FrancophonIA/ELRC3.0 huggingface dataset:
English: Of these, bleeding was the most common adverse reaction for both drugs leading to study drug discontinuation (2.5% for prasugrel and 1.4% for clopidogrel).
Slovenian: Od teh je bil za obe zdravili najpogostejši neželeni učinek krvavitev, ki je vodila v prekinitev jemanja preiskovanega zdravila (2,5 % za prasugrel in 1,4 % za klopidogrel).
English: Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class.
Slovenian: Preglednica 2 vključuje hemoragične in ne-hemoragične neželene učinke v študiji TRITON, ali tiste, o katerih so poročali spontano, razvrščene po pogostnosti in organskih sistemih.
English: The absorption and metabolism of prasugrel are rapid, with peak plasma concentration (Cmax) of the active metabolite occurring in approximately 30 minutes.
Slovenian: Absorpcija Absorpcija in presnova prasugrela je hitra, vrh plazemske koncentracije (Cmax) aktivnega presnovka se pojavi v približno 30 minutah.
English: Pharmacokinetics of prasugrel and its inhibition of platelet aggregation are similar in patients with moderate renal impairment (GFR 30<50 ml/min/1.73m2) and healthy subjects.
Slovenian: Farmakokinetika prasugrela in njegovo zaviranje agregacije trombocitov sta podobna pri bolnikih z zmerno okvaro ledvic (GFR 30 < 50 ml/min/1,73 m2) in zdravih osebah.
English: (see sections 4.2 and 4.4).
Slovenian: (glejte poglavji 4.4 in 5.1).
English: Efient 10 mg: 3 years.
Slovenian: Efient 10 mg: 3 leti.
English: Other medicines and Efient
Slovenian: Druga zdravila in zdravilo Efient
English: If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death.
Slovenian: Če se strdki tvorijo v trdi žili, kot je arterija, so lahko zelo nevarni, ker lahko prekinijo dotok krvi, s čimer povzročijo srčni infarkt (miokardni infarkt), možgansko kap ali smrt.
English: Prasugrel's pharmacokinetics are similar in healthy subjects, patients with stable atherosclerosis, and patients undergoing percutaneous coronary intervention.
Slovenian: Farmakokinetika prasugrela je podobna pri zdravih osebah, bolnikih s stabilno aterosklerozo in bolnikih, ki imajo perkutano koronarno intervencijo.
English: Administration of the 60 mg prasugrel loading dose without concomitant use of proton pump inhibitors may provide most rapid onset of action.
Slovenian: Dajanje 60 mg polnilnega odmerka prasugrela brez sočasne uporabe zaviralcev protonske črpalke lahko nudi najhitrejši začetek delovanja.
English: There was an increased incidence of tumours (hepatocellular adenomas) in mice exposed for 2 years to high doses (> 75 times human exposure), but this was considered secondary to prasugrel-induced enzyme-induction.
Slovenian: Povečana incidenca tumorjev (hepatocelularni adenomi) je bila opazna pri miših, ki so bile 2 leti izpostavljene visokim odmerkom (> 75 kratna izpostavljenost pri ljudeh), vendar so to ocenili kot sekundarno glede na indukcijo encima, povzročeno s prasugrelom.
English: These included definite or probable stent thrombosis at study end (0.9% vs 1.8%; HR 0.498; CI 0.364, 0.683); CV death, nonfatal MI, or urgent target vessel revascularisation through 30 days (5.9% vs 7.4%; HR 0.784; CI 0.688,0.894); all cause death, nonfatal MI, or nonfatal stroke through study end (10.2% vs 12.1%; HR 0.831; CI 0.751, 0.919); CV death, nonfatal MI, nonfatal stroke or rehospitalisation for cardiac ischaemic event through study end (11.7% vs 13.8%; HR 0.838; CI 0.762, 0.921).
