FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Lægen vil også give dig instruktioner om acetylsalicylsyre og/eller clopidogrel (andre blodpladehæmmende midler), som du muligvis skal tage sammen med Zontivity.
English: Adverse reactions were evaluated in 19,632 patients treated with Zontivity [13,186 patients, including 2,187 patients treated for more than 3 years, in the TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) study and 6,446 patients in the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) study].
Danish: Bivirkningerne blev vurderet hos 19.632 patienter, som har været i behandling med Zontivity (13.186 patienter, herunder 2.187 patienter, som har været i behandling i mere end 3 år, i TRA 2°P TIMI 50studiet (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) og 6.446 patienter i TRACER-studiet (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome)).
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.
Danish: Ved en dosis på 2,5 mg vorapaxarsulfat (svarende til 2,08 mg vorapaxar) dagligt opnår vorapaxar konsekvent ≥80% hæmning af TRAP-induceret trombocytaggregation inden for en uge efter påbegyndelse af behandlingen.
English: Schering-Plough Labo N.V. Industriepark 30
Danish: Schering-Plough Labo N.V.
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.
Danish: Vorapaxars effekt på det primære endepunkt og det centrale sekundære endepunkt blev demonstreret holdbar og vedvarende under hele TRA 2°P - TIMI 50-studiet.
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.
Danish: Samtidig brug af Zontivity og stærke CYP3A-hæmmere (f.eks. ketoconazol, itraconazol, posaconazol, clarithromycin, nefazodon, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin og conivaptan) frarådes.
English: Overall Population
Danish: Samlet population
English: • have ever had stomach ulcers or small growths in your gut (‘colon polyps')
Danish: • hvis du nogensinde har haft mavesår eller små vækster i din tarm (”tyktarmspolypper”)
English: Therefore, Zontivity may be administered without regard to co-administration of agents that increase gastric pH (antacid or proton pump inhibitor).
Danish: Derfor kan Zontivity administreres uden hensyntagen til samtidig anvendelse af lægemidler, der øger gastrisk pH (antacidum eller protonpumpehæmmer).
English: Patients undergoing urgent CABG, PCI, non CABG surgery, or other invasive procedures while on Zontivity may remain on Zontivity.
Danish: Patienter, der får foretaget akut CABG, PCI, ikke-CABG-kirurgi eller andre invasive indgreb, mens de er i behandling med Zontivity, kan fortsætte behandlingen med Zontivity.
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.
Danish: Eksponeringen for vorapaxar stiger tilnærmelsesvist dosisproportionalt efter enkeltdoser på 1 til 40 mg og multiple doser på 0,5 til 2,5 mg vorapaxarsulfat.
English: Consistent with its selective molecular target (PAR-1), vorapaxar has no effect on ADP-induced platelet aggregation in healthy subjects and patient populations.
Danish: I overensstemmelse med vorapaxars selektive molekylære target (PAR-1) har vorapaxar ingen indvirkning på ADP-induceret trombocytaggregation hos raske forsøgspersoner og patientpopulationer.
English: Strong CYP3A inducers
Danish: Stærke CYP3A-induktorer
English: Outer carton
Danish: Ydre karton
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
Danish: EU/1/14/976/001 7 filmovertrukne tabletter EU/1/14/976/002 10 x 1 filmovertrukne tabletter (enhedsdosis) EU/1/14/976/003 28 filmovertrukne tabletter EU/1/14/976/004 30 filmovertrukne tabletter EU/1/14/976/005 50 x 1 filmovertrukne tabletter (enhedsdosis) EU/1/14/976/006 100 filmovertrukne tabletter
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.
Danish: Vorapaxars farmakokinetik er sammenlignelig hos patienter med let (Child-Pugh, 5 til 6 point) og moderat (Child-Pugh, 7 til 9 point) nedsat leverfunktion og raske patienter.
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.
Danish: Præ- og postnatale studier udelukkende i rotter viste nogle inkonsekvente udviklingsmæssige effekter ved eksponeringsniveauer, der var tilstrækkeligt højere end eksponeringen hos mennesker ved den anbefalede humane dosis på 2,08 mg vorapaxar.
