DERMESTRIL Transdermal Patch 25 Microgram/day

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

OESTRADIOL HEMIHYDRATE

제공처:

Rottapharm Ltd

복용량:

25 Microgram/day

약제 형태:

Transdermal Patch

승인 날짜:

1999-08-23

제품 특성 요약

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