FrancophonIA/ELRC3.0 huggingface dataset:
English: If you need to have surgery or a procedure which may cause bleeding, your doctor might ask you to temporarily stop taking this medicine for a short while.
Danish: Hvis De skal gennemgå en operation eller en undersøgelse, som kan medføre blødning, vil Deres læge muligvis bede Dem om midlertidigt at stoppe med at tage denne medicin i en kort periode.
English: • Transfer all the powder carefully into a suitable container then mix the powder with a little e.g., 30 mL (2 tablespoons), water or one of the other liquids mentioned above to make a mixture.
Danish: • Hæld omhyggeligt al pulveret over i en passende beholder og bland det med lidt vand, f.eks. 30 ml (2 spiseskefuld), eller en af de andre ovennævnte væsker for at lave blandingen.
English: Key secondary endpoints of major bleeding and all cause death were tested in a pre-specified hierarchical testing strategy to control the overall type 1 error in the trial.
Danish: Sekundære nøgleendepunkter for major blødning og død uanset årsag blev testet i en præspecificeret hierarkisk teststrategi for at kontrollere for den generelle type 1-fejl i forsøget.
English: Start treatment with Eliquis at the time you would have had the next dose of anticoagulant medicine, then continue as normal.
Danish: Start behandlingen med Eliquis på det tidspunkt, hvor De ville have taget den næste dosis blodfortyndende medicin og fortsæt derefter som normalt.
English: Apixaban efficacy for prevention of a recurrence of a VTE was maintained across subgroups, including age, gender, BMI, and renal function.
Danish: Apixabans effekt ved forebyggelse af recidiv af VTE blev opretholdt på tværs af undergrupperne, herunder alder, køn, BMI og nyrefunktion.
English: If you take more Eliquis than recommended, you may have an increased risk of bleeding.
Danish: Hvis De tager mere Eliquis end anbefalet, øges risikoen for blødning.
English: This exploratory study showed comparable efficacy and safety between apixaban and heparin and/or VKA treatment groups in the setting of cardioversion.
Danish: Dette eksplorative studie viste sammenlignelig effekt og sikkerhed mellem apixaban- og heparinog/eller VKA-behandlingsgrupperne i forbindelse med kardiovertering.
English: In case of major bleeding events, it should be stopped immediately.
Danish: I tilfælde af major blødning, skal det straks seponeres.
English: The pharmacodynamic effects of apixaban are reflective of the mechanism of action (FXa inhibition).
Danish: De farmakodynamiske virkninger af apixaban afspejler virkningsmekanismen (FXa‑hæmning).
English: Apixaban is not a significant inhibitor of P-gp.
Danish: Apixaban er ikke en signifikant hæmmer af P-gp.
English: Apixaban is not recommended during pregnancy.
Danish: Apixaban bør ikke anvendes under graviditet.
English: In the apixaban group, 342 patients received a loading dose (331 patients received the 10 mg dose and 11 patients received the 5 mg dose).
Danish: I apixaban-gruppen fik 342 patienter en støddosis (331 patienter fik en dosis på 10 mg, og 11 patienter fik en dosis på 5 mg).
English: The first dose of apixaban was given 12 to 24 hours post-surgery, whereas enoxaparin was started 9 to 15 hours prior to surgery.
Danish: Første dosis apixaban blev givet 12‑24 timer efter operationen, hvorimod enoxaparin blev givet 9‑15 timer før operationen.
English: AMPLIFY-EXT STUDY
Danish: AMPLIFY-EXT-STUDIET
English: AVERROES was stopped early based on a recommendation by the independent Data Monitoring Committee due to clear evidence of reduction of stroke and systemic embolism with an acceptable safety profile.
Danish: AVERROES blev afbrudt tidligt i forløbet efter anbefaling af den uafhængige datamonitoreringskomite (the Independent Data Monitoring Committee) på grund af klart bevis for reduktion af apopleksi og systemisk emboli med en acceptabel sikkerhedsprofil.
