FrancophonIA/ELRC3.0 huggingface dataset:
English: Most reported symptoms of dyspnoea were mild to moderate in intensity, and most were reported as a single episode early after starting treatment.
Danish: De hyppigst rapporterede symptomer af dyspnø var milde til moderate i styrke og de fleste blev rapporteret som enkelte episoder tidligt efter behandlingsstart.
English: Frequency categories are defined according to the following conventions: Very common (≥1/10), common (≥1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden er opdelt i følgende kategorier: Meget almindelig (≥1/10), almindelig (≥1/100 til 1/10), ikke almindelig (≥1/1.000 til 1/100), sjælden (≥1/10.000 til 1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Creatinine levels may increase during treatment with ticagrelor.
Danish: Kreatininniveauerne kan blive forhøjet under behandling med ticagrelor.
English: Patients in PLATO receiving ticagrelor took a variety of statins, with no concern of an association with statin safety among the 93% of the PLATO cohort taking these medicinal products.
Danish: Patienter i PLATO, der fik ticagrelor, anvendte forskellige statiner, uden at dette blev sat i forbindelse med sikkerhedsproblemer ved statin hos de 93 % i PLATO-kohorten, der tog disse lægemidler.
English: If you have trouble swallowing the tablet If you have trouble swallowing the tablet you can crush it and mix with water as follows:
Danish: Hvis du har problemer med at sluge tabletten, kan du knuse den og blande den med vand på følgende måde:
English: TIMI Major
Danish: Anden TIMI Major
English: For further details see section 4.8.
Danish: 4.8 for yderligere information.
English: • morphine and other opioids (used to treat severe pain)
Danish: • morfin og andre opioider (til behandling af stærke smerter)
English: A weakly significant treatment interaction was observed with region whereby the hazard ratio (HR) for the primary endpoint favours ticagrelor in the rest of world but favours clopidogrel in North America, which represented approximately 10% of the overall population studied (interaction p-value=0.045).
Danish: Der sås en svagt signifikant behandlingsinteraktion i forhold til region, hvorved hazard ratio (HR) for det primære endepunkt falder ud til fordel for ticagrelor i resten af verden men ikke i Nordamerika, hvor udfaldet er til fordel for clopidogrel i Nordamerika, som udgjorde ca. 10 % af den samlede undersøgte population (interaktion-p-værdi = 0,045).
English: ACS patients with prior ischaemic stroke can be treated with ticagrelor for up to 12 months (PLATO study).
Danish: AKS-patienter med tidligere iskæmisk apopleksi kan behandles med ticagrelor i op til 12 måneder (PLATO-studiet).
English: Treating 54 ACS patients with ticagrelor instead of clopidogrel will prevent 1 atherothrombotic event; treating 91 will prevent 1 CV death (see Figure 1 and Table 4).
Danish: Ved at behandle 54 AKS-patienter med ticagrelor i stedet for clopidogrel forebygges 1 aterotrombotisk hændelse; ved at behandle 91 patienter forebygges 1 kardiovaskulært dødsfald (se figur 1 og tabel 4).
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely with the use of ticagrelor.
Danish: Trombotisk trombocytopenisk purpura (TTP) er meget sjældent rapporteret ved brug af ticagrelor.
English: • Feeling dizzy or light-headed, or having blurred vision - these are signs of low blood pressure
Danish: • Svimmelhed eller ørhed eller sløret syn - dette er tegn på lavt blodtryk
English: PLATO included patients with baseline congestive heart failure, COPD or asthma; these patients, and the elderly, were more likely to report dyspnoea.
Danish: PLATO omfattede patienter med baseline kongestivt hjertesvigt, KOL eller astma; det var mere sandsynligt, at disse patienter, og de ældre, indberettede dyspnø.
English: The result appeared early (absolute risk reduction [ARR] 0.6% and relative risk reduction [RRR] of 12% at 30 days), with a constant treatment effect over the entire 12-month period, yielding ARR 1.9% per year with RRR of 16%.
