FrancophonIA/ELRC3.0 huggingface dataset:
English: Zontivity increases the risk of bleeding in proportion to the patient's underlying bleeding risk.
Slovenian: Zdravilo Zontivity poveča tveganje za krvavitve sorazmerno z bolnikovim osnovnim tveganjem zanje.
English: Transfusion of human platelet rich plasma normalised bleeding times with partial recovery of ex vivo platelet aggregation induced with arachidonic acid, but not induced with ADP or TRAP.
Slovenian: Transfuzija plazme, bogate s človeškimi trombociti, je normalizirala čas krvavitve in je dosegla delno obnovo agregacije trombocitov ex vivo, sprožene z arahidonsko kislino, ne pa sprožene z ADP ali TRAP.
English: The percentages of patients who underwent CABG surgery and had CABG-related bleeds are shown in Table 3.
Slovenian: Odstotki bolnikov, pri katerih so opravili CABG in so imeli s posegom povezane krvavitve, so prikazani v preglednici 3.
English: What you need to know before you take Zontivity
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zontivity
English: Zontivity increases the risk of bleeding, including ICH and sometimes fatal bleeding.
Slovenian: Zdravilo Zontivity poveča tveganje za krvavitve, vključno z ICH in v nekaterih primerih za krvavitve s smrtnim izidom.
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).
Slovenian: Celoten odmerek, ki ni imel vpliva na pre- in post-natalne razvojne učinke je znašal 5 mg/kg/dan (6,8-kratnik [samice živali] izpostavljenosti v stanju dinamičnega ravnovesja pri človeku pri odmerku 2,5 mg/dan).
English: The effect of Zontivity on GUSTO severe or moderate bleeding relative to placebo was shown to be consistent across the subgroups examined.
Slovenian: Učinek zdravila Zontivity na hude ali zmerne krvavitve po GUSTO je bil v primerjavi s placebom konsistenten v vseh raziskanih podskupinah.
English: The tablet may be taken with or without food.
Slovenian: Tableta se lahko jemlje s hrano ali brez nje.
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:
Slovenian: Vpliv okvare ledvic (končna odpoved ledvic na dializi) in okvare jeter na farmakokinetiko vorapaksarja so ocenili v specifičnih farmakokinetičnih študijah in so povzeti v nadaljevanju:
English: Your doctor will also give you instructions about acetylsalicylic acid or clopidogrel (other anti-platelet agents) that you may need to take with Zontivity.
Slovenian: Zdravnik vam bo dal tudi navodila glede acetilsalicilne kisline ali klopidogrela (drugi zdravili proti strjevanju krvi), ki ju boste morda morali jemati z zdravilom Zontivity.
English: Vorapaxar is eliminated primarily in the form of metabolites, with no vorapaxar detected in urine.
Slovenian: Vorapaksar se izloči predvsem v obliki presnovkov in v urinu ni zaznavnega vorapaksarja.
English: Includes all CV Death, MI, Stroke and GUSTO severe events up to each timepoint as indicated in the table.
Slovenian: Vključuje vse CV smrti, MI, možgansko kap in hude dogodke po opredelitvi GUSTO do časovne točke, navedene v preglednici.
English: As vorapaxar is highly protein-bound, haemodialysis is unlikely to be effective in the treatment of an overdose.
Slovenian: Ker je vorapaksar v veliki meri vezan na beljakovine, ni verjetno, da bi bila hemodializa učinkovita za zdravljenje prevelikega odmerjanja.
English: Vorapaxar is a selective and reversible inhibitor of the PAR-1 receptors on platelets that are activated by thrombin.
Slovenian: Vorapaksar je selektiven in reverzibilen zaviralec trombocitnih receptorjev PAR-1, ki jih aktivira trombin.
English: Based on population pharmacokinetic analysis using data from healthy subjects and patients with atherosclerotic disease, vorapaxar mean AUC is estimated to be higher in patients with mild (17%) and moderate (34%) renal impairment compared to those with normal renal function; these differences are not considered to be clinically relevant.
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov zdravih preiskovancev in bolnikov z aterosklerotično boleznijo ocenjujejo, da je povprečna AUC vorapaksarja višja pri bolnikih z blago (17 %) in zmerno (34 %) okvaro ledvic kot pri tistih z normalnim delovanjem ledvic; te razlike niso klinično pomembne.
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.
