FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will discuss with you the benefits and risks of taking Brilique during this time.
Danish: Din læge vil drøfte fordelene og risiciene ved at tage Brilique i denne periode.
English: If bleeding occurs other appropriate supportive measures should be taken.
Danish: Der skal i tilfælde af blødning tages andre relevante understøttende forholdsregler.
English: Fatal: A bleeding event that directly led to death within 7 days.
Danish: Fatal: En blødningshændelse, der fører direkte til dødsfald inden for 7 dage.
English: Sun/Moon symbol
Danish: Sol/måne-symbol
English: • You can check when you last took a tablet of Brilique by looking on the blister.
Danish: • Du kan kontrollere, hvornår du sidst tog en tablet Brilique, ved at kigge på blisterkortet.
English: Ticagrelor may be resumed after the cause of bleeding has been identified and controlled.
Danish: Ticagrelor kan genoptages, når årsagen til blødningen er blevet identificeret og kontrolleret.
English: Severe bleeding is uncommon but can be life threatening.
Danish: Svære blødninger er ikke almindelige, men kan være livstruende.
English: • Put the tablet on your tongue and let it disintegrate.
Danish: • Læg tabletten på tungen og lad den gå i opløsning.
English: Therefore, in the absence of data, treatment beyond one year is not recommended in these patients.
Danish: På grund af manglende data frarådes behandling ud over et år derfor til disse patienter.
English: It is not recommended to use Brilique if you are pregnant or may become pregnant.
Danish: Det frarådes at bruge Brilique hvis du er gravid eller kan blive gravid.
English: If you are taking both Brilique and heparin:
Danish: Hvis du tager både Brilique og heparin:
English: • You can then swallow it with or without water.
Danish: • Du kan derefter sluge den med eller uden vand.
English: Do not take Brilique if:
Danish: Tag ikke Brilique:
English: Your doctor will tell you how much to take (usually between 75-150 mg daily).
Danish: Din læge vil fortælle dig, hvor meget du skal tage (sædvanligvis 75-150 mg dagligt).
English: Bleeding may occur in any part of the body.
Danish: Der kan opstå blødninger i alle dele af kroppen.
English: This interaction may be related to reduced gastrointestinal motility and apply to other opioids.
Danish: Denne interaktion kan være forbundet med nedsat gastrointestinal motilitet og gælder for andre opioider.
English: • Blood in your ear
Danish: • Blod i øret
English: Renal function should be checked according to routine medical practice.
Danish: Nyrefunktionen bør kontrolleres ifølge rutinemæssig medicinsk praksis.
English: Hypersensitivity including angioedema
Danish: Overfølsomhed inklusive angioødem
English: • You have had any problems with your liver or have previously had any disease which may have affected your liver.
Danish: • hvis du har haft problemer med leveren eller tidligere har haft en sygdom, som kan have påvirket din lever.
English: This is because Brilique can affect the way some medicines work and some medicines can have an effect on Brilique.
Danish: Det skyldes, at Brilique kan påvirke virkningen af nogle lægemidler, og at nogle lægemidler kan påvirke Brilique.
English: See a doctor straight away if you notice any of the following - you may need urgent medical treatment:
Danish: Søg straks læge, hvis du bemærker noget af det følgende - du kan have brug for akut lægebehandling:
English: • a heart attack, or
Danish: • et hjerteanfald eller
English: There are limited data on the efficacy and safety of ticagrelor beyond 3 years of extended treatment.
Danish: Der er begrænsede data om virkning og sikkerhed af ticagrelor ud over 3 års udvidet behandling.
English: In the event of an overdose, the above potential adverse reactions could occur and ECG monitoring should be considered.
Danish: I tilfælde af en overdosis kan ovennævnte potentielle bivirkninger opstå, og EKG-monitorering bør overvejes.
English: • Your doctor may require a sample of your blood for diagnostic tests if they suspect a rare platelet disorder caused by heparin.
