FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk to newborns and infants cannot be excluded.
Danish: En risiko for nyfødte og spædbørn kan ikke udelukkes.
English: Doctor's Name:
Danish: Lægens navn:
English: • The use of coagulation tests and their interpretation
Danish: • Brug af koagulationstest og deres fortolkning
English: Take the medicine pack with you, even if there are no tablets left.
Danish: Tag pakningen med, også selv om der ikke er flere tabletter tilbage.
English: Ethnic origin and race
Danish: Etnisk oprindelse og race
English: Effect of apixaban on other medicinal products
Danish: Apixabans virkning på andre lægemidler
English: Maximum daily dose
Danish: Maksimal daglig dosis
English: The reduction in exposure is not considered clinically relevant.
Danish: Den nedsatte eksponering anses ikke for klinisk relevant.
English: The volume of distribution (Vss) is approximately 21 litres.
Danish: Fordelingsvolumen (Vss) er ca. 21 l.
English: Median [5th, 95th Percentile]
Danish: Median [5., 95. percentil]
English: No systemic embolism events were reported.
Danish: Der blev ikke rapporteret hændelser om systemisk emboli.
English: Indication:
Danish: Indikation:
English: Contact your doctor immediately if you experience any of these symptoms.
Danish: De skal straks kontakte Deres læge, hvis De oplever nogen af disse symptomer.
English: You should not take Eliquis if you are pregnant.
Danish: De bør ikke tage Eliquis, hvis De er gravid.
English: Treatment with Eliquis does not require routine monitoring of exposure.
Danish: Behandling med Eliquis kræver ikke rutinemæssig monitorering af eksponering.
English: • Active clinically significant bleeding.
Danish: • Aktiv klinisk signifikant blødning.
English: * Dose adjusted population based on 2 of 3 dose reduction criteria in the ARISTOTLE study.
Danish: *Dosisjusteret population baseret på 2 af 3 dosisreduktionskriterier i ARISTOTLE‑studiet.
English: Your doctor might change your anticoagulant treatment as follows:
Danish: Deres læge vil muligvis ændre Deres blodfortyndende behandling på følgende måde:
English: Other Endpoints
Danish: Andre endepunkter
English: Plasma protein binding in humans is approximately 87%.
Danish: Fordeling Plasmaproteinbindingen hos mennesker er ca. 87 %.
English: However, since this may be due to a lower sensitivity of the non-clinical species compared to humans, this result should be interpreted with caution when extrapolating to humans.
Danish: Da dette imidlertid kan skyldes en lavere sensitivitet hos de præ‑kliniske arter sammenlignet med mennesker, bør dette resultat tolkes med forsigtighed, når det ekstrapoleres til mennesker.
English: Some medicines may increase the effects of Eliquis and some may decrease its effects.
Danish: Visse lægemidler kan øge virkningen af Eliquis, og andre kan nedsætte virkningen.
English: Apixaban has multiple routes of elimination.
Danish: Apixaban har flere udskillelsesveje.
English: Hypotension (including procedural hypotension)
Danish: Hypotension (herunder hypotension i forbindelse med indgrebet)
English: Your doctor will decide, if you should be treated with Eliquis when taking these medicines and how closely you should be monitored.
Danish: Lægen vil beslutte, om De skal behandles med Eliquis, når De tager disse lægemidler, og hvor tæt De skal holdes under observation.
English: Start treatment with the anticoagulant medicines (for example heparin) at the time you would have taken the next tablet.
Danish: Start behandlingen med den blodfortyndende medicin (f.eks. heparin) på det tidspunkt, hvor De ville have taget den næste tablet.
English: • Lesion or condition if considered a significant risk factor for major bleeding.
Danish: • Læsioner eller tilstande, hvor det anses som en signifikant risikofaktor for major blødning.
English: - Name: - Birth Date: - Indication: - Dose : ........mg twice daily - Doctor's Name: - Doctor's telephone:
Danish: - Navn: - Fødselsdato: - Indikation: - Dosis: ........mg to gange dagligt - Lægens navn: - Lægens telefonnummer:
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Dyreforsøg har hverken vist direkte eller indirekte skadelige virkninger med hensyn til reproduktionstoksicitet.