English: Reversal of Eliquis pharmacodynamic effects, as demonstrated by changes in the thrombin generation assay, was evident at the end of infusion and reached baseline values within 4 hours after the start of a 4-factor PCC 30 minute infusion in healthy subjects.
Danish: Ophævelse af Eliquis' farmakodynamiske effekt, påvist ved ændringer i analysen for trombindannelse, var evident i slutningen af infusionen og nåede baseline‑værdier inden for 4 timer efter påbegyndelse af 4 faktor PCC‑infusion over 30 minutter hos raske forsøgspersoner.
English: Blood clots may break off and travel to the brain and lead to a stroke or to other organs and prevent normal blood flow to that organ (also known as a systemic embolism).
Danish: En blodprop kan rive sig løs, vandre op til hjernen og forårsage et slagtilfælde eller vandre til andre organer, hvor den forhindrer blodtilstrømningen til det pågældende organ (kaldes også systemisk emboli).
English: If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Eliquis at the times your doctor tells you, to prevent blood clots in blood vessels in your brain and other blood vessels in your body.
Danish: Hvis Deres unormale hjerterytme skal bringes tilbage til normal rytme ved hjælp af en procedure, der kaldes kardiovertering, skal De tage Eliquis på de tidspunkter, lægen fortæller Dem, for at forebygge blodpropper i blodårerne i hjernen og andre blodårer i kroppen.
English: • The need to inform Health Care Professionals that they are taking Eliquis if they need to have any surgery or invasive procedure.
Danish: • Nødvendigheden af at oplyse sundhedspersonalet om, at man tager Eliquis, hvis man skal have foretaget kirurgiske eller invasive indgreb.
English: This includes interventions for which any bleeding that occurs is expected to be minimal, non-critical in its location or easily controlled.
Danish: Dette inkluderer indgreb hvor blødninger, hvis de skulle forekomme, vil være minimale, have en ikke‑kritisk placering eller være lette at behandle.
English: *Major bleeding defined per International Society on Thrombosis ad Haemostasis (ISTH) criteria.
Danish: *Major blødning defineret ifølge International Society on Thrombosis ad Haemostasis (ISTH) kriterier.
English: Crushed Eliquis tablets are stable in water, D5W, apple juice, and apple puree for up to 4 hours.
Danish: Knuste Eliquis‑tabletter er stabile i vand, D5W, æblejuice og æblemos i op til 4 timer.
English: If you need surgery, inform your doctor that you are taking Eliquis.
Danish: Hvis du skal opereres, skal du fortælle lægen, at du tager Eliquis.
English: NVAF - No dose adjustment required, unless criteria for dose reduction are met (see Dose reduction at the beginning of section 4.2).
Danish: NVAF - Dosisjustering er ikke nødvendig, medmindre kriterierne for dosisreduktion er opfyldt (se Dosisreduktion i starten af pkt.
English: ¥ p-value < 0.0001 * For patients with more than one event contributing to the composite endpoint, only the first event was reported (e.g., if a subject experienced both a DVT and then a PE, only the DVT was reported) † Individual subjects could experience more than one event and be represented in both classifications
Danish: ¥ p < 0,0001 * For patienter med mere end én hændelse, som bidrog til det sammensatte endepunkt, blev kun den første hændelse rapporteret (f.eks. hvis en forsøgsperson oplevede både DVT og herefter LE, blev kun DVT rapporteret) † De enkelte forsøgspersoner kunne opleve mere end én hændelse og være repræsenteret i begge klassifikationer
English: Ask your doctor, pharmacist or nurse for advice before taking this medicine while breast-feeding.
Danish: Spørg Deres læge, sundhedspersonalet eller apoteket til råds, før De tager denne medicin, mens De ammer.
English: The risk of these events may be increased by the post-operative use of indwelling epidural catheters or the concomitant use of medicinal products affecting haemostasis.
