FrancophonIA/ELRC3.0 huggingface dataset:
English: • having another heart attack or stroke
Danish: • får et nyt hjerteanfald eller et slagtilfælde
English: HR 95% CI p-value (Z) vs (P) 0.83 (0.76, 0.90) <.001
Danish: HR 95% CI p-værdi (Z) vs (P) 0,83 (0,76; 0,90) <0,001
English: Film-coated tablet 7 film-coated tablets 10 x 1 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 x 1 film-coated tablets 100 film-coated tablets
Danish: Filmovertrukken tablet 7 filmovertrukne tabletter 10 x 1 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 x 1 filmovertrukne tabletter 100 filmovertrukne tabletter
English: A delayed onset of action (at least 7 days) should be expected when starting therapy with Zontivity.
Danish: Forsinket virkning skal forventes (mindst 7 dage), når behandling med Zontivity igangsættes.
English: • if you have unusual bleeding now, such as bleeding in your brain, stomach or gut
Danish: • hvis du har usædvanlig blødning nu, f.eks. blødning i hjernen, maven eller tarmen
English: Vorapaxar and the major circulating active metabolite, M20, are extensively bound (≥99%) to human plasma proteins.
Danish: Vorapaxar og dennes primære cirkulerende aktive metabolit, M20, er i udstrakt grad bundet (≥99%) til humane plasmaproteiner.
English: The median duration of treatment with vorapaxar was 823 days (interquartile range: 645-1016 days).
Danish: Den gennemsnitlige varighed af behandlingen med vorapaxar var 823 dage (interkvartilt interval: 6451.016 dage).
English: • low red blood cell count (anaemia)
Danish: • lavt antal røde blodlegemer (anæmi)
English: Incidence (%)
Danish: Incidens (%)
English: Call your doctor straight away, if you have any of these signs or symptoms of bleeding while taking Zontivity:
Danish: Kontakt straks din læge, hvis du får et eller flere af disse tegn eller symptomer på blødning, mens du tager Zontivity:
English: If you have a stroke, ‘mini-stroke', or bleeding in the brain while taking Zontivity, your doctor ought to stop your Zontivity.
Danish: Hvis du får et slagtilfælde, et “minislagtilfælde” eller en blødning i hjernen, mens du tager Zontivity, skal lægen standse din behandling med Zontivity.
English: Any unused medicinal product or material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
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).
Danish: Blødning var den bivirkning, som hyppigst medførte seponering af studiemedicinen for begge behandlinger (3,0% for Zontivity og 1,8% for placebo).
English: BE-2220 Heist-op-den-Berg Belgium
Danish: BE-2220 Heist-op-den-Berg Belgien
English: Patients should be advised to inform physicians and dentists that they are taking Zontivity before any surgery is scheduled and before any new medicinal product is taken.
Danish: Patienterne skal informere deres læge eller tandlæge om, at de tager Zontivity, før der planlægges operationer, og før de tager et hvilket som helst nyt lægemiddel.
English: The effect of Zontivity on GUSTO severe or moderate bleeding relative to placebo was shown to be consistent across the subgroups examined.
Danish: Det blev påvist, at indvirkningen af Zontivity på GUSTO svær eller moderat blødning i forhold til placebo var ensartet på tværs af de undersøgte undergrupper.
English: In general, use of anti-platelet medicines, older age, or a low body weight increase the risk of bleeding.
Danish: Generelt øger brugen af blodpladehæmmende midler, høj alder eller en lav kropsvægt risikoen for blødning.
English: Pharmacokinetics of vorapaxar are similar between elderly, including those ≥75 years of age, and younger patients.
Danish: Vorapaxars farmakokinetik er sammenlignelig mellem ældre patienter, herunder ældre patienter ≥75 år, og yngre patienter.
English: The median Body Mass Index was 28.
Danish: Det mediane BMI (Body Mass Index) var 28.
English: Continued therapy after this time must be based on a re-evaluation of the benefits and risks for the individual of further therapy.
