Vagifem

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Estradiol hemihydrate 25.8ug equivalent to 25 mcg oestradiol;  ;  ;  

Verfügbar ab:

Novo Nordisk Pharmaceuticals Ltd

INN (Internationale Bezeichnung):

Estradiol hemihydrate 25.8 µg (equivalent to 25 mcg oestradiol)

Dosierung:

25 mcg

Darreichungsform:

Vaginal tablet

Zusammensetzung:

Active: Estradiol hemihydrate 25.8ug equivalent to 25 mcg oestradiol       Excipient: Hypromellose   Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch

Einheiten im Paket:

Blister pack, 15 dose units

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Bayer AG

Produktbesonderheiten:

Package - Contents - Shelf Life: Blister pack, - 15 tablets - 36 months from date of manufacture stored at or below 25°C

Berechtigungsdatum:

1990-02-22

Fachinformation

NEW ZEALAND DATASHEET 

NAME OF MEDICINE 
VAGIFEM
®

17ß-oestradiol 25 mcg modified release pessary 
PRESENTATION 
A white, film coated, biconvex modified release pessary marked NOVO
279 on one side, 
blank on the other side with a diameter of 6mm, and containing 25
mcg of 17ß-oestradiol (as 
the hemihydrate). 
USES 
ACTIONS 
Vagifem is an oestrogen preparation for intravaginal application based
on the active human 
oestrogen oestradiol. The Vagifem modified release pessary formulation
is based on a 
hydrophilic cellulose-derived matrix which hydrates upon contact with
moisture and provides 
a controlled release of oestradiol. 

Active ingredients: oestradiol
- chemical name: estra-1,3,5(10)-triene-3,17β-diol (as 
hemihydrate). Oestradiol hemihydrate is a white or almost white
crystalline powder which is 
practically insoluble in water and soluble in acetone. Oestradiol
 hemihydrate has 5 chiral 
centres. The molecular formula is C
18
H
24
O
2
, ½ H
2
O. Oestradiol hemihydrate has a molecular 
weight of 281.39. 

STRUCTURE 
Oestradiol hemihydrate

CAS no.: 35380-71-3 

During the climacteric the decline in endogenous oestrogen
production causes atrophic 
changes in the vaginal mucosa which may induce symptoms such as
vaginal dryness, 
irritation and dyspareunia. 

’½H
2
O’ 

2
Pharmacodynamics 
Vagifem relieves the symptoms of atrophic vaginitis due to
oestrogen deficiency following 
the menopause. Vagifem therapy reverses the atrophic changes
due to oestrogen deficiency 
found in the affected post-menopausal vagina.  

The active ingredient, synthetic 17β-oestradiol, is chemically and
biologically identical to 
endogenous human oestradiol. 

Endogenous 17ß-oestradiol induces and maintains the primary and
secondary female 
sexual characteristics. The biological effect of 17ß-oestradiol
is carried out through a number 
of specific oestrogen receptors. The steroid receptor c