FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients ≥ 75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4,
Slovenian: ≥ 75 let so imeli večje tveganje za krvavitev, vključno s smrtno (glejte poglavja 4.2, 4.4 in 4.8).
English: An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Slovenian: Alergijsko reakcijo lahko prepoznate kot izpuščaj, srbenje, otečen obraz, otečene ustnice ali kratko sapo.
English: Switching data: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg.
Slovenian: Podatki o zamenjavi: Po dajanju 75 mg klopidogrela enkrat na dan 10 dni, so 40 zdravim preiskovancem pričeli dajati prasugrel v odmerku 10 mg enkrat na dan, z ali brez 60 mg polnilnega odmerka.
English: History of stroke or transient ischaemic attack (TIA).
Slovenian: Možganska kap ali tranzitorna ishemična ataka (TIA) v anamnezi.
English: Patients with a history of TIA or a history of ischaemic stroke more than 3 months prior to prasugrel therapy had no reduction in the primary composite endpoint.
Slovenian: Bolniki s TIA v anamnezi ali ishemično možgansko kapjo v anamnezi več kot 3 mesece pred zdravljenjem s prasugrelom, niso imeli znižanja primarnega sestavljenega cilja.
English: Safety in patients with acute coronary syndrome undergoing PCI was evaluated in one clopidogrelcontrolled study (TRITON) in which 6741 patients were treated with prasugrel (60 mg loading dose and 10 mg once daily maintenance dose) for a median of 14.5 months (5802 patients were treated for over 6 months, 4136 patients were treated for more than 1 year).
Slovenian: Varnost pri bolnikih z akutnim koronarnim sindromom, ki so imeli PCI, so ocenjevali v eni, s klopidogrelom nadzorovani študiji (TRITON), v kateri je bilo 6741 bolnikov zdravljenih s prasugrelom (60 mg polnilni odmerek in 10 mg vzdrževalni odmerek enkrat na dan) z mediano 14,5 mesecev (5802 bolnikov je bilo zdravljenih preko 6 mesecev, 4136 bolnikov je bilo zdravljenih več kot 1 leto).
English: Rates of TIMI major bleeding (including life threatening, fatal and ICH) were similar in prasugrel and clopidogrel treated patients.
Slovenian: Stopnje večjih krvavitev po TIMI (vključno z življenjsko nevarnimi, smrtnimi in ICH) so bile podobne pri bolnikih, zdravljenih s prasugrelom, in pri tistih, zdravljenih s klopidogrelom.
English: Although bleeding was increased with prasugrel, an analysis of the composite endpoint of death from any cause, nonfatal myocardial infarction, nonfatal stroke, and non-CABG-related TIMI major haemorrhage favoured Efient compared to clopidogrel (Hazard ratio, 0.87; 95% CI, 0.79 to 0.95; p = 0.004).
Slovenian: Čeprav je pri zdravljenju s prasugrelom prišlo do povečanega pojava krvavitve, je analiza sestavljenega cilja študije, smrti iz kateregakoli vzroka, ne-smrtnega miokardnega infarkta, ne-smrtne možganske kapi in večje krvavitve po TIMI, nepovezane s CABG, dala prednost zdravilu Efient v primerjavi s klopidogrelom (razmerje tveganja 0,87; 95 % IZ; 0,79 do 0,95; p=0,004).
English: As in the < 75 years old and ≥60 kg patients treated with 10 mg prasugrel, there was no difference between 5 mg prasugrel and 75 mg clopidogrel in CV outcomes.
Slovenian: Kot pri bolnikih < 75 leti in ≥ 60 kg telesne mase, ki so bili zdravljeni z 10 mg prasugrela, ni bilo razlike med 5 mg prasugrela in 75 mg klopidogrela pri izidih CV.
English: Iron oxide red (E172) {only Efient 10 mg} Iron oxide yellow (E172) Talc
Slovenian: Rdeči železov oksid (E172) {samo Efient 10 mg} Rumeni železov oksid (E172) Smukec
English: What Efient looks like and contents of the pack
Slovenian: Izgled zdravila Efient in vsebina pakiranja
English: Atorvastatin (80 mg daily) did not alter the pharmacokinetics of prasugrel and its inhibition of platelet aggregation.
