FrancophonIA/ELRC3.0 huggingface dataset:
English: In the thrombin generation assay, apixaban reduced endogenous thrombin potential, a measure of thrombin generation in human plasma.
Danish: I analysen for trombindannelse reducerede apixaban endogent trombinpotentiale, som er en målestok for trombindannelse i humant plasma.
English: The signs, symptoms, and severity will vary according to the location and degree or extent of the bleeding (see sections 4.4 and 5.1).
Danish: Tegn, symptomer og sværhedsgrad vil variere alt efter stedet og graden eller omfanget af blødningen (se pkt.
English: The safety and efficacy of Eliquis in children and adolescents below age 18 have not been established.
Danish: Eliquis' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Common reasons for unsuitability for VKA therapy in the AVERROES study included unable/unlikely to obtain INRs at requested intervals (42.6%), patient refused treatment with VKA (37.4%), CHADS2 score = 1 and physician did not recommend VKA (21.3%), patient could not be relied on to adhere to VKA medicinal product instruction (15.0%), and difficulty/expected difficulty in contacting patient in case of urgent dose change (11.7%).
Danish: De mest almindelige årsager til uegnethed til VKA‑behandling i AVERROES studiet omfattede: ude af stand til/vil sandsynligvis ikke kunne opnå INR'er med nødvendige intervaller (42,6%), patient afslog behandling med VKA (37,4%), CHADS2 score = 1 og lægen frarådede VKA (21,3%), patient vil muligvis ikke være i stand til at følge patientvejledningen for VKA‑lægemidler (15,0%) og problemer/forventede problemer med at komme i kontakt med patienten i tilfælde af akut dosisændring (11,7%).
English: * There were no occurrences of generalized pruritus in CV185057 (long term prevention of VTE) † The term “Brain haemorrhage” encompasses all intracranial or intraspinal haemorrhages (ie., haemorrhagic stroke or putamen, cerebellar, intraventricular, or subdural haemorrhages).
Danish: * Der forekom ingen tilfælde af generaliseret pruritus i CV185057 (langsigtet forebyggelse af VTE) † Udtrykket ”hjerneblødning” omfatter alle intrakranielle eller intraspinale blødninger (dvs. hæmoragisk apopleksi eller putaminel-, cerebellar-, intraventrikulær- eller subdural blødning).
English: - if you have a prosthetic heart valve - if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned
Danish: - hvis De har en kunstig hjerteklap - hvis Deres læge har konstateret, at Deres blodtryk er ustabilt eller hvis anden behandling eller operation til fjernelse af blodproppen i Deres lunger er planlagt.
English: - Anaemia which may cause tiredness or paleness - Bleeding including:
Danish: - Blodmangel (anæmi) som kan medføre træthed eller bleghed - Blødning, herunder:
English: Eliquis should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding.
Danish: Eliquis skal seponeres mindst 24 timer inden elektiv kirurgi eller invasive indgreb med en lav risiko for blødning.
English: All the bleeding criteria included surgical site bleeding.
Danish: Alle blødningskriterierne inkluderede blødning i operationssåret.
English: If a dose is missed, the patient should take Eliquis immediately and then continue with twice daily intake as before.
Danish: Hvis patienten glemmer en dosis af Eliquis, skal patienten straks tage denne, og derefter fortsætte med at tage dosis to gange dagligt som før.
English: Increases in clotting tests (PT, INR, and aPTT) were consistent with the effects of apixaban alone.
Danish: Stigninger i koagulationstests (PT, INR og aPTT) svarede til apixabans effekt alene.
English: Apixaban did not induce CYP1A2, CYP2B6, CYP3A4/5 at a concentration up to 20 µM.
Danish: Apixaban inducerer ikke CYP1A2, CYP2B6, CYP3A4/5 ved en koncentration på op til 20 µM.
English: For situations when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, a reversal agent for factor Xa inhibitors is available (see section 4.4).
Danish: For situationer, hvor reversering af antikoagulering er nødvendig på grund af livstruende eller ukontrolleret blødning, er en antidot mod faktor Xa-hæmmere tilgængelig (se pkt.
English: When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis.
Danish: Ved neuraksial anæstesi (spinal-/epiduralanæstesi) eller spinal-/epiduralpunktur, har patienter, som får antitrombotika til forebyggelse af tromboemboliske komplikationer, risiko for at udvikle epiduralt eller spinalt hæmatom, hvilket kan føre til langvarig eller permanent lammelse.
