FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be told that it might take longer than usual to stop bleeding when they take prasugrel (in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Croatian: Bolesnicima treba napomenuti da bi moglo trajati dulje nego obično da se zaustavi krvarenje dok uzimaju prasugrel (u kombinaciji s ASK-om) te da svom liječniku moraju prijaviti svako neuobičajeno krvarenje (mjesto ili trajanje krvarenja).
English: Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding.
Croatian: Odmah se javite svom liječniku ili idite u bolnicu jer postoji rizik od jakog krvarenja.
English: You should tell your doctor before taking Efient if any of the situations mentioned below apply to you:
Croatian: Morate obavijestiti liječnika prije nego uzmete Efient ako se bilo što od navedenog u nastavku odnosi na Vas:
English: - If you have a medical condition that is currently causing bleeding, such as bleeding from your stomach or intestines.
Croatian: - ako bolujete od neke bolesti koja trenutno izaziva krvarenje, kao što je krvarenje iz želuca ili crijeva.
English: You will start the treatment with a single dose of 60 mg.
Croatian: Liječenje ćete započeti jednokratnom dozom od 60 mg.
English: No data are available on the reversal of the pharmacological effect of prasugrel; however, if prompt correction of prolonged bleeding time is required, platelet transfusion and/or other blood products may be considered.
Croatian: Nema podataka o reverziji farmakološkog učinka prasugrela, međutim, ako je potrebna brza korekcija produljenog vremena krvarenja, može se razmotriti transfuzija trombocita i/ili drugih krvnih pripravaka.
English: The active metabolite has an elimination half-life of about 7.4 hours (range 2 to 15 hours).
Croatian: Približno poluvrijeme eliminacije aktivnog metabolita iz plazme iznosi 7,4 sata (raspon 2-15 sati).
English: Acetylsalicylic acid:
Croatian: Acetilsalicilatna kiselina:
English: Efient is available in packs of 14, 28, 30, 56, 84, 90 and 98 tablets.
Croatian: Efient je dostupan u pakiranjima od 14, 28, 30, 56, 84, 90 i 98 tableta.
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne štetne učinke na trudnoću, razvoj embrija i fetusa, okot i postnatalni razvoj (vidjeti dio 5.3).
English: - If you have severe liver disease.
Croatian: - ako bolujete od teške bolesti jetre.
English: Non-steroidal anti-inflammatory drugs (NSAIDs):
Croatian: Nesteroidni protuupalni lijekovi (NSAIL):
English: • with body weight < 60 kg (see sections 4.2 and 4.8).
Croatian: • tjelesne težine < 60 kg (vidjeti dijelove 4.2 i 4.8).
English: de la Industria 30 28108 Alcobendas Madrid
Croatian: Avda de la Industria 30 28108 Alcobendas Madrid
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
Croatian: Farmakoterapijska skupina: Inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC22.
English: No clinical study has been conducted in pregnant or breast-feeding women.
Croatian: Nisu provedena klinička ispitivanja u trudnica i dojilja.
English: A treatment of up to 12 months is recommended unless the discontinuation of Efient is clinically indicated (see sections 4.4 and 5.1).
Croatian: Preporučuje se liječenje u trajanju do 12 mjeseci osim ako obustava primjene lijeka Efient nije klinički indicirana (vidjeti dijelove 4.4 i 5.1).
English: The use of prasugrel during breastfeeding is not recommended.
Croatian: Primjena prasugrela tijekom dojenja se ne preporučuje.
English: The clinical study protocol provided for all patients to receive aspirin and a daily maintenance dose of prasugrel.
Croatian: Protokolom kliničkog ispitivanja bilo je predviđeno da svi bolesnici primaju aspirin i dnevnu dozu održavanja prasugrela.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Efient 10 mg:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Efient 10 mg:
English: Hypersensitivity including angioedema
Croatian: Preosjetljivost uključujući angioedem
English: At a very high dose (> 240 times the recommended daily human maintenance dose on a mg/m2 basis) that caused effects on maternal body weight and/or food consumption, there was a slight decrease in offspring body weight (relative to controls).
Croatian: Pri vrlo visokim dozama (> 240 puta većima od preporučene dnevne doze održavanja u ljudi na temelju mg/m2) koje su imale učinak na maternalnu tjelesnu težinu i/ili unos hrane, opaženo je malo smanjenje tjelesne težine potomaka (u odnosu na kontrolnu skupinu).
English: Likewise, prasugrel did not significantly alter the effect of heparin on measures of coagulation.