Danish: Resultatet viste sig tidligt (absolut risikoreduktion [ARR] på 0,6 % og relativ risikoreduktion [RRR] på 12 % efter 30 dage) med en konstant behandlingseffekt gennem hele den 12 måneders periode, hvilket gav en ARR på 1,9 % pr. år med en RRR på 16 %.
English: When radiolabelled ticagrelor is administered, the mean recovery of radioactivity is approximately 84% (57.8% in faeces, 26.5% in urine).
Danish: Ved administration af radioaktivt mærket ticagrelor genfindes gennemsnitligt ca. 84 % af radioaktiviteten (57,8 % i fæces, 26,5 % i urin).
English: Ticagrelor does not prevent ADP binding but when bound to the P2Y12 receptor prevents ADP-induced signal transduction.
Danish: Ticagrelor hindrer ikke ADP-binding, men når det er bundet til P2Y12-receptoren, forhindrer det ADP-induceret signaltransduktion.
English: Patients received a 300 mg loading dose of clopidogrel (600 mg possible if having PCI) or 180 mg of ticagrelor.
Danish: Patienterne fik en mætningsdosis på 300 mg clopidogrel (evt. 600 mg, hvis de skulle have PCI) eller 180 mg ticagrelor.
English: Taking Brilique with other medicines for blood clotting Your doctor will usually also tell you to take acetylsalicylic acid.
Danish: Indtagelse af Brilique sammen med anden blodfortyndende medicin Din læge vil i reglen anbefale, at du også tager acetylsalicylsyre.
English: Similarly, when removing all procedure related bleeds, more bleeding occurred with ticagrelor than with clopidogrel (Table 2).
Danish: Ligeledes forekom der, når alle procedurerelaterede blødninger blev fjernet, flere blødninger med ticagrelor end med clopidogrel (tabel 2).
English: Brilique contains an active substance called ticagrelor.
Danish: Brilique indeholder et aktivt stof, der hedder ticagrelor.
English: The following adverse reactions have been identified following studies or have been reported in post-marketing experience with ticagrelor (Table 1).
Danish: Følgende bivirkninger er identificeret i studier med ticagrelor eller indberettet efter markedsføringen af ticagrelor (tabel 1).
English: • phenytoin, carbamazepine and phenobarbital (used to control seizures)
Danish: • phenytoin, carbamazepin og phenobarbital (anvendes til at kontrollere krampeanfald)
English: In PEGASUS, TIMI Major bleeding for ticagrelor 60 mg twice daily was higher than for ASA alone.
Danish: I PEGASUS var TIMI Major bleeding for ticagrelor 60 mg to gange dagligt højere end for ASA alene.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Brilique, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: This will tell you whether you have taken the dose.
Danish: Så kan du nemt se, om du har taget tabletten.
English: • Active pathological bleeding.
Danish: • Aktiv patologisk blødning
English: Initial exposure (0.5 and 1 hour post-dose) from crushed ticagrelor tablets mixed in water was higher compared to whole tablets, with a generally identical concentration profile thereafter (2 to 48 hours).
Danish: Den initiale eksposition (0,5-1 time efter dosering) af knuste ticagrelor-tabletter blandet i vand var højere sammenlignet med hele tabletter, hvorefter koncentrationsprofilerne overordnet var identiske (2 til 48 timer).
English: Therefore, appropriate clinical and/or laboratory monitoring is recommended when giving narrow therapeutic index P-gp dependent medicinal products like digoxin concomitantly with ticagrelor.
Danish: Relevant klinisk og/eller laboratoriemæssig monitorering anbefales derfor, når der gives P-gp-afhængige lægemidler med et snævert terapeutisk indeks såsom digoxin samtidig med ticagrelor.
English: The metabolite parent ratios are 0.28 for Cmax and 0.42 for AUC.
Danish: Metabolit/stamform-forholdet er 0,28 for Cmax og 0,42 for AUC.