English: • Necessity to carry the Patient alert card with them at all times
Danish: • Nødvendigheden af altid at have patientinformationskortet på sig
English: Major + CRNM 613 (4.07) All
Danish: Major + CRNM 613 (4,07) Alle
English: Following administration of the two medicinal products together, mean apixaban AUC and Cmax were 15% and 18% lower than when administered alone.
Danish: Efter samtidig administration af de to lægemidler var det gennemsnitlige AUC og Cmax for apixaban 15 % og 18 % lavere end, når det blev administreret alene.
English: Despite these findings, there may be individuals with a more pronounced pharmacodynamic response when antiplatelet agents are coadministered with apixaban.
Danish: Til trods for disse fund kan nogle individer have et mere udtalt farmakodynamisk respons, når thrombocythæmmere gives samtidig med apixaban.
English: If cardioversion is required before 5 doses of apixaban can be administered, a 10 mg loading dose should be given, followed by 5 mg twice daily.
Danish: Hvis der er behov for kardiovertering, før der kan indgives 5 doser apixaban, skal der indgives en støddosis på 10 mg efterfulgt af 5 mg to gange dagligt.
English: There is no clinical experience with the use of apixaban with indwelling intrathecal or epidural catheters.
Danish: Der er ingen klinisk erfaring med samtidig brug af apixaban og indlagt intratekalt eller epiduralt kateter.
English: • Prescriber Guide
Danish: • Ordinationsvejledning
English: Clotting tests [e.g., prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT)] are affected as expected by the mechanism of action of apixaban.
Danish: Koagulationstest [f.eks. protrombintid (PT), INR og aktiveret partiel tromboplastintid (aPTT)] påvirkes som forventet af apixabans virkningsmekanisme.
English: In vitro apixaban studies showed no inhibitory effect on the activity of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6 or CYP3A4 (IC50 > 45 µM) and weak inhibitory effect on the activity of CYP2C19 (IC50 > 20 µM) at concentrations that are significantly greater than peak plasma concentrations observed in patients.
Danish: In vitro apixaban forsøg viste ingen hæmmende effekt på aktiviteten af CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6 eller CYP3A4 (IC50 > 45 µM) og svag hæmmende effekt på aktiviteten af CYP2C19 (IC50 > 20 µM) ved koncentrationer, der er signifikant højere end maksimal plasmakoncentration observeret hos patienter.
English: Fatal, n
Danish: Dødelig, n
English: Swallow the tablet with a drink of water.
Danish: Tabletten synkes med vand.
English: Eliquis should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of bleeding.
Danish: Eliquis skal seponeres mindst 48 timer inden elektiv kirurgi eller invasive indgreb med moderat eller høj blødningsrisiko.
English: Thus, administration of activated charcoal may be useful in the management of apixaban overdose or accidental ingestion.
Danish: Derfor kan administration af aktivt kul være hensigtsmæssig til behandling af overdosering med apixaban eller efter utilsigtet indtagelse.
English: † Clinically Relevant Non-Major
Danish: †Klinisk relevant ikke-alvorlig blødning
English: Unchanged apixaban is the major drug-related component in human plasma with no active circulating metabolites present.
Danish: Uomdannet apixaban er hovedstoffet i humant plasma, idet der ikke findes nogen aktive cirkulerende metabolitter.
English: Alu PVC/PVdC perforated unit dose blisters of 60x1 and 100x1 film-coated tablets.
Danish: Alu-PVC/PVDC perforeret enkeltdosisblister med 60x1 og 100x1 filmovertrukne tabletter.
English: Prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors (NVAF)
Danish: Forebyggelse af apopleksi og systemisk emboli hos voksne patienter med NVAF, med en eller flere risikofaktorer (NVAF)
English: In the absence of other criteria for dose reduction (age, body weight), no dose adjustment is necessary (see section 5.2).
Danish: Ved manglende dosisreduktionskriterier (alder, kropsvægt) er dosisjustering ikke nødvendig (se pkt.
English: Preclinical studies of apixaban in animal models have demonstrated antithrombotic efficacy in the prevention of arterial and venous thrombosis at doses that preserved haemostasis.
Danish: Prækliniske forsøg med apixaban i dyremodeller har vist en antitrombotisk effekt som led i forebyggelsen af arteriel- og venøs trombose ved doser der bevarede hæmostase.
English: The tablet may be crushed and mixed with water, or 5% dextrose in water, or apple juice or apple puree, immediately before you take it.
Danish: Tabletten kan knuses og blandes med vand eller 5% glucose i vand eller æblejuice eller æblemos lige inden, De tager den.
English: Myocardial infarction Vascular Death
Danish: Myokardieinfarkt Vaskulær død
English: Table 5: Bleeding Results from Pivotal Phase III Studies* ADVANCE-3
Danish: Tabel 5: Blødningsforekomst i pivotale fase III-forsøg* ADVANCE-3
English: The PK/PD relationship observed in patients was consistent with that established in healthy subjects.
