AFINITOR 2.5 MG

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

EVEROLIMUS

Dostupno od:

NOVARTIS ISRAEL LTD

ATC koda:

L04AA18

Farmaceutski oblik:

TABLETS

Sastav:

EVEROLIMUS 2.5 MG

Administracija rute:

PER OS

Tip recepta:

Required

Proizveden od:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Terapijska grupa:

EVEROLIMUS

Područje terapije:

EVEROLIMUS

Terapijske indikacije:

- For the 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 Afinitor 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 AFINITOR® in the treatment of patients with carcinoid tumors have not been established.- For the 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 follwing a non – steroidal aromatase inhibitor.- Afinitor ® is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of Afinitor 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.- Afinitor ® is indicated for the 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

Datum autorizacije:

2016-10-31

Uputa o lijeku

ءاودلا لوانت تيسن اذإ
.ةيسنملا ةعرجلا نع اضيوعت ةفعاضم ةعرج
لوانت عنم
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ي .بيبطلا رشتساو يدايتعلاا تقولا يف
ةيلاتلا ةعرجلا ل
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وانت ،ددحملا تقولا يف ءاودلا اذه لوانت
تيسن اذإ
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قفو جلاعلا ىلع ةبظاوملا كيلع
ءاودلا لوانت نع تفقوت اذإ
.بيبطلا ةراشتسا نود نم يئاودلا جلاعلا
نع فقوتلا كل زوجي لا .اهيلإ ةجاحب تنك اذإ ةيبطلا تارا
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قحت !ملاظلا يف ةيودلأا لوانت عنم
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يلديصلا وأ بيبطلا ر
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شتساف ،ءاودلا لامعتسا ىلإ ةبسنلاب ة
ّ
يفاضإ ةلئسأ كيدل تناك اذإ
ةيبناجلا ضارعلأا .4
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لا .نيلمعتسملا نم مسق ىدل ة
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ّ
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كلفط وأ تنأ تربتخا اذإ كلذو ،ةيروف
ةيبط ةدعاسم يقلتل هجوتو روتينيفأ
لوانت نع فقوت
•
علاتبلاا وأ س
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فنتلا يف تابوعص
•
.(ةيئاعو ةمذو ىلع لدت تاملاع( ةرجنحلا
وأ ناسللا ،نيتفشلا ،هجولا مروت
•
ةزراب مروت تلااح وأ رمحأ حفط عم ةريطخ
ةيدلج ةكح
:ىلع روتينيفأب ةصاخلا ةريطخلا
ةيبناجلا ضارعلأا لمتشت يتلا ةيبصعلا ءامصلا ددغلا يف ةمدقتم
ماروأو مدقتملا ىلكلا ناطرس ،ي

Svojstava lijeka

AFI API SEP22 V11
REF: Afinitor SmPC August 2022, Votubia SmPC August 2022
Page 1 of 47
1. NAME OF THE MEDICINAL PRODUCT
AFINITOR
®
(everolimus)
Afinitor
®
2.5 mg
Afinitor
®
5 mg
Afinitor
®
10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Afinitor
®
2.5 mg tablets
Each tablet contains 2.5 mg everolimus.
_Excipient with known effect: _
Each tablet contains 74 mg lactose.
Afinitor
®
5 mg tablets
Each tablet contains 5 mg everolimus.
_Excipient with known effect: _
Each tablet contains 149 mg lactose.
Afinitor
®
10 mg tablets
Each tablet contains 10 mg everolimus.
_Excipient with known effect: _
Each tablet contains 297 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White to slightly yellowish, elongated tablets with a bevelled edges
and no score.
AFI API SEP22 V11
REF: Afinitor SmPC August 2022, Votubia SmPC August 2022
Page 2 of 47
Afinitor 2.5 mg tablets
The tablets are debossed with “LCL” on one side and “NVR” on
the other.
Afinitor 5 mg tablets
The tablets are debossed with “5” on one side and “NVR” on the
other.
Afinitor 10 mg tablets
The tablets are debossed with “UHE” on one side and “NVR” on
the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Afinitor 2.5, 5 & 10 mg are indicated for the:
1.
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 AFINITOR 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.
2.
Treatment of progressive neuroendocrine tumors of pancreatic origin
(PNET) in patients with
unresectable, locally advanced or metastatic disease. The safety and
effectiveness of
AFINITOR
®
in the treatment of patients with carcinoid tumors have not been
established.
3.
Treatment of hormone receptor-positive, HER2/neu negative advanced
breast cancer, in
combi