PROGYNOVA

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

Oestradiol valerate

Navodilo za uporabo

PROGYNOVA
®
 CMI

1 
PROGYNOVA 

CONSUMER MEDICINE INFORMATION 

WARNING 

The Women’s Health Initiative (WHI) trial examined the health
benefits and risks of combined 
_oestrogen plus progestogen_ therapy (n=16,608)
and _oestrogen-alone_ therapy (n=10,739) in 
postmenopausal women aged 50 to 79 years. 

The  _oestrogen plus progestogen_ arm of the WHI trial indicated an
increased risk of 
_myocardial infarction (MI), stroke, invasive breast cancer,
pulmonary embolism and deep vein _
_thrombosis _in postmenopausal women receiving treatment with
combined conjugated equine 
oestrogens (CEE, 0.625 mg/day) and medroxyprogesterone acetate (MPA,
2.5 mg/day) for 
5.2 years compared to those receiving placebo. 

The _oestrogen-alone_ arm of the WHI trial indicated an increased
risk of_ stroke and deep vein _
_thrombosis  _in hysterectomized women treated with CEE-alone
(0.625 mg/day) for 6.8 years 
compared to those receiving placebo. 

Other doses of oral conjugated oestrogens with 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. 

Therefore, the following should be given serious consideration at the
time of prescribing: 
• 
Oestrogens with or without progestogens should not  be prescribed
for primary or 
secondary prevention of cardiovascular diseases. 
• 
Oestrogens with or without progestogens should be prescribed at the
lowest effective 
dose for the approved indication.    
• 
Oestrogens with or without progestogens should be prescribed for the
shortest period 
possible for the approved indication. 
• 
For the prevention of osteoporosis, oestrogen treatment should be
considered in light 
of other available therapies. 

PROGYNOVA
®
 CMI

2 
PROGYNOVA
®

(PRO·GUY·NO·VA)

_oestradiol valerate _

CONSUMER MEDICINE INF

Lastnosti izdelka

111017 PROGYNOVA PI  

Page 1 of 16 

PRODUCT INFORMATION 

PROGYNOVA 

WARNING 
OESTROGENS WITH OR WITHOUT PROGESTOGENS SHOULD NOT BE USED FOR
THE PREVENTION OF 
CARDIOVASCULAR DISEASE OR DEMENTIA.  

THE WOMEN’S HEALTH INITIATIVE (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 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 WOMEN’S HEALTH INITIATIVE MEMORY STUDY (WHIMS),
A SUB-STUDY 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 

PROGYNOVA is the trade name for yellow
coloured tablets that contain 1 mg oestradiol 
valerate or blue coloured tablets t