Slovenian: Učinek zdravljenja z vorapaksarjem na primarne in ključne sekundarne opazovane dogodke se je izkazal za obstojnega in trajnega med celotnim trajanjem študije TRA 2°P - TIMI 50.
English: In humans, vorapaxar has been administered in single doses up to 120 mg and daily doses of 5 mg for up to 4 weeks without observation of dose-associated adverse events or identification of a specific risk.
Slovenian: Pri ljudeh so vorapaksar uporabili v enkratnih odmerkih do 120 mg in dnevnih odmerkih 5 mg do 4 tedne, ne da bi opazili z odmerkom povezane neželene učinke ali ugotovili kakšno specifično tveganje.
English: • boceprevir, telaprevir (used to treat hepatitis C virus infections)
Slovenian: • boceprevir, telaprevir (uporabljata se za zdravljenje okužb z virusom hepatitisa C),
English: Co-administration with vorapaxar did not alter the single-dose pharmacokinetics of rosiglitazone (8 mg), a CYP2C8 substrate not marketed in the EU.
Slovenian: Sočasna uporaba vorapaksarja ni spremenila farmakokinetike enkratnega odmerka rosiglitazona (8 mg), substrata CYP2C8, ki ni na trgu EU.
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).
Slovenian: Pri bolnikih po MI in PAD je bilo mediano trajanje zdravljenja z zdravilom Zontivity 2,5 let (do 4 leta).
English: • vomiting blood or your vomit looks like ‘coffee grounds'
Slovenian: • bruhanje krvi ali pa je izbruhana vsebina videti kot "kavna usedlina"
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC26.
Slovenian: Farmakoterapevtska skupina: antitrombotiki, zaviralci agregacije trombocitov brez heparina Oznaka ATC: B01AC26.
English: Other medicines and Zontivity
Slovenian: Druga zdravila in zdravilo Zontivity
English: Vorapaxar and the major circulating active metabolite, M20, are extensively bound (≥99%) to human plasma proteins.
Slovenian: Vorapaksar in njegov glavni aktivni presnovek v obtoku, M20, sta v humani plazmi v veliki meri (≥ 99 %) vezana na beljakovine.
English: If your doctor prescribes you prasugrel or ticagrelor, you should stop Zontivity and talk to your doctor.
Slovenian: Če vam zdravnik predpiše prasugrel ali tikagrelor, morate prenehati jemati zdravilo Zontivity in se posvetovati z zdravnikom.
English: TRA 2°P - TIMI 50 was a multicenter, randomized, double-blind, placebo-controlled study conducted in patients who had evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems.
Slovenian: Študija TRA 2°PTIMI 50 je bila multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana študija pri bolnikih, ki so imeli znake ali anamnezo ateroskleroze s prizadetostjo koronarnega, možganskega ali perifernega ožilja.
English: A patient who misses a dose of Zontivity should skip the missed dose if it is within 12 hours of the next scheduled dose and take the next dose at the regular scheduled time.
Slovenian: Bolnik, ki izpusti odmerek zdravila Zontivity, do naslednjega predvidenega odmerka pa je manj kot 12 ur, mora izpuščeni odmerek preskočiti in naslednji odmerek vzeti ob rednem predvidenem času.
English: Medicinal products that increase gastric pH
Slovenian: Zdravila, ki zvišujejo pH v želodcu
English: Phase 3 data suggest that co-administration of a weak or moderate CYP3A inhibitor with vorapaxar does not increase bleeding risk or alter the efficacy of vorapaxar.
Slovenian: Podatki iz faze 3 kažejo, da sočasna uporaba šibkega ali zmernega zaviralca CYP3A z vorapaksarjem ne poveča tveganja za krvavitve in ne spremeni učinkovitosti vorapaksarja.
English: Patients with events
Slovenian: Bolniki z dogodki
English: No dose adjustment is necessary (see section 4.4).
Slovenian: Prilagoditev odmerka ni potrebna (glejte poglavje 4.4).
English: Schering-Plough Labo N.V. Industriepark 30
Slovenian: Schering-Plough Labo N.V.
English: The systemic pharmacokinetics of vorapaxar are linear with accumulation (6-fold) predictable from single- to multiple-dose data.
Slovenian: Sistemska farmakokinetika vorapaksarja je linearna, s predvidenim kopičenjem (6-kratnim) na podlagi podatkov o enkratnih in večkratnih odmerkih.
