10/252 Factor VII Concentrate (2nd International Standard)

10/252  Factor VII Concentrate (2nd International Standard)

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The 2nd International Standard for Factor VII Concentrate (10/252) was established by Expert Committee on Biological Standardisation of the World Health Organisation in October 2012. The intended use of this preparation is for potency estimation of Factor VII concentrates.

This preparation is not for administration to humans or animals in the human food chain.

The preparation contains material of human origin, and either the final product or the source materials, from which it is derived, have been tested and found negative for HBsAg, anti-HIV and HCV RNA. As with all materials of biological origin, this preparation should be regarded as potentially hazardous to health. It should be used and discarded according to your own laboratory’s safety procedures. Such safety procedures should include the wearing of protective gloves and avoiding the generation of aerosols. Care should be exercised in opening ampoules or vials, to avoid cuts.

 2012年10月,世界卫生组织生物标准化专家委员会制定了第二个因子VII浓缩物国际标准(10/252)。该制剂的预期用途是用于因子VII浓缩物的效价评估。

该制剂不适用于人类或人类食物链中的动物。

该制剂含有人类来源的材料,其最终产物或来源材料经过测试,发现HBsAg、抗HIV和HCV RNA呈阴性。与所有生物来源的材料一样,这种制剂应被视为对健康有潜在危害。应根据您自己实验室的安全程序使用和丢弃它。此类安全程序应包括佩戴防护手套和避免产生气溶胶。打开安瓿或小瓶时应小心,以避免割伤。

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