FEMARA TABLET 2.5 mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

LETROZOLE

Διαθέσιμο από:

NOVARTIS (SINGAPORE) PTE LTD

Φαρμακολογική κατηγορία (ATC):

L02BG04

Δοσολογία:

2.5 mg

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED

Σύνθεση:

LETROZOLE 2.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

NOVARTIS PHARMA STEIN AG

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

1998-07-28

Φύλλο οδηγιών χρήσης

FEMARA


Non-steroidal aromatase inhibitor (inhibitor of oestrogen
biosynthesis); antineoplastic agent.  
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Film-coated tablets  
Coated tablet, dark yellow, round, slightly biconvex with bevelled edges. One side bears the 
imprint “FV”, the other “CG”. 
ACTIVE SUBSTANCE 
 4,4'-[(1H-1,2,4-triazol-1-yl)-methylene]bis-benzonitrile
(INN/USAN= letrozole). 
Each film-coated tablet contains 2.5 mg letrozole. 
EXCIPIENTS 
Colloidal  anhydrous  silica,  microcristalline  cellulose,  lactose  monohydrate,  magnesium 
stearate, maize starch, sodium starch glycollate, hydroxypropyl methylcellulose, polyethylene 
glycol 8000, talc, titanium dioxide (E 171), iron oxide yellow (E
172). 
Pharmaceutical formulations may vary between countries. 
INDICATIONS 
Letrozole is not indicated in hormone receptor negative disease. 
Letrozole is indicated in:  

  Adjuvant  treatment  of  postmenopausal  women  with  hormone  receptor  positive  invasive 
early breast cancer. 

  Extended  adjuvant  treatment  of  invasive  early  breast  cancer  in  post  menopausal  women 
who have received prior standard adjuvant tamoxifen
therapy for five years.  

  First-line treatment in postmenopausal women  with hormone-dependent advanced breast 
cancer. 

  Treatment of advanced breast cancer after relapse or disease progression, in women with 
natural or artificially induced postmenopausal endocrine status, who have previously been 
treated with anti-estrogens 
DOSAGE AND ADMINISTRATION 
ADULTS 
The  recommended  dose  of  Femara  is  2.5  mg  once  daily.  In  the  adjuvant  and  extended 
adjuvant  setting,  treatment  with  Femara  should  continue  for  5  years  or  until  disease 

relapse/recurrence  occurs,  whichever 

Αρχείο Π.Χ.Π.

Femara Dec 2016.SINv2
Page 1 of 21
FEMARA

Non-steroidal aromatase inhibitor (inhibitor of oestrogen
biosynthesis); antineoplastic agent.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablets
Coated tablet, dark yellow, round, slightly biconvex with bevelled
edges. One side bears the
imprint “FV”, the other “CG”.
ACTIVE SUBSTANCE
4,4'-[(1H-1,2,4-triazol-1-yl)-methylene]bis-benzonitrile (INN/USAN=
letrozole).
Each film-coated tablet contains 2.5 mg letrozole.
EXCIPIENTS
Colloidal
anhydrous
silica,
microcristalline
cellulose,
lactose
monohydrate,
magnesium
stearate, maize starch, sodium starch glycollate, hydroxypropyl
methylcellulose, polyethylene
glycol 8000, talc, Pigment suspension white, Pigment suspension
yellow.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Letrozole is not indicated in hormone receptor negative disease.
Letrozole is indicated in:
•
Adjuvant treatment of postmenopausal women with hormone receptor
positive invasive
early breast cancer.
•
Extended adjuvant treatment of invasive early breast cancer in post
menopausal women
who have received prior standard adjuvant tamoxifen therapy for five
years.
•
First-line treatment in postmenopausal women with hormone-dependent
advanced breast
cancer.
•
Treatment of advanced breast cancer after relapse or disease
progression, in women with
natural or artificially induced postmenopausal endocrine status, who
have previously been
treated with anti-estrogens
DOSAGE REGIMEN AND ADMINISTRATION
ADULTS
The recommended dose of Femara is 2.5 mg once daily. In the adjuvant
and extended
adjuvant
setting,
treatment
with
Femara
should
continue
for
5
years
or
until
disease
Femara Dec 2016.SINv2
Page 2 of 21
relapse/recurrence
occurs,
whichever
comes
first.
In
patients
with
metastatic
disease,
treatment with Femara should continue until tumor progression is
evident.
SPECIAL POPULATIONS
HEPATIC IMPAIRMENT
No dose adjustment of Femara is required for patients with mild to
moderate hepatic
insufficiency (Child-Pugh scor