Land: Indonesien
Sprog: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ESTRADIOL HEMIHYDRATE
SYDNA FARMA - Indonesia
ESTRADIOL HEMIHYDRATE
49.6 Mg
GEL
DUS, 1 TUBE @ 80 G
BESINS MANUFACTURING BELGIUM SA - Belgium
2020-09-01
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 Læs hele dokumentet