Slovenian: Te so vključevale določene ali možne tromboze žilne opornice ob koncu študije (0,9 % proti 1,8 %; RT 0,498; IZ 0,364; 0,683); CV smrt, ne-smrtni MI ali urgentno ciljno žilno revaskulizacijo v 30 dneh (5,9 % proti 7,4 %; RT 0,784; IZ 0,688; 0,894); vse vzroke smrti, ne-smrtni MI ali ne-smrtno možgansko kap do konca študije (10,2 % proti 12,1 %; RT 0,831; IZ 0,751; 0,919); CV smrt, ne-smrtni MI, ne-smrtno možgansko kap ali ponovno hospitalizacijo zaradi srčnega ishemičnega dogodka do konca študije (11,7 % proti 13,8 %; RT 0,838;
English: Approximately 40% of patients (in each of the treatment groups) received GPIIb/IIIa inhibitors in support of PCI (no information available regarding the type of GP IIb/IIIa inhibitor used).
Slovenian: Približno 40 % bolnikov (v vsaki skupini zdravljenja) je prejelo zaviralce GPIIb/IIIa, kot podporo PCI (podatkov o uporabljenem tipu zaviralca GPIIb/IIIa ni na voljo).
English: The use of Efient in patients ≥75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.
Slovenian: Uporaba zdravila Efient pri bolnikih ≥ 75 let starosti na splošno ni priporočena in mora biti opravljena previdno, samo po skrbni oceni lečečega zdravnika glede posameznikove koristi/tveganja, ki meni, da koristi v smislu preprečevanja ishemičnih dogodkov pretehtajo tveganje za resne krvavitve.
English: The phase 3 TRITON study compared Efient (prasugrel) with clopidogrel, both co-administered with ASA and other standard therapy.
Slovenian: Faza 3 študije TRITON je primerjala zdravilo Efient (prasugrel) s klopidogrelom, oba s sočasnim dajanjem z ASK in drugo standardno terapijo.
English: Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Efient.
Slovenian: Nosečnost in dojenje Povejte svojemu zdravniku, če zanosite ali poskušate zanositi, medtem ko jemljete zdravilo Efient.
English: An increased risk of bleeding is possible when Efient is co-administered with heparin.
Slovenian: Povečano tveganje za krvavitev je možno, kadar sočasno dajemo zdravilo Efient s heparinom.
English: The MAH should provide educational material to all physicians who may be involved in treating patients with prasugrel.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora vsem zdravnikom, ki bi lahko bili vključeni v zdravljenje bolnikov s prasugrelom, posredovati gradivo za izobraževanje.
English: It is unknown whether prasugrel is excreted in human breast milk.
Slovenian: Ni znano, če se pri ljudeh prasugrel izloča v materino mleko.
English: In a study of healthy subjects between the ages of 20 and 80 years, age had no significant effect on pharmacokinetics of prasugrel or its inhibition of platelet aggregation.
Slovenian: V študiji zdravih oseb, starih med 20 in 80 let, leta niso imela značilnega vpliva na farmakokinetiko prasugrela ali njegovo zaviranje agregacije trombocitov.
English: Prasugrel was associated with a 50% reduction in stent thrombosis through the 15 month follow-up period.
Slovenian: Prasugrel je bil povezan s 50 % zmanjšanjem tromboze žilne opornice v 15 mesečnem obdobju spremljanja.
English: MARKETING AUTHORISATION NUMBER(S) Efient 5 mg:
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Efient 5 mg:
English: Each tablet contains 2.1 mg lactose.
Slovenian: Ena tableta vsebuje 2,1 mg laktoze.
English: The clinical relevance is unknown, but data indicate the potential for reduced prasugrel efficacy in patients coadministered prasugrel and morphine.
Slovenian: Klinični pomen ni znan, vendar podatki kažejo, da pri bolnikih, ki sočasno prejemajo prasugrel in morfin, obstaja potencial za zmanjšano učinkovitost prasugrela.
English: • “non steroidal anti inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib).
Slovenian: • “nesteroidnimi protivnetnimi zdravili” za bolečino in vročino (kot je ibuprofen, naproksen,
English: In the All ACS population, prasugrel was associated with a lower incidence of CV death, non-fatal MI, or non-fatal stroke compared to clopidogrel, regardless of baseline characteristics such as age, sex, body weight, geographical region, use of GPIIb/IIIa inhibitors, and stent type.