Slovenian: Atorvastatin (80 mg na dan) ni spremenil farmakokinetike prasugrela in njegovega zaviranja agregacije trombocitov.
English: Following administration of a 900 mg loading dose of clopidogrel (with ASA), 56 subjects with ACS were treated for 14 days with either prasugrel 10 mg once daily or clopidogrel 150 mg once daily, and then switched to either clopidogrel 150 mg or prasugrel 10 mg for another 14 days.
Slovenian: Po dajanju 900 mg polnilnega odmerka klopidogrela (z ASK), je bilo 56 preiskovancev z ACS 14 dni zdravljenih s prasugrelom 10 mg enkrat na dan ali klopidogrelom 150 mg enkrat na dan, nato pa so za nadaljnjih 14 dni zamenjali na zdravljenje s klopidogrelom 150 mg ali prasugrelom
English: Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised (see section 4.8).
Slovenian: Priporočeno je opazovanje znakov preobčutljivosti pri bolnikih z znano alergijo na tienopiridine (glejte poglavje 4.8).
English: Rates of major bleeding were similar in patients treated with 5 mg prasugrel and those treated with 75 mg clopidogrel.
Slovenian: Stopnje večjih krvavitev so bile podobne pri bolnikih, ki so bili zdravljeni s 5 mg prasugrela, in pri bolnikih, zdravljenih s 75 mg klopidogrela.
English: - If you have ever had a stroke or a transient ischaemic attack (TIA).
Slovenian: - Če ste kadarkoli imeli možgansko kap ali tranzitorno ishemično atako.
English: INFORMATION IN BRAILLE Efient 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Efient 10 mg
English: Therefore, Efient can be administered without regard to food; however, the administration of prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 4.2).
Slovenian: Zato lahko zdravilo Efient dajemo neodvisno od hrane; vendar lahko dajanje polnilnega odmerka prasugrela v obdobju stradanja nudi najhitrejši začetek delovanja (glejte poglavje
English: For patients who received their thienopyridine within 3 days prior to CABG, the frequencies of TIMI major or minor bleeding were 26.7% (12 of 45 patients) in the prasugrel group, compared with 5.0% (3 of 60 patients) in the clopidogrel group.
Slovenian: Za bolnike, ki prejemajo tienopiridin v 3 dneh pred CABG, sta bili pogostnosti večjih in manjših krvavitev po TIMI, povezanih s CABG, 26,7 % (12 od 45 bolnikov) v skupini, ki je jemala prasugrel, v primerjavi s 5,0 % (3 od 60 bolnikov) v skupini, ki je jemala klopidogrel.
English: How to take Efient
Slovenian: Kako jemati zdravilo Efient
English: If you forget your dose for an entire day, just resume taking Efient at its usual dose the next day.
Slovenian: Če ste pozabili vzeti svoj odmerek in je minil že cel dan, nadaljujte z jemanjem običajnega odmerka zdravila
English: The reduction in stent thrombosis with Efient was observed both early and beyond 30 days for both bare metal and drug eluting stents.
Slovenian: Zmanjšanje tromboze žilne opornice z zdravilom Efient so opazili pri obeh, zgodnjih in po 30 dneh, za obe žilni opornici, kovinsko in prevlečeno z zdravili.
English: Patients taking Efient should also take ASA daily (75 mg to 325 mg).
Slovenian: Bolniki, ki jemljejo zdravilo Efient, morajo dnevno jemati tudi ASK (75 mg do 325 mg).
English: Patients randomised to receive prasugrel (60 mg loading dose followed by 10 mg once daily) or clopidogrel (300 mg loading dose followed by 75 mg once daily) were treated for a median of 14.5 months (maximum of 15 months with a minimum of 6 months follow-up).
