ESTRADIOL Implant 25 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
ESTRADIOL
Available from:
Organon (Ireland) Limited
Dosage:
25 Milligram
Pharmaceutical form:
Implant
Authorization date:
1999-04-01
Summary of Product characteristics
License
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Estradiol Implant 25 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implant contains 25 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
○
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women.
○
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
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