Danish: Fortsat behandling herefter skal baseres på en revurdering af fordele og risici for den enkelte ved yderligere behandling.
English: However, if a patient is to undergo elective surgery, if clinically feasible, Zontivity should be discontinued at least 30 days prior to surgery.
Danish: Hvis en patient skal have foretaget elektiv kirurgi, og hvis det er klinisk muligt, skal Zontivity dog seponeres mindst 30 dage før indgrebet.
English: The tablet may be taken with or without food.
Danish: Tabletten kan indtages med eller uden mad.
English: Patients with events (%)
Danish: Patienter med hændelser (%)
English: • if you have had bleeding in the brain
Danish: • hvis du har haft en blødning i hjernen
English: If a dose is missed:
Danish: Glemt dosis:
English: Zontivity contains an active substance called vorapaxar, and it belongs to a group of medicines called ‘anti-platelet medicines.'
Danish: Zontivity indeholder et aktivt stof kaldet vorapaxar og tilhører en lægemiddelgruppe, der kaldes ”blodpladehæmmende midler”.
English: Specific populations
Danish: Særlige populationer
English: Vorapaxar had no effect on the QTc interval at single doses up to 120 mg.
Danish: Vorapaxar havde ingen indvirkning på QTc-intervallet i enkeltdoser på op til 120 mg.
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.
Danish: Hos mennesker er vorapaxar blevet administreret i enkeltdoser på op til 120 mg og i daglige doser på 5 mg i op til 4 uger, uden at der blev observeret dosisrelaterede bivirkninger eller identificeret en specifik risiko.
English: They should talk to the doctor who prescribed Zontivity for you before you have any surgery or invasive procedure.
Danish: De skal tale med den læge, som har ordineret Zontivity til dig, før du får foretaget en operation eller et invasivt indgreb.
English: Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Danish: Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Storbritannien
English: • if you have severe liver disease
Danish: • hvis du har svær leversygdom
English: Vorapaxar is a selective and reversible inhibitor of the PAR-1 receptors on platelets that are activated by thrombin.
Danish: Vorapaxar er en selektiv og reversibel hæmmer af PAR-1-receptorer på trombocytter, som aktiveres ved hjælp af trombin.
English: Zontivity increases the risk of bleeding, including ICH and sometimes fatal bleeding.
Danish: Zontivity øger risikoen for blødning, herunder intrakraniel blødning (ICH) og somme tider letal blødning.
English: There are no reliable data on the use of vorapaxar in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af vorapaxar til gravide kvinder.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: If your doctor prescribes you prasugrel or ticagrelor, you should stop Zontivity and talk to your doctor.
Danish: Hvis lægen ordinerer prasugrel eller ticagrelor, skal du stoppe med at tage Zontivity og tale med lægen.
English: This background therapy was to be continued during the trial at the treating physician's discretion, per standard of care.
Danish: Baggrundsbehandlingen skulle fortsætte under studiet efter den behandlende læges skøn i henhold til standardbehandling.
English: Age, gender, weight and race were included as factors assessed in the population pharmacokinetic model to evaluate vorapaxar pharmacokinetics in healthy subjects and patients:
Danish: Alder, køn, vægt og race blev medtaget som faktorer i den farmakokinetiske populationsmodel med henblik på at vurdere vorapaxars farmakokinetik hos raske forsøgspersoner og patienter:
English: Vorapaxar is eliminated primarily in the form of metabolites, with no vorapaxar detected in urine.
Danish: Vorapaxar elimineres primært i form af metabolitter, og der er ikke fundet vorapaxar i urinen.
English: • have had any recent serious injury or surgery
Danish: • hvis du for nylig har haft en alvorlig skade eller fået foretaget en operation
English: Patients were randomized to receive daily treatment with 2.5 mg vorapaxar sulfate (n=13,225) or placebo (n=13,224) in addition to other standard therapy.
Danish: Patienterne blev randomiseret til at få daglig behandling med 2,5 mg vorapaxarsulfat (n=13.225) eller placebo (n=13.224) i tillæg til anden standardbehandling.