Slovenian: Bolniki, ki so bili randomizirani, da prejmejo prasugrel (60 mg polnilni odmerek, ki mu sledi 10 mg vzdrževalni odmerek enkrat na dan) ali klopidogrel (300 mg polnilni odmerek, ki mu sledi 75 mg vzdrževalni odmerek enkrat na dan) so bili zdravljeni z mediano 14,5 mesecev (največ 15 mesecev z najmanj 6 mesečnim obdobjem sledenja).
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Tveganje za krvavitev
English: Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.
Slovenian: Prasugrel je zaviralec aktivacije in agregacije trombocitov preko nepovratne vezave njegovih aktivnih presnovkov na P2Y12 razred ADP receptorjev na trombocitih.
English: Patients ≥75 years old or those below 60 kg (N=3022) were randomized to 5 mg prasugrel.
Slovenian: Bolniki ≥ 75 let in bolniki s telesno maso pod 60 kg (N=3022) so bili randomizirani v skupino s 5 mg prasugrela.
English: In a study of 276 ACS patients managed with PCI, switching from an initial loading dose of 600 mg clopidogrel or placebo administered upon presentation to the hospital prior to coronary angiography to a 60 mg loading dose of prasugrel administered at the time of percutaneous coronary intervention, resulted in a similar increased inhibition of platelet aggregation for the 72 hour duration of the study.
Slovenian: V študiji s 276 bolniki z ACS, ki so imeli PCI, je zamenjava začetnega polnilnega odmerka 600 mg klopidogrela ali placeba, danega ob vstopu v bolnišnico pred koronarno angiografijo, s 60-mg polnilnim odmerkom prasugrela, danega v času perkutane koronarne intervencije, povzročila podobno povečano zaviranje agregacije trombocitov v 72-urnem obdobju študije.
English: 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).
Slovenian: ACS populaciji (kombinacija UA/NSTEMI in STEMI skupin) je kazala možno statistično superiornost prasugrela proti klopidogrelu v skupini UA/NSTEMI (p < 0,05).
English: INFORMATION IN BRAILLE Efient 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Efient 5 mg
English: • Subcutaneous haematoma (bleeding under the skin causing a swelling)
Slovenian: • Podkožni hematom (podkožna krvavitev, ki povzroča oteklino)
English: Higher inhibition of platelet aggregation was observed in patients switched to prasugrel 10 mg compared with those treated with clopidogrel 150 mg.
Slovenian: 10 mg. Močnejše zaviranje agregacije trombocitov so opazili pri bolnikih, ki so jim zdravljenje zamenjali na zdravljenje s prasugrelom 10 mg v primerjavi s tistimi, ki so bili zdravljeni s klopidogrelom 150 mg.
English: Pharmacokinetics of prasugrel and its inhibition of platelet aggregation were similar in subjects with mild to moderate hepatic impairment compared to healthy subjects.
Slovenian: Farmakokinetika prasugrela in njegovo zaviranje agregacije trombocitov sta podobna pri osebah z blago do zmerno okvaro jeter v primerjavi z zdravimi osebami.
English: No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (see section 5.2).
Slovenian: Prilagoditev odmerka ni potrebna pri bolnikih z okvaro ledvic, vključno z bolniki s končno ledvično odpovedjo (glejte poglavje 5.2).
English: The incidence of Non-CABG-related TIMI major bleeding, including life-threatening and fatal, as well as TIMI minor bleeding, was statistically significantly higher in subjects treated with prasugrel compared to clopidogrel in the UA/NSTEMI and All ACS populations.
Slovenian: Pogostnost večje krvavitve po TIMI, nepovezane s CABG, vključno smrtno nevarno in smrtno, kot tudi manjše krvavitve po TIMI, je bila v UA/NSTEMI in vseh populacijah ACS statistično značilno višja pri bolnikih, zdravljenih s prasugrelom, v primerjavi s klopidogrelom.
English: Switching directly to prasugrel 60 mg loading dose resulted in the most rapid onset of higher platelet inhibition.