English: If clinically indicated, ticagrelor should be used with caution in the following patient groups:
Danish: Hvis ticagrelor er klinisk indiceret, skal det bruges med forsigtighed hos følgende patientgrupper:
English: • Allergic reaction - a rash, itching or a swollen face or swollen lips/tongue may be signs of an allergic reaction
Danish: • Allergisk reaktion - udslæt, kløe eller hævelser i ansigt eller hævede læber eller tunge kan være tegn på en allergisk reaktion
English: In PLATO, 42% of the 1584 patients (12% of cohort) who underwent coronary artery bypass graft (CABG) surgery had a PLATO Major Fatal/Life-threatening bleeding with no difference between treatment groups.
Danish: 42 % af de 1584 patienter (12 % af kohorten) i PLATO, der fik foretaget koronar bypassoperation (CABG), fik en PLATO Major Fatal/Life-threatening bleeding uden forskel behandlingsgrupperne imellem.
English: Brilique treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily.
Danish: Brilique-behandling skal indledes med en enkelt 180 mg mætningsdosis (to tabletter på hver 90 mg) og derefter fortsættes med 90 mg to gange dagligt.
English: • Bleeding after surgery or from cuts (for example while shaving) and wounds more than is normal
Danish: • Blødning efter en operation eller efter flænger (for eksempel under barbering) og sår ud over det sædvanlige
English: Dyspnoea is usually mild to moderate in intensity and often resolves without need for treatment discontinuation.
Danish: Dyspnø er i reglen af mild til moderat styrke og forsvinder ofte uden behov for seponering af behandlingen.
English: Acute coronary syndromes
Danish: Akut koronart syndrom
English: p-value*
Danish: p-værdi*
English: PEGASUS study (History of Myocardial Infarction)
Danish: PEGASUS-studiet (myokardieinfarkt i anamnesen)
English: The mixture can also be administered via a nasogastric tube (CH8 or greater).
Danish: Blandingen kan også administreres via en nasogastrisk sonde (CH8 eller højere).
English: Only limited information is available in patients with moderate hepatic impairment.
Danish: Der er kun begrænset information tilgængelig om patienter med moderat nedsat leverfunktion.
English: Table 1 - Adverse reactions by frequency and system organ class (SOC)
Danish: Bivirkninger, efter hyppighed og systemorganklasse (SOC)
English: The higher incidence of dyspnoea with ticagrelor is not associated with new or worsening heart or lung disease (see section 4.4).
Danish: Den højere frekvens af dyspnø med ticagrelor er ikke forbundet med ny eller forværret hjerte- eller lungesygdom (se pkt.
English: Ticagrelor is also a P-glycoprotein (P-gp) substrate and a weak P-gp inhibitor and may increase the exposure of P-gp substrates.
Danish: Ticagrelor er desuden et P-glykoprotein (P-gp) substrat og en svag P-gp-hæmmer og kan øge eksponeringen for P-gpsubstrater.
English: The AUC of the active metabolite was increased by 32% and Cmax was decreased by 15% in the presence of cyclosporine.
Danish: AUC for den aktive metabolit blev øget med 32 % og Cmax blev reduceret med 15 % ved tilstedeværelse af ciclosporin.
English: It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever.
Danish: Det er karakteriseret ved trombocytopeni og mikroangiopatisk hæmolytisk anæmi forbundet med enten neurologiske fund, nyresvigt eller feber.
English: Tablet coating Talc
Danish: Tabletovertræk Talcum
English: Bleeding findings in PLATO
Danish: Blødningsfund i PLATO
English: Table 5 - Analysis of primary and secondary efficacy endpoints (PEGASUS)
Danish: Tabel 5 - Analyse af primære og sekundære endepunkter for virkning (PEGASUS)
English: This suggests it is appropriate to treat patients with ticagrelor 90 mg twice daily for 12 months (see section 4.2).
