natgillin/translations-raw huggingface dataset:
Similar or higher inhibition of platelet aggregation was observed with prasugrel.
Podobno ali močnejše zaviranje agregacije trombocitov so opazili pri prasugrelu.
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.
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.
Efient inhibits the clumping of platelets and so reduces the chance of a blood clot forming.
Zdravilo Efient zavira združevanje trombocitov in tako zmanjša možnost za tvorbo krvnega strdka.
Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).
Po 7 dneh po prekinitvi jemanja zdravila, so bile opazovane stopnje krvavitve, povezane s CABG, podobne pri obeh skupinah zdravljenja (glejte poglavje 4.4).
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Prasugrel + ASA
Izidi prasugrel + ASA
Each tablet contains 2.7 mg lactose.
Ena tableta vsebuje 2,7 mg laktoze.
Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
Farmakokinetike in farmakodinamike prasugrela v pediatrični populaciji niso preučevali (glejte poglavje 4.2).
Morphine and other opioids:
Morfin in drugi opioidi:
Stroke is an uncommon side effect of Efient in patients who have never had a stroke or transient ischaemic attack (TIA).
Možganska kap je občasen neželen učinek zdravila Efient pri bolnikih, ki niso nikoli imeli možganske kapi ali tranzitorne ishemične atake (TIA).
Patients weighing < 60 kg
Bolniki < 60 kg
Severe hepatic impairment (Child Pugh class C).
Huda jetrna okvara (razred C po Child Pugh-u).
It is particularly important to tell your doctor if you are being treated with:
Še posebej je pomembno, da poveste svojemu zdravniku, če se zdravite s/z:
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.
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.
Patients with STEMI within 12 hours of symptoms and planned for primary PCI could be randomised without knowledge of coronary anatomy.
Bolniki s STEMI z 12 urami simptomov in načrtovano primarno PCI so lahko bili randomizirani brez ugotovljene srčne anatomije.
Film-Coat:
Filmska obloga:
Medicinal products metabolised by CYP2B6:
Zdravila, ki se presnavljajo s CYP2B6:
Efient 5 mg: 2 years.
Efient 5 mg: 2 leti.
Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.
Odmerjanje zdravila Efient moramo začeti z enkratnim 60 mg polnilnim odmerkom in nato nadaljevati z 10 mg enkrat na dan.
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).
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).
If you stop taking Efient
Če ste prenehali jemati zdravilo Efient
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take Efient.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati zdravila Efient.
Concomitant administration of Efient with coumarin derivatives other than warfarin has not been studied.
Študij sočasnega dajanja zdravila Efient s kumarinskimi derivati, razen varfarina, niso opravili.
• If you have had allergic reactions (hypersensitivity) to clopidogrel or any other anti-platelet agent please tell your doctor before starting treatment with Efient.
• Če ste pri jemanju klopidogrela ali drugih zdravil proti trombocitom dobili alergijsko (preobčutljivostno) reakcijo, to pred začetkom jemanja zdravila Efient povejte svojemu zdravniku.
The rodent-specific association of liver tumours and drug-induced enzyme induction is well documented in the literature.
Povezava jetrnih tumorjev in indukcije encima, značilna za glodalce, je dobro dokumentirana v literaturi.
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.
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.
d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below.
d Smrtno nevarna krvavitev je podskupina večje krvavitve po TIMI in vključuje tipe, navedene spodaj.
Film-coated tablet (tablet).
FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta)
LIST OF EXCIPIENTS Contains lactose.
SEZNAM POMOŽNIH SNOVI Vsebuje laktozo.
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.
Primarno merilo izida preskušanja je bil čas do pojava srčnožilne (CV) smrti, ne-smrtnega miokardnega infarkta (MI) ali ne-smrtne možganske kapi.
Efient may be administered with or without food.
Zdravilo Efient se lahko daje s hrano ali brez hrane.
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.
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.
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.
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.
Patients also received ASA (75 mg to 325 mg once daily).
Bolniki so prejeli tudi ASK (75 mg do 325 mg enkrat na dan).
