FrancophonIA/ELRC3.0 huggingface dataset:
English: Temporary discontinuation
Danish: Midlertidig seponering
English: Table 2 shows the adverse reactions ranked under headings of system organ class and frequency using the following convention: 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) for VTEp, NVAF, and VTEt respectively.
Danish: Tabel 2 viser bivirkningerne anført under systemorganklasse og hyppighed under anvendelse af følgende kategorier: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 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) for henholdsvis VTEp, NVAF og VTEt.
English: There was an increase in apixaban exposure correlated to decrease in renal function, as assessed via measured creatinine clearance.
Danish: Stigning i eksponeringen til apixaban var korreleret til reduktionen i nyrefunktionen (vurderet ved måling af kreatininclearance).
English: Spinal/epidural anaesthesia or puncture
Danish: Spinal-/epiduralanæstesi eller -punktur
English: - to treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.
Danish: - til at behandle blodpropper i blodårerne i benene (dyb venetrombose) og i blodårerne i lungerne (lungeemboli) samt til at forebygge, at der opstår nye blodpropper i blodårerne i ben og/eller lunger.
English: What you need to know before you take Eliquis
Danish: Det skal De vide, før De begynder at tage Eliquis
English: Eliquis is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 4.3).
Danish: Eliquis er kontraindiceret hos patienter med leversygdom, som er forbundet med koagulopati og klinisk relevant blødningsrisiko (se pkt.
English: The administration of the loading dose should be given at least 2 hours before cardioversion (see section 5.1).
Danish: Støddosis skal indgives mindst 2 timer før kardiovertering (see pkt.
English: 10 film-coated tablets 20 film-coated tablets 60 film-coated tablets 60 x 1 film-coated tablets 100 x 1 film-coated tablets 168 film-coated tablets 200 film-coated tablets
Danish: 10 filmovertrukne tabletter 20 filmovertrukne tabletter 60 filmovertrukne tabletter 60 x 1 filmovertrukne tabletter 100 x 1 filmovertrukne tabletter 168 filmovertrukne tabletter 200 filmovertrukne tabletter
English: In a clinical trial of high-risk post acute coronary syndrome patients, characterised by multiple cardiac and non-cardiac comorbidities, who received ASA or the combination of ASA and clopidogrel, a significant increase in risk of ISTH (International Society on Thrombosis and Haemostasis) major bleeding was reported for apixaban (5.13% per year) compared to placebo (2.04% per year).
Danish: I et klinisk studie med høj risiko patienter med post akut koronarsyndrom, karakteriseret ved flere hjerterelaterede eller ikke hjerterelaterede komorbiditeter, som fik ASA eller en kombination af ASA og clopidogrel, blev der rapporteret om signifikant stigning i risikoen for ISTH (International Society on Thrombosis and Haemostasis) major blødning ved apixaban (5,13% pr. år) sammenlignet med placebo (2,04% pr. år).
English: Compared to apixaban exposure in subjects with body weight of 65 to 85 kg, body weight > 120 kg was associated with approximately 30% lower exposure and body weight < 50 kg was associated with approximately 30% higher exposure.
Danish: Sammenlignet med eksponering til apixaban hos personer med legemsvægt på 65‑85 kg, sås en ca. 30 % lavere eksponering hos personer med legemsvægt på > 120 kg, og ved legemsvægt på < 50 kg sås en ca. 30 % højere eksponering.
English: Oral use Eliquis should be swallowed with water, with or without food.
Danish: Eliquis skal synkes med vand, med eller uden føde.
English: Treatment of DVT and PE, and prevention of recurrent DVT and PE (VTEt)
Danish: Behandling af DVT og PE og forebyggelse af recidiverende DVT og LE (VTEt)
English: Eliquis is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of apixaban have not been established in these clinical situations.
Danish: Eliquis bør ikke anvendes som alternativ til ufraktioneret heparin hos patienter med lungeemboli som er hæmodynamisk ustabile, eller som måske får behov for trombolyse eller lungeembolektomi, da apixabans sikkerhed og virkning ikke er undersøgt i disse kliniske situationer.
English: • The other ingredients are: - Tablet core: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, sodium laurilsulfate, magnesium stearate (E470b).
Danish: • Øvrige indholdsstoffer: - Tabletkerne: vandfri lactose, mikrokrystallinsk cellulose, croscarmellosenatrium, natriumlaurilsulfat, magnesiumstearat (E470b).
English: For patients initiating treatment with apixaban, 5 mg should be given twice daily for at least 2.5 days (5 single doses) before cardioversion to ensure adequate anticoagulation (see section 5.1).