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:
Danish: Effekten af nedsat nyrefunktion (patienter med terminal nyresygdom i hæmodialyse) og nedsat leverfunktion på vorapaxars farmakokinetik blev vurderet i særlige farmakokinetiske studier og er opsummeret nedenfor:
English: Zontivity contains lactose.
Danish: Zontivity indeholder lactose.
English: Patients with events
Danish: Patienter med hændelser
English: The study's primary endpoint was the composite of cardiovascular death, MI, stroke, and UCR.
Danish: Studiets primære sammensatte endepunkt var kardiovaskulær død, MI, apopleksi og UCR.
English: Vorapaxar does not inhibit platelet aggregation induced by other agonists such as adenosine diphosphate (ADP), collagen or a thromboxane mimetic.
Danish: Vorapaxar hæmmer ikke trombocytaggregation, der er induceret af andre agonister såsom adenosindiphosphat (ADP), collagen eller tromboxan-mimetika.
English: Therefore, vorapaxar should not be used with prasugrel or ticagrelor.
Danish: Derfor må vorapaxar ikke anvendes sammen med prasugrel eller ticagrelor.
English: • if you have ever had a stroke or ‘mini stroke' (also called a ‘transient ischemic attack' or TIA)
Danish: • hvis du nogensinde har haft et slagtilfælde eller et “mini-slagtilfælde” (også kaldet en forbigående blodprop i hjernen (”transitorisk cerebral iskæmi” eller TCI))
English: What you need to know before you take Zontivity
Danish: Det skal du vide, før du begynder at tage Zontivity
English: Hazard Ratio and p-value were calculated based on Andersen-Gill model with covariates treatment and stratification factor (planned thienopyridine use).
Danish: Hazard Ratio og p-værdi blev beregnet på basis af Andersen-Gill modellen med kovariaterne behandling og stratificeringsfaktor (planlagt anvendelse af thienopyridin).
English: No defects were observed in embryo-foetal developmental studies in rats and rabbits at exposures sufficiently in excess of human exposure at the recommended human dose (RHD).
Danish: Der blev ikke observeret misdannelser i embryo-føtale udviklingsstudier med rotter og kaniner ved eksponeringsniveauer, der var tilstrækkeligt højere end eksponeringen hos mennesker ved den anbefalede humane dosis (RHD).
English: The mean estimated vorapaxar Cmax and AUC were 35% and 33% higher, respectively, in patients with a body weight of <60 kg compared to those weighing 60-100 kg. By comparison, vorapaxar exposure (AUC and Cmax) is estimated to be 19-21% lower in patients with a body weight of >100 kg compared to those weighing 60-100 kg.
Danish: Den gennemsnitlige estimerede Cmax og AUC for vorapaxar var henholdsvis 35% og 33% højere hos patienter med en legemsvægt på <60 kg i forhold til de patienter, der vejede 60-100 kg. Til sammenligning estimeres eksponering for vorapaxar (AUC og Cmax) at være 19-21% lavere hos patienter med en legemsvægt på >100 kg i forhold til de patienter, der vejer 60-100 kg.
English: Excipient(s) with known effect: Each film-coated tablet contains 66.12 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 66,12 mg lactose (som monohydrat).
English: • nefazodone (used to treat depression)
Danish: • nefazodon (medicin til behandling af depression)
English: When Zontivity was co-administered with warfarin, there were no alterations in the pharmacokinetics or pharmacodynamics of warfarin.
Danish: Ved samtidig administration af Zontivity og warfarin var der ingen ændringer i farmakokinetikken eller farmakodynamikken for warfarin.
English: There is limited experience with the concomitant use of vorapaxar with warfarin or other oral anticoagulants.
Danish: Der er begrænset erfaring med samtidig brug af vorapaxar og warfarin eller andre orale antikoagulantia.
English: Other medicines and Zontivity
Danish: Brug af anden medicin sammen med Zontivity
English: • unexpected bleeding or bleeding that lasts a long time
Danish: • uventet eller langvarig blødning
English: The mean absolute bioavailability of vorapaxar from the 2.5 mg dose of vorapaxar sulfate is 100%.
