CAPECITABINE TEVA 500 MG

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

CAPECITABINE

Доступно од:

ABIC MARKETING LTD, ISRAEL

АТЦ код:

L01BC06

Фармацеутски облик:

FILM COATED TABLETS

Састав:

CAPECITABINE 500 MG

Пут администрације:

PER OS

Тип рецептора:

Required

Произведен од:

PHARMACHEMIE B.V., THE NETHERLANDS

Терапеутска област:

CAPECITABINE

Терапеутске индикације:

Adjuvant Colon Cancer: Capecitabine Teva® is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes stage C) colon cancer. Colorectal Cancer: Capecitabine Teva® is indicated for the treatment of patients with advanced or metastatic colorectal cancer. Advanced gastric cancer: Capecitabine Teva® is indicated for first line treatment of advanced gastric cancer in combination with chemotherapy. Breast Cancer Combination Therapy: Capecitabine Teva® in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. Breast Cancer Monotherapy: Capecitabine Teva® is also indicated for the treatment of advanced or metastatic breast cancer after failure of standard therapy including a taxane unless therapy with a taxane is clinically contraindicated.

Датум одобрења:

2019-07-31

Информативни летак

دكأتلاو ءاودلا عبﺎط صيخشت بجي !ةمتعلا
يف ةيودأ لوﺎنت زوجي لا تارﺎظنلا عض .ءاود ﺎهيف لوﺎنتت ةرم لك
يف يئاودلا رادقملا نم
.كلذ رملأا مزل اذإ ةيبطلا بيبطلا رشتسا ،ءاودلا لﺎمعتسإ لوح
ةيفﺎضإ ةلئسأ كيدل ترفوت اذإ
.يلديصلا وأ
ةيبنﺎجلا ضارعلأا )4
ةيبنﺎج
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ﺎضارعأ ببسي دق عڤيت نيبﺎتيسيﭘﺎك
لﺎمعتسإ نإ ،ءاود لكب ﺎمك
زئﺎجلا نم .ةيبنﺎجلا ضارعلأا ةمئﺎق نم
شهدنت لا .نيلمعتسملا ضعب دنع
.ﺎهنم
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ﺎيأ ينﺎعت لاأ
اذإ بيبطلا ىلإ هجوتو يروف لكشب عڤيت
نيبﺎتيسيﭘﺎك لوﺎنت نع فقوت
:ةيلﺎتلا ضارعلأا ىدحإ ترهظ
وأ تارم 4 ـب ربكأ مويلا يف كيدل زربتلا
تارم ددع نﺎك اذإ :تلاﺎهسإ ●
.ليللا للاخ لﺎهسإ نم تينﺎع اذإ وأ
ةيدﺎعلا ةلﺎحلﺎب ةنرﺎقم رثكأ
.ةعﺎس 24 للاخ ةدحاو ةرم نم رثكأ تأيقت
اذإ :تاؤيقت ●
ةيمكب حضاو صقنو مﺎعطلل ةيهشلا نادقف
نم ينﺎعت تنك اذإ :نﺎيثغ ●
.مويلا يف ﺎهكلهتست يتلا مﺎعطلا
،رارمحإ ،ملأ نم ينﺎعت تنك اذإ :)STOMATITIS(
مفلا ةيطﺎخم بﺎهتلإ ●
.ةرجنحلا يف وأ/و مفلا يف ةيسﺎسح وأ
خﺎفتنإ
،ملأ نم ينﺎعت تنك اذإ :نيمدقلاو نيديلا
يتحار يف يدلج لعف در ●
.نيمدقلا يتحار يف وأ/و نيديلا يف زخو وأ
رارمحإ ,خﺎفتنإ
.قوف ﺎمو ةيوئم ةجرد 38 ﺎهردق ةنوخس نم
ينﺎعت تنك اذإ :ةنوخس ●
وأ ،سوريﭬ وأ موثرج نع جتﺎن ثولتل
تﺎملاع كيدل تدجو اذإ :ثولت ●
.ىرخأ ةيوضع تﺎنئ�

Карактеристике производа

1
Capecitabine-Teva-150mg_500mg_SPC-Notification-prac_01-2022_NS
SUMMARY OF PRODUCT CHARACTERISTICS
CAPECITABINE TEVA 150 MG, CAPECITABINE TEVA 500 MG
FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine Teva 150 mg film-coated tablets.
Capecitabine Teva 500 mg
film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capecitabine Teva 150 mg film-coated tablets
Each film-coated tablet contains 150 mg capecitabine.
Capecitabine Teva 500 mg film-coated tablets
Each film-coated tablet contains 500 mg capecitabine.
Excipient(s) with known effect
Capecitabine Teva 150 mg film-coated tablets
Each 150 mg film-coated tablet contains 15.6 mg lactose.
Capecitabine Teva 500 mg film-coated tablets
Each 500 mg film-coated tablet contains 52.0 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Capecitabine Teva 150 mg film-coated tablets:
The film-coated tablets are oval, biconvex peach with inscription "C"
on one side and "150" on the other
side.
Capecitabine Teva 500 mg film-coated tablets:
The film-coated tablets are oval biconvex peach with inscription "C"
on one side and "500" on the other
side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Capecitabine Teva is indicated for the treatment of:
ADJUVANT COLON CANCER:
Capecitabine Teva is indicated for the adjuvant treatment of patients
following surgery of stage III
(Dukes’ stage C) colon cancer (see section 5.1).
COLORECTAL CANCER:
Capecitabine Teva is indicated for the treatment of patients with
advanced or metastatic colorectal cancer
(see section 5.1).
2
Capecitabine-Teva-150mg_500mg_SPC-Notification-prac_01-2022_NS
ADVANCED GASTRIC CANCER:
Capecitabine Teva is indicated for first line treatment of advanced
gastric cancer in combination with
chemotherapy (see section 5.1).
BREAST CANCER COMBINATION THERAPY:
Capecitabine Teva in combination with docetaxel (see section 5.1) is
indicated for the treatment of
patients with metastatic breast cancer after failure of prior
anthracycline-containi