Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
CAPECITABINE
ABIC MARKETING LTD, ISRAEL
L01BC06
FILM COATED TABLETS
CAPECITABINE 150 MG
PER OS
Required
PHARMACHEMIE B.V., THE NETHERLANDS
CAPECITABINE
Adjuvant Colon Cancer: Capecitabine Teva® is indicated for the adjuvant treatment of patients following surgery of stage III (Dukesע 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.
2019-07-31
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 ً ﺎضارعأ ببسي دق عڤيت نيبﺎتيسيﭘﺎك لﺎمعتسإ نإ ،ءاود لكب ﺎمك زئﺎجلا نم .ةيبنﺎجلا ضارعلأا ةمئﺎق نم شهدنت لا .نيلمعتسملا ضعب دنع .ﺎهنم ً 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 Pročitajte cijeli dokument
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 Pročitajte cijeli dokument