Letrole

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Letrozole 2.5mg; Letrozole 2.5mg

Доступно од:

Viatris Limited

INN (Међународно име):

Letrozole 2.5 mg

Дозирање:

2.5 mg

Фармацеутски облик:

Film coated tablet

Састав:

Active: Letrozole 2.5mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Opadry yellow 40L92586 Purified water Sodium starch glycolate Active: Letrozole 2.5mg Excipient: Colloidal silicon dioxide Opadry II Yellow 40L38238 Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Purified water Sodium starch glycolate

Јединице у пакету:

Blister pack, PVC/PVdC/Aluminum, 30 tablets

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Natco Pharma Limited

Терапеутске индикације:

Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. · Extended adjuvant treatment of early breast cancer in post menopausal women who have received greater than or equal to 4.5 and less than or equal to 6.0 years prior standard adjuvant tamoxifen therapy. · First-line treatment in postmenopausal women with advanced breast cancer. · Treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status, who have previously been treated with antioestrogens.

Резиме производа:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Aluminum - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Датум одобрења:

2008-12-23

Информативни летак

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
LETROLE
_LETROZOLE FILM-COATED TABLETS 2.5 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Letrole.
This leaflet answers some common
questions about Letrole tablets.
It does not contain all the
information available on this
medicine. It does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Letrole
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT
LETROLE IS TAKEN
FOR
Letrole is taken for the treatment of
breast cancer in women who are
post-menopausal, i.e. women who
no longer have periods, either
because of their natural age, or
following surgery or chemotherapy.
Letrole contains the active
ingredient, letrozole. It belongs to a
family of medicines called
aromatase inhibitors, also referred
to as "anti-oestrogens" as they
function by reducing the production
of oestrogen in your body.
The growth of certain types of
breast cancer is stimulated by
oestrogen. These cancers are
known as "oestrogen-dependent."
Reducing the production of
oestrogen may help to prevent the
cancer from growing.
This may be the first time you are
taking an "anti-oestrogen" such as
Letrole or you may have taken
another "anti-oestrogen" such as
tamoxifen in the past.
Your doctor may have prescribed
Letrole for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LETROLE HAS
BEEN PRESCRIBED FOR YOU.
There is no evidence that Letrole is
addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
LETROLE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LETROLE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
letrozole
•
any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include
shortness of breath, whee

Карактеристике производа

Page 1 of 16
NEW ZEALAND DATA SHEET
LETROLE
1. PRODUCT NAME
Letrole, 2.5 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 2.5 mg of letrozole.
Excipients with known effect: Lactose monohydrate and maize starch
Allergen declaration: Lactose and sulfites
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Dark yellow, capsule shape, film-coated, slightly biconvex tablet,
debossed with “LZ 2.5” on one side
and “G” on the other.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
•
Adjuvant treatment of postmenopausal women with hormone receptor
positive early breast
cancer.
•
Extended adjuvant treatment of early breast cancer in post-menopausal
women who have
received
≥
4.5 and
≤
6.0 years prior standard adjuvant tamoxifen therapy.
•
First-line treatment in postmenopausal women with advanced breast
cancer.
•
Treatment
of
advanced
breast
cancer
in
women
with
natural
or
artificially
induced
postmenopausal status, who have previously been treated with
anti-oestrogens.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
_DOSE_
The recommended dose of Letrole is 2.5 mg once daily.
In the adjuvant and extended adjuvant setting, treatment with Letrole
should continue for 5 years or
until tumour relapse occurs, whichever comes first.
In patients with metastatic disease, treatment with Letrole should
continue until tumour progression
is evident.
Page 2 of 16
_SPECIAL POPULATIONS_
ELDERLY
No dose adjustment is required for elderly patients.
HEPATIC AND/OR RENAL IMPAIRMENT
No dosage adjustment is required for patients with renal impairment
(creatinine clearance
≥
10
mL/min.). Insufficient data are available to justify a dose advice in
cases of renal insufficiency with a
creatinine clearance less than 10 mL/min or in patients (see section
4.4 and 5.2).
HEPATIC IMPAIRMENT
No dose adjustment of letrozole is required for patients with mild to
moderate hepatic insufficiency
(Child-Pugh A or B). Insufficient data are available for patients with