FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical experience involving co-administration of oral anticoagulants with vorapaxar is limited, and there is no experience with oral Factor Xa or Factor IIa inhibitors in the vorapaxar Phase 3 program.
Croatian: Kliničko iskustvo istodobne primjene peroralnih antikoagulansa s vorapaksarom je ograničeno, a nema iskustva s istodobnom primjenom peroralnih inhibitora faktora Xa ili faktora IIa u programu kliničkih ispitivanja vorapaksara faze 3.
English: There is limited therapeutic experience in patients with severe renal impairment or end stage renal disease.
Croatian: Terapijsko iskustvo u bolesnika s teškim oštećenjem funkcije bubrega ili bolesnika u terminalnoj fazi bubrežne bolesti je ograničeno.
English: Therefore, Zontivity may be administered without regard to co-administration of agents that increase gastric pH (antacid or proton pump inhibitor).
Croatian: Stoga se Zontivity može uzimati neovisno o istodobnoj primjeni lijekova koji povisuju želučani pH (antacida ili inhibitora protonske pumpe).
English: Of the patients with MI without a history of stroke or TIA, 21% were receiving acetylsalicylic acid without thienopyridine, 1% was receiving a thienopyridine without acetylsalicylic acid, and 77% were receiving both acetylsalicylic acid and a thienopyridine when they enrolled in the trial.
Croatian: Među bolesnicima s IM-om koji u anamnezi nisu imali moždani udar ili TIA-u, njih 21% primalo je acetilsalicilatnu kiselinu bez tienopiridina, 1% primalo je tienopiridin bez acetilsalicilatne kiseline, a 77% primalo je i acetilsalicilatnu kiselinu i tienopiridin, kada su bili uključeni u ovo ispitivanje.
English: TIMI Major: Clinically apparent with >50 g/L decrease in haemoglobin or intracranial haemorrhage.
Croatian: Značajno prema TIMI kriterijima: klinički značajno krvarenje uz smanjenje hemoglobina za >50 g/l ili intrakranijalno krvarenje
English: The findings for the primary efficacy composite endpoint show a 3-year Kaplan-Meier (K-M) event rate of 11.2% in the Zontivity group compared with that of 12.4% in the placebo group (Hazard Ratio [HR]: 0.88; 95% Confidence Interval [CI], 0.82 to 0.95; p=0.001) and demonstrated superiority of Zontivity over placebo in preventing CV death, MI, stroke, or UCR.
Croatian: Rezultati mjere primarnog objedinjenog ishoda za djelotvornost pokazuju da je 3-godišnja stopa događaja po Kaplan-Meieru (K-M) iznosila 11,2% u skupini liječenoj lijekom Zontivity naspram 12,4% u skupini koja je primala placebo (omjer rizika [HR]: 0,88; 95% interval pouzdanosti [CI], 0,82 do 0,95; p=0,001) te su pokazali da je Zontivity superioran u odnosu na placebo u prevenciji smrti zbog KV uzroka te IM-a, moždanog udara ili UCR-a.
English: Of the patients with PAD without a history of stroke or TIA, 61% were receiving acetylsalicylic acid without thienopyridine, 8% were receiving a thienopyridine without acetylsalicylic acid, and 27% were receiving both acetylsalicylic acid and a thienopyridine when they enrolled.
Croatian: Među bolesnicima s PAD-om koji u anamnezi nisu imali moždani udar ili TIA-u, njih 61% primalo je acetilsalicilatnu kiselinu bez tienopiridina, 8% primalo je tienopiridin bez acetilsalicilatne kiseline, a 27% primalo je i acetilsalicilatnu kiselinu i tienopiridin kada su bili uključeni u ispitivanje.
English: Pharmacokinetics of vorapaxar are similar between patients with end-stage renal disease (ESRD) undergoing haemodialysis and healthy subjects.
Croatian: Farmakokinetika vorapaksara slična je u bolesnika u terminalnoj fazi bubrežne bolesti na hemodijalizi i zdravih ispitanika.
English: You and your doctor will decide if you will take Zontivity or breast-feed.
Croatian: Vi i Vaš liječnik donijet ćete odluko o tome hoćete li uzimati Zontivity ili dojiti.
