TAMOXIFEN TEVA 20 MG

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

TAMOXIFEN AS CITRATE

Tersedia dari:

TEVA ISRAEL LTD

Kode ATC:

L02BA01

Bentuk farmasi:

TABLETS

Komposisi:

TAMOXIFEN AS CITRATE 20 MG

Rute administrasi :

PER OS

Jenis Resep:

Required

Diproduksi oleh:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Kelompok Terapi:

TAMOXIFEN

Area terapi:

TAMOXIFEN

Indikasi Terapi:

For the palliative treatment of breast cancer generally in post menopausal women, either alone or in combination with other modalities.

Tanggal Otorisasi:

2015-02-28

Selebaran informasi

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
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Karakteristik produk

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