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.
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.
Morphine and other opioids
Morfin in drugi opioidi
Prasugrel has no clinically significant effect on the pharmacokinetics of digoxin.
Prasugrel nima klinično značilnega učinka na farmakokinetiko digoksina.
Limited data are available in children with sickle cell anaemia (see section 5.1).
Pri otrocih z anemijo srpastih celic so na voljo omejeni podatki (glejte poglavje 5.1).
Concomitant administration with chronic NSAIDs has not been studied.
Študij sočasnega dajanja s kroničnim zdravljenjem z NSAIDs niso opravili.
In the phase 3 clinical trial, Efient was administered without regard to co-administration of a proton pump inhibitor or H2 blocker.
V kliničnem preskušanju faze 3 so dajali zdravilo Efient brez ozira na sočasno dajanje zaviralca protonske črpalke ali blokatorja H2.
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.
Zato se za statine, ki so substrati CYP3A, ne pričakuje, da imajo učinek na farmakokinetiko prasugrela ali njegovo zaviranje agregacije trombocitov.
Efient is contraindicated in patients with severe hepatic impairment (Child Pugh class C).
Zdravilo Efient je kontraindicirano pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu).
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.
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.
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.
Bolnikom moramo svetovati, naj pred kakršnimkoli načrtovanim kirurškim posegom in preden začnejo jemati kakršnokoli novo zdravilo povedo zdravnikom in zobozdravnikom, da jemljejo prasugrel.
Efient is to be administered concomitantly with acetylsalicylic acid (ASA).
Zdravilo Efient se daje sočasno z acetilsalicilno kislino (ASK).
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%.
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 %.
Pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic impairment have not been studied.
Farmakokinetike in farmakodinamike prasugrela pri bolnikih s hudo okvaro jeter niso preučevali.
Thrombotic Thrombocytopaenic Purpura (TTP) TTP has been reported with the use of prasugrel.
Trombotična trombocitopenična purpura (TTP) Pri uporabi prasugrela so poročali o TTP.
Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, including in patients with a history of hypersensitivity reaction to clopidogrel.
O preobčutljivostni reakciji, vključno z angioedemom, so poročali pri bolnikih, ki so prejemali presugrel, vključno z bolniki s predhodno preobčutljivostno reakcijo na klopidogrel.
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%).
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.
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.
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.
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.
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.
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.
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 %.
In healthy subjects, prasugrel decreased exposure to hydroxybupropion, a CYP2B6-mediated metabolite of bupropion, by 23%.
Pri zdravih osebah je prasugrel za 23 % zmanjšal izpostavljenost hidroksibupropionu, presnovku bupropiona, ki se presnavlja s CYP2B6.
a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria.
a Centralno določeni dogodki, definirani po kriterijih preiskovane skupine za trombolizo pri miokardnem infarktu
Patients ≥ 75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4,
≥ 75 let so imeli večje tveganje za krvavitev, vključno s smrtno (glejte poglavja 4.2, 4.4 in 4.8).
An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Alergijsko reakcijo lahko prepoznate kot izpuščaj, srbenje, otečen obraz, otečene ustnice ali kratko sapo.
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.
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.
History of stroke or transient ischaemic attack (TIA).
Možganska kap ali tranzitorna ishemična ataka (TIA) v anamnezi.
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.
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.
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).
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).
Rates of TIMI major bleeding (including life threatening, fatal and ICH) were similar in prasugrel and clopidogrel treated patients.
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.
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).
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).
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.
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.
Iron oxide red (E172) {only Efient 10 mg} Iron oxide yellow (E172) Talc
Rdeči železov oksid (E172) {samo Efient 10 mg} Rumeni železov oksid (E172) Smukec
What Efient looks like and contents of the pack
Izgled zdravila Efient in vsebina pakiranja
Atorvastatin (80 mg daily) did not alter the pharmacokinetics of prasugrel and its inhibition of platelet aggregation.