English: This can cause the legs to swell, with or without pain.
Danish: Dette kan medføre, at benene svulmer op med eller uden smerter.
English: If the bleeding does not stop on its own, seek medical attention immediately.
Danish: Hvis blødningen ikke holder op af sig selv, skal du straks søge lægehjælp.
English: Of these, 836 patients (33.7%) participated in the AMPLIFY study prior to enrollment in the AMPLIFY-EXT study.
Danish: Af disse deltog 836 patienter (33,7%) i AMPLIFY‑studiet, inden de indgik i AMPLIFY‑EXT‑studiet.
English: • Crush the tablets with a pestle and mortar.
Danish: • Knus tabletterne i en morter.
English: AVERROES STUDY
Danish: AVERROES STUDIET
English: Doctor's telephone:
Danish: Lægens telefonummer:
English: It does not require antithrombin III for antithrombotic activity.
Danish: Antitrombin III er ikke nødvendig for antitrombotisk aktivitet.
English: Therapy should be continued long-term.
Danish: Behandlingen bør være langvarig.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodiumfree".
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natriumfrit.
English: ADVANCE-2 (knee)
Danish: ADVANCE-2 (knæ)
English: This medicine helps to prevent blood clots from forming by blocking Factor Xa, which is an important component of blood clotting.
Danish: Denne medicin medvirker til at forebygge blodpropper ved at blokere Faktor Xa, som er en vigtig komponent i dannelsen af blodpropper.
English: There are no data from the use of apixaban in pregnant women.
Danish: Der foreligger ingen data om brugen af apixaban hos gravide kvinder.
English: Eliquis is not recommended in children and adolescents under 18 years of age.
Danish: Eliquis kan ikke anbefales til børn og unge under 18 år.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe apixaban are provided with the following educational material:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der forventes at udskrive apixaban, får udleveret følgende undervisningsmateriale:
English: If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Eliquis.
Danish: Hvis De har svært ved at sluge tabletten hel, kan De tale med Deres læge om andre måder at tage Eliquis.
English: Complete the following sections or ask your doctor to do it:
Danish: Udfyld følgende felter eller bed Deres læge om at gøre det:
English: Renal excretion of apixaban accounts for approximately 27% of total clearance.
Danish: Den renale udskillelse af apixaban er på ca. 27 % af total clearance.
English: Eliquis can be given for three different medical conditions.
Danish: Eliquis kan anvendes til behandling af tre forskellige sygdomstilstande.
English: As per available medical guidelines, short duration of treatment (at least 3 months) should be based on transient risk factors (e.g., recent surgery, trauma, immobilisation).
Danish: Ifølge gældende kliniske retningslinjer bør kort behandlingsvarighed (mindst 3 måneder) baseres på forbigående risikofaktorer (f.eks. nyligt operativt indgreb, traume, immobilisering).
English: - Bleeding:
Danish: - Blødning:
English: This Patient Alert Card includes information that will be helpful to you and alert other doctors that you are taking Eliquis.
Danish: Dette patientinformationskort indeholder oplysninger, som er nyttige for Dem og som gør andre læger opmærksomme på, at De tager Eliquis.
English: For all patients undergoing cardioversion, confirmation should be sought prior to cardioversion that the patient has taken apixaban as prescribed.
Danish: For alle patienter, der gennemgår kardiovertering, skal det bekræftes før kardiovertering, at patienten har taget apixaban som foreskrevet.
English: Investigations Occult blood positive
Danish: Undersøgelser Okkult positiv blodprøve
English: In the toxicity studies little to no increase of bleeding tendency was found.
Danish: I toksicitetsstudier blev der påvist ringe eller ingen øget blødningstendens.
English: After an operation to the hip or knee you may be at a higher risk of developing blood clots in your leg veins.
