17:17 Sep 6, 2000 |
German to English translations [PRO] Medical | |||||||
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| Selected response from: Uta Moerschell (X) Local time: 13:17 | ||||||
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Summary of answers provided | ||||
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na | see below |
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na | pyrogen-free |
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na | pyrogen-free |
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see below Explanation: pyrogen free or free of pyrogen pyrogen=Any substance that produces fever Taber's Medical Dictionary |
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pyrogen-free Explanation: Before a drug is launched on the market it is required to pass a pyrogen test to assure consumers that it does not cause fevers or intoxications. |
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pyrogen-free Explanation: pyrogens are parts of bacteria (chemically they are lipopolproteins) that remain in water or on parts even after sterilization. The immune system reacts to pyrogens, which is why they can cause fever (the word comes from greek and means causing fire). Obviously, in anything that is injected or implanted into the human body, no pyrogens may be present, so a device used to treat plasma (which is then used to produce injectable drugs) has to be pyrogen-free. The common test for pyrogens is the LAL-Assay, which indicates endotoxin units, with 0.25 EU being the maximum admissible for injectables (and 0.03 the lower detection limit) |
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