Slovenian: Zamenjava neposredno na 60 mg polnilni odmerek prasugrela je vodila v najhitrejši začetek močnejšega zaviranja trombocitov.
English: • Bleeding in the stomach or bowels
Slovenian: • Krvavitev v želodec ali črevesje
English: The active metabolite's exposure (AUC) has moderate to low between-subject (27%) and within-subject (19%) variability.
Slovenian: Izpostavljenost (AUC) aktivnemu presnovku je zmerno do nizko variabilna med-osebami (27 %) in pri-osebah (19 %).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (Logo)
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Daiichi-Sankyo (Logo)
English: Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions System Organ
Slovenian: Preglednica 2: Hemoragični in ne-hemoragični neželeni učinki
English: Efient was administered without regard to food in TRITON.
Slovenian: Zdravilo Efient so v študiji TRITON dajali neodvisno od hrane.
English: Effects of other medicinal products on Efient
Slovenian: Učinki drugih zdravil na zdravilo Efient
English: TRITON was a 13,608 patient, multicentre international, randomised, double blind, parallel group study.
Slovenian: TRITON s 13.608 bolniki je bila multicentrična,
English: In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should only be given at the time of PCI (see sections 4.4, 4.8 and 5.1).
Slovenian: Bolnikom z UA/NSTEMI, pri katerih je koronarna angiografija opravljena v 48 urah po sprejemu, je treba polnilni odmerek dati le v času perkutane koronarne intervencije (glejte poglavja 4.4, 4.8 in 5.1).
English: • While you are taking Efient:
Slovenian: • Med jemanjem zdravila Efient:
English: Approximately 68% of the prasugrel dose is excreted in the urine and 27% in the faeces, as inactive metabolites.
Slovenian: Približno 68 % odmerka prasugrela se v obliki neaktivnih presnovkov izloči z urinom in 27 % z blatom.
English: • A copy of the SPC
Slovenian: • Izvod SPC-ja • S poudarkom na:
English: EU/1/08/503/008 14 film-coated tablets EU/1/08/503/009 28 film-coated tablets EU/1/08/503/010 30x1 film-coated tablet EU/1/08/503/011 56 film-coated tablets EU/1/08/503/012 84 film-coated tablets EU/1/08/503/013 90x1 film-coated tablet EU/1/08/503/014 98 film-coated tablets EU/1/08/503/016 30 film-coated tablets
Slovenian: EU/1/08/503/008 14 filmsko obloženih tablet EU/1/08/503/009 28 filmsko obloženih tablet EU/1/08/503/010 30x1 filmsko obložena tableta EU/1/08/503/011 56 filmsko obloženih tablet EU/1/08/503/012 84 filmsko obloženih tablet EU/1/08/503/013 90x1 filmsko obložena tableta EU/1/08/503/014 98 filmsko obloženih tablet EU/1/08/503/016 30 filmsko obloženih tablet
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Efient naslednji dan. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in healthy subjects and patients with a body weight of < 60 kg compared to those weighing ≥ 60 kg. Prasugrel should be used with caution in patients with a body weight of < 60 kg due to the potential risk of bleeding in this population (see section 4.4).
Slovenian: Srednja izpostavljenost (AUC) aktivnemu presnovku prasugrela je približno 30 do 40 % višja pri zdravih osebah in bolnikih s telesno maso < 60 kg, v primerjavi s tistimi, ki tehtajo ≥ 60 kg. Prasugrel moramo uporabljati previdno pri bolnikih s telesno maso < 60 kg, zaradi možnega tveganja za krvavitev v tej populaciji (glejte poglavje 4.4).
English: Patients ≥ 75 years old Non-CABG-related TIMI major or minor bleeding rates:
Slovenian: Bolniki, stari ≥ 75 let Stopnje večjih in manjših krvavitev po TIMI, nepovezanih s CABG:
English: The increase in liver tumours with prasugrel administration in mice is not considered a relevant human risk.