Danish: Risikoen for disse hændelser kan stige ved postoperativ brug af epiduralkateter eller samtidig brug af lægemidler, der påvirker hæmostasen.
English: Discontinuing anticoagulants, including Eliquis, for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of thrombosis.
Danish: Ved seponering af antikoagulantia, herunder Eliquis, i forbindelse med aktiv blødning, elektiv kirurgi eller invasive indgreb har patienten øget risiko for trombose.
English: Patients undergoing cardioversion Apixaban can be initiated or continued in NVAF patients who may require cardioversion.
Danish: Behandling med apixaban kan påbegyndes eller fortsættes hos patienter med NVAF, som kan få brug for kardiovertering.
English: Eliquis contains the active substance apixaban and belongs to a group of medicines called anticoagulants.
Danish: Eliquis indeholder det aktive stof apixaban og tilhører en gruppe medicin, som kaldes blodfortyndende medicin.
English: In rat milk, a high milk to maternal plasma ratio (Cmax about 8, AUC about 30) was found, possibly due to active transport into the milk.
Danish: I rottemælk blev der set et højt mælk/maternal plasma‑ratio (Cmax omkring 8, AUC omkring 30), hvilket muligvis skyldes aktiv transport til modermælken.
English: As with all new anticoagulant medicinal products, experience with neuraxial blockade is limited and extreme caution is therefore recommended when using apixaban in the presence of neuraxial blockade.
Danish: Som med alle nye antikoagulantia er erfaring med neuraksial blokade begrænset, og apixaban bør derfor anvendes med yderste forsigtighed ved brug af neuraksial blokade.
English: Patients are to be frequently monitored for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel or bladder dysfunction).
Danish: Patienten skal overvåges hyppigt for tegn eller symptomer på neurologiske udfald (f.eks. følelsesløshed eller svaghed i benene og afførings- eller vandladningsforstyrrelser).
English: Eliquis (apixaban) is an oral anticoagulant acting by direct selective inhibition of factor Xa.
Danish: Eliquis (apixaban) er et oralt antiokoagulans, der virker ved direkte selektiv hæmning af faktor Xa.
English: Key Elements of the Prescriber Guide:
Danish: Hovedelementerne af ordinationsvejledningen:
English: Separate your language as needed (this is facilitated by the perforated edges)
Danish: Riv kortet på Deres sprog af (gøres nemt langs den stiplede kant)
English: Given the predictable, dose-proportional pharmacokinetic profile of apixaban, the bioavailability results from the conducted studies are applicable to lower apixaban doses.
Danish: På grund af apixabans forudsigelige dosisproportionelle farmakokinetiske profil er resultaterne for biotilgængelighed fra de udførte studier også gældende ved lavere apixaban‑doser.
English: The use of Eliquis may be associated with an increased risk of occult or overt bleeding from any tissue or organ, which may result in posthaemorrhagic anaemia.
Danish: Brugen af Eliquis kan være forbundet med øget risiko for okkult eller synlig blødning fra væv eller organer, hvilket kan forårsage posthæmoragisk anæmi.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, fertility and embryo-foetal development and juvenile toxicity.
Danish: De prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktionstoksicitet og udvikling og toksicitet hos unge.
English: Information for patients
Danish: Oplysninger til patienten
English: Gamma-glutamyltransferase increased
Danish: Førhøjet gamma-glutamyltransferase
English: Available data in animals have shown excretion of apixaban in milk.
Danish: Tilgængelige data fra dyreforsøg har vist, at apixaban udskilles i mælk.
English: Eliquis may increase the risk of bleeding.
Danish: Eliquis kan øge risikoen for blødning.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The next dose of apixaban may be given at least 5 hours after catheter removal.
Danish: Den næste apixaban‑dosis kan gives mindst 5 timer efter kateteret er blevet fjernet.
English: The ADVANCE-3 study included 5,407 patients undergoing elective hip replacement, and the ADVANCE-2 study included 3,057 patients undergoing elective knee replacement.