English: It is not known whether vorapaxar is excreted in human breast milk.
Danish: Det er ukendt, om vorapaxar udskilles i human mælk.
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).
Danish: Indtagelse af vorapaxar sammen med et fedtholdigt måltid resulterede ikke i nogen betydningsfuld ændring i AUC med et mindre (21%) fald i Cmax og en forsinket tmax (45 minutter).
English: Follow your doctor's instructions about stopping Zontivity.
Danish: Følg lægens anvisning om at stoppe behandlingen med Zontivity.
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).
Danish: Seponering af Zontivity i en kort periode vil ikke være gavnlig med hensyn til at forebygge eller behandle en akut blødningshændelse på grund af Zontivitys lange halveringstid (se pkt.
English: Co-administration with vorapaxar did not alter the single-dose pharmacokinetics of rosiglitazone (8 mg), a CYP2C8 substrate not marketed in the EU.
Danish: Samtidig administration af vorapaxar ændrede ikke enkeltdosis-farmakokinetikken for rosiglitazon (8 mg), som er et CYP2C8-substrat, der ikke er markedsført i EU.
English: Keep a list of them to show your doctor and pharmacist when you get a new medicine.
Danish: Før en liste over din medicin, som du kan vise lægen eller apotekspersonalet, når du skal have en ny type medicin.
English: If you forget to take Zontivity
Danish: Hvis du har glemt at tage Zontivity
English: The systemic pharmacokinetics of vorapaxar are linear with accumulation (6-fold) predictable from single- to multiple-dose data.
Danish: Vorapaxars systemiske farmakokinetik er lineær med akkumulation (6 gange), som kan forudses fra enkelt- til flerdosisdata.
English: The composite of cardiovascular death, MI, and stroke were assessed as secondary endpoint.
Danish: Kardiovaskulær død, MI og apopleksi blev vurderet som sekundære endepunkter.
English: The effect of vorapaxar on the QTc interval was evaluated in a thorough QT study and in other studies.
Danish: Evaluering af Zontivitys indvirkning på QTc-intervallet Vorapaxars indvirkning på QTc-intervallet blev vurderet i et indgående QT-studie og i andre studier.
English: Zontivity has no or negligible influence on the ability to drive and use machines.
Danish: Zontivity påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: • rifampin (used to treat tuberculosis and some other infections)
Danish: • rifampin (medicin til behandling af tuberkulose og nogle andre infektionstyper)
English: Vorapaxar exposure (AUC and Cmax) in patients of African descent is estimated to be 17-19% lower compared to that of Caucasians.
Danish: Eksponering for vorapaxar (AUC og Cmax) hos patienter med afrikansk herkomst estimeres at være 17-19% lavere sammenlignet med kaukasere.
English: Effects of vorapaxar on other medicinal products
Danish: Vorapaxars virkning på andre lægemidler
English: Vorapaxar should not be initiated in patients taking prasugrel or ticagrelor and in case of need for additional therapy with these agents, vorapaxar should be stopped.
Danish: Behandlingen med vorapaxar må ikke initieres hos patienter, der tager prasugrel eller ticagrelor, og hvis der er behov for yderligere behandling med disse midler, skal behandlingen med vorapaxar stoppes.
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.
Danish: Den underliggende blødningsrisiko (f.eks. nyligt traume, nylig operation, nylig eller recidiverende gastrointestinal blødning eller aktivt peptisk ulcus) skal tages i betragtning, før behandling med Zontivity påbegyndes.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zontivity in one or more subsets of the paediatric population in prevention of arterial thromboembolism (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Zontivity i en eller flere undergrupper af den pædiatriske population ved forebyggelse af arteriel tromboemboli (se pkt.
English: Effects of other medicinal products on vorapaxar
Danish: Andre lægemidlers virkning på vorapaxar
English: This medicinal product does not require any special temperature storage conditions.
Danish: Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.
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.
Danish: Der blev ikke observeret betydningsfulde ændringer i koncentrationen af P-selectin, sCD40L og hs-CRP hos patienter, der var i behandling med vorapaxar i kliniske fase II/III-studier.
