OESTROGEL 0.06%

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

OESTRADIOL

Verfügbar ab:

PHARMED IMPORT & EXPORT PTE LTD

ATC-Code:

G03CA03

Dosierung:

0.06%

Darreichungsform:

GEL

Zusammensetzung:

OESTRADIOL 0.06%

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

Besins Manufacturing Belgium

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

1991-08-14

Fachinformation

0,06%
Estradiol – Gel for cutaneous application in tube
The active substance is: 17-ß estradiol.
The other constituents are: carbomer, trolamine, ethanol, purified
water.
One graduated dose corresponds to 2.5 g of gel, the
equivalent of 1.5 mg of
oestradiol.
MARKETING AUTHORISATION HOLDER:
Besins Healthcare S.A.
Rue Washington 80, 1050, Ixelles, Belgium
MANUFACTURER:
Besins Manufacturing Belgium
Groot-Bijgaardenstraat, 128. 1620 Drogenbos (Belgium)
Laboratoires Besins International
13, rue Périer. 92120 Montrouge (France)
1.
WHAT IS OESTROGEL
®
AND WHAT IT IS USED FOR ?
Gel for cutaneous
application, tube of 80
g.
ATC classification:
G03CA03
OESTROGENS - (G: genital-urinary system
and sex hormones).
This medicine contains
natural oestrogen.
It is prescribed:
-
for the treatment of problems due to a deficiency in
oestrogens linked to menopause. It is hormone replacement
therapy or HRT.
-
for the prevention of post-menopausal osteoporosis for
women with an increased
risk of fracture and showing either
an intolerance or a contraindication to other
treatments
employed in the prevention of osteoporosis. The choice of this
treatment
should be discussed with your doctor.
Experience of this treatment in women above 65 years of age is
limited.
2.
WARNING!
WHEN SHOULD OESTROGEL
®
NOT BE USED?
OESTROGEL
®
SHOULD NO BE USED in the following cases:
-
history or a current venous or arterial thrombo-embolic
diseases (phlebitis,
pulmonary embolia, angina pectoris,
myocardial infarction, cerebral vascular incidents);
-
breast
cancer,
uterine
or
any
other
oestrogen-dependent
cancer;
-
endometrial
hyperplasia
(excessive
development
of
the
uterine mucous
membrane);
-
undiagnosed vaginal bleeding;
-
certain liver illnesses;
-
known allergies to one of its constituents;
-
porphyria (_hereditary disease_).
WARNINGS AND SPECIAL PRECAUTIONS FOR USE:
A
medical examination is required before and periodically in
the course of
treatment. At regular intervals (at least once a
year), your doctor will invite you
to discuss the benefits a