Danish: Dette indikerer, at det er hensigtsmæssigt at behandle patienter med ticagrelor 90 mg to gange dagligt i 12 måneder (se pkt.
English: Bleeding findings in PEGASUS Overall outcome of bleeding events in the PEGASUS study are shown in Table 3.
Danish: Blødningsfund i PEGASUS Det samlede resultat af blødningshændelser i PEGASUS-studiet er vist i tabel 3.
English: Switching from clopidogrel 75 mg to ticagrelor 90 mg twice daily results in an absolute IPA increase of 26.4% and switching from ticagrelor to clopidogrel results in an absolute IPA decrease of 24.5%.
Danish: Et skift fra clopidogrel 75 mg til ticagrelor 90 mg to gange dagligt resulterer i en absolut IPA-stigning på 26,4 %, og et skift fra ticagrelor til clopidogrel resulterer i en absolut IPA-reduktion på 24,5 %.
English: Patients who reported dyspnoea tended to be older and more frequently had dyspnoea, COPD or asthma at baseline.
Danish: De patienter, som rapporterede dyspnø havde en tendens til at være ældre og med en hyppigere frekvens af dyspnø, CHF, KOL eller astma ved baseline.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Danish: Hvis et eller flere af ovennævnte udsagn gælder for dig (eller du er usikker), så tal med lægen eller apotekspersonalet, før du tager dette lægemiddel.
English: Hazard ratio and p-values are calculated separately for ticagrelor vs. ASA therapy alone from Cox proportional hazards model with treatment group as the only explanatory variable.
Danish: Hazard ratio og p-værdier er beregnet separat for ticagrelor versus ASA-behandling alene ud fra Cox proportional hazards-model med behandlingsgruppe som den eneste forklarende variabel.
English: The mean trough digoxin levels were increased about 30% with ticagrelor co-administration with some individual maximum increases to 2-fold.
Danish: De laveste gennemsnitlige digoxin-niveauer blev øget med omkring 30 % ved samtidig administration af ticagrelor med nogle enkeltstående maksimum-stigninger til det dobbelte.
English: • The PLATO [PLATelet Inhibition and Patient Outcomes] study, a comparison of ticagrelor to clopidogrel, both given in combination with ASA and other standard therapy.
Danish: • PLATO [PLATelet Inhibition and Patient Outcomes]-studiet, en sammenligning mellem ticagrelor og clopidogrel, begge givet i kombination med ASA og anden standardbehandling.
English: A delayed and decreased exposure to oral P2Y12 inhibitors, including ticagrelor and its active metabolite, has been observed in patients with ACS treated with morphine (35% reduction in ticagrelor exposure).
Danish: Der er observeret en forsinket og reduceret eksponering for orale P2Y12-inhibitorer, herunder ticagrelor og dets aktive metabolit, hos patienter med AKS, som blev behandlet med morfin (35 % reduktion i ticagreloreksponering).
English: Overall outcome of bleeding rates in the PLATO study are shown in Table 2.
Danish: Det samlede resultat for blødningshyppigheder i PLATO-studiet er vist i tabel 2.
English: • Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of ticagrelor dosing.
Danish: • Patienter med samtidig administration af lægemidler, der kan øge blødningsrisikoen (f.eks. nonsteroide antiinflammatoriske stoffer (NSAID), orale antikoagulantia og/eller fibrinolytika) inden for 24 timer fra dosering af ticagrelor.
English: • Bleeding into your joints and muscles causing painful swelling
Danish: • Blødning i led og muskler, som giver smertefulde hævelser
English: Patients with asthma/chronic obstructive pulmonary disease (COPD) may have an increased absolute risk of experiencing dyspnoea with ticagrelor.
Danish: Patienter med astma/kronisk obstruktiv lungesygdom (KOL) kan have en øget absolut risiko for at få dyspnø under behandling med ticagrelor.
English: Premature discontinuation with any antiplatelet therapy, including Brilique, could result in an increased risk of cardiovascular (CV) death, MI or stroke due to the patient's underlying disease.