Danish: For patienter, der påbegynder behandling med apixaban, skal der gives 5 mg to gange dagligt i mindst 2,5 dage (5 enkeltdoser) før kardiovertering for at sikre tilstrækkelig antikoagulation (se pkt.
English: Therefore, apixaban is not expected to alter the metabolic clearance of coadministered medicinal products that are metabolised by these enzymes.
Danish: Derfor forventes apixaban ikke at ændre den metaboliske clearance af samtidigt indgivede lægemidler, som metaboliseres af disse enzymer.
English: By inhibiting factor Xa, apixaban prevents thrombin generation and thrombus development.
Danish: Ved at hæmme faktor Xa forhindrer apixaban dannelsen af trombin og udviklingen af tromber.
English: Your doctor needs to do blood-measurements and instruct you when to start taking Eliquis.
Danish: Lægen vil tage blodprøver og vil fortælle Dem, hvornår De skal begynde at tage Eliquis.
English: Eliquis helps to thin your blood.
Danish: Eliquis forebygger blodpropper ved at fortynde dit blod.
English: This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
Danish: Denne tilstand (blodprop i lungen) kan være livstruende og kræver omgående lægehjælp.
English: • Management of overdose situations and haemorrhage
Danish: • Behandling af overdosering og blødning
English: The initial dose should be taken 12 to 24 hours after surgery.
Danish: Første dosis skal tages 12‑24 timer efter indgrebet.
English: ASA N = 2,791 n (%/year)
Danish: ASA N = 2.791 n (%/år)
English: 14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets 60 film-coated tablets 100x 1 film-coated tablets 168 film-coated tablets 200 film-coated tablets
Danish: 14 filmovertrukne tabletter 20 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 60 filmovertrukne tabletter 100 x 1 filmovertrukne tabletter 168 filmovertrukne tabletter 200 filmovertrukne tabletter
English: When converting patients from Eliquis to VKA therapy, administration of Eliquis should be continued for at least 2 days after beginning VKA therapy.
Danish: Når patienter skifter fra Eliquis til VKA-behandling, skal administration af Eliquis fortsætte i mindst 2 dage efter VKA-behandlingen er påbegyndt.
English: The adjudicated major bleeding and CRNM bleeding at any anatomical site were generally lower in the apixaban group as compared to the enoxaparin/warfarin group.
Danish: Bekæftet major blødning og CRNM‑blødning ved ethvert anatomisk sted var generelt lavere i apixaban‑gruppen sammenlignet med enoxaparin/warfarin gruppen.
English: If you forget to take Eliquis
Danish: Hvis De har glemt at tage Eliquis
English: Efficacy across subgroups, including age, gender, body mass index (BMI), renal function, extent of index PE, location of DVT thrombus, and prior parenteral heparin use was generally consistent.
Danish: Virkningen på tværs af undergrupper, herunder alder, køn, body mass index (BMI), nyrefunktion, omfang af LE‑indeks, placering af DVT‑trombose og tidligere parenteral heparin, var generelt ens.
English: • Guidance regarding surgery or invasive procedure, and temporary discontinuation
Danish: kirurgi eller invasive indgreb og midlertidig seponering
English: There was no impact of impaired renal function on peak concentration of apixaban.
Danish: Der var ingen påvirkning af nedsat nyrefunktion på den maksimale koncentration af apixaban.
English: Not known Uncommon
Danish: Ikke almindelig Ikke almindelig
English: Each tablet contains 5 mg of apixaban.
Danish: Hver tablet indeholder 5 mg apixaban.
English: In a clinical study in atrial fibrillation patients, diminished efficacy and a higher risk of bleeding were observed with coadministration of apixaban with strong inducers of both CYP3A4 and P-gp compared with using apixaban alone.
Danish: I et klinisk studie hos patienter med atrieflimren, blev virkningen reduceret og der blev observeret en højere blødningsrisiko, når apixaban blev administreret sammen med både stærke CYP3A4- og P-gp-induktorer sammenlignet med, når det blev administreret alene.
English: In patients with severe renal impairment (creatinine clearance 15-29 mL/min) the following recommendations apply (see sections 4.4 and 5.2):
Danish: Hos patienter med svært nedsat nyrefunktion (kreatininclearance 15‑29 ml/min) gælder følgende anbefalinger (se pkt.
