国: イスラエル
言語: 英語
ソース: Ministry of Health
ESTRADIOL
CTS LTD
G03CA03
GEL
ESTRADIOL 0.06 %W/W
TRANSDERMAL
Required
LABORATORIES BESINS INTERNATIONAL, FRANCE
ESTRADIOL
ESTRADIOL
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.
2023-10-31
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 完全なドキュメントを読む
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 完全なドキュメントを読む