Slovenian: populaciji, je bil prasugrel povezan z nižjo incidenco CV smrti, ne-smrtnega MI ali ne-smrtne možganske kapi, v primerjavi s klopidogrelom, neodvisno od osnovnih značilnosti, kot so starost, spol, telesna masa, geografsko področje, uporaba zaviralcev GPIIb/IIIa in tip žilne opornice.
English: Acetylsalicylic acid:
Slovenian: Acetilsalicilna kislina:
English: Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Slovenian: Aluminijasti pretisni omot v škatlah po 14, 28, 30, 30 (x1), 56, 84, 90 (x1) in 98 tablet.
English: In TRITON, for every 1000 patients treated with Efient, there were 22 fewer patients with myocardial infarction, and 5 more with non-CABG-related TIMI major haemorrhages, compared with patients treated with clopidogrel.
Slovenian: V študiji TRITON je bilo na vsakih 1000 bolnikov, zdravljenih z zdravilom Efient, 22 manj bolnikov z miokardnim infarktom in 5 več z večjo krvavitvijo po TIMI, nepovezano s CABG, v primerjavi z bolniki, zdravljenimi s klopidogrelom.
English: If you forget to take Efient
Slovenian: Če ste pozabili vzeti zdravilo Efient
English: In an analysis of patients who survived an ischaemic event, prasugrel was associated with a reduction in the incidence of subsequent primary endpoint events (7.8% for prasugrel vs 11.9% for clopidogrel).
Slovenian: Pri analizi bolnikov, ki so preživeli ishemični dogodek, je bil prasugrel povezan z zmanjšanjem incidence nadaljnjih primarnih ciljnih dogodkov (7,8 % za prasugrel proti 11,9 % za klopidogrel).
English: Non-CABG- related TIMI bleeding rates through 7 days for patients were as follows:
Slovenian: Stopnje krvavitve po TIMI, ki niso bile povezane s CABG, so bile v obdobju 7 dni za bolnike:
English: Efient can also be concomitantly administered with ASA, heparin, digoxin, and medicinal products that elevate gastric pH, including proton pump inhibitors and H2 blockers.
Slovenian: Zdravilo Efient lahko dajemo sočasno tudi z ASK, heparinom, digoksinom in zdravili, ki višajo želodčni pH, vključno z zaviralci protonske črpalke ter H2 blokatorji.
English: Similar or higher inhibition of platelet aggregation was observed with prasugrel.
Slovenian: Podobno ali močnejše zaviranje agregacije trombocitov so opazili pri prasugrelu.
English: Although not studied in specific interaction studies, Efient has been co-administered in the phase 3 clinical trial with low molecular weight heparin, bivalirudin, and GP IIb/IIIa inhibitors (no information available regarding the type of GP IIb/IIIa inhibitor used) without evidence of clinically significant adverse interactions.
Slovenian: Čeprav ga niso preučevali v posebnih študijah medsebojnega delovanja, so v kliničnem preskušanju faze 3 zdravilo Efient sočasno dajali z nizko molekularnim heparinom, bivalirudinom in zaviralci GP IIb/IIIa (na voljo ni podatkov o uporabljenih zaviralcih GP IIb/IIIa), brez dokazov o klinično pomembnem neželenem medsebojnem delovanju.
English: Efient inhibits the clumping of platelets and so reduces the chance of a blood clot forming.
Slovenian: Zdravilo Efient zavira združevanje trombocitov in tako zmanjša možnost za tvorbo krvnega strdka.
English: Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).
Slovenian: Po 7 dneh po prekinitvi jemanja zdravila, so bile opazovane stopnje krvavitve, povezane s CABG, podobne pri obeh skupinah zdravljenja (glejte poglavje 4.4).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Prasugrel + ASA
Slovenian: Izidi prasugrel + ASA
English: Each tablet contains 2.7 mg lactose.