Danish: Den gennemsnitlige absolutte biotilgængelighed for vorapaxar fra en dosis på 2,5 mg vorapaxarsulfat er 100%.
English: • sudden confusion, difficulty speaking,or understanding others
Danish: • pludseligt opstået forvirring, talebesvær eller opfattelsesproblemer
English: Increased tendency to bruise Ecchymosis, Skin haemorrhage
Danish: Øget tendens til blå mærker Ekkymose, blodudtrædning under huden
English: Patients taking Zontivity should also take acetylsalicylic acid with or without clopidogrel according to their indications or standard of care.
Danish: Patienter, der tager Zontivity, skal også tage acetylsalicylsyre med eller uden clopidogrel i henhold til indikationerne herfor eller standardbehandling.
English: • Patients with a history of intracranial haemorrhage (ICH).
Danish: • Patienter, der tidligere har haft intrakraniel blødning (ICH).
English: The duration of platelet inhibition is dose and concentration dependent.
Danish: Varigheden af trombocythæmningen er dosis- og koncentrationsafhængig.
English: Gastritis, Gastrointestinal haemorrhage, Gingival bleeding, Melaena, Rectal haemorrhage
Danish: Gastritis, gastrointestinal blødning, gingival blødning, melæna, rektalblødning
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.
Danish: Blødningssygdomme i anamnesen og samtidig brug af visse typer medicin (f.eks. behandling med antikoagulantia og fibrinolytika og nonsteroide antiinflammatoriske lægemidler til kronisk behandling (NSAID), selektive serotonin-reuptake-hæmmere, serotonin-noradrenalinreuptake-hæmmere) kan ligeledes øge risikoen for blødning hos patienter, der tager Zontivity.
English: Fatal Bleeding
Danish: Letal blødning
English: Vorapaxar was not mutagenic or genotoxic in a battery of in vitro and in vivo studies.
Danish: Vorapaxar var ikke mutagent elle genotoksisk i en serie af in vitro- og in vivo-studier.
English: Driving and using machines Zontivity is not likely to affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Det forventes ikke, at Zontivity påvirker evnen til at køre eller til at bruge maskiner.
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).
Danish: Der blev ikke observeret klinisk relevante forskelle i farmakokinetikken for vorapaxar efter daglig samtidig anvendelse af et antacidum indeholdende aluminiumhydroxid/magnesiumcarbonat eller pantoprazol (en protonpumpehæmmer).
English: There is no known treatment to reverse the antiplatelet effect of Zontivity.
Danish: Der findes ingen kendt behandling til at reversere Zontivitys trombocytfunktionshæmmende effekt.
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.
Danish: In vitro-metabolismestudier viser, at det er usandsynligt, at vorapaxar forårsager klinisk signifikant hæmning af human CYP1A2, CYP2B6, CYP3A, CYP2C8, CYP2C9, CYP2C19 eller CYP2D6.
English: Platelet transfusion may be considered as supportive therapy should bleeding occur (see section 5.3).
Danish: Transfusion af trombocytter kan overvejes som understøttende behandling, hvis der forekommer blødning (se pkt.
English: The mean estimated vorapaxar Cmax and AUC were 24% and 22% higher in Asian patients compared to that of Caucasians.
Danish: Den gennemsnitlige estimerede Cmax og AUC for vorapaxar var 24% og 22% højere hos asiatiske patienter sammenlignet med kaukasere.
English: • ritonavir, nelfinavir, indinavir, saquinavir (used to treat HIV-AIDS)
Danish: • ritonavir, nelfinavir, indinavir, saquinavir (medicin til behandling af hiv og aids)
English: The adverse reactions of bleeding in Table 1 are summarized for the TRA 2°P TIMI 50 study.
Danish: De blødningsrelaterede bivirkninger i tabel 1 er opsummeret for TRA 2°P TIMI 50-studiet.
English: Platelets are blood cells that help with normal blood clotting.
Danish: Blodplader er blodlegemer, som hjælper til med at få blodet til at størkne.
