FrancophonIA/ELRC3.0 huggingface dataset:
English: Call your doctor straight away if you have any of these symptoms of a stroke, which is uncommon:
Danish: Kontakt straks din læge, hvis du får et eller flere af disse sjældne symptomer på et slagtilfælde :
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).
Danish: Når Zontivity blev administreret som tillæg til standardbehandling, normalt acetylsalicylsyre og et thienopyridin, øgede Zontivity risikoen for GUSTO (Global utilization of streptokinase and tpa for occluded arteries) moderat eller svær blødning sammenlignet med standardbehandling alene (se pkt.
English: Zontivity should be used with caution in patients with moderate hepatic impairment.
Danish: Zontivity skal anvendes med forsigtighed hos patienter med moderat nedsat leverfunktion.
English: No clinically meaningful inhibition of CYP2B6, CYP3A, CYP2C19, or CYP2D6 by M20 is expected.
Danish: Der forventes ingen klinisk betydningsfuld hæmning af CYP2B6, CYP3A, CYP2C19 eller CYP2D6 via M20.
English: The findings for the key secondary efficacy endpoint, a 3-year K-M event rate of 9.3% in the Zontivity group compared with that of 10.5% in placebo group (HR: 0.87; 95% CI, 0.80 to 0.94; p <0.001).
Danish: Resultatet for det centrale sekundære endepunkt, 3-års K-M-event rate på 9,3% i Zontivity-gruppen, var sammenligneligt med resultatet på 10,5% i placebogruppen (HR: 0,87; 95% CI, 0,80 til 0,94; p <0,001).
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
Danish: Figur 1: Tid til første forekomst af CV-død, MI, apopleksi eller UCR hos post-MI- og PADpatienter uden apopleksi eller TCI i anamnesen
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.
Danish: Hos post-MI- og PAD-patienter uden apopleksi eller TCI i anamnesen var 3-års K-M-event rate for ICH henholdsvis 0, 6% og 0,5% for Zontivity plus standardbehandling og standardbehandling alene.
English: The combination of vorapaxar with warfarin or other oral anticoagulants may increase the risk of bleeding and should be avoided.
Danish: Samtidig brug af vorapaxar og warfarin eller andre orale antikoagulantia kan øge risikoen for blødning og derfor frarådes dette.
English: • Patients with any active pathological bleeding (see sections 4.4 and 4.8).
Danish: • Patienter med aktiv patologisk blødning (se pkt.
English: Endpoints
Danish: Endepunkter
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.
Danish: Af patienterne med MI uden apopleksi eller TCI i anamnesen var 21% i behandling med acetylsalicylsyre uden thienopyridin, 1% var i behandling med et thienopyridin uden acetylsalicylsyre, og 77% fik både acetylsalicylsyre og et thienopyridin, da de blev inkluderet i studiet.
English: Vorapaxar is highly bound to human serum albumin and does not preferentially distribute into red blood cells.
Danish: Vorapaxar er bundet med høj affinitet til humant serumalbumin og fordeles ikke fortrinsvis i erytrocytter.
English: The findings for the primary efficacy composite endpoint show a 3-year Kaplan-Meier (K-M) event rate of 11.2% in the Zontivity group compared with that of 12.4% in the placebo group (Hazard Ratio [HR]: 0.88; 95% Confidence Interval [CI], 0.82 to 0.95; p=0.001) and demonstrated superiority of Zontivity over placebo in preventing CV death, MI, stroke, or UCR.
Danish: Resultaterne for det primære sammensatte endepunkt viser en 3-års Kaplan-Meier (K-M)-event rate på 11,2% i Zontivity-gruppen sammenlignet med 12,4% i placebogruppen (Hazard ratio [HR]: 0,88; 95% konfidensinterval [CI], 0,82 til 0,95; p=0,001) og påviste superioritet af Zontivity i forhold til placebo med hensyn til at forebygge CV-død, MI, apopleksi eller UCR.
English: Do not take Zontivity if you are currently being treated with prasugrel or ticagrelor (other anti-platelet agents).
Danish: Tag ikke Zontivity, hvis du samtidigt er i behandling med prasugrel eller ticagrelor (andre blodpladehæmmende midler).
English: • digoxin (used to treat heart failure)
Danish: • digoxin (medicin til behandling af hjertesvigt)
English: Packs of 7, 28, 30 and 100 tablets in aluminium blister cards.
Danish: Pakninger med 7, 28, 30 og 100 tabletter i aluminiumblisterkort.
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%).
