Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
OESTRADIOL HEMIHYDRATE
Rottapharm Ltd
25 Microgram/day
Transdermal Patch
1999-08-23
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dermestril 25 Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DERMESTRIL 25 has a nominal in vivo release rate of 25 microgram estradiol per day (active surface area 9 cm ; estradiol content 2 mg as 2.066 mg of Estradiol Hemihydrate). For excipients, see 6.1 3 PHARMACEUTICAL FORM DERMESTRIL ® is a transdermal delivery system (transdermal patch) consisting of a transparent backing foil and an estradiol-containing self-adhesive matrix, covered by a protective liner which is removed prior to use. An identification code number is printed on the external part of the backing foil for each DERMESTRIL ® 25 patch (ER 25). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women. The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Posology Adults and the elderly: Three strengths of DERMESTRIL ® are available, DERMESTRIL 25, 50 and 100, releasing respectively 25, 50 and 100µg/day of oestradiol. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration of time (see also section 4.4) should be used. Treatment is usually initiated with one DERMESTRIL ® 25 patch applied to the skin twice weekly in order to ensure a continuous supply of oestradiol to the body; thus each used system is removed after three or four days and replaced by a new one. If after a treatment of 2-3 weeks with DERMESTRIL ® 25 the symptoms of estrogen-deficiency appear not to be neutralized, a higher dosage can be given. A maximum dose of 100 µg per day should not be exceeded. In case of undesirable effects or symptoms of overdose (e.g. breast tenderness and/or vaginal ble Přečtěte si celý dokument