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http://linked.opendata.cz/resource/sukl/spc/section/SPC157043_doc-5-3
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5.3. Předklinické údaje vztahující se k bezpečnosti
(cs)
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005.003
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U laboratorních zvířat nebyly prokázány účinky, které by zaznamenaly zvýšené riziko bezpečnosti přípravku pro pacienty. Týká se to toxicity a bezpečnosti přípravku při opakovaném podávání, genové toxicity, kancerogenity a reprodukční toxicity.
(cs)
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http://linked.opendata.cz/resource/sukl/spc/paragraph/SPC157043_doc-5-3-1
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http://linked.opendata.cz/resource/sukl/spc/document/SPC157043_doc
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http://linked.opendata.cz/resource/sukl/spc/section/SPC157043_doc-5
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