产品特点
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Estradiol Implants 100 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implant contains 100 mg estradiol (as hemihydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Implant.
White to pale brown opaque or translucent cylinder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
o
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women.
o
Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of,
or contraindicated for, other medicinal products approved for the prevention of osteoporosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Frequency of replacement depends on the duration of activity of the implants administered and the severity of the
symptoms. Patients require a further implant when symptoms return, usually every 4 to 8 months.
Estradiol implants should be inserted subcutaneously under local anesthetic either by means of a trocar and cannula or
in the wound at the time of laparotomy, into an area where there is little movement, such as the upper outer part of the
buttock or the lower abdominal wall.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest
duration (see also Section 4.4, special warnings and precautions for use) should be used.
Because of the sustained absorption of Estradiol, the endometrium of post-menopausal or ovariectomized women is
liable to progressive hypertrophy. Therefore, in women with an intact uterus, additional administration of a
progestogen is essential, for 12 – 14 days every month, to prevent endometrial hyperplasia. Literature data suggests that
co-administration of progestogens with Estradiol
阅读完整的文件
产品特点 