FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall no effect level for the pre- and postnatal development effects was 5 mg/kg/day (6.8-times [female animals] the human steady-state exposure at 2.5 mg/day).
Croatian: Ukupna razina pri kojoj nisu primijećeni učinci na prenatalni i postnatalni razvoj iznosila je 5 mg/kg/dan (izloženost 6,8 puta veća [ženke životinja] od izloženosti u ljudi u stanju dinamičke ravnoteže nakon primjene doze od 2,5 mg/dan).
English: Pharmacokinetics of vorapaxar are similar between patients with mild (Child Pugh, 5 to 6 points) to moderate (Child Pugh, 7 to 9 points) hepatic impairment and healthy patients.
Croatian: Farmakokinetika vorapaksara slična je u bolesnika s blagim (Child-Pugh: 5-6 bodova) do umjerenim (Child-Pugh: 7-9 bodova) oštećenjem funkcije jetre i zdravih ispitanika.
English: Phospholipidosis occurs at acceptable human to animal safety margins and was reversible.
Croatian: Pojava fosfolipidoze bila je unutar prihvatljivih sigurnosnih margina s obzirom na omjer izloženosti između životinja i ljudi, te je bila reverzibilna.
English: The effects of renal (end-stage renal disease undergoing haemodialysis) and hepatic impairment on the pharmacokinetics of vorapaxar were evaluated in specific pharmacokinetic studies and are summarized below:
Croatian: Učinci oštećenja funkcije bubrega (bolesnici u terminalnoj fazi bubrežne bolesti na hemodijalizi) i oštećenja funkcije jetre na farmakokinetiku vorapaksara ocjenjivani su u specifičnim farmakokinetičkim ispitivanjima, a sažeto prikazani u nastavku:
English: Inhibition of TRAP-induced platelet aggregation at a level of ≥80% may last for 2 to 4 weeks after discontinuation of daily doses of vorapaxar sulfate 2.5 mg.
Croatian: Inhibicija TRAP-om inducirane agregacije trombocita na razini od ≥ 80% može potrajati 2 do 4 tjedna nakon prekida primjene dnevne doze vorapaksarsulfata od 2,5 mg.
English: The systemic pharmacokinetics of vorapaxar are linear with accumulation (6-fold) predictable from single- to multiple-dose data.
Croatian: Sistemska farmakokinetika vorapaksara je linearna, uz kumulaciju (šesterostruku) koja se može predvidjeti na temelju podataka o primjeni jednokratne i višestrukih doza.
English: No vorapaxar-related tumours were observed in 2-year rat and mouse studies at oral doses up to 30 mg/kg/day in rats and 15 mg/kg/day in mice (8.9 and 30 times the recommended therapeutic exposures in humans based on plasma exposure to vorapaxar for rats and mice, respectively).
Croatian: Nisu primijećeni tumori povezani s primjenom vorapaksara u 2-godišnjim ispitivanjima u štakora i miševa, u kojima su se primjenjivale peroralne doze do 30 mg/kg/dan u štakora odnosno do 15 mg/kg/dan u miševa (izloženost 8,9 odnosno 30 puta veća od preporučene terapijske izloženosti u ljudi na temelju izloženosti vorapaksaru u plazmi štakora odnosno miševa).
English: Zontivity increases the risk of bleeding, including ICH and sometimes fatal bleeding.
Croatian: Zontivity povećava rizik od krvarenja, uključujući intrakranijalno krvarenje te ponekad krvarenje sa smrtnim ishodom.
English: Pre and postnatal studies in rats only showed some inconsistent developmental effects at exposures sufficiently in excess of human exposure at the RHD of 2.08 mg vorapaxar.
Croatian: Prenatalna i postnatalna ispitivanja u štakora pokazala su samo neke nedosljedne učinke na razvoj pri razinama izloženosti dovoljno većima od izloženosti u ljudi nakon primjene preporučene doze vorapaksara od 2,08 mg.
English: The composite of cardiovascular death, MI, and stroke were assessed as secondary endpoint.
Croatian: Smrt zbog kardiovaskularnog uzroka, IM i moždani udar objedinjeno su procjenjivani kao mjera sekundarnog ishoda.