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).
Danish: Det generelle nul-effekt-niveau for præ- og postnatale udviklingsmæssige effekter var 5 mg/kg/dag (6,8 gange (hundyr) eksponeringen hos mennesker ved steady-state ved en dosis på 2,5 mg/dag).
English: No relevant effects were observed in animals (see section 5.3).
Danish: Der blev ikke observeret nogen relevant virkning hos dyr (se pkt.
English: Renal and urinary disorders Injury, poisoning, and procedural complications
Danish: Nyrer og urinveje Traumer, forgiftninger og behandlingskomplikationer
English: No effects on fertility were observed in animal studies (see section 5.3).
Danish: Der blev ikke observeret nogen virkning på fertiliteten i dyrestudier (se pkt.
English: Due to the unknown potential for adverse reactions in breast-feeding infants from Zontivity, discontinue breast-feeding or discontinue Zontivity; taking into account the importance of the medicinal product to the mother.
Danish: På grund af den ukendte risiko for bivirkninger fra Zontivity hos ammede spædbørn, skal det besluttes, om amning eller behandling med Zontivity skal ophøre, idet der tages hensyn til vigtigheden af lægemidlet for moderen.
English: When Zontivity was co-administered with prasugrel, no clinically significant pharmacokinetic interaction was demonstrated.
Danish: Når Zontivity blev administreret samtidig med prasugrel, blev der ikke påvist klinisk signifikant farmakokinetisk interaktion.
English: • bleeding in your eye
Danish: • blødning i øjet
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.
Danish: TRA 2°P - TIMI 50 var et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie gennemført i patienter, som havde tegn på eller tidligere havde haft aterosklerose involverende det koronare, cerebrale eller det perifere karsystem.
English: General risk of bleeding
Danish: Generel blødningsrisiko
English: This reduces the chance of a blood clot forming and blocking the arteries, such as the arteries in the heart.
Danish: Dette nedsætter risikoen for dannelse af blodpropper og tilstopning af pulsårer såsom pulsårerne i hjertet.
English: If you stop taking Zontivity
Danish: Hvis du holder op med at tage Zontivity
English: Bleeding events were treated in the same manner as for other antiplatelet agents including addressing the source of bleeding while providing supportive care.
Danish: Blødningshændelser blev behandlet på samme måde som ved andre trombocytfunktionshæmmende midler, herunder håndtering af blødningsårsagen, samtidig med at patienten får understøttende behandling.
English: Patients with events*
Danish: Patienter med hændelser*
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC26.
Danish: Farmakoterapeutisk klassifikation: Antitrombotiske midler, trombocytaggregationshæmmere, eksklusive heparin, ATC-kode: B01AC26.
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.
Danish: Vorapaxar elimineres gennem metabolisering via CYP3A4 og CYP2J2, der er ansvarlig for dannelsen af M20, dets primære cirkulerende aktive metabolit, og M19, den mest fremtrædende metabolit i ekskreter.
English: • have had bleeding problems in the past
Danish: • hvis du tidligere har haft blødningsproblemer
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.
Danish: Zontivitys effekt var i overensstemmelse med de overordnede resultater på tværs af mange undergrupper, herunder køn; alder; nedsat nyrefunktion; diabetes mellitus i anamnesen; brug af tobak; samtidige behandlinger ved baseline, inkluderende thienopyridin, acetylsalicylsyre og statiner.
English: Vorapaxar is a weak inhibitor of the intestinal P-glycoprotein (P-gp) transporter.
Danish: Vorapaxar er en svag hæmmer af transportproteinet P-glykoprotein (P-gp) i tarmen.
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.
Danish: Transfusion af humant trombocytrigt plasma normaliserede blødningstiderne med delvis bedring af ex vivo-trombocytaggregation induceret af arachidonsyre, men ikke induceret af ADP eller TRAP.
English: As vorapaxar is highly protein-bound, haemodialysis is unlikely to be effective in the treatment of an overdose.
