Mestane

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Exemestane 25mg;  

متاح من:

Douglas Pharmaceuticals Limited

INN (الاسم الدولي):

Exemestane 25 mg

جرعة:

25 mg

الشكل الصيدلاني:

Film coated tablet

تركيب:

Active: Exemestane 25mg   Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Magnesium stearate Mannitol Microcrystalline cellulose Opadry white Y-1-7000 Polysorbate 80 Sodium starch glycolate

الوحدات في الحزمة:

Blister pack, PVC/PVDC-AI., 30 tablets

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Trifarma SpA

الخصائص العلاجية:

Mestane is indicated for: · the adjuvant treatment of postmenopausal women with oestrogen receptor positive or receptor unknown early breast cancer after initial adjuvant tamoxifen to reduce the risk of recurrence (distant and loco-regional) and contralateral breast cancer.

ملخص المنتج:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC-AI. - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC-AI. - 90 tablets - 36 months from date of manufacture stored at or below 30°C

تاريخ الترخيص:

2009-12-09

خصائص المنتج

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
MESTANE® 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg exemestane
Excipients with known effect:
Each film-coated tablet contains mannitol
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
MESTANE 25 mg are white to off-white, round, biconvex, bevel-edged,
film-coated tablets
engraved with ‘E’ on one face and plain on the other.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
MESTANE is indicated for:

the adjuvant treatment of postmenopausal women with oestrogen receptor
positive or
receptor unknown early breast cancer after initial adjuvant tamoxifen
to reduce the risk
of recurrence (distant and loco-regional) and contralateral breast
cancer

the treatment of advanced breast cancer in women with natural or
induced
postmenopausal status whose disease has progressed following
anti-oestrogen therapy

the third-line hormonal treatment of advanced breast cancer in women
with natural or
induced postmenopausal status whose disease progressed following
treatment with
anti-oestrogens and either non-steroidal aromatase inhibitors or
progestins.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS AND ELDERLY PATIENTS _
The recommended dose of MESTANE is one 25 mg tablet to be taken once
daily, preferably after
a meal.
2 | P a g e
In patients with early breast cancer, treatment should continue until
completion of five years
adjuvant hormonal therapy, or until tumour relapse occurs.
In patients with advanced breast cancer, treatment with MESTANE should
continue until tumour
progression is evident.
No dose adjustments are required for patients with hepatic or renal
insufficiency, see Section
5.2.
_PAEDIATRIC POPULATION _
Not recommended for use in children.
METHOD OF ADMINISTRATION
MESTANE tablets should preferably be taken after a meal.
4.3.
CONTRAINDICATIONS
MESTANE tablets are contraindicated in:

pregnant or lactating women

patients with hypersensitivity to the