Danish: Præmatur seponering af en antitrombotisk behandling, herunder Brilique, kan resultere i øget risiko for kardiovaskulært (CV) dødsfald, MI eller apopleksi som følge af patientens tilgrundliggende sygdom.
English: Co-administration of ticagrelor and levonorgestrel and ethinyl estradiol increased ethinyl estradiol exposure approximately 20% but did not alter the pharmacokinetics of levonorgestrel.
Danish: Samtidig administration af ticagrelor og levonorgestrel og ethinylestradiol øgede ethinylestradiols eksponering med ca. 20 %, men ændrede ikke farmakokinetikken for levonorgestrel.
English: Mon Tue Wed Thu Fri Sat Sun Sun/Moon symbol
Danish: Man Tir Ons Tor Fre Lør Søn Sol/måne-symbol
English: • Non-Steroidal Anti-Inflammatory Drugs (abbreviated as NSAIDs) often taken as painkillers such as ibuprofen and naproxen.
Danish: • Non-Steroide Antiinflammatoriske Midler (forkortet NSAID) der ofte tages som smertestillende medicin, såsom ibuprofen og naproxen.
English: When the orodispersible tablet was dispersed in saliva and swallowed with water, ticagrelor AUC was similar, while Cmax was about 15% lower than for the film-coated tablet.
Danish: Når smeltetabletten blev dispergeret i spyt og sunket med vand, var ticagrelors AUC ens, mens Cmax var omkring 15 % lavere end for den filmovertrukne tablet.
English: PLATO Minor: Requires medical intervention to stop or treat bleeding.
Danish: PLATO Minor: Kræver medicinsk intervention for at stoppe eller behandle blødninger.
English: False negative results in a platelet function test (to include, but may not be limited to the HIPA test) for HIT have been reported in patients administered ticagrelor.
Danish: Der er rapporteret om falsk negative resultater i en trombocytfunktionstest (herunder, men måske ikke begrænset til HIPA-test) for HIT hos patienter, der får indgivet ticagrelor.
English: Ticagrelor has no or negligible influence on the ability to drive and use machines.
Danish: Ticagrelor påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If you forget to take Brilique
Danish: Hvis du har glemt at tage Brilique
English: Dyspnoea was reported in patients treated with ticagrelor.
Danish: Dyspnø blev indberettet hos patienter, der blev behandlet med ticagrelor.
English: In PEGASUS, dyspnoea was reported in 14.2% of patients taking ticagrelor 60 mg twice daily and in 5.5% of patients taking ASA alone.
Danish: I PEGASUS blev der rapporteret dyspnø hos 14,2 % af de patienter, der tog ticagrelor 60 mg to gange dagligt og hos 5,5 % af de patienter, der kun tog ASA.
English: The tablet can also be dispersed in water and administered via a nasogastric tube (CH8 or greater).
Danish: Tabletten kan også dispergeres i vand og administreres via en nasogastrisk sonde (CH8 eller større).
English: How to take Brilique Do not open the blister until it is time to take your medicine.
Danish: Åbn ikke blisteren, før det er tid til at tage din medicin.
English: Brilique contains ticagrelor, a member of the chemical class cyclopentyltriazolopyrimidines (CPTP), which is an oral, direct acting, selective and reversibly binding P2Y12 receptor antagonist that prevents ADP-mediated P2Y12 dependent platelet activation and aggregation.
Danish: Brilique indeholder ticagrelor, som tilhører den kemiske gruppe CPTP (cyklopentyltriazolpyrimidiner), som er en oral direkte virkende, selektiv og reversibelt bindende P2Y12-receptorantagonist, der hindrer ADP-medieret P2Y12-afhængig trombocytaktivering ogaggregation.
English: Brilique in combination with acetylsalicylic acid (another antiplatelet agent) is to be used in adults only.
Danish: Brilique i kombination med acetylsalicylsyre (et andet blodfortyndende middel) må kun bruges til voksne.
