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plodnost in zgodnji razvoj zarodka
fertility and early embryonic development
Last Update: 2017-04-26
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zadeva brejost, razvoj zarodka in ploda, skotitev ali postnatalni razvoj.
in studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.
Študije na živalih so pokazale reproduktivno toksičnost, tj. učinkovanje na razvoj zarodka ali ploda.
evaluation of experimental animal studies has shown reproductive toxicity, i.e. effects on the development of the embryo or the foetus.
pri izpostavljenostih, ki so pomembno večje od izpostavljenostih pri ljudeh po terapevtskih odmerkih, empagliflozin ni imel neželenih učinkov na sposobnost razmnoževanja ali zgodnji razvoj zarodka.
at exposures sufficiently in excess of exposure in humans after therapeutic doses, empagliflozin had no adverse effects on fertility or early embryonic development.
odmerek, pri katerem še ni opaziti toksičnega učinka na plodnost, zgodnji razvoj zarodka in teratogenost pri podganah, 900-krat presega mejo izpostavljenosti za človeka.
the noael for fertility, early embryonic development and teratogenicity in rats was set at >900 times the human exposure.
Študije na podganah niso pokazale škodljivih vplivov na porod, razvoj zarodka/ploda in otroka po porodu.
animal studies performed in rats did not indicate harmful effects on parturition, embryonal/foetal and post-natal development.
Študije na živalih kažejo, da empagliflozin v pozni dobi gestacije v zelo omejenem obsegu prehaja skozi placento, vendar ne kažejo neposrednih ali posrednih škodljivih učinkov na zgodnji razvoj zarodka.
animal studies show that empagliflozin crosses the placenta during late gestation to a very limited extent but do not indicate direct or indirect harmful effects with respect to early embryonic development.
testiranje reproduktivne toksičnosti ni pokazalo nikakršnih dokazov o vplivih na plodnost, razvoj zarodka/plodu ali postnatalni razvoj.
reproductive toxicity testing showed no evidence of effects on fertility, embryofetal, or postnatal development.
Študije na živalih niso pokazale neposrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Študije na živalih ne zadostujejo za oceno vpliva na nosečnost in razvoj zarodka/plodu (glejte poglavje 5.3).
animal studies are insufficient with respect to effects on pregnancy and embryofoetal development (see section 5.3).