FERA

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

letrozole, Quantity: 2.5 mg

متاح من:

Aspen Pharma Pty Ltd

INN (الاسم الدولي):

Letrozole

الشكل الصيدلاني:

Tablet, film coated

تركيب:

Excipient Ingredients: magnesium stearate; hypromellose; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; iron oxide yellow; macrogol 400

طريقة التعاطي:

Oral

الوحدات في الحزمة:

30 tablets

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Treatment of postmenopausal women with hormone receptor positive breast cancer (See Clinical Trials).,The safety and efficacy of neoadjuvant use of letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.

ملخص المنتج:

Visual Identification: Round, yellow, biconvex, film-coated tablet; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

2011-09-23

نشرة المعلومات

FERA- Consumer Medicine Information
Page 1 of 3
FERA
letrozole
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FERA.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking FERA against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT FERA IS USED FOR
FERA is used to treat breast cancer
in women who are post-menopausal
- that is, women who no longer
have periods, either naturally due to
their age or after surgery or
chemotherapy.
FERA belongs to a family of
medicines called aromatase
inhibitors. They are also called
"antioestrogens" because they act
by reducing the production of
oestrogen in your body.
Oestrogen stimulates the growth of
certain types of breast cancer.
These cancers are called
"oestrogen-dependent." Reducing
the production of oestrogen may
help to keep the cancer from
growing.
This may be the first time you are
taking an "antioestrogen" or you
may have taken another
"antioestrogen" such as tamoxifen
in the past.
Your doctor may have prescribed
FERA for another reason. Ask your
doctor if you have any questions
about why FERA has been
prescribed for you.
FERA is available only with a
doctor's prescription.
BEFORE YOU TAKE FERA
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE FERA IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
LETROZOLE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include skin
rash, itching or hives, swelling of
the face, lips or tongue which may
cause difficulty in swallowing or
breathing, wheezing or shortness of
breath.
DO NOT TAKE FERA IF YOU ARE STILL
HAVING PERIODS.
This medicine is only used in
women who are no longer having
periods.
WOMEN OF CHILD-BEARING AGE

خصائص المنتج

FERA- Product Information
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION - FERA (LETROZOLE)
1.
NAME OF THE MEDICINE
Letrozole
2. QUALITATIVE AND QUATITATIVE COMPOSIITION
Fera tablets contain 2.5 mg of letrozole. The tablets also contain
lactose, sodium starch
glycollate, cellulose - microcrystalline, hypromellose, silica -
colloidal anhydrous,
magnesium stearate and Opadry Yellow 03B52094 (ID No. 106949). The
tablets are gluten
free.
For full list of excipients, see Section 6.1 List of excipients.
3.PHARMACEUTICAL FORM
Yellow, round, biconvex tablet
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of postmenopausal women with hormone receptor
positive breast cancer
(see CLINICAL TRIALS).
The safety and efficacy of neoadjuvant use of letrozole has not been
established. Letrozole
is not indicated in hormone receptor negative disease. 4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose of letrozole is one tablet daily.
In the adjuvant setting, treatment should continue for five years or
until tumour relapse
occurs, whichever comes first.
In the extended adjuvant setting, the optimal treatment duration with
letrozole is not
known. The planned duration of treatment in the pivotal study was five
years. However,
at the time of the analysis, the median duration of treatment was 24
months, 25% of
patients were treated for at least three years and less than 1% of
patients were treated for
the planned five years. The median duration of follow-up was 28
months. Treatment
should be discontinued at tumour relapse.
In the adjuvant setting the median duration of treatment was 25
months, 73% of the
patients were treated for more than two years, 22% of the patients for
more than four
years. The median duration of follow-up was 30 months (the efficacy
data mentioned in
CLINICAL TRIALS are based on the primary core analysis with a median
duration of follow-up
of 26 months).
In patients with metastatic disease, treatment with letrozole should
continue until tumour
progression is evident.
ELDERLY PATIEN