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.
Slovenian: V skupini bolnikov po MI ali PAD brez anamneze možganske kapi ali TIA, je analiza neto kliničnih izidov na podlagi večkratnih pojavov končnih dogodkov (CV smrt/MI/možganska kap/GUSTO resni dogodki) konstantna v vsaki ocenjevani časovni točki (12, 18, 24, 30 in 36 mesecev) v 6-mesečnih intervalih.
English: The composite of cardiovascular death, MI, and stroke were assessed as secondary endpoint.
Slovenian: Sestavljeni dogodek srčno-žilne smrti, MI in možganske kapi je bil ocenjen kot sekundarni opazovani dogodek.
English: Zontivity may be taken with or without food.
Slovenian: Zdravilo Zontivity se lahko jemlje s hrano ali brez nje.
English: The duration of platelet inhibition is dose and concentration dependent.
Slovenian: Trajanje zaviranja trombocitov je odvisno od odmerka in koncentracije.
English: Bleeding was the most common adverse reaction leading to study drug discontinuation for both treatments (3.0% for Zontivity and 1.8% for placebo).
Slovenian: V obeh primerih je bila krvavitev najpogostejši neželeni učinek, ki je povzročil prenehanje uporabe raziskovanega zdravila (Zontivity 3,0 %, placebo 1,8 %).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: No dosage adjustment of digoxin or Zontivity is recommended.
Slovenian: Prilagoditev odmerka digoksina ali zdravila Zontivity ni potrebna.
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.
Slovenian: Na osnovi rezultatov predkliničnih študij, kjer so preučevali krvavitev med uporabo vorapaksarja skupaj z acetilsalicilno kislino in klopidogrelom, je hemostazo morda mogoče ponovno vzpostaviti z dajanjem eksogenih trombocitov.
English: What Zontivity is and what it is used for
Slovenian: Kaj je zdravilo Zontivity in za kaj ga uporabljamo
English: Effects of vorapaxar on other medicinal products
Slovenian: Vpliv vorapaksarja na druga zdravila
English: • if you have ever had a stroke or ‘mini stroke' (also called a ‘transient ischemic attack' or TIA)
Slovenian: • če ste kdaj imeli možgansko kap ali "mini kap" (imenujejo jo tudi "tranzitorna ishemična ataka"
English: • dying from a heart attack
Slovenian: • smrt zaradi srčnega infarkta,
English: EU/1/14/976/001 7 film-coated tablets EU/1/14/976/002 10 x 1 film-coated tablets (unit-dose) EU/1/14/976/003 28 film-coated tablets EU/1/14/976/004 30 film-coated tablets EU/1/14/976/005 50 x 1 film-coated tablets (unit-dose) EU/1/14/976/006 100 film-coated tablets
Slovenian: EU/1/14/976/001 7 filmsko obloženih tablet EU/1/14/976/002 10 x 1 filmsko obložena tableta EU/1/14/976/003 28 filmsko obloženih tablet EU/1/14/976/004 30 filmsko obloženih tablet EU/1/14/976/005 50 x 1 filmsko obložena tableta EU/1/14/976/006 100 filmsko obloženih tablet
English: • have had bleeding problems in the past
Slovenian: • če ste imeli v preteklosti težave s krvavitvami,
English: Concomitant use of Zontivity with strong (potent) inducers of CYP3A (e.g., rifampin, carbamazepine and phenytoin) should be avoided.
Slovenian: Sočasni uporabi zdravila Zontivity in močnih induktorjev CYP3A (npr. rifampina, karbamazepina in fenitoina) se je treba izogibati.
English: The combination of vorapaxar with warfarin or other oral anticoagulants may increase the risk of bleeding and should be avoided.
Slovenian: Sočasna uporaba vorapaksarja in varfarina ali drugih peroralnih antikoagulantov lahko poveča tveganje za krvavitve in se ji je treba izogibati.
English: Vorapaxar does not inhibit platelet aggregation induced by other agonists such as adenosine diphosphate (ADP), collagen or a thromboxane mimetic.
Slovenian: Vorapaksar ne zavira agregacije trombocitov, sprožene z drugimi agonisti, kot so adenozin-difosfat (ADP), kolagen ali tromboksanski mimetik.
English: Platelet poor plasma had no effect on bleeding times or platelet aggregation.