Slovenian: Ena tableta vsebuje 2,7 mg laktoze.
English: Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
Slovenian: Farmakokinetike in farmakodinamike prasugrela v pediatrični populaciji niso preučevali (glejte poglavje 4.2).
English: Morphine and other opioids:
Slovenian: Morfin in drugi opioidi:
English: Stroke is an uncommon side effect of Efient in patients who have never had a stroke or transient ischaemic attack (TIA).
Slovenian: Možganska kap je občasen neželen učinek zdravila Efient pri bolnikih, ki niso nikoli imeli možganske kapi ali tranzitorne ishemične atake (TIA).
English: Patients weighing < 60 kg
Slovenian: Bolniki < 60 kg
English: Severe hepatic impairment (Child Pugh class C).
Slovenian: Huda jetrna okvara (razred C po Child Pugh-u).
English: It is particularly important to tell your doctor if you are being treated with:
Slovenian: Še posebej je pomembno, da poveste svojemu zdravniku, če se zdravite s/z:
English: Patients with acute coronary syndromes undergoing PCI treated with Efient and ASA showed an increased risk of major and minor bleeding according to the TIMI classification system.
Slovenian: Pri bolnikih z akutnim koronarnim sindromom, ki so imeli PCI, zdravljenih z zdravilom Efient in ASK, se je pokazalo povečano tveganje za velike in manjše krvavitve, glede na TIMI sistem klasifikacije.
English: Patients with STEMI within 12 hours of symptoms and planned for primary PCI could be randomised without knowledge of coronary anatomy.
Slovenian: Bolniki s STEMI z 12 urami simptomov in načrtovano primarno PCI so lahko bili randomizirani brez ugotovljene srčne anatomije.
English: Film-Coat:
Slovenian: Filmska obloga:
English: Medicinal products metabolised by CYP2B6:
Slovenian: Zdravila, ki se presnavljajo s CYP2B6:
English: Efient 5 mg: 2 years.
Slovenian: Efient 5 mg: 2 leti.
English: Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.
Slovenian: Odmerjanje zdravila Efient moramo začeti z enkratnim 60 mg polnilnim odmerkom in nato nadaljevati z 10 mg enkrat na dan.
English: In pre- and post-natal rat studies, maternal treatment had no effect on the behavioural or reproductive development of the offspring at doses up to an exposure 240 times the recommended daily human maintenance dose (based on mg/m2).
Slovenian: V pre- in post-natalnih študijah pri podganah zdravljenje breje samice ni imelo učinka na vedenjski ali razmnoževalni razvoj mladičev pri odmerkih do izpostavitve 240-kratnemu priporočenemu dnevnemu vzdrževalnemu odmerku pri ljudeh (na osnovi mg/m2).
English: If you stop taking Efient
Slovenian: Če ste prenehali jemati zdravilo Efient
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take Efient.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati zdravila Efient.
English: Concomitant administration of Efient with coumarin derivatives other than warfarin has not been studied.
Slovenian: Študij sočasnega dajanja zdravila Efient s kumarinskimi derivati, razen varfarina, niso opravili.
English: • If you have had allergic reactions (hypersensitivity) to clopidogrel or any other anti-platelet agent please tell your doctor before starting treatment with Efient.
Slovenian: • Če ste pri jemanju klopidogrela ali drugih zdravil proti trombocitom dobili alergijsko (preobčutljivostno) reakcijo, to pred začetkom jemanja zdravila Efient povejte svojemu zdravniku.
English: The rodent-specific association of liver tumours and drug-induced enzyme induction is well documented in the literature.
Slovenian: Povezava jetrnih tumorjev in indukcije encima, značilna za glodalce, je dobro dokumentirana v literaturi.
English: For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.4% (3 of 89 patients) in the clopidogrel group.
Slovenian: Za bolnike, ki so prejeli zadnji odmerek tienopiridina v 4 do 7 dneh pred CABG, je pogostnost padla na 11,3 % (9 od 80 bolnikov) v skupini, ki je jemala prasugrel in 3,4 % (3 od 89 bolnikov) v skupini, ki je jemala klopidogrel.