Danish: ADVANCE-3-forsøget omfattede 5.407 patienter, som fik elektiv hoftealloplastik, og ADVANCE‑2‑forsøget omfattede 3.057 patienter, som fik elektiv knæalloplastik.
English: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) A total of 23,799 patients were randomised in the clinical program (ARISTOTLE: apixaban versus warfarin, AVERROES: apixaban versus ASA) including 11,927 randomised to apixaban.
Danish: Forebyggelse af apopleksi og systemisk emboli hos patienter med non-valvulær atrieflimren (NVAF) I alt 23.799 patienter blev randomiseret i det kliniske program (ARISTOTLE: apixaban versus warfarin, AVERROES: apixaban versus ASA) herunder 11.927 randomiseret til apixaban.
English: However, there is no clinical experience with the use of 4-factor PCC products to reverse bleeding in individuals who have received Eliquis.
Danish: Der er dog ingen klinisk erfaring med brug af 4 faktor PCC-præparater til at stoppe blødning hos personer, som har fået Eliquis.
English: If bleeding occurs, surgery, blood transfusions, or other treatments that may reverse anti-factor Xa activity may be required.
Danish: Hvis der opstår blødning, kan det være nødvendigt med operation, blodtransfusioner eller andre behandlinger, der kan modvirke anti-faktor Xa-aktiviteten.
English: Body weight Low body weight (< 60 kg) may increase haemorrhagic risk (see section 5.2).
Danish: Legemsvægt Lav legemsvægt (< 60 kg) kan medføre øget blødningsrisiko (se pkt.
English: ADVANCE-3 (hip)
Danish: ADVANCE-3 (hofte)
English: The major observed effects in the repeated dose toxicity studies were those related to the pharmacodynamic action of apixaban on blood coagulation parameters.
Danish: De mest betydningsfulde effekter i undersøgelser af toksicitet efter gentagne doser var relateret til apixabans farmakodynamiske virkning på blodkoagulationsparametre.
English: Safety and efficacy of Eliquis have not been studied in patients with prosthetic heart valves, with or without atrial fibrillation.
Danish: Eliquis' sikkerhed og virkning er ikke blevet undersøgt hos patienter med mekaniske hjerteklapper, med eller uden atrieflimren.
English: * Noninferior compared to enoxaparin/warfarin (p-value < 0.0001)
Danish: *Non-inferior sammenlignet med enoxaparin/warfarin (p < 0,0001)
English: In case there is such need and based on the general PK characteristics of apixaban, a time interval of 20-30 hours (i.e., 2 x half-life) between the last dose of apixaban and catheter withdrawal should elapse, and at least one dose should be omitted before catheter withdrawal.
Danish: I tilfælde af behov for dette og baseret på PK‑data for apixaban, bør der være et interval på mindst 20-30 timer (dvs. 2 x halveringstid) fra den sidste apixaban‑dosis til kateteret bliver fjernet, og mindst en dosis bør udelades, før kateteret bliver fjernet.
English: Mean half-life of apixaban decreased from 13.4 hours when apixaban was administered alone to 5.3 hours and 4.9 hours, respectively, when activated charcoal was administered 2 and 6 hours after apixaban.
Danish: Apixabans gennemsnitlige halveringstid mindskedes fra henholdsvis 13,4 timer, når apixaban blev administreret alene, til 5,3 timer og 4,9 timer, når aktivt kul blev administreret 2 og 6 timer efter apixaban.
English: A decision must be made to either discontinue breast-feeding or to discontinue/abstain from apixaban therapy.
Danish: Der bør træffes beslutning om ophør af amning eller at ophøre/fravælge apixaban-behandling.
English: It is unknown whether apixaban or its metabolites are excreted in human milk.
Danish: Det vides ikke om apixaban eller dets metabolitter udskilles i modermælken.
