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trials of Esmya inducing hepatic toxicity

Italian translation: (vedi frase)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:trials of Esmya inducing hepatic toxicity
Italian translation:(vedi frase)
Entered by: Mario Altare

11:31 Feb 15, 2018
English to Italian translations [PRO]
Medical - Medical: Pharmaceuticals / ulipristal acetato
English term or phrase: trials of Esmya inducing hepatic toxicity
PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya. In addition to these, a preliminary assessment of a recently reported case of liver transplantation with fatal outcome was performed. Follow-up information on this case was also reviewed by the PRAC, as well as additional information provided by the Marketing Authorisation Holder while the review was ongoing.

No signal of hepatic toxicity was identified during the review of non-clinical or clinical ** trials of Esmya inducing hepatic toxicity **. The absence of findings in clinical trials has to be interpreted with caution as abnormal values of ALT/AST was an exclusion criterion as per protocols
Mario Altare
Local time: 18:23
(vedi frase)
Explanation:
No signal of hepatic toxicity was identified during the review of non-clinical or clinical trials of Esmya inducing hepatic toxicity.
=
Da una rassegna di studi clinici e non clinici sulla possibile induzione di tossicità epatica da parte di Esmya non si riscontravano segnali di tossicità epatica.
Selected response from:

Daniel Frisano
Italy
Local time: 18:23
Grading comment
Grazie mille (anche agli altri che hanno risposto) :-)
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1(vedi frase)
Daniel Frisano
4studi sulla presunta / sull'eventuale tossicità epatica indotta da Esmya
Gaetano Silvestri Campagnano
4test di tossicità epatica indotta da Esmya
Anna Brancaleon


  

Answers


5 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
(vedi frase)


Explanation:
No signal of hepatic toxicity was identified during the review of non-clinical or clinical trials of Esmya inducing hepatic toxicity.
=
Da una rassegna di studi clinici e non clinici sulla possibile induzione di tossicità epatica da parte di Esmya non si riscontravano segnali di tossicità epatica.


Daniel Frisano
Italy
Local time: 18:23
Specializes in field
Native speaker of: Native in ItalianItalian
PRO pts in category: 46
Grading comment
Grazie mille (anche agli altri che hanno risposto) :-)

Peer comments on this answer (and responses from the answerer)
agree  Maria Teresa Sammarco
3 mins
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10 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
trials of esmya inducing hepatic toxicity
studi sulla presunta / sull'eventuale tossicità epatica indotta da Esmya


Explanation:
"Non si riscontrava alcun segno di tossicità epatica nella rassegna di studi clinici e non clinici sulla presunta / sull'eventuale tossicità epatica indotta da Esmya".

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Note added at 14 min (2018-02-15 11:45:56 GMT)
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Il termine "indotto" è tipicamente utilizzato nel linguaggio medico, esattamente come il corrispondente inglese. Va inoltre specificato che si tratta di tossicità presunta o eventuale, data anche la specificazione dell'assenza di segni riscontrati. Ciò soprattutto per evitare che la frase risulti contraddittoria se interpretata letteralmente, a causa del modo un po' frettoloso in cui l'autore l'ha scritta nel testo originale.

Gaetano Silvestri Campagnano
Italy
Local time: 18:23
Native speaker of: Native in ItalianItalian
PRO pts in category: 672
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2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
trials of esmya inducing hepatic toxicity
test di tossicità epatica indotta da Esmya


Explanation:
Una traduzione alternativa.

I test di tossicità sono comuni per i farmaci:

http://www.tecnicidellaprevenzione.com/aggiornamenti/tossici...

Anna Brancaleon
Spain
Local time: 17:23
Native speaker of: Italian
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