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Openai/693ba2e3-b928-8004-920f-e506d7f76c92
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==== 15. 特殊族群(Use in Specific Populations) ==== ===== 15.1 懷孕 ===== * semaglutide 產品(Ozempic / Rybelsus / Wegovy):仿單指示懷孕期間不可使用;若計畫懷孕,建議至少於受孕前 2 個月停用(與半衰期長相關)。【TFDA|Pregnancy】Wegovy 衛部菌疫輸字第001224號114.03.04 Rybelsus 衛部菌疫輸字第001171號114.05.22 Mounjaro 衛部藥輸字第028468號114.05.21 * Saxenda:懷孕期間應停止使用(體重管理藥物在懷孕通常無臨床利益)。【TFDA|Pregnancy】Rybelsus 衛部菌疫輸字第001171號114.05.22 * Mounjaro: - 若用於體重管理:仿單載明孕婦不應接受體重減輕治療;確認懷孕應停用。【TFDA|Pregnancy】Saxenda 衛部菌疫輸字第001140號114.04.07 - 若用於 type 2 DM:僅在潛在效益大於胎兒風險時考慮使用(仿單用語)。【TFDA|Pregnancy】Saxenda 衛部菌疫輸字第001140號114.04.07 * Trulicity / Victoza:人類資料有限;仿單一般採「效益大於風險」之審慎用語。【TFDA|Pregnancy】Soliqua 衛部菌疫輸字第001080號114.05.21 Soliqua 衛部菌疫輸字第001080號114.05.21 ===== 15.2 哺乳 ===== * 多數仿單指出是否分泌至人乳/對乳兒影響資料有限,原則上需衡量母乳益處與用藥需要與潛在風險。【TFDA|Lactation】Soliqua 衛部菌疫輸字第001080號114.05.21 Soliqua 衛部菌疫輸字第001080號114.05.21 * Soliqua:仿單明確寫「哺乳期間不可使用」。【TFDA|Lactation】Soliqua 衛部菌疫輸字第001080號114.05.21 ===== 15.3 兒科 ===== * Victoza、Trulicity:核准用於 ≥10 歲兒童的 type 2 DM 血糖控制。【TFDA|Indications】Saxenda 衛部菌疫輸字第001140號114.04.07 Trulicity 衛部菌疫輸字第000978號114.05.… * Wegovy、Saxenda:核准用於青少年慢性體重管理(Wegovy:≥12 歲;Saxenda:12–18 歲且具體重條件)。【TFDA|Indications】Wegovy 衛部菌疫輸字第001224號114.03.04 Saxenda 衛部菌疫輸字第001140號114.04.07 * Ozempic、Rybelsus、Mounjaro、Soliqua:本次整理之適應症段落以成人為主(兒科使用依各仿單是否載明為準;未載者視為仿單未提及)。【TFDA|Indications】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 Mounjaro 衛部藥輸字第028468號114.05.21 Soliqua 衛部菌疫輸字第001080號114.05.21
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