English: • itraconazole, ketoconazole, posaconazole (used to treat fungal infections)
Danish: • itraconazol, ketoconazol, posaconazol (medicin til behandling af svampeinfektioner)
English: No dose adjustment for vorapaxar is required in patients taking weak to moderate inhibitors of CYP3A.
Danish: Dosisjustering af vorapaxar er ikke nødvendig hos patienter, der tager svage eller moderate CYP3A-hæmmere.
English: Discontinuation of Zontivity
Danish: Seponering af Zontivity
English: The mean estimated vorapaxar Cmax and AUC were 30% and 32% higher, respectively, in females compared to males.
Danish: Den gennemsnitlige estimerede Cmax og AUC for vorapaxar var henholdsvis 30% og 32% højere hos kvinder sammenlignet med mænd.
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.
Danish: Blandt post-MI- og PAD-patienter uden apopleksi eller TCI i anamnesen syntes Zontivity at reducere raten af definitiv stenttrombose (HR: 0,71 (0,51-0,99) for bedømmelsen “definitiv”) versus placebo hos forsøgspersoner, der fik nogen form for stent før eller under studiet.
English: The median Body Mass Index was 27.
Danish: Det mediane BMI var 27.
English: • clarithromycin, telithromycin (used to treat infections)
Danish: • clarithromycin, telithromycin (medicin til behandling af infektioner)
English: Co-administration of an aluminium hydroxide/magnesium carbonate antacid or proton pump inhibitor (pantoprazole) did not affect vorapaxar AUC with only small decreases in Cmax.
Danish: Samtidig anvendelse af et antacidum indeholdende aluminiumhydroxid/magnesiumcarbonat eller en protonpumpehæmmer (pantoprazol) påvirkede ikke AUC for vorapaxar og resulterede i et mindre fald i Cmax.
English: In post-MI or PAD patients with no history of stroke or TIA, an analysis of multiple occurrences of adjudicated endpoints indicates that Zontivity was associated with a reduction in the incidence of recurrent events.
Danish: Hos post-MI- og PAD-patienter uden apopleksi eller TCI i anamnesen indikerede en analyse af gentagne forekomster af endepunkter, bekræftet af en uafhængig komite, at Zontivity var associeret med en reduktion i incidensen af recidiverende hændelser.
English: In healthy volunteer studies, no changes in platelet P-selectin and soluble CD40 ligand (sCD40L) expression or coagulation test parameters (TT, PT, aPTT, ACT, ECT) occurred after single or multiple dose (28 days) administration of vorapaxar.
Danish: I studier med raske forsøgspersoner forekom der ingen ændringer i ekspression af trombocyt Pselectin og opløselig CD40 ligand (sCD40L) eller koagulationstestparametre (TT, PT, aPTT, ACT, ECT) efter administration af vorapaxar som enkelt- eller flerdosis (28 dage).
English: In repeat dose oral toxicity studies in rodents and monkeys, the principal treatment-related findings were urinary bladder and ureter hyperplasia in mice, hepatic vascular thrombi, lymphoid necrosis and retinal vacuolation in rats and phospholipidosis in all species.
Danish: I toksicitetsstudier med gentagne orale doser hos gnavere og aber var de vigtigste behandlingsrelaterede fund hyperplasi af urinblæren og urinlederne hos mus, blodpropper i leverblodkar, lymfoid nekrose og dannelse af blærer (vakuoler) i nethinden hos rotter og fosfolipidose hos alle arter.
English: The clinical evidence for the effect of Zontivity in patients with a history of myocardial infarction, defined as a spontaneous MI ≥2 weeks but 12 months prior, is derived from TRA 2°P - TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events).
Danish: Den kliniske evidens for Zontivitys virkning hos patienter med myokardieinfarkt i anamnesen, defineret som et spontant MI ≥2 uger siden, men inden for 12 måneder, er udledt fra TRA 2°P - TIMI 50-studiet (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events).
English: In addition, vorapaxar inhibits thrombin receptor agonist peptide (TRAP)-induced platelet aggregation without affecting coagulation parameters.
Danish: Derudover hæmmer vorapaxar trombin-receptor-agonist-peptid (TRAP)-induceret trombocytaggregation uden at påvirke koagulationsparametre.