Atorvastatin (80 mg na dan) ni spremenil farmakokinetike prasugrela in njegovega zaviranja agregacije trombocitov.
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.
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
Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised (see section 4.8).
Priporočeno je opazovanje znakov preobčutljivosti pri bolnikih z znano alergijo na tienopiridine (glejte poglavje 4.8).
Rates of major bleeding were similar in patients treated with 5 mg prasugrel and those treated with 75 mg clopidogrel.
Stopnje večjih krvavitev so bile podobne pri bolnikih, ki so bili zdravljeni s 5 mg prasugrela, in pri bolnikih, zdravljenih s 75 mg klopidogrela.
- If you have ever had a stroke or a transient ischaemic attack (TIA).
- Če ste kadarkoli imeli možgansko kap ali tranzitorno ishemično atako.
INFORMATION IN BRAILLE Efient 10 mg
PODATKI V BRAILLOVI PISAVI Efient 10 mg
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).
Zato lahko zdravilo Efient dajemo neodvisno od hrane; vendar lahko dajanje polnilnega odmerka prasugrela v obdobju stradanja nudi najhitrejši začetek delovanja (glejte poglavje
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.
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.
How to take Efient
Kako jemati zdravilo Efient
If you forget your dose for an entire day, just resume taking Efient at its usual dose the next day.
Če ste pozabili vzeti svoj odmerek in je minil že cel dan, nadaljujte z jemanjem običajnega odmerka zdravila
The reduction in stent thrombosis with Efient was observed both early and beyond 30 days for both bare metal and drug eluting stents.
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.
Patients taking Efient should also take ASA daily (75 mg to 325 mg).
Bolniki, ki jemljejo zdravilo Efient, morajo dnevno jemati tudi ASK (75 mg do 325 mg).
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).
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).
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Tveganje za krvavitev
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.
Prasugrel je zaviralec aktivacije in agregacije trombocitov preko nepovratne vezave njegovih aktivnih presnovkov na P2Y12 razred ADP receptorjev na trombocitih.
Patients ≥75 years old or those below 60 kg (N=3022) were randomized to 5 mg prasugrel.
Bolniki ≥ 75 let in bolniki s telesno maso pod 60 kg (N=3022) so bili randomizirani v skupino s 5 mg prasugrela.
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.
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.
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).
ACS populaciji (kombinacija UA/NSTEMI in STEMI skupin) je kazala možno statistično superiornost prasugrela proti klopidogrelu v skupini UA/NSTEMI (p < 0,05).
INFORMATION IN BRAILLE Efient 5 mg
PODATKI V BRAILLOVI PISAVI Efient 5 mg
• Subcutaneous haematoma (bleeding under the skin causing a swelling)
• Podkožni hematom (podkožna krvavitev, ki povzroča oteklino)
Higher inhibition of platelet aggregation was observed in patients switched to prasugrel 10 mg compared with those treated with clopidogrel 150 mg.
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.
Pharmacokinetics of prasugrel and its inhibition of platelet aggregation were similar in subjects with mild to moderate hepatic impairment compared to healthy subjects.
Farmakokinetika prasugrela in njegovo zaviranje agregacije trombocitov sta podobna pri osebah z blago do zmerno okvaro jeter v primerjavi z zdravimi osebami.
No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (see section 5.2).
Prilagoditev odmerka ni potrebna pri bolnikih z okvaro ledvic, vključno z bolniki s končno ledvično odpovedjo (glejte poglavje 5.2).
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.
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.
Switching directly to prasugrel 60 mg loading dose resulted in the most rapid onset of higher platelet inhibition.
Zamenjava neposredno na 60 mg polnilni odmerek prasugrela je vodila v najhitrejši začetek močnejšega zaviranja trombocitov.
• Bleeding in the stomach or bowels
• Krvavitev v želodec ali črevesje
The active metabolite's exposure (AUC) has moderate to low between-subject (27%) and within-subject (19%) variability.
Izpostavljenost (AUC) aktivnemu presnovku je zmerno do nizko variabilna med-osebami (27 %) in pri-osebah (19 %).