Danish: Da vorapaxar har en høj proteinbinding, vil hæmodialyse højst sandsynligt ikke være en effektiv metode til behandling af en overdosering.
English: Concomitant use of Zontivity with strong (potent) inducers of CYP3A (e.g., rifampin, carbamazepine and phenytoin) should be avoided.
Danish: Samtidig brug af Zontivity og stærke (potente) CYP3A-induktorer (f.eks. rifampin, carbamazepin og phenytoin) frarådes.
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.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager dette lægemiddel.
English: Zontivity prevents platelets from sticking together.
Danish: Zontivity forhindrer, at blodpladerne klæber sammen.
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).
Danish: Ingen vorapaxar-relaterede tumorer blev observeret i studier med rotter og mus af 2-års varighed ved orale doser på op til 30 mg/kg/dag hos rotter og 15 mg/kg/dag hos mus (8,9 og 30 gange de anbefalede terapeutiske eksponeringsniveauer hos mennesker på basis af eksponering for vorapaxar i plasma for henholdsvis rotter og mus).
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.
Danish: Fase III-data tyder på, at samtidig administration af en svag eller moderat CYP3A-hæmmer og vorapaxar ikke øger blødningsrisikoen eller påvirker vorapaxars virkning.
English: • bleeding that is severe or that you cannot control
Danish: • kraftig blødning, som du ikke kan kontrollere
English: • boceprevir, telaprevir (used to treat hepatitis C virus infections)
Danish: • boceprevir, telaprevir (medicin til behandling af hepatitis C-virusinfektioner)
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.
Danish: Blandt patienterne med et kvalificerende MI blev behandling med Zontivity initieret mindst 2 uger efter myokardieinfarktet og inden for de første 12 måneder efter den akutte hændelse.
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.
Danish: Af disse patienter fik 10.080 Zontivity (8.458 post-MI og 1.622 PAD), og 10.090 fik placebo (8.439 post-MI og 1.651 PAD) i tillæg til standardbehandling, inklusive trombocytfunktionshæmmende behandling med acetylsalicylsyre og thienopyridin.
English: Your doctor may advise stopping Zontivity before surgery.
Danish: Lægen vil måske råde dig til at stoppe behandlingen med Zontivity før operationen.
English: The percentages of patients who underwent CABG surgery and had CABG-related bleeds are shown in Table 3.
Danish: Procentdelen af patienter, som fik foretaget bypassoperation (CABG) og som havde CABG-relaterede blødninger, er vist i tabel 3.
English: Platelet inhibition with vorapaxar is gradual and reversible.
Danish: Trombocythæmningen med vorapaxar sker gradvist og er reversibel.
English: Acetylsalicylic acid, vorapaxar, and clopidogrel in combination produced significant prolongation of bleeding time.
Danish: Kombinationsbehandling med acetylsalicylsyre, vorapaxar og clopidogrel gav en signifikant forlængelse af blødningstiden.
English: Bleeding should be suspected in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or other surgical procedures, even if the patient does not have any signs of bleeding.
Danish: Blødning bør mistænkes hos alle patienter, som har et lavt blodtryk og som for nyligt har fået foretaget koronarangiografi (KAG), perkutan koronarintervention (PCI), bypassoperation (CABG) eller andre kirurgiske indgreb, dette også selv om patienten ikke viser tegn på blødning.
English: * Each patient was counted only once (first component event) in the component summary that contributed to the primary efficacy endpoint K-M estimate at 1,080 days Hazard ratio is Zontivity group versus placebo group Cox proportional hazard model with covariates treatment and stratification factors (qualifying atherosclerotic disease and planned thienopyridine use)
Danish: * Hver patient blev kun talt med én gang (første hændelse) i de komponenter, som udgjorde det primære virkningsendepunkt K-M-estimat efter 1.080 dage Hazard ratio er Zontivity-gruppen versus placebogruppen Cox proportional hazards-model med kovariaterne behandling og stratificeringsfaktorer (kvalificerende aterosklerotisk sygdom og planlagt brug af thienopyridin)