FrancophonIA/ELRC3.0 huggingface dataset:
English: Reduced hepatic function is a risk factor for bleeding and should be considered before initiating Zontivity.
Slovenian: Zmanjšano delovanje jeter je dejavnik tveganja za krvavitve in ga je treba upoštevati pred uvedbo zdravila Zontivity.
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.
Slovenian: Med bolniki z MI brez možganske kapi ali TIA v anamnezi jih je ob vključitvi v preskušanje 21 % prejemalo acetilsalicilno kislino brez tienopiridina, 1% tienopiridin brez acetilsalicilne kisline in 77 % acetilsalicilno kislino in tienopiridin.
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.
Slovenian: Med bolniki s PAD brez možganske kapi ali TIA v anamnezi jih je ob vključitvi v preskušanje 61 % prejemalo acetilsalicilno kislino brez tienopiridina, 8 % tienopiridin brez acetilsalicilne kisline in 27 % acetilsalicilno kislino in tienopiridin.
English: There are no data on fertility in humans administered Zontivity.
Slovenian: Podatkov o plodnosti pri ljudeh, ki so prejemali zdravilo Zontivity, ni.
English: Vorapaxar had no effects on fertility of male and female rats at exposures sufficiently in excess of human exposure at the RHD.
Slovenian: Vorapaksar ni vplival na plodnost samcev in samic podgan pri izpostavljenostih, ki so dovolj presegale izpostavljenost pri človeku med uporabo priporočenega odmerka za človeka.
English: In addition, no clinically meaningful inhibition of OATP1B1, OATP1B3, BCRP, OAT1, OAT3, and
Slovenian: Poleg tega ni pričakovati klinično pomembnega zaviranja OATP1B1, OATP1B3, BCRP, OAT1, OAT3 in OCT2 z vorapaksarjem ali M20.
English: Your doctor will determine if you should also take aspirin, clopidogrel, or both, while taking Zontivity.
Slovenian: Zdravnik bo določil, ali morate z zdravilom Zontivity jemati tudi acetilsalicilno kislino, klopidogrel ali oba.
English: Platelet transfusion may be considered as supportive therapy should bleeding occur (see section 5.3).
Slovenian: V primeru krvavitve pride kot podporno zdravljenje v poštev transfuzija trombocitov (glejte poglavje 5.3).
English: Packs of 7, 28, 30 and 100 film-coated tablets in aluminium/aluminium blister cards.
Slovenian: Pakiranja po 7, 28, 30 in 100 filmsko obloženih tablet v aluminij/aluminijskih pretisnih omotih.
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.
Slovenian: Zaviranje agregacije trombocitov, sprožene s TRAP, na ravni ≥ 80 % lahko traja od 2 do 4 tedne po prenehanju uporabe dnevnih odmerkov vorapaksarjevega sulfata 2,5 mg. Trajanje teh farmakodinamičnih učinkov je skladno z eliminacijskim razpolovnim časom zdravila.
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.
Slovenian: Med bolniki po MI ali PAD, ki v anamnezi niso imeli možganske kapi ali TIA, je bil delež prekinitev zdravljenja zaradi neželenih učinkov pri zdravilu Zontivity 6,8 % in pri placebu 6,9 %.
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
Slovenian: Slika 1: Čas do prvega pojava srčno-žilne smrti, MI, možganske kapi ali UCR pri bolnikih po MI ali PAD in brez možganske kapi ali TIA v anamnezi
English: • warfarin, other oral anticoagulants, heparin, or low molecular weight heparin (blood thinner medicines)
Slovenian: • varfarin, druga peroralna zdravila proti strjevanju krvi, heparin ali nizkomolekularni heparin
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: (See Table 5.)
Slovenian: (Glejte preglednico 5.)
English: Gastritis, Gastrointestinal haemorrhage, Gingival bleeding, Melaena, Rectal haemorrhage
Slovenian: Bolezni prebavil gastritis, krvavitev v prebavila, krvavitev iz dlesni, melena, rektalna krvavitev
English: This background therapy was to be continued during the trial at the treating physician's discretion, per standard of care.
Slovenian: Med preskušanjem so po zdravnikovi presoji in v skladu s standardno oskrbo osnovno zdravljenje nadaljevali.
English: Co-administration of ketoconazole (400 mg once-daily) with vorapaxar significantly increased the vorapaxar mean Cmax and AUC by 93% and 96%, respectively.
