Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
CAPMATINIB AS DIHYDROCHLORIDE MONOHYDRATE
NOVARTIS ISRAEL LTD
L01EX17
FILM COATED TABLETS
CAPMATINIB AS DIHYDROCHLORIDE MONOHYDRATE 200 MG
PER OS
Required
NOVARTIS PHARMA PRODUKTIONS GMBH
CAPMATINIB
TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an approved test.
2022-02-09
فقوي نأ ،يئاودلا رادقملا كل ريغي نأ بيبطلا نأش نم يناعت تنك اذإ مئاد وأ تقؤم لكشب اتكيربات ـب جلاعلا .ةنيعم ةيبناج ضارعأ نم لوانت نع فقوتلا وأ يئاودلا رادقملا رييغت زوجي لا .بيبطلا نم تاميلعتب لاإ ،اتكيربات تأيقت وأ ددحملا تقولا يف ءاودلا اذه لوانت تيسن اذإ ً ايئاود ارادقم لوانت زوجي لا ،اتكيربات نم ايئاود ارادقم داتعملا تقولا يف يلاتلا يئاودلا رادقملا لوانت .افعاضم .بيبطلا رشتسإو .بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا بجي عباط صيخشت بجي !ةمتعلا يف ةيودأ لوانت زوجي لا اهيف لوانتت ةرم لك يف يئاودلا رادقملا نم دكأتلاو ءاودلا .كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض .ءاود ،ءاودلا اذه لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا وأ بيبطلا رشتسإ ةيبناجلا ضارعلأا )4 ً اضارعأ ببسي دق اتكيربات لامعتسإ نإ ،ءاود لكب امك ةمئاق نم شهدنت لا .نيلمعتسملا ضعب ىدل ةيبناج .اهنم ايأ يناعت لاأ زئاجلا نم .ةيبناجلا ضارعلأا :كلذ يف امب ،ةيدج ةيبناج اضارعأ اتكيربات ببسي دق باهتلإ ،يللاخ يوئر ضرم( ةيسفنت وأ ةيوئر لكاشم • يدؤي نأ نكمي ايوئر اباهتلإ اتكيربات ببسي دق .)نيتئرلا كيدل تروطت اذإ يروف لكشب بيبطلا غلب .ةافولا ىلإ :كلذ يف امب ،ضارعلأا يف مقافت وأ ةديدج ضارعأ ةيأ لاعس ○ ةنوخس ○ سفنتلا يف قيض وأ سفنتلا يف تابوعص ○ ةذاش جئاتن ىلإ اتكيربا Belgenin tamamını okuyun
TAB SPI 27APR23 V3 USPI 03.23 TABRECTA 150 MG, TABRECTA 200 MG Film coated tablets QUALITATIVE AND QUANTITATIVE COMPOSITION TABRECTA 150 MG: Each film-coated tablet contains 150 mg capmatinib (as capmatinib dihydrochloride monohydrate). TABRECTA 200 MG: Each film-coated tablet contains 200 mg capmatinib (as capmatinib dihydrochloride monohydrate). For the full list of excipients, see section 16. 1 INDICATIONS AND USAGE TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an approved test. 2 DOSAGE AND ADMINISTRATION 2.1 Patient Selection Select patients for treatment with TABRECTA based on the presence of a mutation that leads to MET exon 14 skipping in tumor specimens _[see Clinical Studies (14)]_ . 2.2 Recommended Dosage The recommended dosage of TABRECTA is 400 mg orally twice daily with or without food, adequate hydration is recommended. Swallow TABRECTA tablets whole. Do not break, crush or chew the tablets. If a patient misses or vomits a dose, instruct the patient not to make up the dose, but to take the next dose at its scheduled time. 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions for the management of adverse reactions are listed in Table 1. Table 1: Recommended TABRECTA Dose Reductions for Adverse Reactions Dose reduction Dose and schedule First 300 mg orally twice daily Second 200 mg orally twice daily Permanently discontinue TABRECTA in patients who are unable to tolerate 200 mg orally twice daily. The recommended dosage modifications of TABRECTA for adverse reactions are provided in Table 2. TAB SPI 27APR23 V3 USPI 03.23 Table 2: Recommended TABRECTA Dosage Modifications for Adverse Reactions Adverse reaction Severity Dosage modification Interstitial Lung Disease (ILD)/Pneumonitis _[see Warnings and Precautions (5.1)]_ Any grade Permanently discontinue TABRECTA. Increased ALT and/or AST without incre Belgenin tamamını okuyun