Danish: • Din læge kan muligvis få brug for en blodprøve til diagnostiske tests, hvis der er mistanke om en sjælden blodpladeforstyrrelse forårsaget af heparin.
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire, SK10 2NA United Kingdom
Danish: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire, SK10 2NA Storbritannien
English: 90% of patients had final extent IPA>70% by 2 hours post dose.
Danish: 90 % af patienterne havde en endelig påvirkning af IPA på >70 % 2 timer efter dosering.
English: Note: the number of first events for the components CV death, MI and stroke are the actual number of first events for each component and do not add up to the number of events in the composite endpoint (s) Indicates statistical significance.
Danish: Bemærk: antallet af første hændelser for komponenterne CV-dødsfald, MI og apopleksi er det faktiske antal af første hændelser for hver komponent og adderer ikke op til antallet af hændelser i det sammensatte endepunkt (s) Indikerer statistisk signifikans.
English: The glass should be rinsed with a further half glass of water and the contents drunk.
Danish: Glasset skal renses med yderligere et halvt glas vand og indholdet drikkes.
English: Holter substudy:
Danish: Holter-substudie:
English: Within each SOC the adverse reactions are ranked by frequency category.
Danish: Inden for hver SOC er bivirkningerne opstillet efter frekvenskategori.
English: The tablet should be placed on the tongue, where it will rapidly disperse in saliva.
Danish: Tabletten skal placeres på tungen, hvor den hurtigt vil dispergeres i spyttet.
English: TIMI Requiring medical attention: Requiring intervention, OR leading to hospitalisation, OR prompting evaluation.
Danish: TIMI, der kræver lægehjælp: Kræver intervention, ELLER medfører hospitalsindlæggelse, ELLER foranlediger vurdering.
English: • cyclosporine (used to lessen your body's defenses)
Danish: • ciclosporin (anvendes til at nedsætte din krops forsvarssystem)
English: It might be due to your heart disease or another cause, or it might be a side effect of Brilique.
Danish: Det kan skyldes din hjertesygdom eller en anden årsag, eller det kan være en bivirkning til Brilique.
English: Figure 1 shows the estimate of the risk to the first occurrence of any event in the composite efficacy endpoint.
Danish: Figur 1 viser den estimerede risiko for den første forekomst af en hændelse ved det sammensatte effekt-endepunkt.
English: Ticagrelor may have similar effect on lovastatin.
Danish: Ticagrelor kan have en lignende indvirkning på lovastatin.
English: • Crush the tablet to a fine powder.
Danish: • Knus tabletten til et fint pulver
English: However, a link between the observed increases in adenosine and clinical outcomes (e.g. morbidity-mortality) has not been clearly elucidated.
Danish: En forbindelse mellem de observerede adenosin-stigninger og de kliniske resultater (f.eks. morbiditet-mortalitet) er dog ikke blevet fuldstændigt klarlagt.
English: • rifampicin (an antibiotic)
Danish: • rifampicin (et antibiotikum)
English: If a switch is needed, the first dose of Brilique should be administered 24 hours following the last dose of the other antiplatelet medication.
Danish: Hvis der er behov for et skift, skal første dosis af Brilique administreres 24 timer efter sidst indgivne dosis af den foregående antitrombotiske behandling.
English: PLATO genetic substudy
Danish: Genetisk PLATO-substudie
English: Effects of ticagrelor on other medicinal products
Danish: Indvirkning af ticagrelor på andre lægemidler
English: This magnitude of increased exposure is not expected to be clinically relevant to most patients.
Danish: Øget eksponering af denne størrelse forventes ikke at være klinisk relevant for størstedelen af patienterne.
English: Therefore, premature discontinuation of treatment should be avoided.
Danish: Præmatur seponering af behandling skal derfor undgås.
English: Therefore, patients who experience these symptoms should be cautious while driving or using machines.
Danish: Patienter, der oplever disse symptomer, skal derfor være forsigtige, når de fører motorkøretøj eller betjener maskiner.
English: • You are due to have surgery (including dental work) at any time while taking Brilique.