Danish: PAD-patientpopulationen uden apopleksi eller TCI i anamnesen bestod af 90% kaukasere, 29% var kvinder og 57% ≥65 år, medianalderen var 66 år, og inkluderede patienter med diabetes (35%) og patienter med hypertension (82%).
English: Patients experiencing acute coronary syndrome (ACS) while on Zontivity can remain on Zontivity.
Danish: Patienter, som får akut koronarsyndrom (AKS), mens de er i behandling med Zontivity, kan fortsætte behandlingen med Zontivity.
English: • warfarin, other oral anticoagulants, heparin, or low molecular weight heparin (blood thinner medicines)
Danish: • warfarin, andre orale blodfortyndende midler, heparin eller lavmolekylært heparin
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%).
Danish: Post-MI-patientpopulationen uden apopleksi eller TCI i anamnesen bestod af 88% kaukasere, 20% var kvinder og 29% ≥65 år, medianalderen var 58 år, og inkluderede patienter med diabetes (21%) og patienter med hypertension (62%).
English: The coadministration of Zontivity with anticoagulants e.g., warfarin and new oral anticoagulants (NOACs), should be avoided.
Danish: Samtidig administration af Zontivity og antikoagulantia, f.eks. warfarin og nye orale antikoagulantia (NOAC), frarådes (se pkt.
English: Zontivity is contraindicated in patients with severe hepatic impairment (Child Pugh, 10 to 15 points) (see sections 4.3 and 4.4).
Danish: Zontivity er kontraindiceret hos patienter med svært nedsat leverfunktion (Child-Pugh, 10 til 15 point) (se pkt.
English: Zontivity should be initiated at least 2 weeks after a MI and preferably within the first 12 months from the acute event (see section 5.1).
Danish: Behandlingen med Zontivity skal initieres mindst 2 uger efter et myokardieinfarkt (MI) og preferentielt inden for de første 12 måneder efter den akutte hændelse (se pkt.
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.
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Zontivity.
English: You and your doctor will decide if you will take Zontivity.
Danish: Du og din læge skal beslutte, om du skal tage Zontivity eller ej.
English: The film-coated tablets are yellow, oval-shaped, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side.
Danish: Gule, ovale, filmovertrukne tabletter, 8,48 mm x 4,76 mm, med “351” præget på den ene side og MSD-logoet på den anden side.
English: Non-bleeding adverse reactions in Table 1 are summarized for both the TRA 2°P TIMI 50 and TRACER studies.
Danish: De ikke-blødningsrelaterede bivirkninger i tabel 1 er opsummeret for både TRA 2°P TIMI 50-studiet og TRACER-studiet (se tabel 1).
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.
Danish: Af patienterne med PAD uden apopleksi eller TCI i anamnesen fik 61% acetylsalicylsyre uden thienopyridin, 8% fik et thienopyridin uden acetylsalicylsyre, og 27% fik både acetylsalicylsyre og et thienopyridin, da de blev inkluderet i studiet.
English: Your doctor will determine if you should also take aspirin, clopidogrel, or both, while taking Zontivity.
Danish: Din læge vil beslutte, om du også skal tage acetylsalicylsyre og/eller clopidogrel, mens du tager Zontivity.
English: Total Events
Danish: Hændelser i alt
English: TIMI Minor: Clinically apparent with 30-50 g/L decrease in haemoglobin.
Danish: Mindre blødning i henhold til TIMI: Klinisk tydelig blødning med et fald på 30-50 g/l i hæmoglobin.
English: • carbamazepine, phenytoin (anti-seizure medicines)
Danish: • carbamazepin, phenytoin (krampestillende medicin til behandling af epilepsi)
English: In TRA 2°P - TIMI 50, 367 post-MI or PAD patients with no history of stroke or TIA underwent CABG surgery.
Danish: I TRA 2°P - TIMI 50 fik 367 post-MI- eller PAD-patienter uden apopleksi eller TCI i anamnesen foretaget bypassoperation (CABG).
English: After oral administration of a single vorapaxar sulfate 2.5 mg dose, vorapaxar is rapidly absorbed and peak concentrations occur at a median tmax of 1 hour (range: 1 to 2) under fasted conditions.
Danish: Vorapaxar absorberes hurtigt efter oral administration af en enkeltdosis vorapaxarsulfat på 2,5 mg, og maksimalkoncentrationen forekommer ved en gennemsnitlig tmax på 1 time (interval: 1 til 2) i fastende tilstand.
