País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
ESTRADIOL
Organon (Ireland) Limited
100 Milligram
Implant
1999-04-01
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 Llegiu el document complet