English: In vitro metabolism studies demonstrate that vorapaxar is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP3A, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Croatian: In vitro ispitivanja metabolizma pokazuju da nije vjerojatno da će vorapaksar uzrokovati klinički značajnu inhibiciju humanog CYP1A2, CYP2B6, CYP3A, CYP2C8, CYP2C9, CYP2C19 ili CYP2D6.
English: • itraconazole, ketoconazole, posaconazole (used to treat fungal infections)
Croatian: • itrakonazol, ketokonazol, posakonazol (koriste se za liječenje gljivičnih infekcija),
English: Severe hepatic impairment increases the risk of bleeding; therefore, the use of Zontivity in these patients is contraindicated (see sections 4.2 and 5.2).
Croatian: Teško oštećenje funkcije jetre povećava rizik od krvarenja; stoga je primjena lijeka Zontivity u tih bolesnika kontraindicirana (vidjeti dijelove 4.2 i 5.2).
English: Strong CYP3A inducers
Croatian: Potentni induktori CYP3A
English: No clinically relevant differences in vorapaxar pharmacokinetics were observed following daily co-administration of an aluminium hydroxide/magnesium carbonate antacid or pantoprazole (a proton pump inhibitor).
Croatian: Nisu primijećene klinički značajne razlike u farmakokinetici vorapaksara nakon istodobne svakodnevne primjene antacida koji sadrži aluminijev hidroksid/magnezijev karbonat ili pantoprazola (inhibitora protonske pumpe).
English: When Zontivity was co-administered with prasugrel, no clinically significant pharmacokinetic interaction was demonstrated.
Croatian: Kada se Zontivity primjenjivao istodobno s prasugrelom, nije primijećena klinički značajna farmakokinetička interakcija.
English: • clarithromycin, telithromycin (used to treat infections)
Croatian: • klaritromicin, telitromicin (koriste se za liječenje infekcija),
English: Because of the limited therapeutic experience and the increased inherent risk of bleeding in patients with severe hepatic impairment, Zontivity is contraindicated in such patients (see sections 4.3, 4.4, and 5.2).
Croatian: Zbog ograničenog terapijskog iskustva i povišenog inherentnog rizika od krvarenja u bolesnika s teškim oštećenjem funkcije jetre, Zontivity je u tih bolesnika kontraindiciran (vidjeti dijelove 4.3, 4.4 i 5.2).
English: In the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trial, comprising patients with a NSTEACS (non-ST segment elevation acute coronary syndrome) who were largely antiplatelet naive, vorapaxar, with a loading dose of 40 mg and then maintained at 2.5 mg/day in addition to standard of care, initiated within 24 hours of NSTEACS, did not achieve its primary efficacy endpoint (cardiovascular death, MI, stroke, urgent coronary revascularization, and recurrent ischemia with rehospitalisation) and there was an increased risk of GUSTO moderate or severe bleeding.
Croatian: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome), u kojem su sudjelovali bolesnici s akutnim koronarnim sindromom bez elevacije ST-spojnice (engl. non-ST segment elevation acute coronary syndrome, NSTEACS) koji prethodno pretežno nisu primali antitrombocitne lijekove, liječenje vorapaksarom započeto udarnom dozom od 40 mg unutar 24 sata nakon NSTEACS-a i zatim nastavljeno dozom od 2,5 mg/dan uz standardnu terapiju nije postiglo primarnu mjeru ishoda za djelotvornost (smrt zbog kardiovaskularnog uzroka, IM, moždani udar, hitna koronarna revaskularizacija i rekurentna ishemija s rehospitalizacijom), a postojao je i povećan rizik od umjerenog ili teškog krvarenja prema GUSTO kriterijima.
English: In the cohort of post-MI or PAD patients with no history of stroke or TIA, the net clinical outcome analysis based on multiple occurrences of endpoints (CV Death/MI/Stroke/GUSTO Severe) is constant over time at each of the censoring times examined (12, 18, 24, 30, and 36 months) at cumulative 6-month intervals.
Croatian: U kohorti bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIAu, rezultat analize neto kliničkog ishoda, temeljen na višestrukim nastupima ishoda (smrt zbog KV uzroka/IM/moždani udar/teško prema GUSTO kriterijima), tijekom vremena je konstantan za svaki ispitivani cenzurirajući interval (12, 18, 24, 30 i 36 mjeseci) u kumulativnim 6-mjesečnim intervalima. (Vidjeti Tablicu 5).