English: The program was designed to demonstrate the efficacy and safety of apixaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and one or more additional risk factors, such as:
Danish: Programmet var tilrettelagt med henblik på at påvise apixabans virkning og sikkerhed til forebyggelse af apopleksi og systemisk emboli hos patienter med non-valvulær atrieflimren (NVAF) og en eller flere risikofaktorer såsom:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 5 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON 5 mg
English: ASA N = 2,780 n (%/year)
Danish: ASA N = 2.780 n (%/år)
English: Prevention of VTE (VTEp): elective hip or knee replacement surgery The apixaban clinical program was designed to demonstrate the efficacy and safety of apixaban for the prevention of VTE in a broad range of adult patients undergoing elective hip or knee replacement.
Danish: Forebyggelse af VTE (VTEp): elektiv hofte- eller knæalloplastik Det kliniske program for apixaban blev udformet til at påvise apixabans virkning og sikkerhed i forebyggelsen af VTE i et bredt udvalg af voksne patienter, som fik elektiv hofte- og knæalloplastik.
English: If you have had a major hip operation you will usually take the tablets for 32 to38 days If you have had a major knee operation you will usually take the tablets for 10 to 14 days
Danish: Hvis De har gennemgået en større hofteoperation, skal De sædvanligvis tage tabletterne i 32‑38 dage.
English: Following oral administration of 10 mg of apixaban as 2 crushed 5 mg tablets with 30 g of apple puree, the Cmax and AUC were 21% and 16% lower, respectively, when compared to administration of 2 whole 5 mg tablets.
Danish: Efter oral administration af 10 mg apixaban som 2 knuste 5 mg tabletter med 30 g æblemos var Cmax og AUC henholdsvis 21% og 16% lavere sammenlignet med administration af 2 hele 5 mg tabletter.
English: The safety endpoints of major bleeding, the composite of major and clinically relevant non-major (CRNM) bleeding, and all bleeding showed similar rates for patients treated with apixaban 2.5 mg compared with enoxaparin 40 mg (see Table 5).
Danish: Sikkerhedsendepunkter for alvorlig blødning (kombination af alvorlig og klinisk relevant ikke-alvorlig blødning (CRNM) og alle blødninger) viste samme hyppighed for patienter behandlet med apixaban 2,5 mg som for patienter behandlet med enoxaparin 40 mg (se tabel 5).
English: Medicinal products associated with serious bleeding are not recommended concomitantly with Eliquis, such as: thrombolytic agents, GPIIb/IIIa receptor antagonists, thienopyridines (e.g., clopidogrel), dipyridamole, dextran and sulfinpyrazone.
Danish: Lægemidler forbundet med alvorlig blødning anbefales ikke til samtidig brug med Eliquis, herunder: trombolytika, GPIIb/IIIa‑receptor antagonister, thienopyridiner (f.eks. clopidogrel), dipyridamol, dextran og sulfinpyrazon.
English: Following oral administration of 10 mg of apixaban as 2 crushed 5 mg tablets suspended in 30 mL of water, exposure was comparable to exposure after oral administration of 2 whole 5 mg tablets.
Danish: Efter oral administration af 10 mg apixaban som 2 knuste 5 mg tabletter opløst i 30 ml vand var eksponeringen sammenlignelig med eksponeringen efter oral administration af 2 hele 5 mg tabletter.
English: The overall incidences of adverse reactions of bleeding, anaemia and abnormalities of transaminases (e.g., ALT levels) were numerically lower in patients on apixaban compared to enoxaparin in the phase II and phase III studies in elective hip and knee replacement surgery.
Danish: Den samlede forekomst af bivirkninger som blødning, anæmi og transaminase‑abnormiteter (f.eks. ALAT‑niveauer) var numerisk lavere hos patienter, der fik apixaban sammenlignet med enoxaparin i fase II- og fase III‑forsøgene med elektiv hofte- eller knæalloplastik.
English: Apixaban efficacy in initial treatment of VTE was consistent between patients who were treated for a PE [Relative Risk 0.9; 95% CI (0.5, 1.6)] or DVT [Relative Risk 0.8; 95% CI (0.5, 1.3)].
Danish: Apixabans virkning ved initial behandling af VTE var sammenlignelig for patienter, som blev behandlet for LE [relativ risiko 0,9; 95% CI (0,5-1,6)] og DVT [relativ risiko 0,8; 95% CI (0,5-1,3)].
English: Other medicines and Eliquis
Danish: Brug af anden medicin sammen med Eliquis
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, sundhedspersonalet eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: Dose: mg twice daily
Danish: Dosis: mg to gange dagligt
English: - Changing from treatment with anticoagulant containing vitamin K antagonist (e.g., warfarin) to Eliquis
Danish: - Skift fra behandling med blodfortyndende medicin, der indeholder vitamin K-antagonist (f.eks. warfarin) til Eliquis
English: The results across phase I studies showed no discernible difference in apixaban pharmacokinetics between White/Caucasian, Asian and Black/African American subjects.