Danish: Resultaterne af PK/PD‑forholdet hos patienter er i overensstemmelse med resultatet hos raske forsøgspersoner.
English: If necessary, your doctor may also give you the crushed Eliquis tablet mixed in 60 mL of water or 5% dextrose in water, through a nasogastric tube.
Danish: Hvis det er nødvendigt, kan lægen også give Dem den knuste Eliquis‑tablet blandet i 60 ml vand eller 5% glucose i vand gennem en sonde i næsen.
English: Anti-FXa activity exhibits a close direct linear relationship with apixaban plasma concentration, reaching maximum values at the time of apixaban peak plasma concentrations.
Danish: Anti-faktor Xa-aktivitet viser en tæt direkte lineær sammenhæng med plasmakoncentrationen af apixaban, som når de maksimale værdier på tidspunktet for apixabans maksimale plasmakoncentrationer.
English: All-cause death occurred in 2 patients (0.27%) in the apixaban group and 1 patient (0.13%) in the heparin and/or VKA group.
Danish: Død uanset årsag forekom hos 2 patienter (0,27%) i apixaban-gruppen og 1 patient (0,13%) i heparin- og/eller VKA-gruppen.
English: Especially, if you are older than 75 years and are taking acetylsalicylic acid, you may have an increased chance of bleeding.
Danish: De kan især have en øget risiko for blødning, hvis De er over 75 år og tager acetylsalicylsyre.
English: Apixaban also demonstrates anti-FXa activity as evident by reduction in Factor Xa enzyme activity in multiple commercial anti-FXa kits, however results differ across kits.
Danish: Apixaban udviser også anti-faktor Xa-aktivitet, afspejlet ved reduktion i faktor Xa enzymaktiviteten i adskillige kommercielle anti faktor Xa-prøvesæt; resultaterne var imidlertid forskellige for de forskellige prøvesæt.
English: Major bleeding and CRNM bleeding events occurred in 3 (0.41%) and 11 (1.50%) patients, respectively, in the apixaban group, compared to 6 (0.83%) and 13 (1.80%) patients in the heparin and/or VKA group.
Danish: Major blødning og CRNM-blødningshændelser opstod hos henholdsvis 3 (0,41%) og 11 (1,50%) patienter i apixaban-gruppen sammenlignet med 6 (0,83%) og 13 (1,80%) patienter i heparin- og/eller VKA-gruppen.
English: Included in this total were 1,262 patients (618 in the apixaban group) of age 75 or older, 1,004 patients (499 in the apixaban group) with low body weight (≤ 60 kg), 1,495 patients (743 in the apixaban group) with BMI ≥ 33 kg/m2, and 415 patients (203 in the apixaban group) with moderate renal impairment.
Danish: Af det samlede antal patienter var 1.262 patienter (618 i apixaban-gruppen) i alderen 75 år eller ældre, 1.004 patienter (499 i apixaban-gruppen) havde lav legemsvægt (≤ 60 kg), 1.495 patienter (743 i apixaban-gruppen) havde BMI ≥ 33 kg/m2, og 415 patienter (203 i apixaban‑gruppen) havde moderat nedsat nyrefunktion.
English: An agent to reverse the anti-factor Xa activity of apixaban is available.
Danish: Et middel til at reversere anti-faktor Xa-aktiviteten af apixaban er tilgængeligt.
English: • Rinse the pestle and mortar you used for crushing the tablet and the container, with a little water or one of the other liquids (e.g., 30 mL), and swallow the rinse.
Danish: • Skyl pistilen og morteren og beholderen med lidt vand eller en af de andre væsker (f.eks. 30 ml) og drik væsken.
English: Limited clinical data indicate that apixaban plasma concentrations are increased in patients with severe renal impairment (creatinine clearance 15-29 mL/min) which may lead to an increased bleeding risk.
Danish: Begrænsede kliniske data indikerer, at apixabans plasmakoncentration er øget hos patienter med svært nedsat nyrefunktion (kreatininclearance 15‑29 ml/min), hvilket kan medføre øget blødningsrisiko.
English: For patients who are unable to swallow whole tablets, Eliquis tablets may be crushed and suspended in water, or 5% dextrose in water (D5W), or apple juice or mixed with apple puree and immediately administered orally (see section 5.2).
Danish: Til patienter, som ikke er i stand til at synke hele tabletter, kan Eliquis‑tabletter knuses og røres ud i vand, 5% glucose i vand (D5W) eller æblejuice, eller de kan blandes med æblemos og indtages umiddelbart efter (se pkt.