Slovenian: Sočasna uporaba ketokonazola (400 mg enkrat na dan) in vorapaksarja je bistveno zvečala povprečno Cmax vorapaksarja za 93 % in AUC za 96 %.
English: Table 4: Primary and Key Secondary Efficacy Endpoints in Post-MI or PAD Patients with No History of Stroke or TIA
Slovenian: Preglednica 4: Primarni in ključni sekundarni opazovani dogodki učinkovitosti pri bolnikih po MI ali PAD in brez možganske kapi ali TIA v anamnezi
English: Packs of 10 and 50 film-coated tablets in aluminium/aluminium unit-dose blister cards.
Slovenian: Pakiranja po 10 in 50 filmsko obloženih tablet v aluminij/aluminijskih enoodmernih pretisnih omotih.
English: Vorapaxar exposure increases in an approximately dose-proportional manner following single doses of 1 to 40 mg and multiple doses of 0.5 to 2.5 mg of vorapaxar sulfate.
Slovenian: Izpostavljenost vorapaksarju se po enkratnih odmerkih od 1 do 40 mg in večkratnih odmerkih od 0,5 do 2,5 mg vorapaksarjevega sulfata povečuje približno sorazmerno odmerku.
English: Patients with only one Event Patients with two Events Patients with ≥3 Events
Slovenian: Randomizacija do 12 mesecev skupni dogodki bolniki s samo enim dogodkom bolniki z dvema dogodkoma bolniki z ≥ 3 dogodki
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.
Slovenian: Pred uvedbo zdravila Zontivity je treba pretehtati bolnikovo osnovno tveganje za krvavitve (npr. nedavno poškodbo, nedavno operacijo, nedavno ali ponavljajočo se gastrointestinalno krvavitev ali aktivno peptično ulkusno bolezen).
English: Conjunctival haemorrhage, diplopia
Slovenian: Očesne bolezni krvavitev veznice, diplopija
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.
Slovenian: Poleg standardne oskrbe (vključno z antiagregacijskim zdravljenjem z acetilsalicilno kislino in tienopiridinom) je 10.080 teh bolnikov prejemalo zdravilo Zontivity (8.458 po MI in 1.622 po PAD) in 10.090 placebo (8.439 po MI in 1.651 po PAD).
English: Discontinuation of Zontivity
Slovenian: Ukinitev zdravila Zontivity
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.
Slovenian: Pri bolnikih, ki se zdravijo z vorapaksarjem, je lahko sočasna uporaba heparina (vključno z nizko molekularnim heparinom) povezana s povečanim tveganjem za krvavitve, zato svetujemo previdnost.
English: When Zontivity was co-administered with prasugrel, no clinically significant pharmacokinetic interaction was demonstrated.
Slovenian: Med sočasno uporabo zdravila Zontivity in prasugrela niso ugotovili klinično pomembnega farmakokinetičnega medsebojnega delovanja.
English: Zontivity is contraindicated in patients with severe hepatic impairment (Child Pugh, 10 to 15 points) (see sections 4.3 and 4.4).
Slovenian: Pri bolnikih s hudo okvaro jeter (Child Pugh od 10 do 15 točk) je zdravilo Zontivity kontraindicirano (glejte poglavji 4.3 in 4.4).
English: Increased tendency to bruise Ecchymosis, Skin haemorrhage
Slovenian: Bolezni kože in podkožja ekhimoze, kožne krvavitve
English: Therefore, vorapaxar should not be used with prasugrel or ticagrelor.
Slovenian: Vorapaksarja se ne sme uvesti pri bolnikih, ki jemljejo prasugrel ali tikagrelor.
English: • plan to have surgery including dental surgery
Slovenian: • če imate predvideno kakšno operacijo (vključno z zobno operacijo),
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.
Slovenian: Tablete so rumene, ovalne, filmsko obložene tablete, velikosti 8,48 mm x 4,76 mm, z oznako "351" na eni strani in MSD logotipom na drugi strani.
English: Co-administration of rifampin (600 mg once-daily) with vorapaxar substantially decreased the vorapaxar mean Cmax and AUC by 39% and 55%, respectively.
Slovenian: Sočasna uporaba rifampicina (600 mg enkrat na dan) in vorapaksarja je znatno zmanjšala povprečno Cmax vorapaksarja za 39 % in AUC za 55 %.
