Maa: Singapore
Kieli: englanti
Lähde: HSA (Health Sciences Authority)
Estradiol Hemihydrate eqv Estradiol
ORION PHARMA (SG) PTE. LTD.
G03CA03
0.5 mg
GEL
Estradiol Hemihydrate eqv Estradiol 0.5 mg/dose
TOPICAL
Prescription Only
ORION CORPORATION (TURKU PLANT)
ACTIVE
2001-08-22
1. DIVIGEL 0.1 % GEL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT AND EXCIPIENTS Estradiol hemihydrate corresponding to 1.0 mg estradiol per single-dose container Estradiol hemihydrate corresponding to 0.5 mg estradiol per single-dose container Excipients with known effect One gram of gel contains 125 mg propylene glycol and 585 mg ethanol (96%). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORMS Gel, single-dose aluminium sachet Smooth and opalescent gel 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the climacteric syndrome associated with natural or artificial menopause (estrogenic deficiency, e.g. hot flushes, night sweatings, urogenital atrophy and prevention of postmenopausal (type 1) osteoporosis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Divigel can be used for continuous or cyclical treatment. The usual starting dose is 1.0 mg estradiol (1.0 g gel) daily but the selection of the initial dose can be based on the severity of the patient’s symptoms. Depending on the clinical response, the dosage can be readjusted after 2–3 cycles individually from 0.5 g to 1.5 g per day, corresponding to 0.5 to 1.5 mg estradiol per day. In patients with an intact uterus, it is necessary to combine Divigel with an adequate dose of progestin for adequate duration, at least 12–14 consecutive days per month/28 day cycle or to oppose estrogen- stimulated hyperplasia of the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestin in hysterectomised women. Estrogen 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 women. Method of administration Apply on dry and clean skin. The Divigel dose is applied once daily, on the skin of the lower trunk or the right or left thighs, on alternate days. The application surface should be 1-2 times the size of the hand. Divigel should not be applied on Lue koko asiakirja