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1 ml sisaldab 100 Ü laronidaasi.
1 ml contains 100 u of laronidase.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 3
Qualità:
5 ml viaal sisaldab 500 Ü laronidaasi.
each vial of 5 ml contains 500 u of laronidase.
Ultimo aggiornamento 2012-04-11
Frequenza di utilizzo: 2
Qualità:
Üks 5 ml viaal sisaldab 500 Ü laronidaasi.
each vial of 5 ml contains 500 u of laronidase.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 3
Qualità:
puuduvad kliinilised andmed laronidaasi mõju kohta fertiilsusele.
there are no clinical data on the effects of laronidase on fertility.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 1
Qualità:
1 ml sisaldab 100 Ü (umbes 0,58 mg) laronidaasi.
ml contains 100 u (approximately 0.58 mg) of laronidase.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 3
Qualità:
järelikult ei tohiks nõrgenenud maksafunktsioon kliiniliselt oluliselt mõjutada laronidaasi farmakokineetikat.
consequently, impaired liver function is not expected to affect the pharmacokinetics of laronidase in a clinically significant way.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 3
Qualità:
laronidaasi ranaalset eliminatsiooni peetakse eliminatsiooni vähemtähtsaks kõrvalteeks (vt lõik 4.2).
renal elimination of laronidase is considered to be a minor pathway for clearance (see section 4.2).
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 3
Qualità:
aldurazyme’i ei tohiks manustada koos klorokviini või prokaiiniga laronidaasi rakusisese transpordi häirumise riski tõttu.
aldurazyme should not be administered simultaneously with chloroquine or procaine due to a potential risk of interference with the intracellular uptake of laronidase.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 3
Qualità:
aldurazymet ei tohi kasutada patsientidel, kes on laronidaasi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
aldurazyme must not be used in people who are severely allergic to laronidase or any of the other ingredients.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 1
Qualità:
kuna pole andmeid toimete kohta vastsündinutele, kes saavad laronidaasi rinnapiima kaudu, siis soovitatakse rinnaga toitmine aldurazyme’i kasutamise ajal lõpetada.
because there are no data available in neonates exposed to laronidase via breast milk, it is recommended to stop breast-feeding during aldurazyme treatment.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 3
Qualità:
aldurazymet ei tohi kasutada patsiendid, kes võivad olla tugevalt allergilised (anafülaktilise reaktsiooniga) laronidaasi või selle ravimi mis tahes muu koostisaine suhtes.
aldurazyme should not be used in people who may have a severe allergic reaction (anaphylactic reaction) to laronidase or any of the other ingredients.
Ultimo aggiornamento 2012-04-11
Frequenza di utilizzo: 2
Qualità:
pärast laronidaasi intravenoosset manustamist infusiooniajaga 240 minutit ning kasutades annust 100 Ü/kg kehakaalu kohta, mõõdeti farmakokineetilisi omadusi 1., 12. ja 26. nädalal.
after intravenous administration of laronidase with an infusion time of 240 minutes and at a dose of 100 u/kg body weight pharmacokinetic properties were measured at weeks 1, 12 and 26.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 3
Qualità:
seda valmistatakse rekombinant-dna-tehnika abil: ensüümi toodavad rakud, millesse on viidud laronidaasi teket võimaldav geen (dna).
it is produced by a method known as ‘recombinant dna technology’: the enzyme is made by cells into which a gene (dna) has been introduced that makes them able to produce laronidase.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 1
Qualità:
neljal patsiendil (kolm iii faasi uuringu ja üks ii faasi uuringu patsienti) kirjeldati marginaalset kuni nõrka laronidaasi ensümaatilise aktiivsuse in vitro pärssimist, mis ei mõjutanud kliinilist efektiivsust ja/või gag vähenemist uriinis.
four patients (three in the phase 3 study and one in the phase 2 study) showed marginal to low level in vitro inhibition of laronidase enzymatic activity, which did not appear to impact clinical efficacy and/or urinary gag reduction.
Ultimo aggiornamento 2017-04-26
Frequenza di utilizzo: 3
Qualità: