DUAVIVE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BAZEDOXIFENE ACETATE; ESTROGENS CONJUGATED

متاح من:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC رمز:

G03CC07

الشكل الصيدلاني:

TABLETS MODIFIED RELEASE

تركيب:

BAZEDOXIFENE ACETATE 20 MG; ESTROGENS CONJUGATED 0.45 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PFIZER INC, USA

المجال العلاجي:

CONJUGATED ESTROGENS AND BAZEDOXIFENE

الخصائص العلاجية:

Treatment of the following conditions in women with a uterus:• Treatment of moderate to severe vasomotor symptoms associated with menopause• Prevention of postmenopausal osteoporosis

تاريخ الترخيص:

2021-10-31

نشرة المعلومات

Duavive PIL CC Technical change 310523
2023-0086206
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DUAVIVE
®
Modified release tablets
Each tablet contains:
0.45 mg conjugated estrogens
20 mg bazedoxifene acetate (equivalent to 20 mg bazedoxifene)
Inactive ingredients and allergens: See section 2 under "Important
information about
some of this medicine’s ingredients" and section 6 “Further
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about this medicine. If you have any further
questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
The medicine is intended for menopausal and postmenopausal women.
IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT DUAVIVE:
•
Do not take additional estrogen containing products while you are
taking
Duavive.
•
Using estrogen alone may increase your chance of developing cancer of
the
uterus.
•
Report any unusual vaginal bleeding right away while you are taking
Duavive.
Vaginal bleeding after menopause may be a warning sign of cancer of
the
uterus. Your doctor should check any unusual vaginal bleeding to find
out its
cause.
•
Do not use estrogen to prevent heart disease, heart attacks, strokes
or
dementia (decline in brain function).
•
Using estrogen alone may increase your chances of getting a stroke or
blood
clots.
•
Using estrogen alone may increase your chance of getting dementia,
based
on a study of women 65 years of age or older.
•
The risks listed above are based on a study of an estrogen-alone oral
product. Since other products and doses have not been studied in the
same
way, it is unknown how the use of Duavive will affect your chances of
getting
these conditions.
•
Duavive should be taken for the shortest possible period and only for
as

خصائص المنتج

Duavive LPD CC 130123
2022-0081472, 2018-0046723
DUAVIVE
®
NAME OF THE MEDICINAL PRODUCT
Duavive
®
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 0.45 mg of conjugated estrogens
and bazedoxifene acetate
equivalent to 20 mg bazedoxifene.
Excipients with known effect:
Each modified-release tablet contains sucrose, lactose and maltitol
liquid.
For the full list of excipients,
_see Description (9)_
in this leaflet.
PHARMACEUTICAL FORM
Modified-release tablet.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND
PROBABLE DEMENTIA
_ _
•
WOMEN TAKING DUAVIVE
® SHOULD NOT TAKE ADDITIONAL ESTROGENS _[SEE WARNINGS AND _
_PRECAUTIONS (4.1)]_
•
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO USES
UNOPPOSED ESTROGENS. DUAVIVE
® HAS BEEN SHOWN TO REDUCE THE RISK OF ENDOMETRIAL
HYPERPLASIA, WHICH MAY BE A PRECURSOR TO ENDOMETRIAL CANCER. ADEQUATE
DIAGNOSTIC
MEASURES, INCLUDING DIRECTED OR RANDOM ENDOMETRIAL SAMPLING WHEN
INDICATED, SHOULD
BE UNDERTAKEN TO RULE OUT MALIGNANCY IN POSTMENOPAUSAL WOMEN WITH
UNDIAGNOSED
PERSISTENT OR RECURRING ABNORMAL GENITAL BLEEDING_ [SEE WARNINGS AND
PRECAUTIONS (4.3)]_
•
ESTROGEN THERAPY SHOULD NOT BE USED FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE OR
DEMENTIA _[SEE WARNINGS AND PRECAUTIONS (4.2, 4.4)]_
•
THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED
INCREASED RISKS
OF STROKE AND DEEP VEIN THROMBOSIS (DVT) IN POSTMENOPAUSAL WOMEN (50
TO 79 YEARS OF
AGE) DURING 7.1 YEARS OF TREATMENT WITH DAILY ORAL CONJUGATED
ESTROGENS (0.625 MG)-
ALONE, RELATIVE TO PLACEBO _[SEE WARNINGS AND PRECAUTIONS (4.2)]_
•
THE WHI MEMORY STUDY (WHIMS) ESTROGEN-ALONE ANCILLARY STUDY OF WHI
REPORTED AN
INCREASED RISK OF PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS
OF AGE AND
OLDER DURING 5.2 YEARS OF TREATMENT WITH DAILY CONJUGATED ESTROGENS
(0.625 MG)-ALONE,
RELATIVE TO PLACEBO. IT IS UNKNOWN WHETHER THIS FINDING APPLIES TO
YOUNGER
POSTMENOPAUSAL WOMEN _[SEE WARNINGS AND PRECAUTIONS (4.4)]_ ONLY DAILY ORAL 0