Classe B3 (rischio teratogenico ADEC)

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La classe B3 di rischio teratogeno secondo la classificazione operata dall'Australian Drug Evaluation Committee (ADEC) include quei farmaci assunti da un numero moderato di donne durante la gravidanza o in età fertile. Non sono stati rilevati aumenti provati di malformazioni o effetti tossici diretti e indiretti sul feto. Gli studi su animali hanno provato una maggiore frequenza di danni fetali, ma si è incerti sull'effettiva rilevanza di tali risultati per gli esseri umani.[1]

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  1. ^ Come sottolineato espressamente nel documento dell'ADEC, dal momento che tutti i farmaci delle classi B si basano solamente su studi animali, non sussiste alcuna sicurezza maggiore certa dei farmaci di tali classi rispetto a quelli di classe C.

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