Kliovance

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

Norethisterone acetate; Oestradiol hemihydrate; Oestradiol

Предлага се от:

Novo Nordisk Pharmaceuticals Pty Ltd

Клас:

Medicine Registered

Листовка

 
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’

Данни за продукта

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