Slovenian: S trombociti revna plazma ni vplivala na čas krvavitve ali agregacijo trombocitov.
English: Zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).
Slovenian: Ugotovljeno je, da zdravilo Zontivity zmanjša delež kombiniranega opazovanega dogodka srčno-žilnih smrti, MI, možganske kapi in nujne koronarne revaskularizacije (UCR - urgent coronary revascularization).
English: Ingestion of vorapaxar with a high-fat meal resulted in no meaningful change in AUC with a small (21%) decrease in Cmax and delayed tmax (45 minutes).
Slovenian: Zaužitje vorapaksarja z zelo mastnim obrokom ni pomembno spremenilo AUC, je pa nekoliko (21 %) zmanjšalo Cmax in podaljšalo tmax (45 minut).
English: • inflammation of the stomach
Slovenian: • vnetje želodca
English: • nefazodone (used to treat depression)
Slovenian: • nefazodon (uporablja se za zdravljenje depresije),
English: This is because it is not known if Zontivity passes into your breast milk.
Slovenian: Ni namreč znano, ali zdravilo Zontivity prehaja v materino mleko.
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.
Slovenian: Čeprav preskušanje TRA 2°P - TIMI 50 ni bilo namenjeno ugotavljanju relativne koristi zdravila Zontivity v posameznih podskupinah bolnikov, je bila korist najbolj očitna pri bolnikih, vključenih zaradi nedavnega MI, tj. z anamnezo spontanega MI ≥ 2 tedna, toda  12 mesecev prej (populacija bolnikov po MI ali PAD) in brez možganske kapi ali TIA v anamnezi.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
English: Call your doctor straight away if you have any of these symptoms of a stroke, which is uncommon:
Slovenian: Takoj pokličite zdravnika, če imate katerega od naslednjih simptomov možganske kapi, ki se pojavi občasno:
English: For patients being started on Zontivity due to symptomatic PAD, therapy may be initiated at any time.
Slovenian: Pri bolnikih, ki bodo prejeli zdravilo Zontivity zaradi simptomatske PAD, se lahko terapijo uvede kadar koli.
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).
Slovenian: Kratkotrajna prekinitev jemanja zdravila Zontivity za preprečevanje in obvladovanje akutne krvavitve zaradi dolge razpolovne dobe zdravila ni uporabna (glejte poglavje 5.2).
English: Elderly No dose adjustment is necessary in the elderly (see sections 4.4 and 5.2).
Slovenian: Starejši Pri starejših odmerka ni treba prilagajati (glejte poglavji 4.4 in 5.2).
English: Vorapaxar is eliminated by metabolism, with CYP3A4 and CYP2J2 responsible for formation of M20, its major active circulating metabolite, and M19, the predominant metabolite identified in excreta.
Slovenian: Vorapaksar se odstrani s presnovo; CYP3A4 in CYP2J2 sta odgovorna za nastajanje M20, glavnega aktivnega presnovka vorapaksarja v obtoku, in M19, prevladujočega presnovka, ugotovljenega v izločkih.
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.
Slovenian: Farmakokinetika vorapaksarja je pri bolnikih z blago (Child Pugh od 5 do 6 točk) do zmerno (Child Pugh od 7 do 9 točk) okvaro jeter in zdravih osebah podobna.
English: Strong CYP3A inducers
Slovenian: Močni induktorji CYP3A
English: If you forget to take Zontivity
Slovenian: Če ste pozabili vzeti zdravilo Zontivity
English: Zontivity contains an active substance called vorapaxar, and it belongs to a group of medicines called ‘anti-platelet medicines.'
Slovenian: Zdravilo Zontivity vsebuje zdravilno učinkovino, imenovano vorapaksar, in spada v skupino zdravil, imenovanih "antiagregacijska zdravila - zdravila proti strjevanju krvi".
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Hazard Ratio (95% CI)
Slovenian: Razmerje tveganj (95 % IZ )
English: If a dose is missed:
Slovenian: V primeru izpuščenega odmerka:
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).
Slovenian: V kohorti bolnikov po MI ali PAD, ki v anamnezi niso imeli možganske kapi ali TIA, so bili izsledki glede primarnega in ključnih sekundarnih sestavljenih opazovanih dogodkov skladni s celotno populacijo (glejte sliko 1 in preglednico 4).
