OESTROGEL

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

ESTRADIOL HEMIHYDRATE

Tersedia dari:

SYDNA FARMA - Indonesia

INN (Nama Internasional):

ESTRADIOL HEMIHYDRATE

Dosis:

49.6 Mg

Bentuk farmasi:

GEL

Unit dalam paket:

DUS, 1 TUBE @ 80 G

Diproduksi oleh:

BESINS MANUFACTURING BELGIUM SA - Belgium

Tanggal Otorisasi:

2020-09-01

Karakteristik produk

PI Oestrogel-ID
_OESTROGEL _® GEL
Estradiol 0.06%
Please read all of the instructions carefully before using this
medicine.
•
Keep these instructions; you may need to read them again.
•
If you have any question, if you are in doubt, ask for more
information from your doctor or
pharmacist.
This medicine has been prescribed for you only. Never give it someone
else, even in cases of
identical symptoms as this could be harmful to them.
COMPOSITION
17- β estradiol 0.06%
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 estradiol.
Gel for cutaneous application, tube 80 g.
ATC classification: G03CA03
OESTROGENS- (G. genital-urinary system and sex hormone).
INDICATION
This medicine contains a natural oestrogen. It is prescribed: Hormone
replacement therapy (HRT) for
oestrogen deficiency symptoms in postmenopausal women.
POSOLOGY AND METHOD OF ADMINISTRATION
Transdermal
The posology can be varied according to individual need.
The minimum effective dose for the treatment of post-menopausal
symptoms is 1.25 g of gel per day
(= 0.75 mg of oestradiol) for 21 to 28 days each month. This dose can
be altered according to need
and the average dose is 2.5 g of gel daily. In initiating and
continuing the treatment of the symptoms
of the menopause, the lowest effective dose must be used for the
shortest possible duration.
Continuous oestrogen treatment without a progesterone is not advisable
owing to the dangers this
can create for the endometrium (glandulocystic hyperplasia, dysplasia
with a possible heightened risk
of endometrial carcinoma); treatment must be continued for at least
three consecutive weeks followed
by one week during which no treatment is used and must be combined
with an oral progesterone for
12 to 14 days each month. The gel can be applied from Day 1 to Day 25
of each month together with
an oral progesterone. Withdrawal haemorrhage may occur during the week
during which no treatment
is used. Only those progestat