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kod primjene prasugrela prijavljen je ttp.
ttp has been reported with the use of prasugrel.
Letzte Aktualisierung: 2017-04-26
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primjena prasugrela tijekom dojenja se ne preporučuje.
the use of prasugrel during breastfeeding is not recommended.
Letzte Aktualisierung: 2017-04-26
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jedna tableta sadrži 10 mg prasugrela (u obliku prasugrelklorida).
each tablet contains 10 mg prasugrel (as hydrochloride)
Letzte Aktualisierung: 2017-04-26
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nisu ispitivane farmakokinetika i farmakodinamika prasugrela u bolesnika s teškim oštećenjem jetre.
pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic impairment have not been studied.
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korist od primjene prasugrela vidjela se već u prva 3 dana i trajala je do kraja ispitivanja.
the benefit of prasugrel was apparent within the first 3 days and it persisted to the end of study.
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povećanje broja tumora jetre uz primjenu prasugrela u miševa ne smatra se relevantnim rizikom za ljude.
the increase in liver tumours with prasugrel administration in mice is not considered a relevant human risk.
Letzte Aktualisierung: 2017-04-26
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efient 10 mg: jedna tableta sadrži 10 mg prasugrela (u obliku prasugrelklorida).
efient 10 mg: each tablet contains 10 mg of prasugrel (as hydrochloride).
Letzte Aktualisierung: 2017-04-26
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djelotvornost prasugrela nije ovisila o dozi ask-a (75-325 mg jedanput na dan).
the efficacy of prasugrel was independent of the asa dose (75 mg to 325 mg once daily).
Letzte Aktualisierung: 2017-04-26
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farmakokinetika prasugrela i njegova inhibicija agregacije trombocita bile su podjednake u ispitanika s blagim do umjerenim oštećenjem jetre i zdravih ispitanika.
pharmacokinetics of prasugrel and its inhibition of platelet aggregation were similar in subjects with mild to moderate hepatic impairment compared to healthy subjects.
Letzte Aktualisierung: 2017-04-26
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preporučuje se uzimanje drugog antitrombotika na kojeg ne utječe cyp inhibicija ili indukcija (npr. prasugrela).
use of other antiplatelets not affected by cyp inhibition or induction (e.g. prasugrel) is recommended.
Letzte Aktualisierung: 2017-04-26
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primjena udarne doze od 60 mg prasugrela natašte može omogućiti najbrži početak djelovanja (vidjeti dio 5.2).
administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
Letzte Aktualisierung: 2017-04-26
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pedijatrijska populacija: farmakokinetika i farmakodinamika prasugrela nisu ispitivane u pedijatrijskoj populaciji (vidjeti dio 4.2).
paediatric population: pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
Letzte Aktualisierung: 2017-04-26
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apsorpcija i metabolizam prasugrela su brzi, a vršna koncentracija (cmax) aktivnog metabolita u plazmi postiže se za otprilike 30 minuta.
the absorption and metabolism of prasugrel are rapid, with peak plasma concentration (cmax) of the active metabolite occurring in approximately 30 minutes.
Letzte Aktualisierung: 2017-04-26
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alternativno, udarna doza tikagrelora ili prasugrela, ali ne i klopidogrela, smije se primijeniti do 30 minuta prije završetka infuzije, vidjeti dio 4.5.
alternatively, a loading dose of ticagrelor or prasugrel, but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see section 4.5.
Letzte Aktualisierung: 2017-04-26
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stopa bolesnika u kojih je zbog nuspojava prekinuta primjena ispitivanog lijeka bila je 7,2% kod primjene prasugrela te 6,3% kod primjene klopidogrela.
the rate of study drug discontinuation due to adverse events was 7.2% for prasugrel and 6.3% for clopidogrel.
Letzte Aktualisierung: 2017-04-26
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agregacija trombocita se nakon liječenja postupno vratila na početne vrijednosti, i to za 7 do 9 dana nakon primjene jednokratne udarne doze prasugrela od 60 mg, odnosno za 5 dana nakon prekida primjene doze održavanja u stanju dinamičke ravnoteže.
platelet aggregation gradually returned to baseline values after treatment in 7 to 9 days after administration of a single 60 mg loading dose of prasugrel and in 5 days following discontinuation of maintenance dosing at steady-state.
Letzte Aktualisierung: 2017-04-26
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korist od primjene prasugrela bila je primjetnija u bolesnika u dobi od ≥ 75 godina koji su imali šećernu bolest, stemi, povećan rizik od tromboze stenta te onih u kojih su se kardiovaskularni događaji ponavljali.
patients ≥ 75 years in whom the benefit with prasugrel was more evident included those with diabetes, stemi, higher risk of stent thrombosis, or recurrent events.
Letzte Aktualisierung: 2017-04-26
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po primjeni udarne doze od 60 mg prasugrela inhibicija adp-om potaknute agregacije trombocita nastupa nakon 15 minuta uz 5 µm adp-a, a nakon 30 minuta uz 20 µm adp-a.
following a 60 mg loading dose of prasugrel, inhibition of adp-induced platelet aggregation occurs at 15 minutes with 5 µm adp and 30 minutes with 20 µm adp.
Letzte Aktualisierung: 2017-04-26
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analiza objedinjenog ishoda u populaciji svih bolesnika s akutnim koronarnim sindromom (združene ua/nstemi i stemi kohorte) ovisila je o dokazivanju statističke superiornosti prasugrela u odnosu na klopidogrel u kohorti bolesnika koji su imali ua/nstemi (p < 0,05).
analysis of the composite endpoint in the all acs population (combined ua/nstemi and stemi cohorts) was contingent on showing statistical superiority of prasugrel versus clopidogrel in the ua/nstemi cohort (p < 0.05).
Letzte Aktualisierung: 2017-04-26
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