English: Co-administration of ketoconazole (400 mg once-daily) with vorapaxar significantly increased the vorapaxar mean Cmax and AUC by 93% and 96%, respectively.
Croatian: Istodobna primjena ketokonazola (400 mg jedanput na dan) s vorapaksarom značajno je povećala srednju vrijednost Cmax vorapaksara za 93%, a AUC-a za 96%.
English: There is limited experience with the concomitant use of vorapaxar with warfarin or other oral anticoagulants.
Croatian: Iskustvo s istodobnom primjenom vorapaksara s varfarinom ili drugim peroralnim antikoagulansima je ograničeno.
English: Patients undergoing urgent CABG, PCI, non CABG surgery, or other invasive procedures while on Zontivity may remain on Zontivity.
Croatian: Bolesnici koji se tijekom liječenja lijekom Zontivity podvrgavaju hitnom CABG-u, PKI-u, odnosno drugom hitnom kirurškom ili invazivnom zahvatu mogu nastaviti uzimati Zontivity.
English: In post-MI or PAD patients with no history of stroke or TIA, an analysis of multiple occurrences of adjudicated endpoints indicates that Zontivity was associated with a reduction in the incidence of recurrent events.
Croatian: U bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u, analiza višestruke pojave ocijenjenih mjera ishoda upućuje na povezanost lijeka Zontivity sa smanjenjem incidencije rekurentnih događaja.
English: Packs of 7, 28, 30 and 100 film-coated tablets in aluminium/aluminium blister cards.
Croatian: Pakiranja sa 7, 28, 30 i 100 filmom obloženih tableta u aluminij/aluminij blister karticama.
English: The PAD patient population with no history of stroke or TIA was 90% Caucasian, 29% female, and 57% ≥65 years of age, with a median age of 66 years, and included patients with diabetes (35%) and patients with hypertension (82%).
Croatian: Među populacijom bolesnika s PAD-om koji u anamnezi nisu imali moždani udar ni TIA-u, njih 90% bili su bijelci, 29% bile su žene, a 57% ih je bilo u dobi od ≥ 65 godina, dok je medijan dobi iznosio 66 godina; populacija je uključivala bolesnike s dijabetesom (35%) i bolesnike s hipertenzijom (82%).
English: Zontivity should be used with caution in patients with moderate hepatic impairment.
Croatian: Zontivity treba primjenjivati uz oprez u bolesnika s umjerenim oštećenjem funkcije jetre.
English: A delayed onset of action (at least 7 days) should be expected when starting therapy with Zontivity.
Croatian: Na početku liječenja lijekom Zontivity treba očekivati odgođeni početak djelovanja (najmanje 7 dana).
English: The clinical evidence for the effect of Zontivity in patients with a history of myocardial infarction, defined as a spontaneous MI ≥2 weeks but 12 months prior, is derived from TRA 2°P - TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events).
Croatian: Klinički dokazi o učinku lijeka Zontivity u bolesnika s infarktom miokarda u anamnezi, koji se definira kao spontani IM ≥2 tjedna, ali 12 mjeseci prije početka ispitivanja, proizlaze iz ispitivanja TRA 2°P - TIMI 50 (engl.
English: • ritonavir, nelfinavir, indinavir, saquinavir (used to treat HIV-AIDS)
Croatian: • ritonavir, nelfinavir, indinavir, sakvinavir (koriste se za liječenja HIV infekcije/SIDA-e),
English: In TRA 2°P - TIMI 50, among patients who entered the trial, those with a history of ischaemic stroke had a higher 3 year K-M event rate for ICH on Zontivity plus standard care (2.7%) than on standard care alone (0.9%).
Croatian: Među bolesnicima koji su bili uključeni u ispitivanje TRA 2°P - TIMI 50, bolesnici s ishemijskim moždanim udarom u anamnezi koji su primali Zontivity i standardnu terapiju imali su višu 3-godišnju stopu događaja po Kaplan-Meieru za intrakranijalno krvarenje (2,7%) nego oni koji su primali samo standardnu terapiju (0,9%).
English: When administered in addition to standard care, generally acetylsalicylic acid and a thienopyridine, compared with standard care alone, Zontivity increased the risk of GUSTO (Global utilization of streptokinase and tpa for occluded arteries) moderate or severe bleeding (see section 4.8).