English: d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below.
Slovenian: d Smrtno nevarna krvavitev je podskupina večje krvavitve po TIMI in vključuje tipe, navedene spodaj.
English: Film-coated tablet (tablet).
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta)
English: LIST OF EXCIPIENTS Contains lactose.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje laktozo.
English: The trial's primary outcome measure was the time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
Slovenian: Primarno merilo izida preskušanja je bil čas do pojava srčnožilne (CV) smrti, ne-smrtnega miokardnega infarkta (MI) ali ne-smrtne možganske kapi.
English: Efient may be administered with or without food.
Slovenian: Zdravilo Efient se lahko daje s hrano ali brez hrane.
English: It is rapidly hydrolysed in the intestine to a thiolactone, which is then converted to the active metabolite by a single step of cytochrome P450 metabolism, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9 and CYP2C19.
Slovenian: V črevesju se hitro hidrolizira v tiolakton, ki se nato v eni stopnji s citokromom P450, zlasti s CYP3A4 in CYP2B6 ter v manjši meri s CYP2C9 in CYP2C19, presnovi do aktivnega presnovka.
English: Patients with UA/NSTEMI within 72 hours of symptoms or STEMI between 12 hours to 14 days of symptoms were randomised after knowledge of coronary anatomy.
Slovenian: Bolniki z UA/NSTEMI z 72 urami simptomov ali s STEMI med 12 urami do 14 dni simptomov so bili randomizirani po ugotovljeni srčni anatomiji.
English: Patients also received ASA (75 mg to 325 mg once daily).
Slovenian: Bolniki so prejeli tudi ASK (75 mg do 325 mg enkrat na dan).
English: Of those patients, the rate of CABG-related TIMI major or minor bleeding was 14.1% for the prasugrel group and 4.5% in the clopidogrel group.
Slovenian: Izmed teh bolnikov, je bila stopnja večjih in manjših krvavitev po TIMI, povezanih s CABG, 14,1 % za skupino, ki je jemala prasugrel in 4,5 % za skupino, ki je jemala klopidogrel.
English: Clopidogrel +ASA
Slovenian: klopidogrel +ASA
English: Morphine and other opioids
Slovenian: Morfin in drugi opioidi
English: Prasugrel has no clinically significant effect on the pharmacokinetics of digoxin.
Slovenian: Prasugrel nima klinično značilnega učinka na farmakokinetiko digoksina.
English: Limited data are available in children with sickle cell anaemia (see section 5.1).
Slovenian: Pri otrocih z anemijo srpastih celic so na voljo omejeni podatki (glejte poglavje 5.1).
English: Concomitant administration with chronic NSAIDs has not been studied.
Slovenian: Študij sočasnega dajanja s kroničnim zdravljenjem z NSAIDs niso opravili.
English: In the phase 3 clinical trial, Efient was administered without regard to co-administration of a proton pump inhibitor or H2 blocker.
Slovenian: V kliničnem preskušanju faze 3 so dajali zdravilo Efient brez ozira na sočasno dajanje zaviralca protonske črpalke ali blokatorja H2.
English: Therefore, statins that are substrates of CYP3A are not anticipated to have an effect on the pharmacokinetics of prasugrel or its inhibition of platelet aggregation.
Slovenian: Zato se za statine, ki so substrati CYP3A, ne pričakuje, da imajo učinek na farmakokinetiko prasugrela ali njegovo zaviranje agregacije trombocitov.
English: Efient is contraindicated in patients with severe hepatic impairment (Child Pugh class C).
Slovenian: Zdravilo Efient je kontraindicirano pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu).
English: If you then take Efient and experience allergic reactions that may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath you need to tell your doctor immediately.
Slovenian: Če ob jemanju zdravila Efient opazite alergijske reakcije, ki se kažejo kot izpuščaj, srbenje, otekel obraz, otekle ustnice ali težko dihanje, morate o tem nemudoma obvestiti svojega zdravnika.