Croatian: Isto tako, prasugrel nije značajno promijenio učinak heparina na parametre koagulacije.
English: • Bleeding after surgery
Croatian: • krvarenje nakon operacije
English: Table 3: Patients with Outcome Events in TRITON Primary Analysis
Croatian: Tablica 3: Bolesnici u kojih je nastupio neki događaj uključen u mjeru ishoda u primarnoj analizi ispitivanja TRITON
English: Therefore, both medicinal products can be administered concomitantly.
Croatian: Stoga je moguća istodobna primjena ovih dvaju lijekova.
English: Clots in arteries supplying blood to the heart may also reduce the blood supply, causing unstable angina (a severe chest pain).
Croatian: Ugrušci u arterijama koje opskrbljuju srce krvlju također mogu smanjiti dotok krvi, uzrokujući nestabilnu anginu (jaku bol u prsištu).
English: *TRITON study in ACS patients undergoing PCI **TRILOGY-ACS study in patients not undergoing PCI (see 5.1):
Croatian: *Ispitivanje TRITON provedeno u bolesnika s ACS-om koji su podvrgnuti PCI-u **Ispitivanje TRILOGY-ACS u bolesnika koji nisu podvrgnuti PCI-u (vidjeti dio 5.1):
English: Table 1: Incidence of Non-CABG related bleedinga (% Patients)
Croatian: Tablica 1: Incidencija krvarenja nevezanih uz CABGa (% bolesnika)
English: Therefore, prasugrel should be used with caution in these patients.
Croatian: Stoga prasugrel u tih bolesnika treba primjenjivati uz oprez.
English: Subjects with diabetes had significant reductions in the primary and all secondary composite endpoints.
Croatian: U ispitanika sa šećernom bolešću uočeno je značajno smanjenje primarne i svih objedinjenih sekundarnih mjera ishoda.
English: You should show the doctor your pack of Efient.
Croatian: Pokažite liječniku pakiranje lijeka Efient.
English: You have been prescribed Efient because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart.
Croatian: Liječnik Vam je propisao Efient jer ste već imali srčani udar ili nestabilnu anginu te ste liječeni postupkom kojim se otvaraju začepljene srčane arterije.
English: • with a propensity to bleed (e.g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, or active peptic ulcer disease)
Croatian: • koji su skloni krvarenju (npr. zbog nedavne traume, nedavnog kirurškog zahvata, nedavnog ili opetovanog gastrointestinalnog krvarenja ili aktivnog peptičnog ulkusa)
English: If a patient is to undergo elective surgery, and an antiplatelet effect is not desired, Efient should be discontinued at least 7 days prior to surgery.
Croatian: Ako se kod bolesnika planira elektivni operativni zahvat pri kojem nije poželjan antitrombocitni učinak, primjena lijeka Efient se mora prekinuti najmanje 7 dana prije operacije.
English: The absorption and metabolism of prasugrel are rapid, with peak plasma concentration (Cmax) of the active metabolite occurring in approximately 30 minutes.
Croatian: Apsorpcija Apsorpcija i metabolizam prasugrela su brzi, a vršna koncentracija (Cmax) aktivnog metabolita u plazmi postiže se za otprilike 30 minuta.
English: Gender: In healthy subjects and patients, the pharmacokinetics of prasugrel are similar in men and women.
Croatian: Spol: U zdravih ispitanika i bolesnika farmakokinetika prasugrela podjednaka je u muškaraca i žena.
English: Overdose of Efient may lead to prolonged bleeding time and subsequent bleeding complications.
Croatian: Predoziranje lijekom Efient može dovesti do produljenja vremena krvarenja i kasnijih komplikacija krvarenja.
English: Warfarin:
Croatian: Varfarin:
English: The rodent-specific association of liver tumours and drug-induced enzyme induction is well documented in the literature.
Croatian: Specifična povezanost tumora jetre i lijekom izazvane indukcije enzima u glodavaca dobro je dokumentirana u literaturi.
English: No (N=13090)
Croatian: Ne (N = 13 090)
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: U nekliničkim istraživanjima učinci su zabilježeni tek pri razinama izloženosti koje se smatraju dovoljno većima od maksimalne izloženosti lijeku u ljudi, što ukazuje na malen značaj za kliničku primjenu.
English: Exposure in subjects of African and Hispanic descent is comparable to that of Caucasians.
Croatian: Izloženost u ispitanika afričkog i latinoameričkog podrijetla podjednaka je kao u bijelaca.