English: Total VTE/all-cause death Number of events/subjects Event Rate
Danish: Total VTE/alle dødsårsager Antal tilfælde/patienter Forekomst
English: Birth Date:
Danish: Fødselsdato:
English: Direct acting Oral Anticoagulants (DOACs) including apixaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Danish: Direkte virkende orale antikoagulantia (DOAK), herunder apixaban, anbefales ikke til patienter med tidligere trombose, som er diagnosticerede med antifosfolipidsyndrom.
English: Tell your doctor immediately if you have taken more than the prescribed dose of Eliquis.
Danish: Kontakt straks Deres læge, hvis De har taget en større dosis Eliquis end foreskrevet.
English: The mean age was 56.9 years and 89.8% of randomised patients had unprovoked VTE events.
Danish: Gennemsnitsalderen var 56,9 år, og 89,8% af de randomiserede patienter havde uprovokerede VTE‑hændelser.
English: Therefore, apixaban does not inhibit P-gp mediated substrate transport.
Danish: Derfor hæmmer apixaban ikke P-gp‑medieret substrattransport.
English: If your doctor tells you that you have to start taking the medicine containing a vitamin K antagonist, continue to take Eliquis for at least 2 days after your first dose of the medicine containing a vitamin K antagonist.
Danish: Hvis Deres læge har bedt Dem om at begynde at tage medicin, der indeholder vitamin K-antagonist, skal De fortsætte med at tage Eliquis i mindst 2 dage efter den første dosis af medicinen, der indeholder en vitamin K-antagonist.
English: Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis.
Danish: Før neuraksial intervention skal lægen afveje de potentielle fordele mod risikoen hos patienter, der får antikoagulantia, og hos patienter, der skal have antikoagulantia til tromboseprofylakse.
English: Eliquis has no or negligible influence on the ability to drive and use machines.
Danish: Eliquis har ingen eller ubetydelig indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: With improving monitoring of INR the observed benefits of apixaban compared to warfarin regarding all cause death diminish.
Danish: Med forbedret monitorering af INR mindskes de observerede fordele ved apixaban i forhold til warfarin med hensyn til død uanset årsag.
English: Corresponding increases in clotting tests were observed for apixaban.
Danish: Tilsvarende stigninger i koagulationstests blev set for apixaban.
English: Based on patient medical history in the studied population of ADVANCE-3 and ADVANCE-2 (8,464 patients), 46% had hypertension, 10% had hyperlipidemia, 9% had diabetes, and 8% had coronary artery disease.
Danish: Baseret på patientjournaler for den undersøgte population i ADVANCE‑3 og ADVANCE‑2 (8.464 patienter) havde 46 % hypertension, 10 % hyperlipidæmi, 9 % diabetes og 8 % iskæmisk hjertesygdom.
English: The absolute bioavailability of apixaban is approximately 50% for doses up to 10 mg. Apixaban is rapidly absorbed with maximum concentrations (Cmax) appearing 3 to 4 hours after tablet intake.
Danish: Den absolutte biotilgængelighed for apixaban er ca. 50 % ved en dosis på op til 10 mg. Apixaban absorberes hurtigt, og den maksimale koncentration (Cmax) opnås 3‑4 timer efter indtagelsen af tabletten.
English: Elderly patients (above 65 years) exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 32% higher and no difference in Cmax.
Danish: Ældre patienter (over 65 år) havde højere plasmakoncentrationer end yngre patienter, idet deres gennemsnitlige AUC‑værdier var cirka 32 % højere uden forskel i Cmax.
English: For patients not previously treated with anticoagulants, exclusion of left atrial thrombus using an image guided approach (e.g. transesophogeal echocardiography (TEE) or computed tomographic scan (CT)) prior to cardioversion should be considered, in accordance with established medical guidelines.
Danish: For patienter, som ikke tidligere er behandlet med antikoagulantia, skal udelukkelse af trombe i venstre atrium vha. billeddiagnostik (f.eks. transøsofageal ekkokardiografi (TEE) eller CT-scanning) før kardiovertering overvejes i overensstemmelse med de etablerede medicinske retningslinjer.