English: Conjunctival haemorrhage, diplopia
Danish: Konjunktivalblødning, diplopi (dobbeltsyn)
English: There is limited clinical experience with prasugrel and no experience with ticagrelor in the Phase 3 studies.
Danish: Der er begrænset klinisk erfaring med prasugrel og ingen erfaring med ticagrelor i fase III-studierne.
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.
Danish: Hos patienter i behandling med vorapaxar kan samtidig brug af heparin (herunder lavmolekylært heparin (LMWH)) associeres med øget risiko for blødning, og forsigtighed tilrådes.
English: The results for the bleeding endpoints in the post-MI or PAD patients with no history of stroke or TIA are shown in Table 2.
Danish: Resultaterne for blødningsendepunkterne hos post-MI- eller PAD-patienter uden apopleksi eller TCI i anamnesen er vist i tabel 2.
English: Talk to your doctor, pharmacist, or nurse before taking Zontivity if you:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Zontivity:
English: In TRA 2°P - TIMI 50, among patients who entered the trial, those with a history of ischaemic stroke had a higher 3 year K-M event rate for ICH on Zontivity plus standard care (2.7%) than on standard care alone (0.9%).
Danish: Blandt de patienter, som indtrådte i TRA 2°P - TIMI 50-studiet, havde patienterne med iskæmisk apopleksi i anamnesen en højere 3-års K-M-event rate for ICH, såfremt de fik Zontivity plus standardbehandling (2,7%) sammenlignet med standardbehandling alene (0,9%).
English: Packs of 7, 28, 30 and 100 film-coated tablets in aluminium/aluminium blister cards.
Danish: Pakninger med 7, 28, 30 og 100 filmovertrukne tabletter i aluminium/aluminiumblisterkort.
English: There is limited experience with prasugrel and no experience with ticagrelor in the vorapaxar Phase 3 studies.
Danish: Der er begrænset erfaring med prasugrel og ingen erfaring med ticagrelor i fase III-studierne med vorapaxar.
English: TIMI Major: Clinically apparent with >50 g/L decrease in haemoglobin or intracranial haemorrhage.
Danish: Større blødning i henhold til TIMI: Klinisk tydelig blødning med et fald på >50 g/l i hæmoglobin eller intrakraniel blødning.
English: Based upon in vitro data, chronic administration of vorapaxar is unlikely to induce the metabolism of drugs metabolized by major CYP isoforms.
Danish: at kronisk administration af vorapaxar inducerer metabolismen af lægemidler, der metaboliseres via primære CYP-isoformer.
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.
Danish: Hos de patienter i TRA 2°P - TIMI 50-studiet (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events), der blev behandlet med vorapaxar, herunder patienter med apopleksi i anamnesen, blev der observeret en højere hyppighed af intrakraniel blødning (ICH) hos de patienter, der vejede <60 kg i forhold til de patienter, der vejede ≥60 kg. Zontivity skal anvendes med forsigtighed hos patienter med en legemsvægt <60 kg.
English: • have liver or kidney problems
Danish: • hvis du har lever- eller nyreproblemer
English: Vorapaxar is also a substrate of CYP2J2; therefore, there is a potential for potent inhibitors of CYP2J2 to result in increases in vorapaxar exposure.
Danish: Derfor er der mulighed for, at potente CYP2J2-hæmmere giver forhøjet eksponering for vorapaxar.
English: Minor
Danish: Mindre
English: Co-administration of ketoconazole (400 mg once-daily) with vorapaxar significantly increased the vorapaxar mean Cmax and AUC by 93% and 96%, respectively.
Danish: Samtidig administration af ketoconazol (400 mg en gang dagligt) og vorapaxar øgede i signifikant grad gennemsnitlig Cmax og AUC for vorapaxar med henholdsvis 93% og 96%.
English: In addition, no clinically meaningful inhibition of OATP1B1, OATP1B3, BCRP, OAT1, OAT3, and
Danish: Derudover forventes der ingen klinisk betydningsfuld hæmning af OATP1B1, OATP1B3, BCRP, OAT1, OAT3 og OCT2 via vorapaxar eller M20.
English: • bleeding gums
Danish: • blødende tandkød
English: Pharmacokinetics of vorapaxar are similar between patients with end-stage renal disease (ESRD) undergoing haemodialysis and healthy subjects.
Danish: Vorapaxars farmakokinetik er sammenlignelig mellem patienter med terminal nyresygdom (ESRD) undergående hæmodialyse, og raske forsøgspersoner.
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.