Croatian: Kada se primjenjivao kao dodatak standardnom liječenju, uglavnom acetilsalicilatnoj kiselini i tienopiridinu, u usporedbi s primjenom samo standardnoga liječenja, Zontivity je povećao rizik od umjerenog ili teškog krvarenja prema GUSTO kriterijima (engl.
English: Vorapaxar had no effects on fertility of male and female rats at exposures sufficiently in excess of human exposure at the RHD.
Croatian: Vorapaksar nije utjecao na plodnost mužjaka ni ženki štakora pri razinama izloženosti koje su bile dovoljno veće od izloženosti u ljudi nakon primjene preporučene doze.
English: No dose adjustment is required in patients with renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Primary Efficacy Endpoint (CV death/MI/stroke/UCR) CV Death
Croatian: Mjera primarnog ishoda za djelotvornost (smrt zbog KV uzroka/IM/moždani udar/UCR) Smrt zbog KV uzroka
English: Minor
Croatian: Manje
English: Based on results of pre-clinical studies that investigated bleeding while on vorapaxar on the background of acetylsalicylic acid and clopidogrel, it may be possible to restore hemostasis by administering exogenous platelets.
Croatian: S obzirom na rezultate pretkliničkih ispitivanja u kojima se istraživalo krvarenje tijekom primjene vorapaksara uz osnovnu terapiju acetilsalicilatnom kiselinom i klopidogrelom, hemostaza bi se možda mogla ponovno uspostaviti primjenom transfuzije koncentrata trombocita (vidjeti dio 5.3.).
English: This is because it is not known if Zontivity passes into your breast milk.
Croatian: Naime, nije poznato izlučuje li se Zontivity u majčino mlijeko.
English: For post-MI or PAD patients with no history of stroke or TIA, the rate of study drug discontinuation because of adverse reactions was 6.8% for Zontivity and 6.9% for placebo.
Croatian: U bolesnika koji su pretrpjeli IM ili imaju PAD, a nisu imali moždani udar ni TIA-u u anamnezi, stopa prekida primjene ispitivanoga lijeka zbog nuspojava iznosila je 6,8% uz Zontivity te 6,9% uz placebo.
English: What Zontivity is used for
Croatian: Za što se koristi Zontivity
English: Adverse reactions were evaluated in 19,632 patients treated with Zontivity [13,186 patients, including 2,187 patients treated for more than 3 years, in the TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) study and 6,446 patients in the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) study].
Croatian: Nuspojave su procijenjene u 19 632 bolesnika liječena lijekom Zontivity [13 186 bolesnika, uključujući 2187 bolesnika koji su se liječili dulje od 3 godine, iz ispitivanja TRA 2ºP - TIMI 50 (engl.
English: Key Secondary Efficacy Endpoint (CV death / MI / stroke)
Croatian: Ključna mjera sekundarnog ishoda za djelotvornost (smrt zbog KV uzroka/IM/moždani udar)
English: The mean estimated vorapaxar Cmax and AUC were 30% and 32% higher, respectively, in females compared to males.
Croatian: U žena je srednja procijenjena vrijednost Cmax i AUC-a vorapaksara bila 30% odnosno 32% veća nego u muškaraca.
English: Table 5: Multiple Occurrences of Net Clinical Outcome (CV Death/MI/Stroke/GUSTO Severe*) in Post-MI or PAD Patients with No History of Stroke or TIA
Croatian: Tablica 5: Višestruki nastupi neto kliničkog ishoda (smrt zbog KV uzroka/IM/moždani udar/teško prema GUSTO kriterijima*) u bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u
English: The findings for the key secondary efficacy endpoint, a 3-year K-M event rate of 9.3% in the Zontivity group compared with that of 10.5% in placebo group (HR: 0.87; 95% CI, 0.80 to 0.94; p <0.001).
Croatian: Rezultati ključne mjere sekundarnog ishoda za djelotvornost pokazuju da je 3-godišnja stopa događaja po Kaplan-Meieru iznosila 9,3% u skupini liječenoj lijekom Zontivity naspram 10,5% u skupini koja je primala placebo (HR: 0,87; 95% CI, 0,80 do 0,94; p <0,001).