English: Based upon in vitro data, chronic administration of vorapaxar is unlikely to induce the metabolism of drugs metabolized by major CYP isoforms.
Croatian: In vitro podaci pokazuju da nije vjerojatno da će kronična primjena vorapaksara inducirati metabolizam lijekova koji se metaboliziraju posredstvom glavnih CYP izoformi.
English: The percentages of patients who underwent CABG surgery and had CABG-related bleeds are shown in Table 3.
Croatian: Postotak bolesnika koji su bili podvrgnuti CABG-u i koji su imali krvarenje vezano uz CABG prikazan je u Tablici
English: It is not known whether vorapaxar is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se vorapaksar u majčino mlijeko.
English: Concomitant use of Zontivity with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) should be avoided.
Croatian: Nužno je izbjegavati istodobnu primjenu lijeka Zontivity sa potentnim inhibitorima CYP3A (npr. ketokonazolom, itrakonazolom, posakonazolom, klaritromicinom, nefazodonom, ritonavirom, sakvinavirom, nelfinavirom, indinavirom, boceprevirom, telaprevirom, telitromicinom i konivaptanom).
English: In post-MI and PAD patients, the median duration of treatment with Zontivity in these patients was 2.5 years (up to 4 years).
Croatian: U bolesnika koji su pretrpjeli IM i bolesnika s PAD-om, medijan trajanja liječenja lijekom Zontivity iznosio je 2,5 godine (najviše 4 godine).
English: • double vision
Croatian: • dvoslike,
English: What Zontivity is
Croatian: Što je Zontivity
English: • carbamazepine, phenytoin (anti-seizure medicines)
Croatian: • karbamazepin, fenitoin (lijekovi protiv napadaja),
English: Effects of vorapaxar on other medicinal products
Croatian: Učinci vorapaksara na druge lijekove
English: However, if a patient is to undergo elective surgery, if clinically feasible, Zontivity should be discontinued at least 30 days prior to surgery.
Croatian: Međutim, u slučaju elektivnog kirurškog zahvata, primjena lijeka Zontivity mora se prekinuti najkasnije 30 dana prije kirurškoga zahvata, ako je to klinički izvedivo.
English: Although the TRA 2°P - TIMI 50 trial was not designed to evaluate the relative benefit of Zontivity in individual patient subgroups, the benefit was most apparent in patients who were enrolled on the basis of a recent MI as indicated by a history of spontaneous MI ≥2 weeks but 12 months prior (post-MI or PAD patient population) with no history of stroke or TIA.
Croatian: Iako ispitivanje TRA 2°P - TIMI 50 nije bilo dizajnirano da ocijeni relativnu korist lijeka Zontivity u pojedinačnim podskupinama bolesnika, korist je bila najizraženija u bolesnika koji su bili uključeni u ispitivanje na temelju nedavnog IM-a, definiranog kao spontani IM ≥2 tjedna, ali 12 mjeseci prije početka ispitivanja (populacija bolesnika koji su pretrpjeli IM ili imaju PAD), a koji u anamnezi nisu imali moždani udar ni TIA-u.
English: The film-coated tablets are yellow, oval-shaped, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side.
Croatian: Filmom obložene tablete su žute, ovalne, veličine 8,48 mm x 4,76 mm, s oznakom "351" na jednoj i logotipom tvrtke MSD na drugoj strani.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza "Rok valjanosti" ili na blisteru iza "EXP".
English: • have ever had stomach ulcers or small growths in your gut (‘colon polyps')
Croatian: • ste ikada imali vrijed (čir) na želucu ili malene izrasline u crijevima (polipe u debelom crijevu),
English: If you have a stroke, ‘mini-stroke', or bleeding in the brain while taking Zontivity, your doctor ought to stop your Zontivity.
Croatian: Ako za vrijeme uzimanja lijeka Zontivity doživite moždani udar, mali moždani udar ili krvarenje u mozgu, liječnik bi morao prekinuti njegovu primjenu.
English: A history of bleeding disorders and use of certain concomitant medicinal products (e.g., anticoagulant and fibrinolytic therapy, and chronic nonsteroidal anti-inflammatory drugs (NSAIDS), selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors) may also increase the risk of bleeding in patients taking Zontivity.