Danish: • hvis du på noget som helst tidspunkt skal opereres (herunder tandoperationer), mens du tager Brilique.
English: Patients should be advised to inform physicians and dentists that they are taking ticagrelor before any surgery is scheduled and before any new medicinal product is taken.
Danish: Patienterne skal rådes til at oplyse læger og tandlæger om, at de tager ticagrelor, før planlægning af kirurgi, og før de begynder at anvende ny medicin.
English: Thus, no particular group was identified at risk for any subset of bleeding.
Danish: Der kunne derfor ikke identificeres en særlig risikogruppe for nogen kategorier af blødninger.
English: A patient who misses a dose of Brilique should take only one tablet (their next dose) at its scheduled time.
Danish: En patient, der springer en dosis Brilique over, må kun tage én tablet (næste dosis) på det planlagte doseringstidspunkt.
English: • To make sure there is no medicine left, rinse the empty glass with another half a glass of water and drink it.
Danish: • For at være sikker på, at der ikke er mere medicin tilbage, skal du skylle det tomme glas med endnu et halvt glas vand og drikke det
English: *p-value calculated from Cox proportional hazards model with treatment group as the only explanatory variable.
Danish: *p-værdi beregnet fra Cox proportional hazards-model med behandlingsgruppe som den eneste forklarende variabel.
English: Do not stop taking Brilique without talking to your doctor.
Danish: Du må ikke holde op med at tage Brilique uden først at have talt med din læge.
English: ASA alone N = 7067
Danish: ASA alene N = 7067
English: Ticagrelor also increases local endogenous adenosine levels by inhibiting the equilibrative nucleoside transporter-1 (ENT-1).
Danish: Ticagrelor øger tillige de lokale endogene adenosinniveauer ved at hæmme den equilibrative nukleosidtransportør -1 (ENT-1).
English: • more than 40 mg daily of either simvastatin or lovastatin (medicines used to treat high cholesterol)
Danish: • mere end 40 mg daglig af enten simvastatin eller lovastatin (til behandling af for højt kolesterol)
English: This reduces the chance of a blood clot forming that can reduce blood flow.
Danish: Dette reducerer risikoen for dannelsen af en blodprop, der kan nedsætte blodgennemstrømningen.
English: Patients taking Brilique should also take a daily low maintenance dose of ASA 75-150 mg, unless specifically contraindicated.
Danish: Patienter, der tager Brilique, skal også dagligt tage en lav vedligeholdelsesdosis af ASA 75-150 mg, medmindre det udtrykkeligt er kontraindiceret.
English: The orodispersible tablets may be used as an alternative to Brilique 90 mg film-coated tablets for patients who have difficulty swallowing the tablets whole or for whom there is a preference for orodispersible tablets.
Danish: Smeltetabletterne kan anvendes som et alternativ til Brilique 90 mg filmovertrukne tabletter til patienter, der har svært ved at sluge tabletterne hele, eller for hvem der er en præference for smeltetabletter.
English: Effect of ticagrelor on other P-gp substrates has not been studied.
Danish: Ticagrelors virkning på andre P-gp-substrater er ikke blevet undersøgt.
English: There was no difference in overall fatal bleeds.
Danish: Der var ingen forskel i det samlede antal letale blødninger.
English: Treatment can also be initiated up to 2 years from the MI, or within one year after stopping previous ADP receptor inhibitor treatment.
Danish: Behandlingen kan også indledes i op til 2 år fra MI, eller inden for et år efter ophør af tidligere behandling med ADP-receptorhæmmer.
English: If a patient reports new, prolonged or worsened dyspnoea this should be investigated fully and if not tolerated, treatment with ticagrelor should be stopped.
Danish: Hvis en patient rapporterer ny, langvarig eller forværret dyspnø, skal dette undersøges fuldt ud, og hvis dyspnøen ikke tolereres, skal behandling med ticagrelor stoppes.
English: Exposure of the active metabolite increased to a lesser extent (AUC 13-14% and Cmax 17-36%).
