検索ワード: nyrebeskadigelse (デンマーク語 - 英語)

nyrebeskadigelse:
renal impairment:

(moderat nyrebeskadigelse).
the applicant/ mah was therefore asked to provide support for the cut-off at 40 ml/ min as the range is normally defined as 30- 50 ml/ min (moderate renal impairment).

er antydning af leverbeskadigelser og nyrebeskadigelse hos mennesket efter alvorlig forgiftning.
oral administration of massive doses to dogs and rabbits suggests nephrotoxic effects and there is some evidence of heptotoxic and nephrotoxic effects in man following massive intoxication.

nyrer og urinveje ikke almindelig: nyreinsufficiens, inklusiv nyrebeskadigelse og nyresvigt
renal and urinary disorders uncommon:renal insufficiency, including renal impairment and renal failure

usikkerheden med hensyn til o-effektniveau for nyrebeskadigelse og leverbeskadigelse samt virkninger for formering, herunder teratogenese og carcinogenese, består stadig.
the uncertainties regarding a no—effect level for nephrotoxicity and hepatotoxicity as well as effects on reproduction including teratogenicity and carcinogenicity remain unanswered.

det er vigtigt, at patienter med nyrebeskadigelse samt deres læger er opmærksomme på, at forsøgspersoner med forringet nyrefunktion kan have en øget eksponering for mirtazapin, og at der er en positiv korrelation mellem sværhedsgrad og eksponering.
importantly, patients with renal impairment and their doctors should be aware of the fact that in subjects with impaired renal function exposure to mirtazapine may be increased and that there is a positive correlation between severity and exposure.

for at undersøge virkningen af nyrebeskadigelse på farmakokinetikken for mirtazapin henviser ansøgeren/ indehaveren af markedsføringstilladelsen til en klinisk undersøgelse, som blev udformet specifikt til dette formål (undersøgelse 22503).
to investigate the impact of renal impairment on the pharmacokinetics of mirtazapine, the applicant/ mah made reference to a clinical trial that was designed specifically for that purpose (trial 22503).

en mulig virkning på immumsystemet kan imidlertid endnu ikke udelukkes, navnlig ikke når der tages hensyn til den russiske undersøgelse, som viste, at langtids-fodring med kost, der var blevet bestrålet med 0,5, 5 eller 56 kgy, medførte en dosisafhængig nyrebeskadigelse, som muligvis blev formidlet af en immunologisk mekanisme.
however, a possible effect on the immune system has still not been ruled out, particularly in the light of the russian study indicating that long-term feeding of irradiated diet at 0.5, 5 or 56 kgy induced a dose-dependent kidney damage possibly mediated through an immunological mechanism.