Croatian: Poremećaji hemostaze u anamnezi te istodobna primjena određenih lijekova (npr. antikoagulantna i fibrinolitička terapija te trajna primjena nesteroidnih protuupalnih lijekova (NSAIL), selektivnih inhibitora ponovne pohrane serotonina ili inhibitora ponovne pohrane serotonina i noradrenalina) također mogu povećati rizik od krvarenja u bolesnika koji uzimaju Zontivity.
English: Patients taking Zontivity should also take acetylsalicylic acid with or without clopidogrel according to their indications or standard of care.
Croatian: Bolesnici koji uzimaju Zontivity moraju također uzimati acetilsalicilatnu kiselinu, s klopidogrelom ili bez njega, sukladno indikaciji ili standardima liječenja.
English: • antacids and pantoprazole (used to treat upset stomach)
Croatian: • antacide i pantoprazol (koriste se za liječenje želučanih tegoba),
English: Hazard Ratio and p-value were calculated based on Andersen-Gill model with covariates treatment and stratification factor (planned thienopyridine use).
Croatian: Omjer rizika i p-vrijednosti izračunate su temeljem Andersen-Gill modela s kovarijantama liječenja i stratifikacijskim faktorom (planirana uporaba tienopiridina).
English: In the TRA 2ºP-TIMI 50 trial, although CABG-related TIMI major bleeding was observed in patients taking vorapaxar (see section 4.8), patients who continued therapy with vorapaxar while undergoing CABG did not show an increased risk of major bleeding compared to placebo.
Croatian: Iako je u ispitivanju TRA 2ºP - TIMI 50 u bolesnika liječenih vorapaksarom primijećeno obilno krvarenje vezano uz CABG prema TIMI kriterijima (vidjeti dio 4.8), bolesnici koji su nastavili liječenje vorapaksarom tijekom CABG-a nisu imali povećan rizik od obilnog krvarenja u usporedbi s bolesnicima koji su primali placebo.
English: Among post-MI or PAD patients without a history of stroke or TIA, Zontivity appeared to reduce the rate of definite stent thrombosis (HR 0.71 (0.51-0.99 for adjudicated “definite”) vs. placebo in subjects receiving any stent before or during the study.
Croatian: Među bolesnicima koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u, Zontivity je, čini se, smanjio stopu potpune tromboze stenta (HR 0,71 (0,51-0,99 za događaj ocijenjen kao "definitivan") naspram placeba u ispitanika kojima je bio ugrađen bilo kakav stent prije ili tijekom ispitivanja.
English: Table 1: Tabulated List of Adverse Reactions
Croatian: Tablica 1: Tablični prikaz nuspojava
English: • have had recent bleeding from the stomach or gut
Croatian: • ste nedavno imali krvarenje u želucu ili crijevima,
English: • bleeding that is severe or that you cannot control
Croatian: • teško krvarenje ili krvarenje koje ne možete zaustaviti,
English: At a dose of 2.5 mg of vorapaxar sulfate (equivalent to 2.08 mg vorapaxar) daily, vorapaxar consistently achieves ≥80% inhibition of TRAP-induced platelet aggregation within one week of initiation of treatment.
Croatian: Pri dozi vorapaksarsulfata od 2,5 mg na dan (što odgovara 2,08 mg vorapaksara), vorapaksar dosljedno ostvaruje inhibiciju TRAP-om inducirane agregacije trombocita od ≥ 80% unutar tjedana dana od početka liječenja.
English: No effects on fertility were observed in animal studies (see section 5.3).
Croatian: U ispitivanjima na životinjama nisu primijećeni učinci na plodnost (vidjeti dio 5.3).
English: MI
Croatian: IM
English: Co-administration of vorapaxar (40 mg) and digoxin (0.5 mg single-dose) increased digoxin Cmax and AUC by 54% and 5%, respectively.
Croatian: Istodobna primjena vorapaksara (40 mg) i digoksina (jednokratna doza od 0,5 mg) povisila je Cmax digoksina za 54%, a njegov AUC za 5%.
English: After oral administration of a single vorapaxar sulfate 2.5 mg dose, vorapaxar is rapidly absorbed and peak concentrations occur at a median tmax of 1 hour (range: 1 to 2) under fasted conditions.