Danish: Den kliniske erfaring, som involverer samtidig anvendelse af orale antikoagulantia og vorapaxar, er begrænset, og der er ingen klinisk erfaring med orale faktor Xaeller faktor IIa-hæmmere i fase III-programmet for vorapaxar.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Danish: Dette lægemiddel bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose-galactosemalabsorption.
English: Key Secondary Efficacy Endpoint (CV death / MI / stroke)
Danish: Centralt sekundært virkningsendepunkt (CV-død/MI/ apopleksi) CV-død
English: • Patients with a history of stroke or transient ischaemic attack (TIA) (see section 5.1).
Danish: • Patienter, der tidligere har haft apopleksi eller transitorisk cerebral iskæmi (TCI) (se pkt.
English: Packs of 10 and 50 film-coated tablets in aluminium/aluminium unit-dose blister cards.
Danish: Pakninger med 10 og 50 filmovertrukne tabletter i aluminium/aluminiumblisterkort (enhedsdosis).
English: You and your doctor will decide if you will take Zontivity or breast-feed.
Danish: Du og din læge skal beslutte, om du skal tage Zontivity eller amme.
English: Zontivity and lactose
Danish: Zontivity indeholder lactose
English: Each film-coated tablet contains 2.08 mg vorapaxar (as vorapaxar sulfate).
Danish: Hver filmovertrukken tablet indeholder 2,08 mg vorapaxar (som vorapaxarsulfat).
English: Platelet poor plasma had no effect on bleeding times or platelet aggregation.
Danish: Trombocytfattigt plasma havde ingen virkning på blødningstider eller trombocytaggregation (se pkt.
English: Vorapaxar had no effects on fertility of male and female rats at exposures sufficiently in excess of human exposure at the RHD.
Danish: Vorapaxar havde ingen effekt på fertiliteten hos han- eller hunrotter ved eksponeringsniveauer, der var tilstrækkeligt højere end eksponeringen hos mennesker ved den anbefalede humane dosis.
English: Each tablet contains 2.08 mg of vorapaxar (as vorapaxar sulfate).
Danish: Hver tablet indeholder 2,08 mg vorapaxar (som vorapaxarsulfat).
English: Anticoagulants
Danish: Antikoagulantia
English: No dose adjustment is necessary (see section 4.4).
Danish: Dosisjustering er ikke nødvendig (se pkt.
English: Co-administration of rifampin (600 mg once-daily) with vorapaxar substantially decreased the vorapaxar mean Cmax and AUC by 39% and 55%, respectively.
Danish: Samtidig administration af rifampin (600 mg en gang dagligt) og vorapaxar sænkede i væsentlig grad gennemsnitlig Cmax og AUC for vorapaxar med henholdsvis 39% og 55%.
English: Medicinal product discontinuation
Danish: Seponering af lægemidlet
English: For patients being started on Zontivity due to symptomatic PAD, therapy may be initiated at any time.
Danish: Behandlingen med Zontivity kan initieres når som helst hos patienter, som sættes i behandling med Zontivity på grund af symptomatisk PAD.
English: Table 2: Non-CABG-Related Bleeds in Post-MI or PAD Patients with No History of Stroke or TIA
Danish: Tabel 2: Ikke-CABG-relaterede blødninger hos post-MI- og PAD-patienter uden apopleksi eller TCI i anamnesen
English: Packs of 10 and 50 tablets in aluminium unit-dose blister cards.
Danish: Pakninger med 10 og 50 tabletter i aluminiumblisterkort (enhedsdosis).
English: General risk factors for bleeding include older age (however, no dose adjustment is necessary in the elderly (see section 5.2)), low body weight, and reduced renal or hepatic function.
Danish: Generelle risikofaktorer for blødning omfatter høj alder (dosisjustering er dog ikke nødvendig hos ældre (se pkt.
English: GUSTO Bleeding Categories Severe
Danish: GUSTO-blødningskategorier Svær
English: • coughing up blood or blood clots
Danish: • ophostning af blod eller blodtilblandet opspyt
English: Vorapaxar inhibits thrombin-induced platelet aggregation in in vitro studies.
Danish: Vorapaxar hæmmer trombin-induceret trombocytaggregation i in vitro-studier.
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.
Danish: Hæmningen af TRAP-induceret trombocytaggregation ved et niveau på ≥80% kan vare i 2 til 4 uger efter seponering af daglige doser af vorapaxarsulfat på 2,5 mg. Varigheden af disse farmakodynamiske virkninger er overensstemmende med lægemidlets halveringstid.