English: • If you have any further questions, ask your doctor, pharmacist, or nurse.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa
English: GUSTO Bleeding Categories Severe
Slovenian: Kategorije krvavitev po GUSTO Hude
English: Zontivity 2 mg tablets Vorapaxar
Slovenian: Zontivity 2 mg tablete vorapaksar
English: Each tablet contains 2.08 mg of vorapaxar (as vorapaxar sulfate).
Slovenian: Ena tableta vsebuje 2,08 mg vorapaksarja (kot vorapaksarjevega sulfata).
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.
Slovenian: Če kaj od naštetega velja za vas ali če ste negotovi, se pred jemanjem zdravila Zontivity posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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.
Slovenian: Med bolniki po MI ali PAD in brez možganske kapi ali TIA v anamnezi je bil 3-letni po K-M ocenjeni delež dogodkov ICH z zdravilom Zontivity in standardno oskrbo 0,6 % in s standardno oskrbo samo 0,5 %.
English: Pack sizes
Slovenian: Velikosti pakiranj
English: Zontivity is not recommended for children and adolescents under 18 years of age.
Slovenian: Zdravilo Zontivity ni priporočljivo za otroke in mladostnike, mlajše od 18 let, ker ni znano, ali je zdravilo Zontivity pri njih varno in učinkovito.
English: Coadministration with other antiplatelet medicinal products
Slovenian: Sočasna uporaba z drugimi antiagregacijskimi zdravili
English: In patients treated with Zontivity the concomitant use of heparin (including LMWH) might be associated with an increased risk of bleeding and caution is advised.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Zontivity, je lahko sočasna uporaba heparina (vključno z nizko molekularnim heparinom) povezana s povečanim tveganjem za krvavitve, zato svetujemo previdnost.
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.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo zdravila Zontivity posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Vorapaxar should not be used with prasugrel or ticagrelor (see section 4.2).
Slovenian: V študijah faze 3 z vorapaksarjem je izkušenj s prasugrelom malo, s tikagrelorjem pa jih ni. Vorapaksarja se ne sme uporabljati s prasugrelom ali tikagrelorjem (glejte poglavje 4.2).
English: Table 2: Non-CABG-Related Bleeds in Post-MI or PAD Patients with No History of Stroke or TIA
Slovenian: Preglednica 2: Krvavitve, ki niso povezane s CABG, pri bolnikih po MI ali PAD in brez možganske kapi ali TIA v anamnezi
English: Hazard Ratio is vorapaxar group versus placebo group.
Slovenian: Razmerje tveganj je skupina z vorapaksarjem v primerjavi s skupino s placebom.
English: Film coating Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Iron oxide yellow (E172)
Slovenian: Filmska obloga laktoza monohidrat hipromeloza (E464) titanov dioksid (E171) triacetin (E1518) rumeni železov oksid (E172)
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.
Slovenian: Med bolniki po MI ali PAD, ki v anamnezi niso imeli možganske kapi ali TIA, je zdravilo Zontivity pri bolnikih, ki so dobili kakršno koli žilno opornico pred študijo ali med njo, v primerjavi s placebom kot kaže zmanjšalo delež definitivne tromboze žilne opornice (HR 0,71: od 0,51 do 0,99 za presojo "definitivna«).
English: Each film-coated tablet contains 2.08 mg vorapaxar (as vorapaxar sulfate).
Slovenian: Ena filmsko obložena tableta vsebuje 2,08 mg vorapaksarja (v obliki vorapaksarjevega sulfata).
English: Lactose monohydrate Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Povidone (E1201) Magnesium stearate (E572)
Slovenian: Jedro tablete laktoza monohidrat celuloza, mikrokristalna (E460) premreženi natrijev karmelozat (E468) povidon (E1201) magnezijev stearat (E572)
English: In TRA 2°P - TIMI 50, 367 post-MI or PAD patients with no history of stroke or TIA underwent CABG surgery.
Slovenian: V študiji TRA 2°P - TIMI 50 je bila CABG opravljena pri 367 bolnikih po MI ali PAD, ki v anamnezi niso imeli možganske kapi ali TIA.
English: • The other ingredients are: Tablet core: lactose monohydrate; cellulose microcrystalline (E460); croscarmellose sodium (E468); povidone (E1201); magnesium stearate (E572).
Slovenian: • Pomožne snovi so: Jedro tablete: laktoza monohidrat, mikrokristalna celuloza (E460), premreženi natrijev karmelozat (E468), povidon (E1201), magnezijev stearat (E572).