Croatian: Nakon peroralne primjene jednokratne doze vorapaksarsulfata od 2,5 mg, vorapaksar se brzo apsorbira, a vršne se koncentracije postižu u medijanu tmax od 1 sata (raspon: 1 do 2) nakon primjene natašte.
English: Withholding Zontivity for a brief period will not be useful in preventing or managing an acute bleeding event because of its long half-life (see section 5.2).
Croatian: Zbog dugog poluvijeka lijeka Zontivity, kratkotrajan prekid njegove primjene neće pridonijeti sprječavanju ni zbrinjavanju događaja akutnoga krvarenja (vidjeti dio 5.2).
English: Patients with a history of PAD but without a history of stroke or TIA randomized to vorapaxar had fewer peripheral revascularization procedures (15.4% v 19.3%, 3-year KM rates; HR 0.82 [0.71-0.94, 95% CI]; P=0.005) and fewer hospitalizations for acute limb ischemia (2.0% v 3.3%; HR 0.59 [0.400.86]; P=0.007) than patients randomized to placebo.
Croatian: Bolesnici koji u anamnezi imaju PAD, ali ne i moždani udar ili TIA-u, a koji su randomizirani da primaju vorapaksar imali su manji broj postupaka periferne revaskularizacije (15,4% naspram 19,3%, 3-godišnje stope po Kaplan-Meieru; HR 0,82 [0,71-0,94, 95% CI]; P=0,005) i manji broj hospitalizacija zbog akutne ishemije ekstremiteta (2,0% naspram 3,3%; HR 0,59 [0,40-0,86]; P=0,007) nego bolesnici randomizirani da primaju placebo.
English: Of these patients, 10,080 received Zontivity (8,458 post-MI and 1,622 PAD) and 10,090 received placebo (8,439 post-MI and 1,651 PAD) in addition to standard of care, including antiplatelet therapy with acetylsalicylic acid and thienopyridine.
Croatian: Među tim je bolesnicima njih 10 080 primalo Zontivity (8458 pretrpjelo IM, a 1622 ima PAD), a njih 10 090 placebo (8439 pretrpjelo IM, a 1651 ima PAD) kao dodatak standardnoj terapiji, uključujući antitrombocitnu terapiju acetilsalicilatnom kiselinom i tienopiridinom.
English: Patients taking Zontivity should also take acetylsalicylic acid or clopidogrel according to their indications or standard of care.
Croatian: Bolesnici koji uzimaju Zontivity moraju također uzimati acetilsalicilatnu kiselinu ili klopidogrel sukladno indikaciji ili standardima liječenja.
English: Randomization to 12 months Total Events
Croatian: Randomizirano do 12 mjeseci
English: In addition, vorapaxar inhibits thrombin receptor agonist peptide (TRAP)-induced platelet aggregation without affecting coagulation parameters.
Croatian: Osim toga, vorapaksar inhibira agregaciju trombocita induciranu peptidom koji aktivira trombinske receptore (engl. thrombin receptor agonist peptide, TRAP), a pritom ne utječe na koagulacijske parametre.
English: • inflammation of the stomach
Croatian: • upala želuca.
English: The treatment effect of Zontivity was consistent with the overall results across many subgroups, including sex; age; renal insufficiency; medical history of diabetes mellitus; tobacco use; concomitant therapies at baseline including thienopyridine, acetylsalicylic acid, and statins.
Croatian: Terapijski učinak lijeka Zontivity bio je u skladu s ukupnim rezultatima primijećenima u brojnim podskupinama, uključujući podskupine prema spolu, dobi, oštećenju funkcije bubrega, anamnezi dijabetesa, uživanju duhana, lijekovima u istodobnoj primjeni na početku ispitivanja, uključujući tienopiridin, acetilsalicilatnu kiselinu i statine.
English: They should talk to the doctor who prescribed Zontivity for you before you have any surgery or invasive procedure.
Croatian: Oni bi trebali razgovarati s liječnikom koji Vam je propisao Zontivity prije bilo kakvog kirurškog ili invazivnog zahvata.Vaš liječnik može Vam savjetovati da prestanete uzimati Zontivity prije kirurškog zahvata.
