Letromyl

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Letrozole 2.5mg

Доступно од:

Viatris Limited

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 40L38238 Purified water Sodium starch glycolate

Тип рецептора:

Prescription

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 - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Датум одобрења:

2018-05-18

Информативни летак

Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
LETROMYL
_LETROZOLE FILM-COATED TABLETS 2.5 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Letromyl 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
Letromyl 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
LETROMYL
IS
USED FOR AND HOW IT
WORKS
Letromyl is used 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.
Letromyl 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
Letromyl or you may have taken
another "anti-oestrogen" such as
tamoxifen in the past.
Your doctor may, however have
prescribed Letromyl for another
reason. Ask your doctor if you have
any questions about why Letromyl
has been prescribed for you.
There is no evidence that Letromyl
is addictive.
Letromyl is available only with a
doctor's prescription.
BEFORE YOU TAKE
LETROMYL
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE LETROMYL IF YOU ARE
ALLERGIC TO LETROZOLE, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other part

Карактеристике производа

Page 1 of 15
NEW ZEALAND DATA SHEET
LETROMYL
1. PRODUCT NAME
Letromyl 2.5 mg film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 2.5 mg of letrozole.
Each film coated tablet contains 61.5 mg of lactose monohydrate. 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 Letromyl is 2.5 mg once daily.
In the adjuvant and extended adjuvant setting, treatment with Letromyl
should continue for 5 years
or until tumour relapse occurs, whichever comes first.
In patients with metastatic disease, treatment with Letromyl should
continue until tumour progression
is evident.
_SPECIAL POPULATIONS _
ELDERLY
No dose adjustment is required for elderly patients.
Page 2 of 15
HEPATIC AND/OR RENAL IMPAIRMENT
No dosage adjustment is required for patients with hepatic impairment
or renal impairment
(creatinine clearance ≥ 30 mL/min.). Insufficient data are available
to justify a dose advice in cases
of renal insufficiency with a creatinine clearance less than 30 mL/min
or in patients with severe
hepatic insufficiency. Patients with severe hepatic impairment
(Child-Pugh score C) should be kept
under close supervision (see section 5.2).
PAEDIATRIC
Not applicable.
METHOD OF ADMINISTRATION
Tablets to be swallowed whole