Slovenian: Večje pojavljanje jetrnih tumorjev zaradi dajanja prasugrela pri miših ni ocenjeno kot pomemben dejavnik tveganja za ljudi.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Efient Vsebina pakiranja in dodatne informacije
English: EU/1/08/503/001 14 film-coated tablets EU/1/08/503/002 28 film-coated tablets EU/1/08/503/003 30x1 film-coated tablet EU/1/08/503/004 56 film-coated tablets EU/1/08/503/005 84 film-coated tablets EU/1/08/503/006 90x1 film-coated tablet EU/1/08/503/007 98 film-coated tablets EU/1/08/503/015 30 film-coated tablets
Slovenian: EU/1/08/503/001 14 filmsko obloženih tablet EU/1/08/503/002 28 filmsko obloženih tablet EU/1/08/503/003 30x1 filmsko obložena tableta EU/1/08/503/004 56 filmsko obloženih tablet EU/1/08/503/005 84 filmsko obloženih tablet EU/1/08/503/006 90x1 filmsko obložena tableta EU/1/08/503/007 98 filmsko obloženih tablet EU/1/08/503/015 30 filmsko obloženih tablet
English: • Bleeding from your rectum, blood in your stools or black stools.
Slovenian: • Krvavitev iz danke, kri v blatu ali črno blato
English: <75 years (N=11672)*
Slovenian: < 75 let (N=11672)*
English: Do not stop taking Efient without consulting your doctor; if you stop taking Efient too soon, your risk of a heart attack may be higher.
Slovenian: Efient prenehate jemati prezgodaj, je lahko pri vas tveganje za srčno kap večje.
English: Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (9%) and within-subject (12%) variability with both 5 µM and 20 µM ADP.
Slovenian: Zaviranje agregacije trombocitov, inducirano s prasugrelom, kaže majhno variabilnost med osebami (9 %) in pri osebah (12 %) pri obeh, 5 µM ADP in 20 µM
English: • warfarin (an anti-coagulant),
Slovenian: • klopidogrelom (zdravilom proti trombocitom), • varfarinom (antikoagulantom),
English: Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
Slovenian: Terapevtske izkušnje s prasugrelom so omejene pri bolnikih z okvaro ledvic (vključno s končno ledvično odpovedjo) in pri bolnikih z zmerno okvaro jeter.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Microcrystalline cellulose, mannitol (E421), croscarmellose sodium, hypromellose (E464) magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron oxide red (10 mg tablets only) (E172), iron oxide yellow (E172) and talc.
Slovenian: magnezijev stearat, laktoza monohidrat, titanov dioksid (E171), triacetin (E1518), rdeči železov oksid (samo 10 mg tablete) (E172), rumeni železov oksid (E172) in smukec.
English: A single intravenous bolus dose of unfractionated heparin (100 U/kg) did not significantly alter the prasugrel-mediated inhibition of platelet aggregation.
Slovenian: Heparin: Enkratni intravenski bolusni odmerek nefrakcioniranega heparina (100 enot/kg) ni značilno spremenil zaviranja agregacije trombocitov, povzročenega s prasugrelom.
English: Prasugrel 5 mg provided greater antiplatelet effect than clopidogrel 75 mg. Prasugrel should be used with caution in patients ≥ 75 years old and in patients weighing <60 kg (see sections 4.2, 4.4 and 4.8).
Slovenian: Prasugrel 5 mg je omogočil večji antitrombotični učinek kot klopidogrel 75 mg. Prasugrel je treba uporabljati previdno pri bolnikih ≥ 75 let in pri bolnikih, ki tehtajo < 60 kg (glejte poglavja 4.2, 4.4 in
English: Prasugrel had no effect on fertility of male and female rats at oral doses up to an exposure 240 times the recommended daily human maintenance dose (based on mg/m2).
Slovenian: Prasugrel nima učinka na plodnost samcev in samic podgan pri peroralnih odmerkih, ki so do 240-krat večji od izpostavljenosti, pri priporočenem dnevnem vzdrževalnem odmerku pri ljudeh (glede na mg/m2).
