PHARMACOR LETROZOLE 2.5 letrozole 2.5 mg film-coated tablet blister pack

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

letrozole, Quantity: 2.5 mg

থেকে পাওয়া:

Pharmacor Pty Ltd

INN (International Name):

Letrozole

ফার্মাসিউটিকাল ফর্ম:

Tablet, film coated

রচনা:

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

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

30 tablets

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Indicated for the treatment of post menopausal women with hormone receptor positive breast cancer. . The safety and efficacy of neoadjuvant use of Letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.

পণ্য সারাংশ:

Visual Identification: Yellow, round, biconvex, film-coated tablet plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2010-06-03

তথ্য লিফলেট

Pharmacor Letrozole 2.5 (V – 02)
1
PHARMACOR LETROZOLE 2.5
_letrozole_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
Pharmacor Letrozole 2.5.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Pharmacor
Letrozole 2.5 against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PHARMACOR
LETROZOLE 2.5 IS USED
FOR
Pharmacor Letrozole 2.5 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.
Pharmacor Letrozole 2.5 is available
in tablets containing 2.5 mg of the
active ingredient, letrozole.
Letrozole 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" such as
Pharmacor Letrozole 2.5 or you
may have taken another
"antioestrogen" such as tamoxifen
in the past.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PHARMACOR
LETROZOLE 2.5 HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
Pharmacor Letrozole 2.5
for another
reason.
Pharmacor Letrozole 2.5 are only
available with a doctor's prescription.
It is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE PHARMACOR LETROZOLE
2.5 IF YOU HAVE AN ALLERGY TO:
•
let

পণ্য বৈশিষ্ট্য

Pharmacor Letrozole 2.5 (V-02)
1
AUSTRALIAN PRODUCT INFORMATION - PHARMACOR LETROZOLE 2.5
(LETROZOLE) FILM-COATED TABLET
1 NAME OF THE MEDICINE
Letrozole
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor
Letrozole
2.5
are
yellow,
round,
biconvex,
film-coated
tablets
plain
on
both
sides
containing 2.5 mg Letrozole.
Excipient(s) with known effect: Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.
3 PHARMACEUTICAL FORM
Pharmacor Letrozole 2.5 are presented as yellow, round, biconvex,
film-coated tablets plain on both
sides
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
For treatment of postmenopausal women with hormone receptor positive
breast cancer (see
Section 5.1 Pharmacodynamic Properties, 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 Pharmacor Letrozole 2.5 is one tablet daily.
In the adjuvant setting, treatment should continue for 5 years or
until tumour relapse occurs,
whichever comes first.
In the extended adjuvant setting, the optimal treatment duration with
Pharmacor Letrozole 2.5 is
not known, the planned duration of treatment in the pivotal study was
5 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 5 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 2 years, 22% of the patients for more than 4
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).
Pharmacor Letrozole 2.5 (V-02)
2
In patients with