Danish: Resultater fra fase I-forsøg viste ingen tydelige forskelle mellem hvide/kaukasiske, asiater og sorte/afroamerikanske patienter, hvad angår apixabans farmakokinetik.
English: Adjudicated ISTH major gastrointestinal bleeding occurred in 6 (0.2%) apixaban-treated patients and 17 (0.6%) enoxaparin/warfarin-treated patients.
Danish: Bekræftet ISTH major gastrointestinal blødning forekom hos 6 (0,2%) af de apixaban‑behandlede patienter og hos 17 (0,6%) af de enoxaparin/warfarin‑behandlede patienter.
English: Signs and symptoms of bleeding include bruising or bleeding under the skin, tar-coloured stools, blood in urine, nose-bleed, dizziness, tiredness, paleness or weakness, sudden severe headache, coughing up blood or vomiting blood.
Danish: Tegn og symptomer på blødning omfatter blå mærker eller blødning under huden, tjærefarvet afføring, blod i urinen, næseblod, svimmelhed, træthed, bleghed eller svaghedsfølelse, pludselig kraftig hovedpine, ophostning eller opkastning af blod.
English: Relative Risk (95% CI)
Danish: Relativ risiko (95% CI)
English: In patients with atrial fibrillation and conditions that warrant mono or dual antiplatelet therapy, a careful assessment of the potential benefits against the potential risks should be made before combining this therapy with Eliquis.
Danish: Hos patienter med atrieflimren og tilstande, der berettiger enkelt- eller dobbelt trombocythæmmende behandling, bør der foretages omhyggelig vurdering af de potentielle fordele og risici, inden denne type behandling kombineres med Eliquis.
English: Switching from vitamin K antagonist (VKA) therapy to Eliquis When converting patients from vitamin K antagonist (VKA) therapy to Eliquis, warfarin or other VKA therapy should be discontinued and Eliquis started when the international normalised ratio (INR) is < 2.
Danish: Skift fra vitamin K-antagonist- (VKA) behandling til Eliquis Når patienter skiftes fra behandling med vitamin K-antagonist (VKA) til Eliquis, skal warfarin eller anden VKA-behandling seponeres og behandling med Eliquis påbegyndes, når INR (international normaliseret ratio) er < 2.
English: As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR and activated partial thromboplastin time (aPTT).
Danish: Som et resultat af FXa-hæmningen forlænger apixaban koagulationstiden (protrombintiden (PT), INR og den aktiverede partielle tromboplastintid (aPPT)).
English: In healthy subjects, administration of activated charcoal 2 and 6 hours after ingestion of a 20 mg dose of apixaban reduced mean apixaban AUC by 50% and 27%, respectively, and had no impact on Cmax.
Danish: Hos raske forsøgspersoner reducerede administration af aktivt kul 2 og 6 timer efter indtagelse af en 20 mg apixaban‑dosis gennemsnitlig apixaban AUC med henholdsvis 50% og 27% og påvirkede ikke Cmax.
English: Apixaban demonstrates linear pharmacokinetics with dose proportional increases in exposure for oral doses up to 10 mg. At doses ≥ 25 mg apixaban displays dissolution limited absorption with decreased bioavailability.
Danish: Apixabans farmakokinetik er tilnærmelsesvis lineær med dosis proportionale stigninger i eksponeringen til apixaban ved doser op til 10 mg. Ved doser på ≥ 25 mg apixaban ses en faldende biotilgængelighed forårsaget af opløsningsbegrænset absorption.
English: This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
Danish: Dette kan indbefatte aktiv eller nylig gastrointestinal ulceration, tilstedeværelse af maligne tumorer med høj blødningsrisiko, nylig hjerne- eller rygskade, nylig hjerne-, ryg- eller øjenkirurgi, nylig intrakraniel blødning, kendte eller mistænkte esofagale varicer, arteriovenøse misdannelser, vaskulære aneurismer eller svære intraspinale eller intracerebrale vaskulære abnormaliteter.
English: Of the administered apixaban dose in humans, approximately 25% was recovered as metabolites, with the majority recovered in faeces.
Danish: Af en apixabandosis administreret til mennesker bliver ca. 25 % udskilt som metabolitter, hvoraf det meste bliver udskilt med fæces.
English: The safety of apixaban has been investigated in 4 Phase III clinical studies including more than 15,000 patients: more than 11,000 patients in NVAF studies and more than 4,000 patients in the VTE treatment (VTEt) studies, for an average total exposure of 1.7 years and 221 days respectively (see section 5.1).