Danish: Efter en operation i hoften eller knæet kan De have en større risiko for at udvikle blodpropper i blodårerne i benene.
English: Take Eliquis regularly as instructed.
Danish: Husk at tage Eliquis regelmæssigt som anvist.
English: If surgery or invasive procedures cannot be delayed, appropriate caution should be exercised, taking into consideration an increased risk of bleeding.
Danish: Hvis kirurgi eller invasive indgreb ikke kan udsættes, skal der udvises passende forsigtighed, idet den øgede blødningsrisiko tages i betragtning.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • Swallow the mixture.
Danish: • Drik blandingen.
English: Renal impairment In patients with mild or moderate renal impairment, the following recommendations apply:
Danish: Nedsat nyrefunktion Hos patienter med let eller moderat nedsat nyrefunktion gælder følgende anbefalinger:
English: Apixaban is a substrate of transport proteins, P-gp and breast cancer resistance protein (BCRP).
Danish: Apixaban er et substrat for transportproteinerne P‑gp og brystcancer‑resistensprotein (BCRP).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 May 2011
Danish: Dato for første markedsføringstilladelse: 18. maj 2011
English: Intracranial, n
Danish: Intrakraniel, n
English: Show this card to your pharmacist, dentist and any other healthcare professionals that treat you.
Danish: Vis kortet til apotekspersonalet, tandlægen eller til andre sundhedspersoner, der behandler dig.
English: • Recommended dosages and guidance on the posology for different indications
Danish: • Anbefalede doser og anbefalinger til dosering ved de forskellige indikationer
English: This includes interventions for which the probability of clinically significant bleeding cannot be excluded or for which the risk of bleeding would be unacceptable.
Danish: Dette inkluderer alle indgreb hvor sandsynligheden for klinisk signifikant blødning ikke kan udelukkes, eller hvor risiko for blødning er uacceptabel.
English: Gender Exposure to apixaban was approximately 18% higher in females than in males.
Danish: Køn Eksponering til apixaban var ca. 18 % højere hos kvinder end hos mænd.
English: • Guidance regarding switching from or to Eliquis treatment
Danish: • Vejledning om skift fra eller til behandling med Eliquis
English: Patients were exposed to study drug for a mean of 14 months.
Danish: Patienter fik studiemedicinen i gennemsnitlig 14 måneder.
English: The primary safety endpoint was major bleeding during the treatment period.
Danish: Det primære sikkerhedsendepunkt var major blødning i behandlingsperioden.
English: Administration of prothrombin complex concentrates (PCCs) or recombinant factor VIIa may also be considered.
Danish: Indgivelse af protrombin‑kompleks‑koncentrat (PCC) eller rekombinant faktor VIIa kan også overvejes.
English: • Details of populations potentially at higher risk of bleeding
Danish: • Oplysninger om populationer med potentiel højere blødningsrisisko
English: MI, or vascular death*†
Danish: MI eller vaskulær død*†
English: VTE-related death
Danish: VTE-relateret død
English: • Signs or symptoms of bleeding and when to seek attention from a health care provider.
Danish: • Tegn eller symptomer på blødning og hvornår man skal søge hjælp hos sundhedspersonalet.
English: Lapses in therapy should be avoided and if anticoagulation with Eliquis must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.
Danish: Ændringer i behandlingen bør undgås, og hvis antikoagulering med Eliquis skal seponeres midlertidigt uanset årsag, bør behandlingen genstartes så hurtigt som muligt.
English: They are not recommended to assess the pharmacodynamic effects of apixaban.
Danish: De anbefales ikke til vurdering af apixabans farmakodynamiske effekt.
English: I am under anticoagulation treatment with Eliquis (apixaban) to prevent blood clots
Danish: Jeg er i blodfortyndende behandling med Eliquis (apixaban) for at forebygge blodpropper
English: In the study, the incidence in major bleeding for both apixaban doses was not statistically different from placebo.
Danish: I studiet var incidensen af major blødning for begge apixabandoser ikke statistisk forskellig fra placebo.