English: - for the treatment of DVT and treatment of PE, apixaban should not be used since efficacy may be compromised.
Danish: - til behandling af DVT og behandling af LE: apixaban bør ikke anvendes, da virkningen kan være kompromitteret.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Eliquis in one or more subsets of the paediatric population in venous and arterial embolism and thrombosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at indsende resultater af forsøg med Eliquis i en eller flere undergrupper af den pædiatriske population for venøs og arteriel emboli og trombose (se pkt.
English: Alternatively, Eliquis tablets may be crushed and suspended in 60 mL of water or D5W and immediately delivered through a nasogastric tube (see section 5.2).
Danish: Alternativt kan Eliquis‑tabletterne knuses og røres ud i 60 ml vand eller D5W og straks administreres via en nasogastrisk sonde (se pkt.
English: Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy
Danish: Hæmodynamisk ustabile LE‑patienter og patienter med behov for trombolyse eller lungeembolektomi
English: Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery (VTEp)
Danish: Forebyggelse af VTE hos voksne patienter, som har gennemgået elektiv hofteeller knæalloplastik (VTEp)
English: No changes were observed in the effect of naproxen on arachidonic acid-induced platelet aggregation and no clinically relevant prolongation of bleeding time was observed after concomitant administration of apixaban and naproxen.
Danish: Naproxens virkning på arachidonsyre-induceret trombocytaggregation var ikke ændret, og der var ingen klinisk relevant forlængelse af blødningstiden efter samtidig indtagelse af apixaban og naproxen.
English: Prevention of stroke and systemic embolism: NVAF 2.5 mg twice daily*
Danish: Forebyggelse af apopleksi og systemisk emboli: NVAF 2,5 mg to gange dagligt*
English: Hip fracture surgery
Danish: Hoftefraktur-kirurgi
English: - Blood tests may show: - abnormal liver function - an increase in some liver enzymes - an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes.
Danish: - Blodprøver kan vise: - unormal leverfunktion - stigning i visse leverenzymer - stigning i bilirubin, et nedbrydningsprodukt af røde blodlegemer, som kan medføre gulfarvning af hud og øjne.
English: Also, the co-administration of Eliquis with ASA in elderly patients should be used cautiously because of a potentially higher bleeding risk.
Danish: Ligeledes bør samtidig administration af Eliquis og ASA til ældre patienter foretages med forsigtighed på grund af potentielt øget risiko for blødning.
English: After combined administration of enoxaparin (40 mg single dose) with apixaban (5 mg single dose), an additive effect on anti-Factor Xa activity was observed.
Danish: Efter samtidig indgivelse af enoxaparin (enkeltdosis på 40 mg) og apixaban (enkeltdosis på 5 mg) blev der observeret additiv virkning på anti‑faktor Xa‑aktiviteten.
English: Nervous system disorders Brain haemorrhage†
Danish: Nervesystemet Hjerneblødning†
English: Eliquis is used in adults: - to prevent blood clots (deep vein thrombosis [DVT]) from forming after hip or knee replacement operations.
Danish: Eliquis anvendes til voksne: - til at forebygge blodpropper (dyb venetrombose [DVT]) efter en knæ- eller hofteoperation.
English: Renal impairment had no evident effect on the relationship between apixaban plasma concentration and anti-FXa activity.
Danish: Nedsat nyrefunktion havde ingen indflydelse på forholdet mellem apixabans plasmakoncentrationer og anti‑FXa‑aktiviteten.
English: PE*
Danish: LE*
English: Anti-Xa Activity Max (IU/mL)
Danish: Anti-Xa aktivitet Max (IE/ml)
English: Switching from Eliquis to VKA therapy
Danish: Skift fra Eliquis til VKA behandling
English: The most common general side effect of Eliquis is bleeding which may be potentially life threatening and require immediate medical attention.
Danish: Den hyppigste bivirkning ved Eliquis er blødning, som kan være livstruende og kræve øjeblikkelig lægehjælp.
English: Carry this card with you at all times
Danish: Hav altid dette kort på dig
English: phenobarbital or St. John's Wort) may also lead to reduced apixaban plasma concentrations.
Danish: phenobarbital eller perikon (Hypericum perforatum)) kan også medføre et fald i apixabans plasmakoncentrationer.
English: Prior to initiating Eliquis, liver function testing should be performed.
Danish: Før behandling med Eliquis indledes, bør der udføres leverfunktionstest.
English: The relationship between apixaban plasma concentration and anti-Factor Xa activity was best described by a linear model.