Danish: Eksponering af den aktive metabolit steg i mindre grad (AUC 13-14 % og Cmax 17-36 %).
English: • Pour the powder into half a glass of water.
Danish: • Hæld pulveret i et halvt glas vand
English: Effects of medicinal and other products on ticagrelor
Danish: Lægemidlers og andre produkters indvirkning på ticagrelor
English: Ticagrelor reduced the occurrence of the primary composite endpoint compared to clopidogrel in both the UA/NSTEMI and STEMI population (Table 4).
Danish: Ticagrelor reducerede forekomsten af det primære sammensatte endepunkt sammenlignet med clopidogrel i både UA/NSTEMI- og STEMI-populationen (tabel 4).
English: Brilique affects blood clotting, so most side effects are related to bleeding.
Danish: Brilique påvirker blodstørkningen, så de fleste bivirkninger er forbundet med blødning.
English: Clinical efficacy and safety The clinical evidence for the efficacy and safety of ticagrelor is derived from two phase 3 trials:
Danish: Klinisk virkning og sikkerhed Den kliniske evidens for virkning og sikkerhed ved ticagrelor stammer fra to fase 3-studier:
English: • High level of uric acid in your blood (as seen in tests)
Danish: • Højt niveau af urinsyre i blodet (kan ses i undersøgelser)
English: In patients with ACS, in whom morphine cannot be withheld and fast P2Y12 inhibition is deemed crucial, the use of a parenteral P2Y12 inhibitor may be considered.
Danish: Hos patienter med AKS, hvor morfin ikke kan seponeres og hvor hurtig P2Y12-inhibering anses for afgørende, kan det overvejes at anvende en parenteral P2Y12-inhibitor.
English: Adverse reactions are listed by MedDRA System Organ Class (SOC).
Danish: Bivirkningerne er anført efter MedDRA-systemorganklasse (SOC).
English: If you are in the hospital you may be given this tablet mixed with some water and given through a tube via the nose (nasogastric tube).
Danish: Hvis du er på hospitalet, kan du få denne tablet blandet med noget vand og givet gennem en slange via næsen (nasogastrisk sonde).
English: and not crude adverse event report frequency.
Danish: og ikke summarisk frekvens af bivirkningsindberetning.
English: • A 2-fold increase of ticagrelor exposure was observed after daily consumption of large quantities of grapefruit juice (3x200 ml).
Danish: • Der blev observeret en 2-fold stigning i ticagreloreksponeringen efter daglig indtagelse af større mængder grapefrugtjuice (3 x 200 ml).
English: It is important to flush the nasogastric tube through with water after administration of the mixture.
Danish: Det er vigtigt at skylle den nasogastriske sonde igennem med vand efter administration af blandingen.
English: Ticagrelor is not recommended during pregnancy.
Danish: Ticagrelor bør ikke anvendes under graviditeten.
English: • You are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for ticagrelor eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: • To take out the tablet, tear open the blister foil - do not push it through the foil because the tablet may break.
Danish: • Tag tabletten ud ved at rive blisterfolien af - skub ikke tabletten gennem folien, da tabletten derved kan knække.
English: Your doctor may want you to stop taking this medicine 5 days prior to surgery.
Danish: Din læge vil muligvis have dig til at stoppe behandlingen med dette lægemiddel 5 dage før indgrebet.
English: CI = Confidence interval; CV = Cardiovascular; HR = Hazard ratio; KM = Kaplan-Meier; MI = Myocardial infarction; N = Number of patients.
Danish: CI = Konfidensinterval; CV = Kardiovaskulær; HR = Hazard ratio; KM = Kaplan-Meier; MI = Myokardieinfarkt; N = Antal patienter.
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Danish: TTP er en potentielt fatal tilstand, der kræver hurtig behandling, herunder plasmaferese.
English: Brilique is not likely to affect your ability to drive or use machines.
Danish: Brilique vil sandsynligvis ikke påvirke din evne til at køre eller betjene værktøj eller maskiner.
English: • The usual dose is one tablet of 60 mg twice a day.