English: Activated charcoal Administration of activated charcoal reduces apixaban exposure (see section 4.9).
Danish: Aktivt kul Administration af aktivt kul nedsætter apixaban-eksponering (se pkt.
English: Bleeding Outcomes Major* Fatal Intracranial
Danish: Blødningsresultater Major* Dødelig
English: Therefore, haemodialysis is unlikely to be an effective means of managing apixaban overdose.
Danish: Derfor er hæmodialyse sandsynligvis ikke en effektiv metode til behandling af overdosering med apixaban.
English: In patients undergoing hip replacement surgery The recommended duration of treatment is 32 to 38 days.
Danish: Patienter der gennemgår hofteoperation Den anbefalede behandlingsvarighed er 32‑38 dage.
English: There were no strokes (0%) in the apixaban group (n= 753) and 6 (0.80%) strokes in the heparin and/or VKA group (n = 747; RR 0.00, 95% CI 0.00, 0.64).
Danish: Der var ingen slagtilfælde (0%) i apixaban-gruppen (n = 753), og 6 (0,80%) slagtilfælde i heparinog/eller VKA-gruppen (n = 747; RR 0,00; 95% CI 0,00; 0,64).
English: Apixaban is metabolised mainly via CYP3A4/5 with minor contributions from CYP1A2, 2C8, 2C9, 2C19, and 2J2.
Danish: Apixaban metaboliseres hovedsageligt via CYP3A4/5 og i mindre grad via CYP1A2, 2C8, 2C9, 2C19 og 2J2.
English: The initiation of appropriate treatment, e.g., surgical haemostasis, the transfusion of fresh frozen plasma or the administration of a reversal agent for factor Xa inhibitors should be considered.
Danish: Påbegyndelse af passende behandling, f.eks. operativ hæmostase, transfusion med frisk frosset plasma eller administration af en antidot mod faktor Xa-hæmmere, bør overvejes.
English: Injury, poisoning and procedural complications Contusion
Danish: Traumer, forgiftninger og behandlingskomplikationer Blodudtrædning
English: Data from clinical trials are only available for the Rotachrom® Heparin chromogenic assay.
Danish: Der foreligger kun data fra kliniske forsøg for Rotachrom® Heparin kromogen analysen.
English: In patients undergoing knee replacement surgery The recommended duration of treatment is 10 to 14 days.
Danish: Patienter der gennemgår knæoperation Den anbefalede behandlingsvarighed er 10‑14 dage.
English: Findings from a population pharmacokinetic analysis in patients who received apixaban were generally consistent with the phase I results.
Danish: Fund fra en populationsfarmakokinetisk analyse af patienter, som fik apixaban stemmer generelt overens med resultater fra fase I‑forsøget.
English: If you miss a dose, take it as soon as you remember and continue to follow your dosing schedule.
Danish: Hvis du har glemt en dosis, skal du tage den så snart du kommer i tanke om det og forsætte behandlingen som normalt.
English: Pharmacodynamic effects
Danish: Farmakodynamiske virkning
English: Information for healthcare professionals
Danish: Oplysninger til sundhedspersonalet
English: The mean age was 56.7 years and 91.7% of randomised patients had unprovoked VTE events.
Danish: Gennemsnitsalderen var 56,7 år, og 91,7% af de randomiserede patienter havde uprovokerede VTE‑hændelser.
English: Key Elements of the Patient Alert Card:
Danish: Hovedelementerne af patientinformationskortet:
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb/Pfizer EEIG
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Bristol-Myers Squibb/Pfizer EEIG
English: Switching treatment from parenteral anticoagulants to Eliquis (and vice versa) can be done at the next scheduled dose (see section 4.5).
Danish: Skift fra parenterale antikoagulantia til Eliquis (og omvendt) kan gøres ved næste planlagte dosis (se pkt.