部分中文Cinryze处方资料（仅供参考）

Cinryze冻干粉针-美国FDA批准的首个和迄今唯一常规预防遗传性血管水肿发病的C1抑制剂治疗药

Cinryze作为一种人造C1酯酶抑制剂用于治疗遗传性血管性水肿。患有这种病的人由于体内C1蛋白缺乏或功能异常导致身体出现严重水肿，特别是在面部和呼吸道部位。这是一种遗传病，通常具有家族病史。但是，这种病发作突然，很多人在还没有确诊的情况下就过早死去了。这使得该病比较罕见。Cinryze的制造商Viropharma公司

Cinryze (C1 Inhibitor (Human))
CINRYZE® (C1 esterase inhibitor [human]) contains C1 esterase inhibitor—the protein your body needs if you have HAE—to prevent HAE attacks.
By regulating the systems in the body that cause inflammation, C1 esterase inhibitor ultimately limits the production of bradykinin—a protein that causes your vessels to leak a large amount of fluid into the tissues.
When bradykinin production is not limited, blood vessel walls can become leaky, causing the swelling of an HAE attack.

CINRYZE® (C1 esterase inhibitor [human]) is administered as an IV to help prevent attacks and swelling in teenagers and adults with HAE. CINRYZE therapy increases the working C1 esterase inhibitor to help prevent the causes of swelling and is proven to reduce the frequency, duration, and severity of HAE attacks
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.

美国FDA批准Cinryze冻干粉针上市-血管性水肿治疗新药

美国FDA 批准Lev Pharmaceuticals公司的C1抑制剂Cinryze冻干粉针上市，用于常规预防青少年和成人遗传性血管水肿（也称作C1抑制剂缺乏）患者血管水肿的发病。
本品是美国FDA批准的首个和迄今唯一常规预防遗传性血管水肿发病的C1抑制剂治疗药。遗传性血管水肿的特征是四肢、面部、生殖器、腹部和咽喉疼痛、退行性病变和致命性水肿。据估计，这种病例美国有1万例，发病常不可预测，可能自发或由情绪、劳累诱发。
本品系一美国FDA批准常规预防遗传性血管水肿发作高度纯化、巴斯德法灭菌和纳米过滤人血浆获得的C1抑制剂。C1抑制剂在欧洲治疗C1抑制剂缺乏已有30多年的历史。
在预防性治疗的Ⅲ期临床研究中，本品较安慰剂显著减少遗传性血管水肿的发病次数。此研究对22例患者进行了有效性的交叉研究设计，以本品治疗后血管水肿发病次数较安慰剂在统计学上有显著差异（P<0.000 1）。以本品齐12周的预防性治疗患者发病例数范围为0－17，平均6.1，安慰剂组为6－22，平均为12.7。
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原产地英文商品名:
CINRYZE 500UNIT/VIAL
原产地英文药品名:
C1 ESTERASE INHIBITOR
中文参考商品译名:
CINRYZE 500单位/瓶
中文参考药品译名:
C1酯酶抑制因子
生产厂家中文参考译名:
VIROPHARMA
生产厂家英文名:
VIROPHARMA