资料单张
Kliovance
®
Page 1 of 7
Klvcmi6.doc
KLIOVANCE
®
_Oestradiol/Norethisterone acetate _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHEN YOU MUST NOT USE KLIOVANCE
®
....................................................... 1
WHAT KLIOVANCE
®
IS USED FOR....... 1
BEFORE YOU TAKE KLIOVANCE
®
........ 1
HOW TO TAKE KLIOVANCE
®
.............. 3
WHILE YOU ARE TAKING KLIOVANCE
®
3
SIDE EFFECTS.................................... 3
STORAGE.......................................... 5
PRODUCT DESCRIPTION .................... 5
FURTHER INFORMATION.................... 6
DIRECTIONS FOR USE ........................ 7
This leaflet answers some common
questions about Kliovance
®
, the
menopause (the ‘change of life’),
and
hormone therapy. It does not contain all
the available information. 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 using Kliovance
®
against the
benefits they expect it will have for you.
ASK YOUR DOCTOR OR PHARMACIST IF YOU
HAVE ANY CONCERNS ABOUT USING THIS
MEDICINE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
Kliovance
®
is available only by
prescription at pharmacies.
WHEN YOU MUST NOT USE
KLIOVANCE
®
DO NOT USE KLIOVANCE
®
OR OTHER
OESTROGENS, WITH OR WITHOUT A
PROGESTOGEN TO PREVENT HEART ATTACKS,
STROKE OR DEMENTIA.
A study called the Women’s Health
Initiative indicated increased risk of
heart attack, stroke, breast cancer, and
blood clots in the legs or lungs in
women receiving treatment with a
product containing conjugated
oestrogens 0.625 mg and the
progestogen medroxyprogesterone
acetate (MPA). The researchers stopped
the study after 5 years when it was
determined the risks were greater than
the benefits in this group. The Women’
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产品特点
Product Information
Klvpi8.doc
Page 1 of 19
PRODUCT INFORMATION
KLIOVANCE
®
WARNING
Oestrogens and progestogens should not be used for the prevention of
cardiovascular disease
or dementia.
The Women’s Health Initiative (WHI) study reported increased risks
of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli, and deep
vein thrombosis in
postmenopausal women (50 to 79 years of age) during 5 years of
treatment with conjugated
oestrogens (0.625 mg) combined with medroxyprogesterone acetate
(2.5 mg) relative to
placebo. (See ‘Clinical Trials’and ‘Precautions.’)
The WHI study reported increased risks of stroke and deep vein
thrombosis in
postmenopausal women (50 to 79 years of age) during 6.8 years of
treatment with conjugated
oestrogens (0.625 mg) relative to placebo. (See ‘Clinical
Trials’and ‘Precautions.’)
The Women’s Health Initiative Memory Study (WHIMS), a substudy of
WHI, reported
increased risk of developing probable dementia in postmenopausal
women 65 years of age or
older during 4 to 5.2 years of treatment with conjugated oestrogens,
with or without
medroxyprogesterone acetate, relative to placebo. It is unknown
whether this finding applies
to younger postmenopausal women. (See ‘Clinical Trials’and
‘Precautions.’)
Other doses of conjugated oestrogens and medroxyprogesterone acetate,
and other
combinations and dosage forms of oestrogens and progestogens were not
studied in the WHI
clinical trials and, in the absence of comparable data, these risks
should be assumed to be
similar. Because of these risks, oestrogens with or without
progestogens should be prescribed
at the lowest effective doses and for the shortest duration consistent
with treatment goals and
risks for the individual woman.
NAME OF THE MEDICINE
Oestradiol (as hemihydrate)
Norethisterone acetate
DESCRIPTION
Kliovance
®
is a continuous combined oestrogen/progestogen pr
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