equired per injection. Each vial of Thyrogen is for single use only.
Use aseptic technique
Add 1.2 ml water for injection to the Thyrogen powder in the vial. Swirl the contents of the vial gently until all material is dissolved. Do not shake the solution. When the powder is dissolved the total volume in the vial is 1.2 ml. The pH of the Thyrogen solution is approximately 7.0.
Visually inspect the Thyrogen solution in the vial for foreign particles and discoloration. The Thyrogen solution should be a clear, colourless solution. Do not use vials exhibiting foreign particles, cloudiness or discoloration.
Withdraw 1.0 ml of the Thyrogen solution from the product vial. This equals 0.9 mg thyrotropin alfa to be injected.
Thyrogen does not contain preservatives. Throw away any unused solution immediately.
There are no special requirements for disposal.
The Thyrogen solution should be injected within three hours, however the Thyrogen solution will stay chemically stable for up to 24 hours, if kept in a refrigerator (between 2°C and 8°C). It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.
7. Marketing authorisation holder
Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, The Netherlands
8. Marketing authorisation number(s)
EU/1/99/122/001
EU/1/99/122/002
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 9 March 2000
Date of last renewal: 9 March 2010
10. Date of revision of the text
11-2012
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
——注射用促甲状腺素α（thyrotropin alfa，Thyrogen）
近日表示美国FDA已批准了Thyrogen（促甲状腺素α 注射剂）与放射疗法联用于除去或破坏已进行甲状腺癌切除手术后患者的残余甲状腺组织，可降低复发风险与更好的监测病情。甲状腺癌术后剩余甲状腺组织去除治疗常用在甲状腺癌治疗中都会进行。
公司官员说道：“这项新适应症扩大了Thyrogen对于那些甲状腺癌初始治疗者的益处，Thyrogen之前在检测癌症是否复发的后继诊断过程中使用。”
美国癌症协估计在2007年，约有33550例患者诊断出甲状腺癌，其中90%的甲状腺癌是完全分化的，这些患者可接受剩余甲状腺组织去除治疗。
Thyrogen于1998年初次在美国获得批准，2001年在欧洲获得批准用于作为诊断试剂，用于检测完全分化型甲状腺癌的复发。2005年欧洲批准了Thyrogen用于剩余甲状腺组织去除过程中。
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