English: If you are not sure whether a procedure may cause bleeding ask your doctor.
Danish: Hvis De ikke er sikker på, om en undersøgelse kan medføre blødning, skal De spørge lægen.
English: • symptomatic heart failure (NYHA Class ≥ II)
Danish: • symptomatisk hjertesvigt (NYHA_klasse ≥ II)
English: ASA was given at a once daily dose of 81 mg (64%), 162 (26.9%), 243 (2.1%), or 324 mg (6.6%) at the discretion of the investigator.
Danish: ASA blev givet som én daglig dosis på 81 mg (64%), 162 (26,9%), 243 (2,1%) eller 324 mg (6,6%) efter investigatorernes skøn.
English: If neurological compromise is noted, urgent diagnosis and treatment is necessary.
Danish: Hvis der observeres neurologiske udfald, skal der øjeblikkeligt stilles en diagnose og behandling skal iværksættes.
English: For preventing blood clots from re-occurring following completion of 6 months of treatment
Danish: Til forebyggelse af nye blodpropper efter afslutning af 6 måneders behandling
English: All treated n = 2,673
Danish: Alle behandlede n = 2.673
English: • The active substance is apixaban.
Danish: • Aktivt stof: apixaban.
English: Patients were randomized 1:1 to apixaban or to heparin and/or VKA for the prevention of cardiovascular events.
Danish: Patienterne blev randomiseret 1:1 til apixaban eller til heparin og/eller VKA til forebyggelse af kardiovaskulære hændelser.
English: - medicines for high blood pressure or heart problems (e.g., diltiazem)
Danish: - medicin mod for højt blodtryk eller hjerteproblemer (f.eks. diltiazem)
English: Fold the card and keep it with you at all times
Danish: Fold kortet og hav det altid på Dem
English: Eliquis can be taken with or without food.
Danish: Eliquis kan tages med eller uden mad.
English: ARISTOTLE STUDY
Danish: ARISTOTLE-STUDIET
English: Decisions on initiation and duration of treatment should take established guideline recommendations for anticoagulant treatment in patients undergoing cardioversion into account.
Danish: Når der træffes beslutning om påbegyndelse og varighed af behandlingen, skal der tages højde for de fastsatte anbefalede retningslinjer for behandling med antikoagulantia hos patienter, der gennemgår kardiovertering.
English: Overdose of apixaban may result in a higher risk of bleeding.
Danish: Overdosering af apixaban kan resultere i højere risiko for blødning.
English: As with other anticoagulants, patients taking Eliquis are to be carefully observed for signs of bleeding.
Danish: Som for andre antikoagulantia skal patienter, der tager Eliquis, kontrolleres omhyggeligt for tegn på blødning.
English: See section 2 "Eliquis contains lactose (a type of sugar) and sodium".
Danish: Se afsnit 2 "Eliquis indeholder lactose (en type sukker) og natrium".
English: However, this may increase your risk of bleeding.
Danish: Dette kan imidlertid øge risikoen for blødninger.
English: Stop taking the medicine containing a vitamin K antagonist.
Danish: De skal stoppe med at tage medicin, der indeholder vitamin K-antagonist.
English: Surgery and invasive procedures
Danish: Kirurgi og invasive indgreb
English: Apixaban has a total clearance of about 3.3 L/h and a half-life of approximately 12 hours.
Danish: Apixaban har en total clearance på ca. 3,3 liter/time og en halveringstid på ca. 12 timer.
English: • Recommendations for dose adjustment in at risk populations, including renal or hepatic impairment patients
Danish: • Anbefalinger til dosisjustering hos risikogrupper, herunder patienter med nedsat nyre- eller leverfunktion
English: Inside the Eliquis pack together with the package leaflet you will find a Patient Alert Card or your doctor might give you a similar card.
Danish: I Eliquis-pakken finder De et patientinformationskort sammen med indlægssedlen eller De får et lignende kort af lægen.
English: Alu-PVC/PVdC blisters.
Danish: Alu‑PVC/PVDC blister.