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.
Danish: På basis af prækliniske studier, som undersøgte blødning, mens patienten var i behandling med vorapaxar og i samtidig baggrundsbehandling med acetylsalicylsyre og clopidogrel, er det måske muligt at genoprette hæmostase ved at administrere eksogene trombocytter (se pkt.
English: Co-administration of vorapaxar (40 mg) and digoxin (0.5 mg single-dose) increased digoxin Cmax and AUC by 54% and 5%, respectively.
Danish: Samtidig administration af vorapaxar (40 mg) og digoxin (0,5 mg enkeltdosis) øgede Cmax og AUC for digoxin med henholdsvis 54% og 5%.
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.
Danish: I TRACER-studiet (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome), inkluderende patienter med NSTE-AKS (akut koronart syndrom (AKS) uden elevation af ST-segmentet i ekg (NSTE)), som overvejende ikke havde været i trombocytfunktionshæmmende behandling, opnåede vorapaxar, med en startdosis på 40 mg og en vedligeholdelsesdosis på 2,5 mg/dag som tillæg til standardbehandling, som blev påbegyndt inden for 24 timer efter NSTEAKS, ikke dets primære endepunkt (kardiovaskulær død, MI, apopleksi, akut koronar revaskularisering og recidiverende iskæmi med genindlæggelse), og der var en øget risiko for moderat eller svær blødning i henhold til GUSTO.
English: Patients taking Zontivity should also take acetylsalicylic acid or clopidogrel according to their indications or standard of care.
Danish: Patienter, der tager Zontivity, skal også tage acetylsalicylsyre eller clopidogrel i henhold til indikationerne herfor eller standardbehandling.
English: There is limited therapeutic experience in patients with severe renal impairment or end stage renal disease.
Danish: Der er begrænset terapeutisk erfaring hos patienter med svært nedsat nyrefunktion eller terminal nyresygdom.
English: There are no data on fertility in humans administered Zontivity.
Danish: Der foreligger ingen data om indvirkningen af Zontivity på fertilitet hos mennesker.
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.
Danish: På basis af en farmakokinetisk populationsanalyse med data fra raske forsøgspersoner og patienter med aterosklerose estimeres vorapaxars gennemsnitlige AUC at være højere hos patienter med let (17%) og moderat (34%) nedsat nyrefunktion sammenlignet med patienter med normal nyrefunktion.
English: Primary Efficacy Endpoint (CV death/MI/stroke/UCR) CV Death
Danish: Primært virkningsendepunkt (CV-død/MI/ apopleksi/UCR) CV-død
English: Zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).
Danish: Det er påvist, at Zontivity reducerer hyppigheden af det kombinerede endepunkt kardiovaskulær (CV) død, myokardieinfarkt (MI), apopleksi og akut koronar revaskularisering (UCR).
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).
Danish: I kohorten med post-MI- og PAD-patienter uden apopleksi eller TCI i anamnesen er resultaterne for det primære sammensatte endepunkt og det centrale sekundære sammensatte endepunkt i overensstemmelse med resultatet i den samlede population (se figur 1 og tabel 4).
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.
Danish: Selvom TRA 2°P - TIMI 50-studiet ikke var designet med henblik på at vurdere den relative gavn af Zontivity i de enkelte patientundergrupper, var den gavnlige virkning mest tydelig hos patienter, som blev inkluderet på basis af et nyligt myokardieinfarkt (MI), defineret ved spontant MI ≥2 uger siden, men inden for 12 måneder (post-MI- eller PAD-patientpopulation) uden apopleksi eller TCI i anamnesen.
English: No dose adjustment is necessary for patients with renal impairment, including subjects with ESRD.
Danish: Dosisjustering er ikke nødvendig for patienter med nedsat nyrefunktion, herunder forsøgspersoner med ESRD.
English: • plan to have surgery including dental surgery
Danish: • hvis du skal have foretaget en planlagt operation, herunder tandoperation
English: • have had recent bleeding from the stomach or gut
Danish: • hvis du for nylig har haft blødning fra maven eller tarmen