English: Patients taking Zontivity should also take acetylsalicylic acid with or without clopidogrel according to their indications or standard of care.
Slovenian: Bolniki, ki jemljejo zdravilo Zontivity, morajo jemati tudi acetilsalicilno kislino, s klopidogrelom ali brez njega, v skladu z njunimi indikacijami ali standardno oskrbo.
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.
Slovenian: Učinek zdravljenja z zdravilom Zontivity je bil v skladu s celotnimi rezultati v številnih podskupinah, vključno po spolu, starosti, insuficienci ledvic, anamnezi sladkorne bolezni, uporabi tobaka in izhodiščnih sočasnih zdravil, vključno s tienopiridinom, acetilsalicilno kislino in statini.
English: No effects on fertility were observed in animal studies (see section 5.3).
Slovenian: V študijah na živalih niso opazili vplivov na plodnost (glejte poglavje 5.3).
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).
Slovenian: Huda okvara jeter povečuje tveganje za krvavitve, zato je uporaba zdravila Zontivity pri teh bolnikih kontraindicirana (glejte poglavji 4.2 in 5.2).
English: Call your doctor straight away, if you have any of these signs or symptoms of bleeding while taking Zontivity:
Slovenian: Takoj pokličite zdravnika, če imate med jemanjem zdravila Zontivity katerega od naslednjih znakov ali simptomov krvavitve:
English: If you take more Zontivity than you are supposed to, talk to a doctor or go to hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Zontivity, kot bi smeli Če vzamete več zdravila Zontivity, kot je predvideno, se takoj posvetujte z zdravnikom ali pojdite v bolnišnico.
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.
Slovenian: Čeprav so pri bolnikih, ki so prejemali vorapaksar, v preskušanju TRA 2ºP-TIMI 50 opazili s CABG povezane večje krvavitve po TIMI (glejte poglavje 4.8), pri bolnikih, ki so zdravljenje z vorapaksarjem nadaljevali med CABG, niso ugotovili povečanega tveganja za večje krvavitve v primerjavi s placebom.
English: Patients taking Zontivity should also take acetylsalicylic acid or clopidogrel according to their indications or standard of care.
Slovenian: Bolniki, ki jemljejo zdravilo Zontivity, morajo jemati tudi acetilsalicilno kislino ali klopidogrel v skladu z njunimi indikacijami ali standardno oskrbo.
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).
Slovenian: Uporabljeno kot dodatek standardni oskrbi, po navadi acetilsalicilni kislini in tienopiridinu, je zdravilo Zontivity v primerjavi s standardno oskrbo samo povečalo tveganje za zmerne ali hude krvavitve po opredelitvi GUSTO (Global utilization of streptokinase and tpa for occluded arteries) (glejte poglavje 4.8).
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].
Slovenian: Neželene učinke so ocenili pri 19.632 bolnikih, ki so se zdravili z zdravilom Zontivity [v študiji TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) 13.186 bolnikov, vključno z 2.187 bolnikov, zdravljenih več kot 3 leta, in v študiji TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) 6.446 bolnikov].
English: (See section 5.3.)
Slovenian: (Glejte poglavje 5.3.)
English: • unexpected bleeding or bleeding that lasts a long time
Slovenian: • nepričakovana ali dolgotrajna krvavitev
English: Zontivity contains lactose.
Slovenian: Zdravilo Zontivity vsebuje laktozo.
English: No relevant effects were observed in animals (see section 5.3).
Slovenian: Pri živalih niso opazili nobenih pomembnih učinkov (glejte poglavje 5.3).
English: The study's primary endpoint was the composite of cardiovascular death, MI, stroke, and UCR.
Slovenian: Primarni opazovani dogodek študije je bil sestavljeni dogodek srčno-žilne smrti, MI, možganske kapi in UCR.
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.
Slovenian: V odmerku 2,5 mg vorapaksarjevega sulfata (kar ustreza 2,08 mg vorapaksarja) na dan vorapaksar dosledno doseže ≥ 80 % zaviranje agregacije trombocitov, sprožene s TRAP, v enem tednu po začetku zdravljenja.
English: Primary Efficacy Endpoint (CV death/MI/stroke/UCR) CV Death
Slovenian: Primarni opazovani dogodek učinkovitosti (CV smrt/MI/ možganska kap/UCR) CV smrt
English: Minor
Slovenian: Manjše
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z