OESTROGEL

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

ESTRADIOL

Verfügbar ab:

CTS LTD

ATC-Code:

G03CA03

Darreichungsform:

GEL

Zusammensetzung:

ESTRADIOL 0.06 %W/W

Verabreichungsweg:

TRANSDERMAL

Verschreibungstyp:

Required

Hergestellt von:

LABORATORIES BESINS INTERNATIONAL, FRANCE

Therapiegruppe:

ESTRADIOL

Therapiebereich:

ESTRADIOL

Anwendungsgebiete:

Hormonal replacement therapy for the treatment of symptoms associated with estrogen deficiency in menopausal women. Prevention of postmenopausal osteoporosis in women with an increased risk for osteoporotic fractures and presenting intolerace or a contraindication to others treatments indicated in the prevention of osteoporosis.

Berechtigungsdatum:

2023-10-31

Gebrauchsinformation

ةص
ّ
صخملا ةقطنملاو نيديلا ةملاسو فافج
،ةفاظن ىلع صرحلا بجي
.نهدلل
نهدلا قطانم .دلجلا نم ةريبك ةحاسم ىلع
كيلدت نود لجلا نهد بجي
.ذخفلا نم ىطسولا ة
ّ
يلخادلا ةقطنملا وأ فتكلا ،عارذلا :اهب
ىصوملا
اتلك يف فتكلاو عارذلل
ّ
يجراخلا بناجلا ىلع ا
ّ
مإ لجلا نهد بجي
ميسقت بجي( نيذخفلا نم ىطسولا ةيلخادلا
ةقطنملا ىلع وأ ،نيديلا
يف راتخملا وضعلا ىلع ةيواستم ة
ّ
ي
ّ
مك نهد
ّ
متي ثيحب ة
ّ
يمويلا ةعرجلا
.)مسجلا يبناج لاك
.
ّ
يلسانتلا وضعلاو نييدثلا نم برقلاب
نهدلا نع عانتملاا بجي
ةقطنم قوف بوثلا ءادترا لبق قئاقد 5
راظتنلاا بجي نهدلا دعب
.خيطلتلا لجورتسيإ ب
ّ
بسي لا .نهدلا
ىلع رضحتسملا نهد بجيف ،قئاقد 3 رورم دعب
ا
ً
قبد لجلا يقب اذإ
.ةمداقلا ة
ّ
رملا يف ربكأ ةحاسم
.لامعتسلاا دعب ا
ً
د
ّ
يج كيدي يفطشا
ةباصملا ةقطنملا فطش بجيف لجورتسيلإ
دلو وأ لجر ض
ّ
رعت اذإ
.نوباصلاو ءاملاب ا
ً
روف
ة
ّ
يساسح :رهظت دقف مزلالا نم ربكأ ة
ّ
يئاود ةعرج
ً
أطخ تلمعتسا اذإ
دنع ضارعلأا هذه ىشلاتت .
ّ
يلبهم
ّ
يومد فيزنو نايثغ ،نييدثلا يف
.ة
ّ
يئاودلا ةعرجلا ليلقت وأ جلاعلا فاقيإ
ا
ً
روف ه
ّ
جوتف ،
ً
أطخ ءاودلا علبب دلو ماق اذإ وأ ةطرفم
ةعرج تنهد اذإ
كعم بحطصاو ىفشتسملا يف ئراوطلا ةفرغ
ىلإ وأ بيبطلا ىلإ
.ءاودلا ة
ّ
وبع
اذإ كر
ّ
كذت روف ةعرجلا لامعتسا بجيف ،ءاودلا
لامعتسا تيسن اذ�

Fachinformation

OESTROGEL
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
OESTROGEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 0.6 mg of the active ingredient, Estradiol
(0.06% w/w).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Transdermal gel.
A clear, colourless gel with an odour of alcohol.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormonal replacement therapy for the treatment of symptoms associated
with estrogen deficiency in
menopausal women.
Prevention of postmenopausal osteoporosis in women with an increased
risk for osteoporotic fractures
and presenting intolerance or a contraindication to others treatments
indicated in the prevention of
osteoporosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used.
The generally accepted dosage is: application once a day in the
morning or evening for 24-28
consecutive days every month or for three weeks out of every four.
After the break, the treatment
cycle should be repeated.
The dose should be adjusted during the second and/or third cycle
according to the response.
INITIATION OF TREATMENT:
_WOMEN WHO HAVE NEVER TAKEN HRT AND ARE POST-MENOPAUSAL OR HAVE VERY
INFREQUENT MENSTRUAL CYCLES:_
Treatment with Oestrogel can be started on any day.
_SWITCHING FROM A CONTINUOUS OESTROGEN-PROGESTOGEN COMBINED HRT:
_treatment with Oestrogel can be
started on
any day of the cycle.
_SWITCHING FROM A CYCLIC OR CONTINUOUS SEQUENTIAL HRT TREATMENT:
_finish the therapeutic sequence
before beginning
treatment with Oestrogel.
The correct dose of gel should be dispensed and applied to clean, dry,
intact areas of skin _e.g. _on the
arms and
shoulders, or inner thighs. The area of application should be at least
750 cm
2
. Half the
prescribed dose, should be applied to each arm/shoulder (or thigh).
Oestrogel should NOT be applied
on or
near the breasts or on the vulval region. A frequent change in
application sites is recommended.
Oestrogel should be allowed to dry for 5 minutes befo