Danish: Sikkerheden ved apixaban er undersøgt i 4 kliniske fase‑III‑studier med flere end 15.000 patienter: flere end 11.000 patienter i NVAF‑studierne og flere end 4.000 patienter i VTE‑behandlingsstudierne (VTEt) med en gennemsnitlig total eksponering på henholdsvis 1,7 år og 221 dage (se pkt.
English: - Changing from Eliquis to anticoagulant medicines Stop taking Eliquis.
Danish: - Skift fra behandling med Eliquis til blodfortyndende medicin Stop med at tage Eliquis.
English: - bruising and swelling - Nausea (feeling sick)
Danish: - blå mærker og hævelser - Kvalme
English: General disorders and administration site conditions Application site bleeding
Danish: Almene symptomer og reaktioner på administrationsstedet Blødning fra administrationsstedet
English: Efficacy and safety of apixaban in the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) in patients with active cancer have not been established.
Danish: Apixabans sikkerhed og virkning ved behandling af DVT, behandling af LE og forebyggelse af recidiverende DVT og LE (VTEt) hos patienter med aktiv cancer er ikke klarlagt.
English: They will advise you to either stop breast-feeding or to stop/not start taking Eliquis.
Danish: De vil råde Dem til enten at holde op med at amme, eller til ikke at tage Eliquis.
English: If you stop taking Eliquis
Danish: Hvis De holder op med at tage Eliquis
English: - medicines for high blood pressure or heart problems (e.g., diltiazem) - antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin norepinephrine re-uptake inhibitors
Danish: - medicin mod for højt blodtryk eller hjerteproblemer (f.eks. diltiazem) - antidepressiv medicin (såkaldte selektive serotoningenoptagelseshæmmere eller serotonin- og noradrenalingenoptagelseshæmmere)
English: The incidence of ISTH major gastrointestinal bleeds (including upper GI, lower GI, and rectal bleeding) was 0.76%/year with apixaban and 0.86%/year with warfarin.
Danish: Incidensen af ISTH større gastrointestinal blødning (inklusiv øvre gastrointestinal, nedre gastrointestinal og rektal blødning) var 0,76%/år med apixaban og 0,86%/år med warfarin.
English: The following medicines may increase the effects of Eliquis and increase the chance for unwanted bleeding: - some medicines for fungal infections (e.g., ketoconazole, etc.) - some antiviral medicines for HIV / AIDS (e.g., ritonavir) - other medicines that are used to reduce blood clotting (e.g., enoxaparin, etc.) - anti-inflammatory or pain medicines (e.g., acetylsalicylic acid or naproxen).
Danish: Følgende lægemidler kan øge virkningen af Eliquis og øge risikoen for uønsket blødning: - visse former for medicin mod svampeinfektioner (f.eks. ketoconazol etc.) - visse former for virushæmmende medicin mod HIV/AIDS (f.eks. ritonavir) - anden medicin til forebyggelse af blodpropper (f.eks. enoxaparin etc.) - betændelseshæmmende eller smertestillende medicin (f.eks. acetylsalicylsyre eller naproxen).
English: Talk to your doctor, pharmacist or nurse before you take this medicine if you have any of the following: - an increased risk of bleeding, such as: bleeding disorders, including conditions resulting in reduced platelet activity very high blood pressure, not controlled by medical treatment you are older than 75 years you weigh 60 kg or less
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet før De tager Eliquis: - hvis De har en øget risiko for blødning, som f.eks. blødningsforstyrrelser, herunder tilstande med nedsat blodplade‑aktivitet meget højt blodtryk, som ikke er reguleret med medicin hvis De er ældre end 75 år hvis De vejer 60 kg eller derunder
English: Use of thrombolytic agents for the treatment of acute ischemic stroke There is very limited experience with the use of thrombolytic agents for the treatment of acute ischemic stroke in patients administered apixaban.
Danish: Brug af trombolytika til behandling af akut iskæmisk apopleksi Der er meget begrænset erfaring med brug af trombolytiske lægemidler til behandling af akut iskæmisk apopleksi hos patienter, der får apixaban.
English: INFORMATION IN BRAILLE Eliquis 5 mg
Danish: INFORMATION I BRAILLESKRIFT Eliquis 5 mg
English: The overall discontinuation rate due to adverse reactions was 1.5% for apixaban and 1.3% for ASA in the AVERROES study.
Danish: Den samlede frekvens af afbrudt behandling på grund af bivirkninger relateret til behandlingen var 1,5% for apixaban og 1,3% for ASA i AVERROES studiet.