English: Medicinal products that elevate gastric pH:
Croatian: Lijekovi koji povisuju želučani pH:
English: If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Efient per day.
Croatian: Ako imate manje od 60 kg ili ako ste stariji od 75 godina, doza lijeka Efienta iznosi 5 mg na dan.
English: Patients ≥ 75 years old
Croatian: Bolesnici u dobi od ≥ 75 godina
English: Yes (N=518)
Croatian: Da (N = 518)
English: For all patients, the loading dose could be administered anytime between randomisation and 1 hour after the patient left the catheterisation lab.
Croatian: Svim se bolesnicima udarna doza mogla primijeniti bilo kada u razdoblju od randomizacije do sat vremena nakon što je bolesnik napustio salu za kateterizaciju.
English: • ≥ 75 years of age (see below).
Croatian: • u dobi od ≥ 75 godina (vidjeti u nastavku)
English: - If you have ever had a stroke or a transient ischaemic attack (TIA).
Croatian: - ako ste ikada imali moždani udar ili tranzitornu ishemijsku ataku (TIA).
English: Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
Croatian: Farmakokinetika i farmakodinamika prasugrela nisu ispitivane u pedijatrijskoj populaciji (vidjeti dio 4.2).
English: For the 14, 28, 56 84 and 98 tablet pack sizes, you can check the day on which you last took a tablet of Efient by referring to the calendar printed on the blister.
Croatian: Kod pakiranja sa 14, 28, 56, 84 i 98 tableta možete na kalendaru otisnutom na blisteru provjeriti kada ste uzeli prethodnu tabletu lijeka Efient.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: • Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs
Croatian: • spontana krvarenja iz oka, rektuma, desni ili oko unutarnjih organa u trbuhu
English: Efient is to be administered concomitantly with acetylsalicylic acid (ASA).
Croatian: Efient se mora primjenjivati zajedno s acetilsalicilatnom kiselinom (ASK).
English: In patients with acute coronary syndrome, in whom morphine cannot be withheld and fast P2Y12 inhibition is deemed crucial, the use of a parenteral P2Y12 inhibitor may be considered.
Croatian: U bolesnika s akutnim koronarnim sindromom u kojih se primjena morfina ne može prekinuti, a brza inhibicija P2Y12 smatra se presudnom, može se razmotriti uporaba inhibitora P2Y12 za parenteralnu primjenu.
English: The higher risk for bleeding events in subjects treated with prasugrel persisted up to 7 days from the most recent dose of study drug.
Croatian: Veći rizik za epizode krvarenja u ispitanika liječenih prasugrelom održao se do najviše 7 dana od posljednje doze ispitivanog lijeka.
English: Your doctor will also tell you to take acetylsalicylic acid- (s)he will tell you the exact dose to take (usually between 75 mg and 325 mg daily).
Croatian: Liječnik će Vam također odrediti da uzimate acetilsalicilatnu kiselinu i reći Vam točno koju dozu trebate uzimati (obično između 75 mg i 325 mg na dan).
English: An increased risk of bleeding is possible when Efient is co-administered with heparin.
Croatian: Moguć je povećan rizik od krvarenja kada se Efient primjenjuje istodobno s heparinom.
English: The increase in liver tumours with prasugrel administration in mice is not considered a relevant human risk.
Croatian: Povećanje broja tumora jetre uz primjenu prasugrela u miševa ne smatra se relevantnim rizikom za ljude.
English: Efient contains lactose
Croatian: Efient sadrži laktozu
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: vrlo često (≥ 1/10), često ≥1 /100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i
English: Inducers of cytochromes P450:
Croatian: Induktori citokroma P450:
English: The active metabolite's exposure (AUC) increases proportionally over the therapeutic dose range.
Croatian: Izloženost (AUC) aktivnom metabolitu povećava se razmjerno dozi unutar terapijskog raspona.
English: Approximately 68% of the prasugrel dose is excreted in the urine and 27% in the faeces, as inactive metabolites.
Croatian: Približno 68% doze prasugrela izlučuje se mokraćom, a 27% fecesom u obliku neaktivnih metabolita.
English: Overall, no new safety findings were identified for prasugrel as monotherapy in this patient population.
Croatian: Sveukupno nisu utvrđeni novi sigurnosni nalazi za monoterapiju prasugrelom u ovoj populaciji bolesnika.
English: ТП "Ели Лили Недерланд" Б.В.
Croatian: ТП "Ели Лили Недерланд" Б.В. - България тел.
