国家: 印度尼西亚
语言: 印度尼西亚文
来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
EPOETIN ALFA
INTEGRATED HEALTHCARE INDONESIA - Indonesia
EPOETIN ALFA
2000 IU
INJEKSI
DUS, 6 PRE-FILLED SYRINGE @ 0,5 ML
CILAG AG SWITZERLAND - Switzerland
2021-11-28
ERBITUX TM CETUXIMAB MERCK For intravenous use only. WARNING INFUSION REACTIONS: Severe infusion reaction occurred with the administration of ERBITUX in approximately 3% of patients, rarely with fatal outcome (< in 1000). Approximately 90% of severe infusion reactions were associated with first infusion of ERBITUX. Severe infusion reactions are characteristized by rapid onset of airway obstruction (bronchspasm, stridor,hoarseness), urticaria, hypotension and/or cardiac arrest (see WARNINGS and ADVERSE REACTIONS). Severe infusion reactions required immediate interupption of ERBITUX infusion and permanent discontinuation from further treatment. (See WARNINGS: INFUSION REACTIONS and DOSAGE AND ADMINISTRATION: DOSE MODIFICATIONS.) CARDIOPULMONARY ARREST: Cardipulmonary Arrest and/or sudden death accured in 2% (4/208) of patients with squamous cell carcinoma of the head and neck treated with radiation therapy and ERBITUX as compared to none of 212 patients treated with radiation therapy alone. Fatal events occurred within 1 to 43 days after the last ERBITUX treatment. ERBITUX in combination with radiation therapy should be used with caution in head and neck cancer patients with known coronary artery disease, congestive heart failure, and errhytmias. Although the etiology of these events is unknown, close monitoring of serum electrocytes, including serum magnesium, potassium, and calcium, during and after ERBITUX therapy is recommended. (See WARNINGS: CARDIOPULMARY ARREST, PRECAUTIONS: LABORATORY TEST: ELECTROLYTE MONITORING, AND ADVERSE REACTIONS: ELECTROLYTE DEPLETION.) DESCRIPTION ERBITUX ® (Cetuximab) is a recombinant, human/mouse a chimeric monochlonal antibody that binds specifically to the extracelluler domain of the human epidermal growth factor reseptor (EGFR). Cetuximab is composed of the Fv regions of a murine anti-EGFR antibody with human IgGI heavy and kappa light chain constant regions and has an approximate molecular weight of 152 kDa. Cetuximab is produced in mammalian (murine myeloma) cell culture. ER 阅读完整的文件