Danish: • Den sædvanlige dosis er én tablet på 60 mg to gange dagligt.
English: What Brilique is used for
Danish: Hvad Brilique anvendes til
English: If you feel dizzy or confused while taking this medicine, be careful while driving or using machines.
Danish: Hvis du bliver svimmel eller forvirret, mens du tager dette lægemiddel, skal du være forsigtig, når du kører bil eller betjener maskiner.
English: For patients who are unable to swallow the tablet(s) whole, the tablets can be crushed to a fine powder and mixed in half a glass of water and drunk immediately.
Danish: Til patienter, der ikke er i stand til at synke tabletten hel/tabletterne hele, kan tabletterne knuses til et fint pulver, der blandes i et halvt glas vand og drikkes straks.
English: Ticagrelor is well tolerated in single doses up to 900 mg. Gastrointestinal toxicity was dose-limiting in a single ascending dose study.
Danish: Ticagrelor er veltolereret i enkeltdoser på op til 900 mg. Gastrointestinal toksicitet var dosisbegrænsende i et studie, der undersøgte en enkelt stigende dosis.
English: A similar increase in exposure was observed when ticagrelor was administered immediately prior to dialysis (49% and 61%, respectively) showing that ticagrelor is not dialysable.
Danish: En tilsvarende stigning i eksponeringen blev observeret, da ticagrelor blev administreret umiddelbart før dialyse (henholdsvis 49 % og 61 %), hvilket viser, at ticagrelor ikke er dialyserbar.
English: Frequencies derived from lab observations (Uric acid increases to >upper limit of normal from baseline below or within reference range.
Danish: Frekvenser fra laboratorieobservationer (Urinsyrestigninger til >øvre normalgrænse fra baseline under eller inden for referenceområde.
English: The safety profile of ticagrelor has been evaluated in two large phase 3 outcome trials (PLATO and PEGASUS) including more than 39,000 patients (see section 5.1).
Danish: Ticagrelors sikkerhedsprofil er blevet vurderet i to store fase 3-effektundersøgelser (PLATO og PEGASUS), der omfatter mere end 39.000 patienter (se pkt.
English: What Brilique is
Danish: Hvad Brilique er
English: The mechanism for uterine tumours is likely hormonal imbalance which can lead to tumours in rats.
Danish: De uterine tumorers mekanisme er sandsynligvis hormonforstyrrelser, som kan føre til tumorer hos rotter.
English: KM% p-value
Danish: KM% p-værdi
English: Some bleeding is common (like bruising and nosebleeds).
Danish: Lidt blødning er almindeligt (såsom blå mærker og næseblod).
English: Dose adjustment is not recommended, but ticagrelor should be used with caution (see sections 4.4 and 5.2).
Danish: Dosisjustering anbefales ikke, men ticagrelor bør anvendes med forsigtighed (se pkt 4.4 og 5.2).
English: • You have asthma or other lung problems or breathing difficulties.
Danish: • hvis du har astma eller andre lungesygdomme eller åndedrætsbesvær.
English: The observed increased risk of TIMI Major bleeding with ticagrelor 60 mg was primarily due to a higher frequency of Other TIMI Major bleedings driven by events in the gastrointestinal SOC.
Danish: Den observerede øgede risiko for TIMI Major bleeding med ticagrelor 60 mg skyldtes primært en højere frekvens af andre TIMI Major bleedings på grund af hændelser i den gastrointestinale SOC.
English: The incidence of intracranial bleeding was low in both treatment groups given the significant comorbidity and CV risk factors of the population under study.
Danish: Forekomsten af intrakraniel blødning var lav i begge behandlingsgrupper på trods af den signifikante comorbiditet og CV-risikofaktorer i studiepopulationen.
English: Take this medicine on a regular basis and for as long as your doctor keeps prescribing it.
Danish: Tag dette lægemiddel regelmæssigt, så længe din læge fortsat ordinerer det.
English: • ‘oral anticoagulants' often referred to as ‘blood thinners' which include warfarin.