English: The post-MI patient population with no history of stroke or TIA was 88% Caucasian, 20% female, and 29% ≥65 years of age, with a median age of 58 years, and included patients with diabetes (21%) and patients with hypertension (62%).
Croatian: Među populacijom bolesnika koji su pretrpjeli IM, a u anamnezi nisu imali moždani udar ni TIA-u, njih 88% bili su bijelci, 20% bile su žene, a 29% ih je bilo u dobi od ≥ 65 godina, dok je medijan dobi iznosio 58 godina; populacija je uključivala bolesnike s dijabetesom (21%) i bolesnike s hipertenzijom (62%).
English: • The other ingredients are: Tablet core: lactose monohydrate; cellulose microcrystalline (E460); croscarmellose sodium (E468); povidone (E1201); magnesium stearate (E572).
Croatian: • Drugi sastojci su: Jezgra tablete: laktoza hidrat; celuloza, mikrokristalična (E460); karmelozanatrij, umrežena (E468); povidon (E1201); magnezijev stearat (E572).
English: Each film-coated tablet contains 2.08 mg vorapaxar (as vorapaxar sulfate).
Croatian: Jedna filmom obložena tableta sadrži 2,08 mg vorapaksara (u obliku vorapaksarsulfata).
English: Steady-state is achieved by 21 days following once-daily dosing.
Croatian: Stanje dinamičke ravnoteže postiže se do 21. dana uz doziranje jedanput na dan.
English: Zontivity 2 mg tablets Vorapaxar
Croatian: Zontivity 2 mg tablete vorapaksar
English: What Zontivity looks like and contents of the pack Tablets are yellow, oval-shaped, film-coated tablets, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side.
Croatian: Tablete su žute, ovalne, filmom obložene tablete veličine 8,48 mm x 4,76 mm, s oznakom "351 " na jednoj i logotipom tvrtke MSD na drugoj strani.
English: The coadministration of Zontivity with anticoagulants e.g., warfarin and new oral anticoagulants (NOACs), should be avoided.
Croatian: Treba izbjegavati istodobnu primjenu lijeka Zontivity s antikoagulansima, npr. varfarinom i novim peroralnim antikoagulansima (vidjeti dio 4.4.).
English: TIMI Minor: Clinically apparent with 30-50 g/L decrease in haemoglobin.
Croatian: Manje prema TIMI kriterijima: klinički značajno krvarenje uz smanjenje hemoglobina od 30-50 g/l.
English: Co-administration of rifampin (600 mg once-daily) with vorapaxar substantially decreased the vorapaxar mean Cmax and AUC by 39% and 55%, respectively.
Croatian: Istodobna primjena rifampina (600 mg jedanput na dan) s vorapaksarom značajno je smanjila srednju vrijednost Cmax vorapaksara za 39%, a AUC-a za 55%.
English: • If you have any further questions, ask your doctor, pharmacist, or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: • warfarin, other oral anticoagulants, heparin, or low molecular weight heparin (blood thinner medicines)
Croatian: • varfarin, druge antikoagulanse koje uzimate kroz usta, heparin ili heparin male molekulske mase
English: Film coating Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Iron oxide yellow (E172)
Croatian: Film ovojnica laktoza hidrat hipromeloza (E464) titanijev dioksid (E171) triacetin (E1518) željezov oksid, žuti (E172)
English: Patients experiencing acute coronary syndrome (ACS) while on Zontivity can remain on Zontivity.
Croatian: Bolesnici u kojih se tijekom liječenja lijekom Zontivity razvije akutni koronarni sindrom (AKS) mogu nastaviti uzimati Zontivity.
English: The adverse reactions in the vorapaxar-treated (n=10,059) and placebo-treated (n=10,049) post-MI or PAD patients with no history of stroke or TIA are shown below.
Croatian: U nastavku su prikazane nuspojave zabilježene u bolesnika koji su primali vorapaksar (n=10 059) ili placebo (n=10 049), a koji su pretrpjeli IM ili imaju PAD, no u anamnezi nisu imali moždani udar ni TIA-u.
English: Film-coating: lactose monohydrate; hypromellose (E464); titanium dioxide (E171); triacetin (E1518); iron oxide yellow (E172).
Croatian: Film ovojnica: laktoza hidrat; hipromeloza (E464); titanijev dioksid (E171); triacetin (E1518); željezov oksid, žuti (E172).