English: This effect is likely to be of clinical concern only when prasugrel is co-administered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window (e.g. cyclophosphamide, efavirenz).
Croatian: Taj će učinak vjerojatno biti od kliničke važnosti samo kada se prasugrel primjenjuje istodobno s lijekovima čiji je jedini metabolički put CYP2B6 i koji imaju uzak terapijski prozor (npr. ciklofosfamid, efavirenz).
English: Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Croatian: Blisteri od aluminijske folije u kutijama sa 14, 28, 30, 30 (x 1), 56, 84, 90 (x 1) i 98 tableta.
English: • Low haemoglobin or red blood cell count (anaemia)
Croatian: • niska razina hemoglobina ili malen broj crvenih krvnih stanica (anemija)
English: Embryo-foetal developmental toxicology studies in rats and rabbits showed no evidence of malformations due to prasugrel.
Croatian: Toksikološka istraživanja embrio-fetalnog razvoja na štakorima i kunićima nisu ukazala na malformacije povezane s primjenom prasugrela.
English: Efient is unlikely to affect your ability to drive or use machines.
Croatian: Nije vjerojatno da bi Efient mogao utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Efient can be concomitantly administered with medicinal products metabolised by cytochrome P450 enzymes (including statins), or medicinal products that are inducers or inhibitors of cytochrome P450 enzymes.
Croatian: Efient se može primjenjivati istodobno s lijekovima koji se metaboliziraju pomoću enzima citokroma P450 (uključujući statine) kao i s lijekovima koji su induktori ili inhibitori enzima citokroma P450.
English: Tablet Core:
Croatian: Jezgra tablete:
English: If you stop taking Efient
Croatian: Ako prestanete uzimati Efient
English: TRITON was a 13,608 patient, multicentre international, randomised, double blind, parallel group study.
Croatian: TRITON je bilo multicentrično, međunarodno, randomizirano, dvostruko slijepo ispitivanje s paralelnim skupinama s 13 608 uključenih bolesnika.
English: Efient reduces the chances of you having a further heart attack or stroke or of dying from one of these atherothrombotic events.
Croatian: Efient smanjuje vjerojatnost ponovnog srčanog udara, moždanog udara ili smrti kao posljedice nekog od tih aterotrombotskih događaja.
English: Your doctor will also give you acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.
Croatian: Liječnik će Vam propisati i acetilsalicilatnu kiselinu (npr. aspirin) kao drugi antitrombocitni lijek.
English: For oral use.
Croatian: Za peroralnu primjenu.
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.
Croatian: Ako počnete uzimati Efient i dobijete alergijsku reakciju, koju možete prepoznati kao osip, svrbež, oticanje lica, oticanje usana ili nedostatak zraka, morate odmah obavijestiti svog liječnika.
English: The most common site of spontaneous bleeding was the gastrointestinal tract (1.7% rate with prasugrel and 1.3% rate with clopidogrel); the most frequent site of provoked bleeding was the arterial puncture site (1.3% rate with prasugrel and 1.2% with clopidogrel).
Croatian: Najčešće mjesto spontanog krvarenja bio je gastrointestinalni trakt (stopa od 1,7% kod primjene prasugrela i stopa od 1,3% kod primjene klopidogrela), a najčešće mjesto izazvanog krvarenja je mjesto punkcije arterije (stopa od 1,3% kod primjene prasugrela I stopa od 1,2% kod primjene klopidogrela).
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%).
Croatian: Analiza smrti zbog bilo kojeg uzroka nije pokazala značajnu razliku između prasugrela i klopidogrela u populaciji svih bolesnika s ACS-om (2,76% u odnosu na 2,90%), u populaciji bolesnika koji su imali UA/NSTEMI (2,58% u odnosu na 2,41%) kao ni u populaciji bolesnika koji su imali STEMI (3,28% u odnosu na 4,31%).
English: Efient 10 mg: 3 years.
Croatian: Efient 10 mg: 3 godine.
English: If given together with Efient these medicines may increase the risk of bleeding.
Croatian: Primijenjeni u kombinaciji s lijekom Efient, ovi lijekovi mogu povećati rizik od krvarenja.
English: Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).
Croatian: Više od 7 dana nakon prekida primjene lijeka su zabilježene stope krvarenja vezanog uz CABG bile podjednake u obje terapijske skupine (vidjeti dio 4.4).
English: In clinical pharmacology studies, after adjusting for body weight, the AUC of the active metabolite was approximately 19% higher in Chinese, Japanese, and Korean subjects compared to that of Caucasians, predominantly related to higher exposure in Asian subjects < 60 kg.
