Evista Raloxifene hydrochloride 60mg tablet blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

raloxifene hydrochloride, Quantity: 60 mg

متاح من:

Eli Lilly Australia Pty Ltd

الشكل الصيدلاني:

Tablet, film coated

تركيب:

Excipient Ingredients: crospovidone; polysorbate 80; magnesium stearate; lactose monohydrate; lactose; povidone; Carnauba Wax; Colour; propylene glycol; indigo carmine; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; industrial methylated spirit; ethanol

طريقة التعاطي:

Oral

الوحدات في الحزمة:

28 TABLETS, 7 tablets sample pack

الفئة:

Medicine Registered

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Evista is indicated for the prevention and treatment of osteoporosis in post-menopausal women. Evista is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis. Evista is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer. High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified Gail model). Among the factors included in the modified Gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

ملخص المنتج:

Visual Identification: White oval film coated tablet with 4165 printed in blue ink on one side; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

الوضع إذن:

Licence status A

تاريخ الترخيص:

1999-01-19

نشرة المعلومات

EVISTA
®
_Raloxifene hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It
does not contain all the available
information and does not take the
place of talking with your doctor.
All medicines have risks and
benefits. Your doctor has more
information about this medicine than
is contained in this leaflet. Also,your
doctor has had the benefit of taking a
full and detailed history from you
and is in the best position to make an
expert judgement to meet your
individual needs.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT EVISTA IS USED
FOR
EVISTA belongs to a group of non-
hormonal medicines called Selective
Estrogen Receptor Modulators
(SERMs). When a woman reaches
menopause, the level of the female
sex hormone, oestrogen, goes down.
EVISTA mimics some of the
beneficial effects of oestrogen after
menopause.
EVISTA is used to prevent and treat
osteoporosis in women after
menopause.
Osteoporosis causes your bones to
become thin and fragile - it is
especially common in women after
menopause. While osteoporosis may
have no symptoms at first, it makes
your bones more likely to break,
especially in your spine, hips and
wrists. Osteoporosis may also cause
back pain, loss of height and a curved
back.
Fractures may occur during normal,
everyday activity, such as lifting, or
from minor injury that would not
ordinarily fracture normal bone.
EVISTA is also used to reduce the
risk of invasive breast cancer in
women with osteoporosis after
menopause and reduce the risk of
invasive breast cancer in women at
high risk of invasive breast cancer
after menopause.
Breast cancer is invasive when it has
spread outside the milk duct or milk-
making glands and has grown into
normal tissue inside the breast.
Invasive cancers can spread cancer to
other parts of the body through the
bloodstream and lymphatic syst

خصائص المنتج

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Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
EVISTA
® (RALOXIFENE HYDROCHLORIDE) TABLET
1.
NAME OF THE MEDICINE
Raloxifene hydrochloride.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 60 mg raloxifene hydrochloride, which
is equivalent to
56 mg raloxifene free base.
Excipients with known effect: lactose.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EVISTA is indicated for the prevention and treatment of osteoporosis
in post-menopausal
women.
EVISTA is indicated for the reduction in the risk of invasive breast
cancer in
postmenopausal women with osteoporosis.
EVISTA is indicated for the reduction in the risk of invasive breast
cancer in
postmenopausal women at high risk of invasive breast cancer.
High risk of breast cancer is defined as at least one breast biopsy
showing lobular
carcinoma in situ (LCIS) or atypical hyperplasia, one or more
first-degree relatives with
breast cancer, or a 5-year predicted risk of breast cancer >1.66%
(based on the modified
Gail model). Among the factors included in the modified Gail model are
the following:
current age, number of first-degree relatives with breast cancer,
number of breast biopsies,
age at menarche, nulliparity or age of first live birth. Currently, no
single clinical finding or
test result can quantify risk of breast cancer with certainty.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dosage is one 60 mg EVISTA tablet per day orally,
which may be taken at
any time of day without regard to meals. No dose adjustment is
necessary for the elderly.
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Supplemental calcium should be added to the diet if daily intake is
inadequate.
There are no data on the discontinuation effects of EVISTA. Raloxifene
exerts its effect
through the oestrogen receptor and does not accumulate in any target
tissue. Therefore,
continuous daily treatment with EVISTA is requi