English: Since platelets participate in the initiation and/or evolution of thrombotic complications of atherosclerotic disease, inhibition of platelet function has been shown to reduce the risk of CV events such as death, MI or stroke.
Danish: Eftersom trombocytter deltager i initieringen og/eller udviklingen af trombotiske komplikationer ved aterosklerotisk sygdom, er hæmning af trombocytfunktionen vist at reducere risikoen for CV-hændelser såsom død, MI og apopleksi.
English: • the clot can partly block the blood vessels to the heart; this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina').
Danish: • Blodproppen kan delvist blokere blodkar der fører til hjertet: dette reducerer hjertets blodforsyning og kan give forbigående smerter i brystet (kaldet ”ustabil angina pectoris”).
English: Talk to your doctor before taking this medicine if you are breast-feeding.
Danish: Tal med din læge, før du tager denne medicin, hvis du ammer.
English: Ticagrelor has not been studied in patients with severe hepatic impairment and there is no pharmacokinetic information in patients with moderate hepatic impairment.
Danish: Ticagrelor er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion, og der er ingen farmakokinetisk information om patienter med moderat nedsat leverfunktion.
English: • Feeling short of breath - this is very common.
Danish: • Forpustet/stakåndethed - denne bivirkning er meget almindelig.
English: If you stop taking Brilique
Danish: Hvis du holder op med at tage Brilique
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Danish: Hvis du er usikker, så tal med lægen eller apoteket, før du tager dette lægemiddel.
English: Similar to the overall PLATO study, total PLATO Major bleeding did not differ between ticagrelor and clopidogrel, regardless of CYP2C19 or ABCB1 genotype.
Danish: I lighed med det overordnede PLATO-studie, var samlet PLATO Major Bleeding ikke forskellig ticagrelor og clopidogrel imellem, uanset CYP2C19- eller ABCB1genotypen.
English: This imbalance did not occur at one month: 2.0% versus 2.1% for ticagrelor patients with and without CHF history, respectively; and 3.8% versus 1.4% with clopidogrel.
Danish: Denne ubalance forekom ikke efter en måned: 2,0 % versus 2,1 % af ticagrelor patienter henholdsvis med og uden hjerteinsufficiens i anamnesen, og 3,8 % versus 1,4 % med clopidogrel.
English: • Signs of a blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP) such as: - fever and purplish spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion
Danish: • Tegn på en blodprop-sygdom, som hedder trombotisk trombocytopenisk purpura (TTP), såsom: - feber og lilla pletter (kaldet purpura) på huden eller i munden, med eller uden gulfarvning af huden eller øjne (gulsot), uforklarlig ekstrem træthed eller forvirring.
English: In patients with ACS, it is recommended that renal function is also checked one month after initiating the treatment with ticagrelor, paying special attention to patients ≥75 years, patients with moderate/severe renal impairment and those receiving concomitant treatment with an angiotensin receptor blocker (ARB).
Danish: Hos patienter med AKS anbefales det, at nyrefunktionen også undersøges én måned efter behandlingsstart med ticagrelor, idet der udvises særlig opmærksomhed hos patienter ≥75 år, patienter med moderat/alvorligt nedsat nyrefunktion samt hos patienter, der er i samtidig behandling med en angiotensin II-receptorantagonist (ARB).
English: The majority of these bleedings were of less severity (classified as TIMI Requiring medical attention), e.g. epistaxis, bruising and haematomas.
Danish: Størstedelen af disse blødninger var mindre alvorlige (klassificeret som TIMI, der kræver lægehjælp), f.eks. epistaksis, blå mærker og hæmatomer.
English: Clopidogrel 75 mg once daily (% patients with event) N=9291
Danish: Clopidogrel 75 mg én gang dagligt (% patienter med hændelse) N=9291
English: If the association cannot be avoided, their concomitant use should be made with caution.
Danish: Hvis samtidig behandling ikke kan undgås, tilrådes forsigtighed.