Croatian: U kliničkim farmakološkim ispitivanjima je nakon korekcije za tjelesnu težinu AUC aktivnog metabolita bio približno 19% veći u ispitanika kineskog, japanskog i korejskog podrijetla nego u bijelaca, što je uglavnom bilo povezano s većom izloženošću u Azijata tjelesne težine <60 kg.
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 56 film-coated tablets 84 film-coated tablets 90x1 film-coated tablet 98 film-coated tablets 30 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 30x1 filmom obložena tableta 56 filmom obloženih tableta 84 filmom obložene tablete 90x1 filmom obložena tableta 98 filmom obloženih tableta 30 filmom obloženih tableta
English: If you forget your dose for an entire day, just resume taking Efient at its usual dose the next day.
Croatian: Ako niste uzeli Efient tijekom cijelog dana, samo nastavite s uobičajenom dozom sljedećeg dana.
English: The clinical relevance is unknown, but data indicate the potential for reduced prasugrel efficacy in patients coadministered prasugrel and morphine.
Croatian: Njezin klinički značaj nije poznat, ali podaci ukazuju na moguću smanjenu djelotvornost prasugrela u bolesnika koji istodobno primaju prasugrel i morfin.
English: Severe hepatic impairment (Child Pugh class C).
Croatian: Teško oštećenje jetre (Child-Pugh stadij C).
English: You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart.
Croatian: Možda Vam je ugrađen i jedan ili više stentova, koji osiguravaju da začepljene ili sužene arterije koje opskrbljuju srce krvlju ostanu prohodne.
English: Since platelets participate in the initiation and/or evolution of thrombotic complications of atherosclerotic disease, inhibition of platelet function can result in the reduction of the rate of cardiovascular events such as death, myocardial infarction, or stroke.
Croatian: Budući da trombociti sudjeluju u nastanku i/ili razvoju trombotičkih komplikacija aterosklerotske bolesti, inhibicija funkcije trombocita može rezultirati smanjenjem stope kardiovaskularnih događaja poput smrti, infarkta miokarda ili moždanog udara.
English: The superior efficacy was accompanied by an increase in major bleeding (see sections 4.4 and 4.8).
Croatian: Bolja djelotvornost bila je popraćena povećanjem broja značajnih krvarenja (vidjeti dijelove 4.4 i 4.8).
English: Efient may be administered with or without food.
Croatian: Efient se može uzimati s hranom ili bez nje.
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).
Croatian: U analizi bolesnika koji su preživjeli ishemijski događaj uočena je povezanost prasugrela sa smanjenjem incidencije naknadnog razvoja događaja obuhvaćenih primarnim ishodom (7,8% kod primjene prasugrela u odnosu na 11,9% kod primjene klopidogrela).
English: Although a pharmacodynamic interaction with ASA leading to an increased risk of bleeding is possible, the demonstration of the efficacy and safety of prasugrel comes from patients concomitantly treated with ASA.
Croatian: Iako je moguća farmakodinamička interakcija s ASK-om koja dovodi do povećanog rizika od krvarenja, djelotvornost i sigurnost prasugrela pokazana je u bolesnika istodobno liječenih ASK-om.
English: In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p < 0.001) for prasugrel versus clopidogrel.
Croatian: U populaciji svih bolesnika s ACS-om analiza svake od sekundarnih mjera ishoda pokazala je značajnu korist (p < 0,001) od primjene prasugrela u odnosu na klopidogrel.
English: Prasugrel was associated with a 50% reduction in stent thrombosis through the 15 month follow-up period.
Croatian: Primjena prasugrela bila je povezana s 50%-tnim smanjenjem broja tromboza stenta tijekom razdoblja praćenja od 15 mjeseci.
English: Approximately 98% of patients (in each of the treatment groups) received antithrombins (heparin, low molecular weight heparin, bivalirudin, or other agent) directly in support of PCI.
Croatian: Približno 98% bolesnika (u svakoj od liječenih skupina) primalo je antitrombinske lijekove (heparin, heparin male molekulske težine, bivalirudin ili druge lijekove) kao izravnu potporu PCI-u.
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.
Croatian: U velikom kliničkom ispitivanju, u fazi III, prosječna procijenjena izloženost (AUC) aktivnom metabolitu bila je 19% veća u vrlo starih bolesnika (≥ 75 godina) u usporedbi s ispitanicima mlađima od 75 godina.