English: The adverse reactions in the vorapaxar-treated (n=10,059) and placebo-treated (n=10,049) post-MI or PAD patients with no history of stroke or TIA are shown below.
Danish: Bivirkningerne hos post-MI-patienter (efter myokardieinfarkt) og PAD-patienter, der var blevet behandlet med vorapaxar (n=10.059) eller havde fået placebo (n=10.049) uden apopleksi eller transitorisk cerebral iskæmi (TCI) i anamnesen, er vist nedenfor.
English: Moderate TIMI Bleeding Categories Major
Danish: Moderat TIMI-blødningskategorier Større
English: Zontivity 2 mg tablets Vorapaxar
Danish: Zontivity 2 mg tabletter vorapaxar
English: Vorapaxar should not be used with prasugrel or ticagrelor (see section 4.2).
Danish: Det frarådes at anvende vorapaxar sammen med prasugrel eller ticagrelor (se pkt.
English: Table 4: Primary and Key Secondary Efficacy Endpoints in Post-MI or PAD Patients with No History of Stroke or TIA
Danish: Tabel 4: Primært og centralt sekundært virkningsendepunkt hos post-MI- og PAD-patienter uden apopleksi eller TCI i anamnesen
English: Zontivity is not recommended for children and adolescents under 18 years of age.
Danish: Zontivity må ikke anvendes til børn og unge under 18 år, da Zontivitys sikkerhed og virkning hos børn og unge ikke er klarlagt.
English: If you are not sure, talk to your doctor or pharmacist before taking Zontivity.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Zontivity.
English: Lactose monohydrate Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Povidone (E1201) Magnesium stearate (E572)
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose (E460) Croscarmellosenatrium (E468) Povidon (E1201)
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)
Danish: Hazard ratio er Zontivity-gruppen versus placebogruppen Hazard ratio og p-værdi blev beregnet på basis af Cox proportional hazards-model med kovariaterne behandling og stratificeringsfaktorer (kvalificerende aterosklerotisk sygdom og planlagt brug af thienopyridin)
English: Elderly No dose adjustment is necessary in the elderly (see sections 4.4 and 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre (se pkt.
English: Table 1: Tabulated List of Adverse Reactions
Danish: Tabel 1: Bivirkningstabel
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: However, reduced renal function is a risk factor for bleeding and should be considered before initiating Zontivity.
Danish: Nedsat nyrefunktion er dog en risikofaktor for blødning og skal tages i betragtning før initiering af behandling med Zontivity.
English: Drug Interactions
Danish: Lægemiddelinteraktioner
English: No dose adjustment is required in patients with renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: Reduced renal function is a risk factor for bleeding and should be considered before initiating Zontivity.
Danish: Nedsat nyrefunktion er en risikofaktor for blødning og skal tages i betragtning før initiering af behandling med Zontivity.
English: What Zontivity contains
Danish: Zontivity indeholder:
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.
Danish: Moderat blødning i henhold til GUSTO: blødning, der kræver transfusion af fuldblod eller pakkede erytrocytter uden hæmodynamisk kompromittering.
English: Reduced hepatic function is a risk factor for bleeding and should be considered before initiating Zontivity.
Danish: Nedsat leverfunktion er en risikofaktor for blødning og skal tages i betragtning før initiering af behandling med Zontivity.
English: Bleeding category definitions:
Danish: Blødningskategorier:
English: You may be at increased risk of bleeding.
Danish: Tag medicinpakningen med. Du kan have forøget risiko for blødning.
English: Film-coating: lactose monohydrate; hypromellose (E464); titanium dioxide (E171); triacetin (E1518); iron oxide yellow (E172).
Danish: Filmovertræk: lactosemonohydrat; hypromellose (E464); titaniumdioxid (E171); triacetin
English: Patients with a history of PAD but without a history of stroke or TIA randomized to vorapaxar had fewer peripheral revascularization procedures (15.4% v 19.3%, 3-year KM rates; HR 0.82 [0.71-0.94, 95% CI]; P=0.005) and fewer hospitalizations for acute limb ischemia (2.0% v 3.3%; HR 0.59 [0.400.86]; P=0.007) than patients randomized to placebo.
Danish: 0,82 [0,71-0,94; 95% CI]; P=0,005) og havde færre hospitalsindlæggelser for akut ekstremitetsiskæmi (2,0% versus 3,3%; HR: 0,59 [0,40-0,86]; P=0,007) end patienter, som var randomiseret til placebo.