English: Gastritis, Gastrointestinal haemorrhage, Gingival bleeding, Melaena, Rectal haemorrhage
Croatian: Poremećaji probavnog sustava gastritis, gastrointestinalno krvarenje, krvarenje iz desni, melena, rektalno krvarenje
English: The treatment effect of vorapaxar on the primary and key secondary endpoints was shown to be durable and persistent over the length of the TRA 2°P - TIMI 50 study.
Croatian: Terapijski učinak vorapaksara na mjere primarnog ishoda i ključne mjere sekundarnog ishoda pokazao se dugotrajnim i održao se tijekom čitavog trajanja ispitivanja TRA 2°P - TIMI 50.
English: If any of the above apply to you, or if you are not sure, talk to your doctor, pharmacist, or nurse before taking Zontivity.
Croatian: Ako se bilo što od navedenoga odnosi na Vas ili niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Zontivity.
English: Driving and using machines Zontivity is not likely to affect your ability to drive or use machines.
Croatian: Nije vjerojatno da će Zontivity utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: Hazard Ratio is vorapaxar group versus placebo group.
Croatian: Omjer rizika je vorapaksar skupina naspram placebo skupini.
English: The mean absolute bioavailability of vorapaxar from the 2.5 mg dose of vorapaxar sulfate is 100%.
Croatian: Srednja vrijednost apsolutne bioraspoloživosti vorapaksara nakon primjene doze od 2,5 mg vorapaksarsulfata iznosi 100%.
English: No clinically meaningful inhibition of CYP2B6, CYP3A, CYP2C19, or CYP2D6 by M20 is expected.
Croatian: Ne očekuje se da će M20 klinički značajno inhibirati CYP2B6, CYP3A, CYP2C19 ili CYP2D6.
English: The underlying risk of bleeding (e.g., recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, or active peptic ulcer disease) should be considered before initiating Zontivity.
Croatian: Prije početka liječenja lijekom Zontivity mora se razmotriti već postojeći rizik od krvarenja (npr. nedavna trauma, nedavni kirurški zahvat, nedavno ili rekurentno gastrointestinalno krvarenje ili aktivna peptička ulkusna bolest).
English: • digoxin (used to treat heart failure)
Croatian: • digoksin (koristi se za liječenje zatajenja srca),
English: The study's primary endpoint was the composite of cardiovascular death, MI, stroke, and UCR.
Croatian: Mjera primarnog ishoda ispitivanja objedinjavala je smrt zbog kardiovaskularnog uzroka, IM, moždani udar i UCR.
English: Platelet transfusion may be considered as supportive therapy should bleeding occur (see section 5.3).
Croatian: Kao potporna terapija u slučaju krvarenja može se razmotriti transfuzija trombocita (vidjeti dio 5.3).
English: Packs of 7, 28, 30 and 100 tablets in aluminium blister cards.
Croatian: Pakiranja s 7, 28, 30 i 100 tableta u aluminijskim blister karticama.
English: In addition, no clinically meaningful inhibition of OATP1B1, OATP1B3, BCRP, OAT1, OAT3, and
Croatian: Osim toga, ne očekuje se da će vorapaksar ili M20 klinički značajno inhibirati OATP1B1, OATP1B3, BCRP, OAT1, OAT3 ili OCT2.
English: In the cohort of post-MI or PAD patients with no history of stroke or TIA, the findings for the primary and key secondary composite endpoints are consistent with the overall population (see Figure 1 and Table 4).
Croatian: U kohorti bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u, rezultati mjere primarnog ishoda i ključne mjere sekundarnog kompozitnog ishoda bili su sukladni onima u cjelokupnoj populaciji (vidjeti Sliku 1 i Tablicu 4).
English: • coughing up blood or blood clots
Croatian: • iskašljavanje krvi ili krvnih ugrušaka.
English: • have active peptic ulcer disease
Croatian: • imate aktivnu ulkusnu bolest,
English: In patients treated with vorapaxar the concomitant use of heparin (including low molecular weight heparin (LMWH)) might be associated with an increased risk of bleeding and caution is advised.
Croatian: U bolesnika liječenih vorapaksarom istodobna primjena heparina (uključujući heparin male molekulske mase) može biti povezana s povećanim rizikom od krvarenja te se savjetuje oprez.