت
:ةيلاتلا يسسحتلا لعفلا در تاملاع نم
ً
ايأ كلفط ىساق وأ تنأ
علبلا يف وأ سفنتلا يف تابوعص ●
)ةيئاعولا ةمذولا ضارعأ( ةرجنحلا وأ
ناسللا ،نيتفشلا ،هجولا خافتنإ ●
ةزراب تاخافتنإ وأ نوللا رمحأ حفط عم
،دلجلا يف ةديدش ةكح ●
:لمشت روتيڤيإ ـل ةديدش ةيبناج ضارعأ لبقتسملا وذ مدقتملا يدثلا ناطرس جلاع
ءانثأ ةديدش ةيبناج ضارعأ ءامصلا ةيبصعلا ددغلا ماروأو مدقتملا
ىلكلا ناطرس ،يباجيلإا ينومروهلا
:لمشت نيتئرلا وأ يمضهلا زاهجلا
،سايركنبلا اهردصم يتلاو ةمدقتملا رثكأ ىدل رهظت ضارعأ )
VERY COMMON
(
ً
ادج ةعئاش ةيبناج ضارعأ
ةرشع نم دحاو لمعتسم نم
)ثولتل تاملاع( ةريرعشق ،مسجلا ةرارح
ةجرد عافترإ ●
باهتلإ دوجو ىلع لدت �