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Openai/693ba2e3-b928-8004-920f-e506d7f76c92
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=== 【輸出 2:來源與差異標註】 === ==== A. 本章使用來源(TFDA 為主) ==== * 本章之適應症、禁忌、警語/注意事項、用法用量、腎/肝功能調整、交互作用、不良反應、特殊族群、儲存等,均以使用者提供之 TFDA 仿單為唯一整理依據(未提供 FDA label,故未進行 TFDA vs FDA 對照)。 * 仿單版本日期(部分範例):Ozempic 2025-04-17【TFDA|Label meta】Ozempic 衛部菌疫輸字第001107號114.04.17、Rybelsus 2025-05-22Saxenda 衛部菌疫輸字第001140號114.04.07、Saxenda 2025-04-07Trulicity 衛部菌疫輸字第000978號114.05.…、Trulicity 2025-05-07Victoza 衛署菌疫輸字第000914號114.04.11、Wegovy 2025-03-04Wegovy 衛部菌疫輸字第001224號114.03.04、Soliqua 2025-05-21Soliqua 衛部菌疫輸字第001080號114.05.21、Mounjaro 2025-05-21Mounjaro 衛部藥輸字第028468號114.05.21。 (依系統要求之上傳檔案引用標記)Trulicity 衛部菌疫輸字第000978號114.05.… Victoza 衛署菌疫輸字第000914號114.04.11 Wegovy 衛部菌疫輸字第001224號114.03.04 ==== B. 重要差異清單(提醒以當地核准仿單為準) ==== # 同成分跨產品差異 - semaglutide:Ozempic(type 2 DM + CVD/CKD 結局)vs Wegovy(體重管理 + 特定 CVD/HF 適應症)vs Rybelsus(口服、type 2 DM)。【TFDA|Indications】Wegovy 衛部菌疫輸字第001224號114.03.04 Wegovy 衛部菌疫輸字第001224號114.03.04 Ozempic 衛部菌疫輸字第001107號114.04.17 - liraglutide:Victoza(type 2 DM、含 ≥10 歲、且具 MACE 降低適應症)vs Saxenda(體重管理,最大劑量 3 mg/日)。【TFDA|Indications/Dosage】Saxenda 衛部菌疫輸字第001140號114.04.07 Saxenda 衛部菌疫輸字第001140號114.04.07 Rybelsus 衛部菌疫輸字第001171號114.05.22 # 腎功能不全門檻差異 - 同為 semaglutide:Ozempic 不建議 eGFR <30【TFDA|Renal】Soliqua 衛部菌疫輸字第001080號114.05.21;Wegovy 不建議 eGFR <30(含 ESRD)【TFDA|Renal】Wegovy 衛部菌疫輸字第001224號114.03.04;Rybelsus 則標示腎功能不全(含 ESRD)不需調整劑量【TFDA|Renal】Ozempic 衛部菌疫輸字第001107號114.04.17。 # 「甲狀腺 C 細胞腫瘤風險」警告之覆蓋範圍 - 多數 GLP-1 RA 與 tirzepatide 仿單列此警告與 MTC/MEN2 禁忌;Soliqua 仿單在禁忌段落未列該項,屬產品間差異(不可自行推論其風險相同或不同)。【TFDA|Boxed Warning/Contraindications】Rybelsus 衛部菌疫輸字第001171號114.05.22 Soliqua 衛部菌疫輸字第001080號114.05.21 # 交互作用重點不同 - tirzepatide:口服避孕藥效力可能下降,需 4 週額外避孕策略(起始與每次調升後)。【TFDA|Drug Interactions】Mounjaro 衛部藥輸字第028468號114.05.21 - oral semaglutide:服用方式與 levothyroxine 暴露量改變需留意。【TFDA|Drug Interactions】Ozempic 衛部菌疫輸字第001107號114.04.17 Rybelsus 衛部菌疫輸字第001171號114.05.22
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