Danish: Forholdet mellem plasmakoncentrationen af apixaban og antiFaktor Xa-aktiviteten blev bedst beskrevet ved en lineær model.
English: Redosing of recombinant factor VIIa could be considered and titrated depending on improvement of bleeding.
Danish: Det bør overvejes at redosere og titrere rekombinant faktor VIIa afhængigt af responset på behandlingen af blødningen.
English: In a clinical trial of patients with atrial fibrillation, concomitant use of ASA increased the major bleeding risk on apixaban from 1.8% per year to 3.4% per year and increased the bleeding risk on warfarin from 2.7% per year to 4.6% per year.
Danish: I et klinisk forsøg med patienter med atrieflimren forhøjede samtidig brug af ASA risikoen for major blødning ved apixaban fra 1,8% pr. år til 3,4% pr. år og forhøjede blødningsrisikoen ved warfarin fra 2,7% pr. år til 4,6% pr. år.
English: • Importance of treatment compliance
Danish: • Vigtigheden af medicinefterlevelse
English: Currently there is no experience with the use of recombinant factor VIIa in individuals receiving apixaban.
Danish: Der er aktuelt ingen erfaring med brugen af rekombinant faktor VIIa til personer i behandling med Eliquis.
English: Common adverse reactions were haemorrhage, contusion, epistaxis, and haematoma (see Table 2 for adverse reaction profile and frequencies by indication).
Danish: Almindelige bivirkninger var blødning, blodudtrædning, epistaxis og hæmatom (se tabel 2 for bivirkningsprofil og hyppighed efter indikation).
English: Eliquis contains lactose.
Danish: Eliquis indeholder lactose.
English: A calibrated quantitative anti-Factor Xa assay may be useful in exceptional situations, e.g., overdose and emergency surgery (prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) clotting tests are not recommended) - see SmPC.
Danish: En kalibreret kvantitativ test for anti‑faktor Xa kan være nyttig i særlige situationer, f.eks. ved overdosering og akut kirurgi (protrombintid (PT), international normaliseret ratio (INR) og aktiveret partiel tromboplastintid (aPTT) frarådes) - se produktresuméet.
English: Apixaban has no direct effects on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin.
Danish: Apixaban har ingen direkte effekt på trombocytaggregationen, men hæmmer indirekte trombocytaggregationen induceret af trombin.
English: Reproductive system and breast disorders Abnormal vaginal haemorrhage, urogenital haemorrhage
Danish: Det reproduktive system og mammae Abnorm vaginal blødning, urogenital blødning
English: The incidence of ISTH major intraocular bleeding with apixaban was 0.18%/year.
Danish: Incidensen af ISTH major intraokulær blødning var 0,18%/år med apixaban.
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when apixaban was coadministered with atenolol or famotidine.
Danish: Der blev ikke observeret klinisk signifikante farmakokinetiske eller farmakodynamiske interaktioner, når apixaban blev givet samtidigt med atenolol eller famotidin.
English: Therefore Eliquis should be used cautiously in this population (see section 5.2).
Danish: Derfor bør Eliquis anvendes med forsigtighed til denne patientgruppe (se pkt.
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 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 < 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) for henholdsvis NVAF og VTEt.
English: To prevent blood clots from forming after hip or knee replacement operations.
Danish: Til at forebygge blodpropper efter knæ- eller hofteoperation.
English: Coadministration of Eliquis and VKA therapy should be continued until the INR is ≥ 2.
Danish: Samtidig behandling med Eliquis og VKA skal fortsættes, indtil INR er ≥ 2.
English: Anti-Xa Activity Min (IU/mL)
Danish: Anti-Xa aktivitet Min (IE/ml)
English: • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 5.2).
Danish: • Leversygdom, som er forbundet med koagulopati og klinisk relevant blødningsrisiko (se pkt.
English: In the VTEp studies, in total, 11% of the patients treated with apixaban 2.5 mg twice daily experienced adverse reactions.
Danish: I de samlede VTEp‑studier oplevede 11% af patienterne behandlet med apixaban 2,5 mg 2 gange dagligt bivirkninger.
English: The pharmacokinetic /pharmacodynamic (PK/PD) relationship between apixaban plasma concentration and several PD endpoints (anti-FXa activity, INR, PT, aPTT) has been evaluated after administration of a wide range of doses (0.5 - 50 mg).
Danish: Det farmakokinetiske/farmakodynamiske forhold (PK/PD) mellem apixabans plasmakoncentrationer og forskellige PD-endepunkter (anti-FXa-aktivitet, INR, PT, aPTT) er blevet evalueret efter indgivelse i et bredt dosisinterval (0,5 ‑ 50 mg).