English: Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken.
Slovenian: Bolnikom moramo svetovati, naj pred kakršnimkoli načrtovanim kirurškim posegom in preden začnejo jemati kakršnokoli novo zdravilo povedo zdravnikom in zobozdravnikom, da jemljejo prasugrel.
English: Efient is to be administered concomitantly with acetylsalicylic acid (ASA).
Slovenian: Zdravilo Efient se daje sočasno z acetilsalicilno kislino (ASK).
English: Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the prasugrel active metabolite's AUC and Tmax, but decreased the Cmax by 34% to 46%.
Slovenian: Ketokonazol (400 mg na dan), selektiven in močan zaviralec CYP3A4 in CYP3A5, ni vplival na zaviranje agregacije trombocitov, povzročeno s prasugrelom ali AUC in tmax aktivnega presnovka prasugrela, je pa zmanjšal Cmax za 34 % do 46 %.
English: Pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic impairment have not been studied.
Slovenian: Farmakokinetike in farmakodinamike prasugrela pri bolnikih s hudo okvaro jeter niso preučevali.
English: Thrombotic Thrombocytopaenic Purpura (TTP) TTP has been reported with the use of prasugrel.
Slovenian: Trombotična trombocitopenična purpura (TTP) Pri uporabi prasugrela so poročali o TTP.
English: Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, including in patients with a history of hypersensitivity reaction to clopidogrel.
Slovenian: O preobčutljivostni reakciji, vključno z angioedemom, so poročali pri bolnikih, ki so prejemali presugrel, vključno z bolniki s predhodno preobčutljivostno reakcijo na klopidogrel.
English: Analysis of all cause death did not show any significant difference between prasugrel and clopidogrel in the All ACS population (2.76% vs 2.90%), in the UA/NSTEMI population (2.58% vs 2.41%), and in the STEMI population (3.28% vs 4.31%).
Slovenian: Analiza vseh vzrokov smrti v celotni ACS populaciji (2,76 % proti 2,90 %), UA/NSTEMI populaciji (2,58 % proti 2,41 %), in STEMI populaciji (3,28 % proti 4,31 %) ni pokazala kakršnekoli značilne razlike med prasugrelom in klopidogrelom.
English: Clopidogrel
Slovenian: klopidogrelb
English: 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.
Slovenian: Po 60 mg polnilnem odmerku prasugrela pride do zaviranja agregacije trombocitov, inducirane z ADP, v 15 minutah s 5 µM ADP in 30 minutah z 20 µM ADP.
English: Therefore, known CYP3A inducers such as rifampicin, carbamazepine, and other inducers of cytochromes P450 are not anticipated to have significant effect on the pharmacokinetics of the active metabolite.
Slovenian: Zato se za znane induktorje CYP3A, kot sta rifampicin, karbamazepin in druge induktorje citokroma P450, ne predvideva, da imajo značilen učinek na farmakokinetiko aktivnega presnovka.
English: Prasugrel-mediated inhibition of platelet aggregation was also similar in patients with ESRD who required haemodialysis compared to healthy subjects, although Cmax and AUC of the active metabolite decreased 51% and 42%, respectively, in ESRD patients.
Slovenian: Zaviranje agregacije trombocitov, povzročeno s prasugrelom, je bilo tudi podobno pri bolnikih z ESRD, ki so potrebovali hemodializo, v primerjavi z zdravimi osebami, čeprav je bila pri ESRD bolnikih Cmax aktivnega presnovka zmanjšana za 51 %, AUC pa za 42 %.
English: In healthy subjects, prasugrel decreased exposure to hydroxybupropion, a CYP2B6-mediated metabolite of bupropion, by 23%.
Slovenian: Pri zdravih osebah je prasugrel za 23 % zmanjšal izpostavljenost hidroksibupropionu, presnovku bupropiona, ki se presnavlja s CYP2B6.
English: a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria.
Slovenian: a Centralno določeni dogodki, definirani po kriterijih preiskovane skupine za trombolizo pri miokardnem infarktu