Country: Израел
Језик: Енглески
Извор: Ministry of Health
TAMOXIFEN AS CITRATE
TEVA ISRAEL LTD
L02BA01
TABLETS
TAMOXIFEN AS CITRATE 20 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
TAMOXIFEN
TAMOXIFEN
For the palliative treatment of breast cancer generally in post menopausal women, either alone or in combination with other modalities.
2015-02-28
ةجرد يف عافترا دعب ديدشلا يدلجلا حفطلا اذه رهظي دق .نينيعلاو ةيلسانتلا ءاضعلأا toxic epidermal ،نوسنوج سنڤيتس ةمزلاتم( .ازنولفنلإاب ةهيبش ضارعأو ةرارحلا .ةردان نايحأ يف ةيبناجلا ضارعلأا هذه لصحت .)necrolysis (TEN) • ةمذو( سفنتلا يف ةبوعص وأ علبلا يف ةبوعص ،قلحلا وأ ناسللا ،نيتفشلا ،هجولا خافتنا .)ةيئاعو .ةيثارولا ةيئاعولا ةمذولا ضارعأ مقافت وأ لوصح غلم 20 عڤيت نفيسكومات ببسي دق تقو عرسأ يف بيبطلا ىلإ هجوتلا ِ كيلع ،ةيلاتلا ةيبناجلا ضارعلأا دحأ نم ِ تيناع اذإ :نكمم • .لبهملا نم ذاش فيزن • دق هنلأ ،ريزغ فيزن كلذ ىلإ ةفاضلإاب رهظ اذإ اميس لا ،ةمظتنم ريغ ةيرهش ةرود .)محرلا ةناطب ناطرس( محرلا ناطرس نم نيعم عون ىلإ ريشت ةيريذحت ةملاع نوكي • .لبهملا نم تازارفإ • .طغض وأ ،ملأ :لاثم )نيذخفلاو ضوحلا فيوجت ةقطنم( ةيلفسلا نطبلا يف جاعزناب روعش انايحأ ةريطخ ضارعلأا هذه نوكت .محرلا ةناطب يف تارييغت ىلإ ضارعلأا هذه ريشت دق .غلم 20 عڤيت نفيسكوماتب جلاعلا دعب وأ للاخ ثدحت دق يهو .ناطرسلا ىلع لمتشت دقو :ة ّ يفاضإ ةيبناج ضارعأ )تاج ِ لاعتم 10 نيب نم ةدحاو ةج ِ لاعتم نم رثكأ يف رثؤت دق( ادج ةعئاش بائتكا بعت ةرارح تاجوم يدلج حفط لئاوسلا سابتحا نايثغ )تاج ِ لاعتم 10 نيب نم ةدحاو ةج ِ لاعتم ىتح يف رثؤت دق( ةعئاش ةيؤرلا يف تارييغت )ءارمحلا مدلا تايرك يف صقن ىلإ ريشت Прочитајте комплетан документ
Tamoxifen-Teva-20mg-Tablets_ SPC_Notification-01-2022_LC SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamoxifen Teva 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tamoxifen Citrate 30.4 mg (equivalent to 20 mg tamoxifen). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round biconvex film coated tablet, scored on one side with the number "20" embossed above the score line and the letter "T" below it and plain on and the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tamoxifen Teva is indicated for the palliative treatment of breast cancer generally in postmenopausal women, either alone or in combination with other modalities. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS The recommended daily dose of tamoxifen is normally 20 mg. No additional benefit, in terms of delayed recurrence or improved survival in patients, has been demonstrated with higher doses. Substantive evidence supporting the use of treatment with 30-40 mg per day is not available, although these doses have been used in some patients with advanced disease. ELDERLY PEOPLE Similar dosing regimens of Tamoxifen Teva have been used in the eldery with breast cancer and in some of these patients it has been used as sole therapy. METHOD OF ADMINISTRATION For administration by the oral route. 4.3 CONTRAINDICATIONS Tamoxifen Teva should not be used in the following: • Pregnancy. Premenopausal patients must be carefully examined before treatment to exclude the possibility of pregnancy (see also section 4.6). • Hypersensitivity to the active substance or to any of the excipients listed in Tamoxifen-Teva-20mg-Tablets_ SPC_Notification-01-2022_LC section 6.1. • Concurrent anastrozole therapy (see section 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Menstruation is suppressed in a proportion of premenopausal women receiving Tamoxifen Teva for the treatment of breast cancer. An increased incidence of endometrial Прочитајте комплетан документ