Afinitor Tablet 5mg

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

Everolimus

Saadav alates:

NOVARTIS (SINGAPORE) PTE LTD

ATC kood:

L04AA18

Annus:

5.00mg

Ravimvorm:

TABLET

Koostis:

Everolimus 5.00mg

Manustamisviis:

ORAL

Retsepti tüüp:

Prescription Only

Valmistatud:

Novartis Pharma Stein AG

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2010-01-06

Infovoldik

AFINITOR
®

Protein kinase inhibitors 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
TABLET 
White to slightly yellow, elongated tablets with a bevelled
edge and no score. 
2.5 mg: The tablets are engraved with “LCL” on one side and
“NVR” on the other. 
5 mg: The tablets are engraved with “5” on one side and
“NVR” on the other. 
10 mg: The tablets are engraved with “UHE” on one side and
“NVR” on the other. 
ACTIVE SUBSTANCE 
2.5 MG TABLETS 
Each tablet contains 2.5 mg everolimus. 
5 MG TABLETS  
Each tablet contains 5 mg everolimus. 
10 MG TABLETS  
Each tablet contains 10 mg everolimus. 
Certain dosage strengths may not be available in all countries. 
EXCIPIENTS 
Butylated  hydroxytoluene  (E321),  magnesium  stearate,  lactose  monohydrate,  hypromellose, 
crospovidone, lactose anhydrous. 
Pharmaceutical formulations may vary between countries. 
INDICATIONS 
Afinitor is indicated 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 following a non-steroidal
aromatase inhibitor
.


  Progressive neuroendocrine tumors of pancreatic origin (PNET)
in patients with 
unresectable, locally advanced or metastatic disease 


  Patients  with  advanced  renal  cell  carcinoma  after  failure  of  treatment  with  sunitinib  or 
sorafenib 

  Adult patients (≥18 years of age) with tuberous sclerosis complex (TSC) who have renal 
angiomyolipoma not requiring immediate surgery 

  Patients  with  subependymal  giant  cell  astrocytoma  (SEGA)  associated  with  tuberous 
sclerosis  complex  (TSC)  who  require  therapeutic  intervention  but  are  not  candidates  for 
curative surgical

Toote omadused

Afinitor Jul 2021.SIN
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AFINITOR
®
Everolimus
Protein kinase inhibitor
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
TABLET
White to slightly yellow, elongated tablets with a bevelled edge and
no score.
2.5 mg: The tablets are engraved with “LCL” on one side and
“NVR” on the other.
5 mg: The tablets are engraved with “5” on one side and “NVR”
on the other.
10 mg: The tablets are engraved with “UHE” on one side and
“NVR” on the other.
ACTIVE SUBSTANCE
2.5 MG TABLETS
Each tablet contains 2.5 mg of everolimus.
5 MG TABLETS
Each tablet contains 5 mg of everolimus.
10 MG TABLETS
Each tablet contains 10 mg of everolimus.
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
Butylated hydroxytoluene (E321), magnesium stearate, lactose
monohydrate, hypromellose,
crospovidone, lactose anhydrous.
Information might differ in some countries.
INDICATIONS
Afinitor is indicated 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 following a non-steroidal aromatase
inhibitor.
•
Progressive
neuroendocrine
tumours
of
pancreatic
origin
(PNET)
in
patients
with
unresectable, locally advanced or metastatic disease
•
Unresectable
or
metastatic,
well-differentiated
(Grade
1
or
2)
non-
functional neuroendocrine
tumours
of
gastrointestinal
or
lung origin
in adults with
progressive disease
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•
Patients with advanced renal cell carcinoma whose disease has
progressed on or after
treatment with VEGF-targeted therapy
•
Adult patients (≥18 years of age) with tuberous sclerosis complex
(TSC) who have renal
angiomyolipoma not requiring immediate surgery
•
Patients with subependymal giant cell astrocytoma (SEGA) associated
with tuberous
sclerosis complex (TSC) who require therapeutic intervention, but are
not candidates for
curative surgical resection.
The effectiveness of AFIN