注射用阿必魯肽 TANZEUM (albiglutide) FDA藥品說明書翻譯

FULL PRESCRIBING INFORMATION WARNING: RISK OF THYROID C-CELL TUMORS 警告：甲狀腺C細(xì)胞腫瘤風(fēng)險(xiǎn) ? Thyroid C-cell tumors have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures. It is unknown whether TANZEUM? causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans [see Warnings and Precautions (5.1)]. 嚙齒動物試驗(yàn)中，使用酰化人胰高血糖素樣肽-1(GLP-1)受體激動藥在臨床相關(guān)暴露量下已 觀察到甲狀腺C細(xì)胞腫瘤。尚不明確人類使用本藥是否引起甲狀腺C細(xì)胞腫瘤，包括甲狀腺 髓樣癌(MTC)。 ? TANZEUM is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with TANZEUM. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications (4.1), Warnings and Precautions (5.1)]. 有MTC 病史或家族史者、2 型多發(fā)性內(nèi)分泌腫瘤綜合征(MEN 2)患者禁用本藥。尚不明確 使用本藥患者常規(guī)監(jiān)控血清降鈣素或超聲監(jiān)控甲狀腺的價(jià)值。應(yīng)告知患者甲狀腺腫瘤的風(fēng) 險(xiǎn)和癥狀。 1 INDICATIONS AND USAGE 適應(yīng)癥和用途 TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. 本藥用于2型糖尿病成年患者，作為飲食和運(yùn)動的輔助療法以改善血糖控制。 Limitations of Use:使用限制 ? TANZEUM is not recommended as first-line therapy for patients inadequately controlled on diet and exercise [see Warnings and Precautions (5.1)] . 本藥不推薦用于飲食和運(yùn)動控制不佳患者的一線治療。 ? TANZEUM has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)] . Consider other antidiabetic therapies in patients with a history of pancreatitis. 尚無有胰腺炎病史者用藥的研究，有胰腺炎病史者應(yīng)考慮其他抗糖尿病治療。 ? TANZEUM is not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis. TANZEUM is not a substitute for insulin in these patients. 本藥不可用于1型糖尿病或酮癥酸中毒患者，在這些患者中本藥不可作為胰島素的替代藥物。 ? TANZEUM has not been studied in pati

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