English: Each tablet contains 2.08 mg of vorapaxar (as vorapaxar sulfate).
Croatian: Jedna tableta sadrži 2,08 mg vorapaksara (u obliku vorapaksarsulfata).
English: Packs of 10 and 50 film-coated tablets in aluminium/aluminium unit-dose blister cards.
Croatian: Pakiranja s 10 i 50 filmom obloženih tableta u aluminij/aluminij blister karticama djeljivima na jedinične doze.
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor, pharmacist, or nurse before taking Zontivity.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, posavjetujte se sa svojim liječnikom, ljekarnikom ili medicinskom sestrom prije nego što uzmete Zontivity.
English: Coadministration with other antiplatelet medicinal products
Croatian: Istodobna primjena s drugim antitromboticitnim lijekovima
English: Lactose monohydrate Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Povidone (E1201) Magnesium stearate (E572)
Croatian: Jezgra tablete laktoza hidrat celuloza, mikrokristalična (E460) karmelozanatrij, umrežena (E468) povidon (E1201) magnezijev stearat (E572)
English: Figure 1: Time to First Occurrence of CV death, MI, Stroke or UCR in Post-MI or PAD Patients with No History of Stroke or TIA
Croatian: Slika 1: Vrijeme do prvoga nastupa smrti zbog KV uzroka te nastupa IM-a, moždanog udara ili UCR-a u bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u
English: Method of administration Oral use.
Croatian: Način primjene Za peroralnu primjenu.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: Medicinal product discontinuation
Croatian: Prekid primjene lijeka
English: No defects were observed in embryo-foetal developmental studies in rats and rabbits at exposures sufficiently in excess of human exposure at the recommended human dose (RHD).
Croatian: U ispitivanjima embriofetalnog razvoja u štakora i kunića nisu primijećena oštećenja pri razinama izloženosti koje su bile dovoljno veće od izloženosti u ljudi nakon primjene preporučene doze.
English: Among patients with a qualifying MI, Zontivity was initiated at least 2 weeks after the MI and within the first 12 months from the acute event.
Croatian: Liječenje lijekom Zontivity započeto je najranije 2 tjedna nakon IM-a u bolesnika koje je IM kvalificirao za ispitivanje, a unutar prvih 12 mjeseci od akutnoga događaja.
English: Renal and urinary disorders Injury, poisoning, and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije krvarenje iz rane
English: GUSTO Bleeding Categories Severe
Croatian: Kategorije krvarenja prema GUSTO kriterijima Teško
English: Tell your doctor if you are breast-feeding.
Croatian: Obavijestite svog liječnika ako dojite.
English: GUSTO severe: fatal, intracranial, or bleeding with hemodynamic compromise requiring intervention; GUSTO moderate: bleeding requiring transfusion of whole blood or packed red blood cells without hemodynamic compromise.
Croatian: Umjereno prema GUSTO kriterijima: krvarenje koje zahtijeva transfuziju pune krvi ili pakiranih crvenih krvnih stanica, ali ne narušava hemodinamiku.
English: • Patients with a history of intracranial haemorrhage (ICH).
Croatian: • Bolesnici s intrakranijalnim krvarenjem u anamnezi.
English: In TRA 2°P - TIMI 50, 367 post-MI or PAD patients with no history of stroke or TIA underwent CABG surgery.
Croatian: U ispitivanju TRA 2°P - TIMI 50, CABG-u je bilo podvrgnuto 367 bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u.
English: Fatal Bleeding
Croatian: Intrakranijalno krvarenje
English: Hazard ratio and p-value were calculated based on Cox PH model with covariates treatment and stratification factors (qualifying atherosclerotic disease and planned thienopyridine use)
Croatian: Omjer rizika i p-vrijednost izračunavali su se na temelju Coxova modela proporcionalnog rizika (PH), u kojem su kovarijante bile liječenje i faktori stratifikacije (aterosklerotska bolest koja je bolesnika kvalificirala za ispitivanje i planirana primjena tienopiridina).
English: Packs of 10 and 50 tablets in aluminium unit-dose blister cards.
Croatian: Pakiranja s 10 i 50 tableta u aluminijskim blister karticama djeljivima na jedinične doze.
