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THYROGEN（0.9MG/ML）1.1MG/VIAL
商品名THYROGEN（0.9MG/ML）1.1MG/VIAL
中文名称适谪进
成分阿尔法促甲状腺素
剂型1.1mg/vial
用途
注意事项请冷藏于摄氏2 - 8度
怀孕分级无确认资料
可能副作用
储存条件2-8度ç
适应症
用法用量恶性甲状腺肿瘤，对碘消融，兼职：0.9毫克剂量的IM 2（以1.2毫升注用水稀释后，每1毫升注射液相当于0.9mg每24小时促甲状腺激素阿尔法）
欧洲批准促甲状腺素α粉针用于摘除甲状腺癌患者残余甲状腺组织
欧洲药审委已批准Genzyme公司的促甲状腺素α粉针(thyrotropin alfa，Thyrogen ）与放射性碘联合用于甲状腺癌患者摘除残余的甲状腺组织。
Genzyme公司正在美国申请本品的这一新适应证。在美国和欧洲每年要进行3.5万例甲状腺癌摘除术，本品有可能用于80%的患者。
欧洲批准的新适应证可使本品与放射性碘联用作为治疗甲状腺癌最普通的疗法，包括手术切除甲状腺癌，随后是摘除手术期间未切除干净的残留甲状腺残留组织，包括在甲状腺内的任何癌细胞。
以往，摘除残留组织，患者需服用放射性碘溶液或含放射性碘的胶囊，以使残留甲状腺细胞吸收。为提高放射性碘的摄取量，必须提高患者血液中的促甲状腺激素（TSH）浓度。如此，常造成甲状腺功能减退，如乏力、嗜眠、思想难以集中、短期记忆力损伤和抑郁等。患者现在可停止服用甲状腺激素补充剂来提高TSH浓度。本品系一供注射用的重组TSH，使患者继续补充激素，避免停用激素后出现的症状。
本品现已在40多个国家上市。本品目前开发用于甲状腺已切除的甲状腺癌患者。这些患者必须采用甲状腺激素抑制治疗，还可进行周期检测癌症复发或转移。本品使患者维持其激素抑制治疗，避免临床出现甲状腺功能减退的衰弱症状。
本品与其他试剂合用检测甲状腺癌患者甲状腺癌细胞是否复发或存留。本品肌肉注射，仅处方用药。临床研究中报道最常见的不良反应是恶心、头痛、无力和呕吐。
Thyrogen (α-促甲状腺素)，既可作为辅助诊断工具又可用于治疗甲状腺癌[肌内(IM)注射]。
[件]:/uploadfile/article/uploadfile/201005/20100526031137367.pdf]
Generic Name for THYROGEN
Thyrotropin alfa 1.1mg/vial; lyophilized pwd for IM inj after reconstitution; contains mannitol.
Legal Classification:
Rx
Pharmacological Class for THYROGEN
Thyroid stimulating hormone (recombinant).
Manufacturer of THYROGEN
Genzyme Corporation
Indications for THYROGEN
Adjunctive diagnostic tool for serum thyroglobin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer. Adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer.
Adult dose for THYROGEN
≥16yrs: Give by IM inj into the buttock. 0.9mg, followed by a second 0.9mg injection 24 hours later. For radioiodine imaging or remnant ablation, give radioiodine 24 hours after the final thyrogen injection.
Children's dosing for THYROGEN
<16yrs: not recommended.
Precautions for THYROGEN
See literature. Heart disease, extensive metastatic disease, or other serious underlying illnesses; increased risk of Thyrogen-induced hyperthyroidism, consider hospitalization for administration and post-administration observation. Thyroglobulin (Tg) antibodies may render Tg levels uninterpretable; consider further evaluation with thyroid hormone withdrawal scan. Previous bovine TSH treatment. Residual thyroid tissue. End-stage renal disease. Elderly (increased risk of cardiac effects). Pregnancy (Cat.C). Nursing mothers.
Adverse Reactions for THYROGEN
Nausea, headache, fatigue, influenza-like symptoms.
How is THYROGEN supplied?
2-vial kit—2 vials of Thyrogen
4-vial kit—2 vials of Thyrogen + 2 vials of diluent
Related Disease:
Cancer, thyroid
Neoplasms
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