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vpliv hrane na abirateronacetat
effect of food on abiraterone acetate
Last Update: 2017-04-26
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zdravilna učinkovina je abirateronacetat.
the active substance is abiraterone acetate.
Last Update: 2017-04-26
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zytiga 250 mg tablete abirateronacetat
zytiga 250 mg tablets abiraterone acetate
Last Update: 2017-04-26
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zdravilo zytiga vsebuje učinkovino abirateronacetat.
zytiga contains a medicine called abiraterone acetate.
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abirateronacetat ni bil karcinogen pri podganjih samicah.
abiraterone acetate was not carcinogenic in female rats.
Last Update: 2017-04-26
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opazili so učinke na zunanja spolovila, vendar abirateronacetat ni bil tetatogen.
effects on the external genitalia were observed though abiraterone acetate was not teratogenic.
Last Update: 2017-04-26
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v 24-mesečni študiji karcinogenosti pri podganah je abirateronacetat zvečal pojavljanje novotvorb intersticijskih celic v testisih.
in a 24-month carcinogenicity study in the rat, abiraterone acetate increased the incidence of interstitial cell neoplasms in the testes.
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pri bolnikih, ki so prejemali abirateronacetat, so poročali o hepatotoksičnosti z zvečanimi koncentracijami alt, ast in celokupnega bilirubina.
hepatotoxicity with elevated alt, ast and total bilirubin has been reported in patients treated with abiraterone acetate.
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v študijah plodnosti pri samicah in samcih podgan je abirateronacetat zmanjšal plodnost, ki pa je po 4 do 16 tednih po ukinitvi izzvenela.
in fertility studies in both male and female rats, abiraterone acetate reduced fertility, which was completely reversible in 4 to 16 weeks after abiraterone acetate was stopped.
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abirateronacetat se in vivo hitro pretvori v abirateron, ki je zaviralec biosinteze androgenov (glejte poglavje 5.1).
abiraterone acetate is rapidly converted in vivo to abiraterone, an androgen biosynthesis inhibitor (see section 5.1).
Last Update: 2017-04-26
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v blatu je mogoče najti predvsem nespremenjen abirateronacetat in abirateron (približno 55% oziroma 22% vnešenega odmerka).
the major compounds present in faeces are unchanged abiraterone acetate and abiraterone (approximately 55% and 22% of the administered dose, respectively).
Last Update: 2017-04-26
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v študiji 302 so pri 35 (6,5%) bolnikih, ki so prejemali abirateronacetat opazili 3. ali 4. stopnjo zvišanja koncentracij alt ali ast.
in study 302, grade 3 or 4 alt or ast elevations were observed in 35 (6.5%) patients treated with abiraterone acetate.
Last Update: 2017-04-26
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po peroralnem vnosu 14c-abirateronacetata v obliki kapsul se abirateronacetat hidrolizira v abirateron, ta pa se nato večinoma v jetrih presnavlja naprej, med drugim s sulfacijo, s hidroksilacijo in z oksidacijo.
following oral administration of 14c-abiraterone acetate as capsules, abiraterone acetate is hydrolysed to abiraterone, which then undergoes metabolism including sulphation, hydroxylation and oxidation primarily in the liver.
Last Update: 2017-04-26
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pri bolnikih, ki so prejemali abirateronacetat, so se pojavili naslednji neželeni učinki 3. stopnje po ctcae (verzija 3.0): hipokaliemija pri 3%; okužba sečil, zvišanje koncentracije alaninaminotransferaze, hipertenzija, zvišanje koncentracije aspartat-aminotransferaze, zlomi pri 2%, periferni edemi, srčno popuščanje in atrijska fibrilacija pri 1%.
the following ctcae (version 3.0) grade 3 adverse reactions occurred in patients treated with abiraterone acetate: hypokalaemia 3%; urinary tract infection, alanine aminotransferase increased, hypertension, aspartate aminotransferase increased, fractures 2%; peripheral oedema, cardiac failure, and atrial fibrillation 1% each.
Last Update: 2017-04-26
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