English: Increased tendency to bruise Ecchymosis, Skin haemorrhage
Croatian: Poremećaji kože i potkožnog tkiva pojačana sklonost nastanku ekhimoza, kožno krvarenje
English: The mean estimated vorapaxar Cmax and AUC were 35% and 33% higher, respectively, in patients with a body weight of <60 kg compared to those weighing 60-100 kg. By comparison, vorapaxar exposure (AUC and Cmax) is estimated to be 19-21% lower in patients with a body weight of >100 kg compared to those weighing 60-100 kg.
Croatian: Srednja procijenjena vrijednost Cmax i AUC-a vorapaksara bila je 35% odnosno 33% veća u bolesnika tjelesne težine <60 kg u odnosu na one čija je tjelesna težina 60-100 kg.
English: Patients who experience a stroke, TIA, or ICH while on Zontivity should have therapy discontinued permanently (see sections 4.8 and 5.1).
Croatian: Liječenje lijekom Zontivity mora se trajno obustaviti u bolesnika kod kojih tijekom terapije nastupi moždani udar, TIA ili intrakranijalno krvarenje (vidjeti dijelove 4.8 i 5.1).
English: Table 4: Primary and Key Secondary Efficacy Endpoints in Post-MI or PAD Patients with No History of Stroke or TIA
Croatian: Tablica 4: Mjere primarnog ishoda i ključne mjere sekundarnog ishoda za djelotvornost u bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u
English: - a history of myocardial infarction (MI), co-administered with acetylsalicylic acid (ASA) and,
Croatian: • infarktom miokarda (IM) u anamnezi, uz istodobnu primjenu acetilsalicilatne kiseline i, gdje je prikladno, klopidogrela; ili
English: Platelet poor plasma had no effect on bleeding times or platelet aggregation.
Croatian: Plazma siromašna trombocitima nije utjecala na vremena krvarenja ni na agregaciju trombocita (vidjeti dio 4.4.).
English: Table 2: Non-CABG-Related Bleeds in Post-MI or PAD Patients with No History of Stroke or TIA
Croatian: Tablica 2: Krvarenja nevezana uz CABG u bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u
English: No meaningful changes in P-selectin, sCD40L and hs-CRP concentrations were observed in patients treated with vorapaxar in the Phase 2/3 clinical trials.
Croatian: U bolesnika liječenih vorapaksarom u kliničkim ispitivanjima faze 2/3 nisu primijećene značajne promjene koncentracija P-selektina, sCD40L i hs-CRP.
English: - symptomatic peripheral arterial disease (PAD), co-administered with acetylsalicylic acid (ASA)
Croatian: Peripheral Arterial Disease, PAD), uz istodobnu primjenu acetilsalicilatne kiseline ili, gdje je prikladno, klopidogrela
English: • have liver or kidney problems
Croatian: • imate jetrenih ili bubrežnih tegoba,
English: Zontivity 2 mg film-coated tablets
Croatian: Zontivity 2 mg filmom obložene tablete
English: In post-MI or PAD patients with no history of stroke or TIA, the 3 year K-M event rates for ICH were 0.6% and 0.5% for Zontivity plus standard care and standard care alone, respectively.
Croatian: Među bolesnicima koji su pretrpjeli IM ili PAD, a u anamnezi nisu imali moždani udar ni TIA-u, 3-godišnja stopa događaja po Kaplan-Meieru za intrakranijalno krvarenje iznosila je 0,6% uz Zontivity i standardnu terapiju te 0,5% samo uz standardnu terapiju.
English: Moderate TIMI Bleeding Categories Major
Croatian: Umjereno Kategorije krvarenja prema TIMI kriterijima Značajno
English: In TRA 2°P - TIMI 50, in vorapaxartreated patients, including those with history of stroke, a higher rate of ICH was observed in patients weighing <60 kg compared to patients weighing ≥60 kg. Zontivity should be used with caution in patients with a body weight <60 kg.
Croatian: Među bolesnicima liječenima vorapaksarom u ispitivanju TRA 2ºP - TIMI 50, uključujući one s moždanim udarom u anamnezi, u bolesnika tjelesne težine <60 kg primijećena je viša stopa intrakranijalnog krvarenja nego u bolesnika tjelesne težine ≥60 kg.