---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（201251018575717.PDF）的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文Cinryze处方资料（仅供参考）

血管性水肿治疗新药Cinryze已经获得FDA的批准
    Lev生物制药公司的血管性水肿治疗药Cinryze已获得FDA的批准，用于伴有遗传性血管性水肿症（HAE）的青少年或成人患者，预防疾病的发生，这种疾病主要由体内缺乏C1抑制物而引起。该药有望于在今年年底上市销售。据称，Cinryze是第一种也是唯一一种通过FDA批准，通过C1抑制物疗法治疗HAE的药品。

    FDA在批准这种药物的同时，还要求对其展开另一次临床实验，主要检验药物的安全性，包括在用药过程中发生血栓性不良反应，高于标签标准用药量的疗效和免疫原性等情况。此外，关于该药在后期的临床实验数据也将按要求定期提交。

    经过双方协商之后，FDA已要求Lev公司撤回该药治疗急性HAE的申请。这些相关的数据在以后将以补充性新药申请的形式提交，到时附带的申请内容还应包括Cinryze治疗急性HAE的标签开放临床实验数据，这项实验目前正在进行。

    不久前，Lev和ViroPharm两家公司达成了一项合并协议。按照协议，ViroPharm将收购Lev，该公司希望能在2008年10月份以前完成收购，目前它正计划与Lev公司协商在并购完成之后Cinryze的相关问题。

Indication
CINRYZE® (C1 esterase inhibitor [human]) is an injectable medicine that is used to help prevent swelling and/or painful attacks in teenagers and adults with Hereditary Angioedema (HAE).

Important Risk Information
You should not use CINRYZE if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.

Tell your healthcare provider about all of your medical conditions, including if you:
•Are pregnant or planning to become pregnant. It is not known if CINRYZE can harm your unborn baby.
•Are breastfeeding or plan to breastfeed. It is not known if CINRYZE passes into your milk and if it can harm your baby.
•Have a history of blood clotting problems. Very high doses of C1 esterase inhibitor could increase the risk of blood clots.

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

Allergic reactions may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:
•wheezing
•difficulty breathing
•chest tightness
•turning blue (look at lips and gums)
•fast heartbeat
•swelling of the face
•faintness
•rash
•hives

Because CINRYZE is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob (CJD) agent.

The most common side effects seen with CINRYZE were headache, nausea, rash and vomiting. These are not all the possible side effects of CINRYZE. Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed here. Do not use CINRYZE for a condition for which it is not prescribed. Do not share CINRYZE with other people, even if they have the same symptoms that you have.

Before starting CINRYZE, please read the Patient Information carefully and each time you get a refill. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about CINRYZE. If you have questions after reading this, ask your healthcare provider.

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（201251018575717.PDF）的“原文Priscribing Information”为准
---------------------------------------------------------------