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 bnv

link 10.08.2007 12:02 
Subject: labeled/unlabeled, listed symptoms (side effects, reactions) med.

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labeled/unlabeled, listed symptoms (side effects, reactions)
Документ об испытаниях лекарства XXX

Примеры контекста:
In two cases, non-serious but unlabeled symptoms occurred.

The symptoms are not labeled as possible side effects in the Summary of Product Characteristics of XXX.

Drug eruption and other exanthema are listed side effects of XXX.

Serious and non-serious labeled reactions:
Six cases of labeled reactions were reported (2 serious, 4 non-serious). There is no evidence of an increased reporting frequency of listed reactions. Also there is no change in the characteristics of listed reactions.

 Veresk

link 10.08.2007 12:50 
я бы сказала зарегистрированы/незарегистрированы или отмечены/неотмечены, если бы не фраза: non serious but unlabeled

 ksyusha123

link 11.08.2007 12:26 
Unlabeled symptoms means symptoms described on actual label (etiketke) of this particular medicine.

 ksyusha123

link 11.08.2007 13:36 
Sorry - unlabeled - non-described; labeled - described. The thing is that they HAVE to describe these symptoms according to law or otherwise they can't sell the medicine.

 Maxxicum

link 13.08.2007 8:27 
согласен с ksyusha123: описанные (стандартизованными источниками)/неописанные

а non serious - это вообще про другой аспект, это "не являющиеся серьезными"

 

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