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.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Zontivity, je lahko tveganje za krvavitve večje tudi v primeru motenj strjevanja krvi v anamnezi oziroma sočasne uporabe določenih zdravil (npr. antikoagulantov in fibrinolitikov, kroničnega zdravljenja z nesteroidnimi antirevmatiki (NSAR), selektivnimi zaviralci privzema serotonina, zaviralci privzema serotoninanoradrenalina).
English: What Zontivity is used for
Slovenian: Za kaj uporabljamo zdravilo Zontivity
English: You and your doctor will decide if you will take Zontivity or breast-feed.
Slovenian: Skupaj z zdravnikom se boste odločili, ali boste jemali zdravilo Zontivity ali pa boste dojili.
English: - symptomatic peripheral arterial disease (PAD), co-administered with acetylsalicylic acid (ASA)
Slovenian: - s simptomatsko periferno arterijsko boleznijo (PAD - Peripheral Arterial Disease), v kombinaciji z acetilsalicilno kislino (ASA) in, če je primerno, s klopidogrelom.
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.
Slovenian: Zmerne po opredelitvi GUSTO: krvavitev, ki zahteva transfuzijo polne krvi ali koncentriranih eritrocitov, brez hemodinamske prizadetosti.
English: • Patients with a history of stroke or transient ischaemic attack (TIA) (see section 5.1).
Slovenian: • bolniki, ki imajo v anamnezi možgansko kap ali tranzitorno ishemično atako (TIA) (glejte
English: Wound haemorrhage
Slovenian: Okvara ledvic
English: A delayed onset of action (at least 7 days) should be expected when starting therapy with Zontivity.
Slovenian: Ko začnete zdravljenje z zdravilom Zontivity, morate pričakovati zapoznel začetek delovanja (vsaj 7 dni).
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.
Slovenian: V preskušanju TRA 2ºP-TIMI 50 pri bolnikih, ki so prejemali vorapaksar, vključno s tistimi z možgansko kapjo v anamnezi, so pri tistih, s telesno maso < 60 kg, opazili večji delež ICH kot pri tistih, s telesno maso ≥ 60 kg.
English: • have had recent bleeding from the stomach or gut
Slovenian: • če ste pred nedavnim krvaveli v želodec ali črevo,
English: Packs of 10 and 50 tablets in aluminium unit-dose blister cards.
Slovenian: Pakiranja po 10 in 50 tablet v aluminijskih enoodmernih pretisnih omotih.
English: The mean estimated vorapaxar Cmax and AUC were 24% and 22% higher in Asian patients compared to that of Caucasians.
Slovenian: Pri bolnikih azijskega porekla je bila v primerjavi z belci povprečna ocenjena Cmax vorapaksarja 24 % višja in AUC 22 % višja.
English: What Zontivity contains
Slovenian: Kaj vsebuje zdravilo Zontivity
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)
Slovenian: Razmerje tveganj in vrednost p sta bila izračunana na podlagi Coxovega modela sorazmernih tveganj z zdravljenjem in stratifikacijskima faktorjema (aterosklerotična bolezen, ki je ustrezala kriterijem za vključitev v študijo, in načrtovana uporaba tienopiridina) kot sospremenljivkama
English: No dose adjustment is necessary for patients with renal impairment, including subjects with ESRD.
Slovenian: Bolnikom z okvaro ledvic, vključno z bolniki z ESRD, odmerka ni treba prilagoditi.
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%).
Slovenian: Mediana starost je bila 58 let, populacija pa je vključevala bolnike s sladkorno boleznijo (21 %) in bolnike s hipertenzijo (62 %).
English: Zontivity should be used with caution in patients with a body weight <60 kg.
Slovenian: Pri bolnikih s telesno maso < 60 kg je treba zdravilo Zontivity previdno uporabljati.
English: Fatal Bleeding
Slovenian: Krvavitve s smrtnim izidom
English: Severe renal impairment
Slovenian: Huda okvara ledvic
English: Vorapaxar did not increase bleeding time in non-human primates when administered alone at 1 mg/kg.
Slovenian: Vorapaksar pri primatih, razen človeka, ko je bil uporabljen sam v odmerku 1 mg/kg, ni podaljšal časa krvavitve.
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.
Slovenian: Pri bolnikih, zdravljenih z vorapaksarjem v kliničnih preskušanjih faz 2 in3, niso opazili pomembnih sprememb koncentracije selektina P, sCD40L in hs-CRP.
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).