Danish: • "Orale antikoagulantia", ofte kaldet "blodfortyndende medicin", som omfatter warfarin.
English: Each of the components contributed to the reduction in the primary composite endpoint (CV death 17% RRR, MI 16% RRR and stroke 25% RRR).
Danish: Hver af disse komponenter bidrog til reduktionen i det primære sammensatte endepunkt (CV-dødsfald 17 % RRR, MI 16 % RRR og apopleksi 25 % RRR).
English: The exposure in patients self-identified as Hispanic or Latino was similar to that in Caucasians.
Danish: Eksponeringen hos patienter, der selv opfatter sig som latinamerikanske, var tilsvarende den hos kaukasiske patienter.
English: No increased bleeding risk was seen for fatal bleeding and only a minor increase was observed in intracranial haemorrhages, as compared to ASA therapy alone.
Danish: Der blev ikke set nogen øget blødningsrisiko for letal blødning og kun en mindre stigning blev observeret i intrakranielle blødninger i sammenligning med ASA-behandling alene.
English: Other TIMI Major: Non-fatal non-ICH TIMI Major bleeding.
Danish: Anden TIMI Major: Ikke-fatal ikke- ICH TIMI Major bleeding.
English: ARR (%/yr)
Danish: ARR (%/år)
English: • Fainting (syncope) - a temporary loss of consciousness due to sudden drop in blood flow to the brain (common)
Danish: • Besvimelse (synkope) - midlertidigt tab af bevidsthed på grund af et pludseligt fald i blodgennemstrømningen til hjernen (almindeligt)
English: • Visual problems caused by blood in your eye
Danish: • Synsproblemer på grund af blod i øjet
English: Continue taking Brilique as long as your doctor tells you.
Danish: Fortsæt med at tage Brilique så længe, din læge har sagt.
English: It is important that you inform your doctor that you are taking both Brilique and heparin, as Brilique may affect the diagnostic test.
Danish: Det er vigtigt, at du fortæller din læge, at du tager både Brilique og heparin, da Brilique kan påvirke den diagnostiske test.
English: Also tell your doctor that because you are taking Brilique, you may have an increased risk of bleeding if your doctor gives you fibrinolytics, often called ‘clot dissolvers', such as streptokinase or alteplase.
Danish: Fortæl også din læge, at fordi du tager Brilique, kan du have en øget blødningsrisiko, hvis lægen giver dig fibrinolytika, som er medicin der kan opløse blodpropper, såsom streptokinase eller alteplase.
English: Brilique-related breathlessness is generally mild and characterised as a sudden, unexpected hunger for air usually occurring at rest and may appear in the first weeks of therapy and for many may disappear.
Danish: Stakåndethed på grund af Brilique er almindeligvis mild og kendetegnes som en pludselig, uventet behov for luft, der sædvanligvis forekommer, når du hviler dig og kan forekomme i de første uger af behandlingen.
English: PLATO study (Acute Coronary Syndromes)
Danish: PLATO-studiet (akut koronart syndrom)
English: TIMI Major or Minor or Requiring medical attention
Danish: TIMI Major eller Minor TIMI Major eller Minor eller kræver lægehjælp
English: The clinical relevance is unknown, but data indicate the potential for reduced ticagrelor efficacy in patients co-administered ticagrelor and morphine.
Danish: Den kliniske relevans er ukendt, men data indikerer potentiale for nedsat virkning af ticagrelor hos patienter, der får ticagrelor og morfin samtidig.
English: In PEGASUS, patients with history of MI with prior ischaemic stroke were not included.
Danish: I PEGASUS blev patienter med MI i anamnesen med tidligere iskæmisk apopleksi ikke inkluderet.
English: The small difference in Cmax noted is unlikely to be of clinical relevance.
Danish: Det er usandsynligt, at den bemærkede lille forskel i Cmax er af klinisk relevans.
English: ASA alone N=6996
Danish: ASA alene N=6996
English: Warnings and precautions Talk to your doctor or pharmacist before taking Brilique if:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Brilique: