البلد: الاتحاد الأوروبي
اللغة: البلغارية
المصدر: EMA (European Medicines Agency)
nivolumab
Bristol-Myers Squibb Pharma EEIG
L01FF01
nivolumab
Антинеопластични средства
Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
MelanomaOpdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. Relative to nivolumab monotherapy, an increase in progression free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression. Adjuvant treatment of melanomaOpdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Non-small cell lung cancer (NSCLC)Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Neoadjuvant treatment of NSCLCOPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. Malignant pleural mesothelioma (MPM)Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Neoadjuvant treatment of NSCLCOPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. Renal cell carcinoma (RCC)Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. Classical Hodgkin lymphoma (cHL)Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Squamous cell cancer of the head and neck (SCCHN)Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. Urothelial carcinomaOpdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. Adjuvant treatment of urothelial carcinomaOPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. Oesophageal squamous cell carcinoma (OSCC)OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. Adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (OC or GEJC)Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. Gastric, gastro‑oesophageal junction (GEJ) or oesophageal adenocarcinomaOPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.
Revision: 56
упълномощен
2015-06-19
140 _ _ Б. ЛИСТОВКА 141 _ _ ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ OPDIVO 10 MG/ML КОНЦЕНТРАТ ЗА ИНФУЗИОНЕН РАЗТВОР ниволумаб (nivolumab) ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА, ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ИЗПОЛЗВАТЕ ТОВА ЛЕКАРСТВО, ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА ЗА ВАС ИНФОРМАЦИЯ. - Запазете тази листовка. Може да се наложи да я прочетете отново. - Важно е да носите сигналната карта с Вас по време на лечението. - Ако имате някакви допълнителни въпроси, попитайте Вашия лекар. - Ако получите някакви нежелани реакции, уведомете Вашия лекар. Това включва и всички възможни нежелани реакции, неописани в тази листовка. Вижте точка 4. КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА 1. Какво представлява OPDIVO и за какво се използва 2. Какво трябва да знаете, преди да използвате OPDIVO 3. Как да използвате OPDIVO 4. Възможни нежелани реакции 5. Как да съхранявате OPDIVO 6. Съдържание на опаковката и допълнителна информация 1. КАКВО ПРЕДСТАВЛЯВА OPDIVO И ЗА КАКВО СЕ ИЗПОЛЗВА OPDIVO е лекарствен продукт, който се използва за лечение на: напреднал меланом (вид рак на кожата) при възрастни и юноши на и над 12 години меланом след пълно хирургично отстраняване при възрастни и юноши на и над 12 години اقرأ الوثيقة كاملة
1 _ _ ПРИЛОЖЕНИЕ I КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА 2 _ _ 1. ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ OPDIVO 10 mg/ml концентрат за инфузионен разтвор 2. КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ Всеки ml концентрат за инфузионен разтвор съдържа 10 mg ниволумаб (nivolumab). Един флакон с 4 ml съдържа 40 mg ниволумаб. Един флакон с 10 ml съдържа 100 mg ниволумаб. Един флакон с 12 ml съдържа 120 mg ниволумаб. Един флакон с 24 ml съдържа 240 mg ниволумаб. Ниволумаб се произвежда в клетки от яйчник на китайски хамстер по рекомбинантна ДНК технология. Помощно вещество с известно действие Всеки ml от концентрата съдържа 0,1 mmol (или 2,5 mg) натрий. За пълния списък на помощните вещества вижте точка 6.1. 3. ЛЕКАРСТВЕНА ФОРМА Концентрат за инфузионен разтвор (стерилен концентрат) Бистра до опалесцентна, безцветна до бледо жълта течност, която може да съдържа малко на брой светли частици. Разтворът има рН приблизително 6,0 и осмолалитет около 340 mOsm/kg. 4. КЛИНИЧНИ ДАННИ 4.1 ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ Меланом OPDIVO е показан за лечение на авансирал меланом (неоперабилен или метастатичен) при възрастни и юноши на и над 12 години като монотерапия или в комбинация с ипилимумаб. Установено е повишаване н اقرأ الوثيقة كاملة