Slovenian: Po vsakodnevni sočasni uporabi vorapaksarja in antacida z aluminijevim hidroksidom/magnezijevim karbonatom ali pantoprazola (zaviralec protonske črpalke) niso opazili klinično pomembnih razlik v farmakokinetiki vorapaksarja.
English: Tell your doctor if you are breast-feeding.
Slovenian: Zdravniku morate povedati, če dojite.
English: Zontivity 2 mg film-coated tablets
Slovenian: Zontivity 2 mg filmsko obložene tablete
English: No dose adjustment for vorapaxar is required in patients taking weak to moderate inhibitors of CYP3A.
Slovenian: Bolnikom, ki jemljejo šibke do zmerne zaviralce CYP3A, odmerka vorapaksarja ni treba prilagoditi.
English: Method of administration Oral use.
Slovenian: Način uporabe peroralna uporaba
English: • have liver or kidney problems
Slovenian: • če imate težave z jetri ali ledvicami,
English: Zontivity prevents platelets from sticking together.
Slovenian: Zdravilo Zontivity prepreči zlepljanje trombocitov.
English: In general, use of anti-platelet medicines, older age, or a low body weight increase the risk of bleeding.
Slovenian: Tveganje za krvavitev se na splošno povečuje z uporabo zdravil proti strjevanju krvi, višjo starostjo ali manjšo telesno maso.
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%).
Slovenian: Mediana starost je bila 66 let, populacija pa je vključevala bolnike s sladkorno boleznijo (35 %) in bolnike s hipertenzijo (82 %).
English: • bleeding gums
Slovenian: • krvavitev iz dlesni
English: No dose adjustment is required for patients with mild hepatic impairment.
Slovenian: Bolnikom z blago okvaro jeter odmerka ni treba prilagoditi.
English: Post-MI or PAD Patients with No History of Stroke or TIA
Slovenian: Bolniki po MI ali PAD brez možganske kapi ali TIA v anamnezi
English: Weight
Slovenian: Vrednost
English: There is limited clinical experience with prasugrel and no experience with ticagrelor in the Phase 3 studies.
Slovenian: Ker je kliničnih izkušenj s prasugrelom malo, izkušenj s tikagrelorjem v študijah faze 3 pa ni, se vorapaksarja s prasugrelom ali tikagrelorjem ne sme uporabljati.
English: What Zontivity is
Slovenian: Kaj je zdravilo Zontivity
English: • If you get any side effects, talk to your doctor, pharmacist, or nurse.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Zontivity 2 mg film-coated tablets Vorapaxar
Slovenian: Zontivity 2 mg filmsko obložene tablete vorapaksar
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.
Slovenian: Kliničnih izkušenj s sočasno uporabo peroralnih antikoagulantov in vorapaksarja je malo, s peroralnimi zaviralci faktorja Xa ali faktorja IIa v programu faze 3 raziskav vorapaksarja pa izkušenj ni. Sočasni uporabi zdravila Zontivity in antikoagulantov, npr. varfarina in novih peroralnih antikoagulantov, se je treba izogibati.
English: There is limited therapeutic experience in patients with severe renal impairment or end stage renal disease.
Slovenian: Terapevtskih izkušenj pri bolnikih s hudo okvaro ledvic ali končno odpovedjo ledvic je malo, zato je treba pri teh bolnikih zdravilo Zontivity previdno uporabljati.
English: Film-coating: lactose monohydrate; hypromellose (E464); titanium dioxide (E171); triacetin (E1518); iron oxide yellow (E172).
Slovenian: Filmska obloga: laktoza monohidrat, hipromeloza (E464), titanov dioksid (E171), triacetin
English: They should talk to the doctor who prescribed Zontivity for you before you have any surgery or invasive procedure.
Slovenian: Pred kakršno koli operacijo ali invazivnim posegom se morajo pogovoriti z zdravnikom, ki vam je predpisal zdravilo Zontivity.
English: Renal and urinary disorders Injury, poisoning, and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih krvavitev iz rane
English: Tabulated list of Adverse Reactions
Slovenian: Seznam neželenih učinkov v preglednici
English: Moderate TIMI Bleeding Categories Major
Slovenian: Kategorija krvavitve po TIMI Večje
English: Vorapaxar inhibits thrombin-induced platelet aggregation in in vitro studies.
Slovenian: Vorapaksar v študijah in vitro zavre s trombinom sproženo agregacijo trombocitov.
English: • bruising
Slovenian: • podplutbe