English: In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients ≥75 years old taking 5 mg prasugrel was approximately half that in patients < 65 years old taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was reduced but was non-inferior compared to 10 mg.
Slovenian: V študiji z bolniki s stabilno aterosklerozo je povprečna AUC aktivnemu presnovku pri bolnikih ≥ 75 let, ki so jemali 5 mg prasugrela, znašala približno polovico AUC pri bolnikih < 65 let, ki so jemali 10 mg prasugrela, antitrombotični učinek 5-mg odmerka pa je bil manjši, vendar ni bil slabši od 10-mg odmerka.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: Clopidogrelb +ASA (N = 4980)
Slovenian: klopidogrelb +ASK (N=4980)
English: No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2).
Slovenian: Prilagoditev odmerka ni potrebna pri bolnikih z blago do zmerno okvaro jeter (razreda A in B po Child Pugh-u) (glejte poglavje 5.2).
English: In the large phase 3 clinical trial, the mean estimated exposure (AUC) of the active metabolite was 19% higher in very elderly patients (≥ 75 years of age) compared to subjects < 75 years of age.
Slovenian: V velikem kliničnem preskušanju faze 3, je bila srednja ocenjena izpostavljenost (AUC) aktivnemu presnovku 19 % višja pri zelo starih bolnikih
English: CV death, nonfatal MI, or nonfatal stroke CV death Nonfatal MI Nonfatal stroke STEMI Primary Composite Outcome Events
Slovenian: CV smrt, ne-smrtni MI ali ne-smrtna možganska kap CV smrt Ne-smrtni MI Ne-smrtna možganska kap STEMI Primarni sestavljeni izidi
English: Prasugrel is a weak inhibitor of CYP2B6.
Slovenian: Prasugrel je šibek zaviralec CYP2B6.
English: In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients <60 kg taking 5 mg prasugrel was 38% lower than in patients ≥60 kg taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was similar to 10 mg.
Slovenian: V študiji z bolniki s stabilno aterosklerozo je bila povprečna AUC aktivnemu presnovku pri bolnikih < 60 kg, ki so jemali 5 mg prasugrela, za 38 % nižja kot pri bolnikih ≥ 60 kg, ki so jemali 10 mg prasugrela, antitrombotični učinek 5-mg odmerka pa je bil podoben 10-mg odmerku.
English: Efient is unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Za zdravilo Efient je malo verjetno, da vpliva na vašo sposobnost upravljanja vozil in strojev.
English: Requiring surgical intervention
Slovenian: Zahteva kirurški poseg
English: No dose adjustment is necessary for patients with mild to moderate impaired hepatic function (Child Pugh Class A and B).
Slovenian: Prilagoditev odmerka ni potrebna pri bolnikih z blago do zmerno okvaro jeter (razreda A in B po Child Pugh-u).
English: Specifically, prasugrel did not significantly reduce the frequency of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, urgent revascularization (UR), or glycoprotein (GP) IIb/IIIa inhibitor bailout through 7 days from randomization in subjects receiving prasugrel prior to coronary angiography compared to patients receiving the full loading dose of prasugrel at the time of PCI, and the rate of the key safety objective for all TIMI major bleeding (CABG and non-CABG events) through 7 days from randomization in all treated subjects was significantly higher in subjects receiving prasugrel prior to coronary angiography versus patients receiving the full loading dose of prasugrel at the time of PCI.
Slovenian: Natančneje, prasugrel ni bistveno zmanjšal pogostnosti sestavljenega opazovanega dogodka srčnožilne (CV) smrti, miokardnega infarkta (MI), možganske kapi, urgentne revaskularizacije (UR) ali reševalnega zdravljenja z zaviralci glikoproteina (GP) IIb/IIIa v obdobju 7 dni od randomizacije pri bolnikih, ki so prejeli prasugrel pred koronarno angiografijo, v primerjavi z bolniki, ki so prejeli poln polnilni odmerek prasugrela v času perkutane koronarne intervencije; stopnja ključnih z varnostjo povezanih dogodkov za vse večje krvavitve po