English: Major* Fatal, n
Danish: Major* Dødelig, n
English: The effects of Eliquis on pregnancy and the unborn child are not known.
Danish: Virkningen af Eliquis under graviditet og på det ufødte barn kendes ikke.
English: * Assessed by sequential testing strategy designed to control the overall type I error in the trial.
Danish: * Vurderet ved sekventiel teststrategi udviklet for at kontrollere for den generelle type I-fejl i studiet.
English: Do not stop taking Eliquis without talking to your doctor, as you are at risk of suffering from a stroke or other complications.
Danish: Stop ikke med at tage Eliquis uden først at tale med lægen, da du har risiko for at få et slagtilfælde eller få andre komplikationer.
English: • prior stroke or transient ischaemic attack (TIA)
Danish: • tidligere apopleksi eller transitorisk iskæmisk attak (TIA)
English: You should take the first tablet 12 to 24 hours after your operation.
Danish: Tag den første tablet 12‑24 timer efter operationen.
English: Apixaban is a potent, oral, reversible, direct and highly selective active site inhibitor of factor Xa.
Danish: Apixaban er en potent, oral, reversibel, direkte og yderst selektiv faktor Xa‑hæmmer.
English: Take Eliquis as recommended for the following:
Danish: Tag Eliquis som anvist til behandling af følgende:
English: Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risks of post-surgical bleeding in deciding on the time of administration within this time window.
Danish: Lægen kan overveje de potentielle fordele ved tidligere antikoagulering for VTE‑profylakse såvel som risikoen for post-operativ blødning, når administrationstidspunktet skal fastsættes inden for denne tidsramme.
English: The duration of overall therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Danish: Den samlede behandlingsvarighed skal tilpasses individuelt efter omhyggelig afvejning af fordele ved behandling mod risikoen for blødning (se pkt.
English: Indwelling epidural or intrathecal catheters must be removed at least 5 hours prior to the first dose of Eliquis.
Danish: Et epiduralt eller intratekalt kateter skal fjernes mindst 5 timer inden den første dosis Eliquis gives.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.
English: EMANATE, an open-label, multi-center study, enrolled 1500 patients who were either oral anticoagulant naïve or pre-treated less than 48 hours, and scheduled for cardioversion for NVAF.
Danish: EMANATE, et åbent multicenterstudie, inkluderede 1.500 patienter, som enten var oral antikoagulantnaive eller forudbehandlet mindre end 48 timer og med planlagt kardiovertering for NVAF.
English: Contact your doctor immediately if you become pregnant while taking Eliquis.
Danish: Kontakt straks Deres læge, hvis De bliver gravid under behandlingen med Eliquis.
English: Prevention of recurrent DVT and/or PE following completion of 6 months of treatment for DVT or PE
Danish: Forebyggelse af recidiverende DVT og/eller LE efter afsluttet 6 måneders behandling af DVT eller LE
English: This risk of bleeding should be weighed against the urgency of intervention.
Danish: Blødningsrisikoen bør afvejes imod vigtigheden af indgrebet.
English: It is not known if Eliquis passes into human breast milk.
Danish: Det vides ikke, om Eliquis passerer over i modermælken.
English: Depending on local availability, a consultation of a coagulation expert should be considered in case of major bleedings.
Danish: Hvor det er muligt, bør det overvejes at konsultere en koagulationsekspert i tilfælde af major blødninger.
English: VTE, VTE-related death, or major bleeding
Danish: VTE, VTE-relateret død eller major blødninger
English: Take special care with Eliquis - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Danish: Vær ekstra forsigtig med at tage Eliquis - hvis De ved, at De har en sygdom, der hedder antifosfolipidsyndrom (en forstyrrelse i immunsystemet, der giver øget risiko for blodpropper), skal De sige det til lægen, som vil vurdere, om behandlingen skal ændres.
English: Do not stop taking Eliquis without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early.
Danish: De bør ikke holde op med at tage Eliquis uden først at have talt med Deres læge, da risikoen for udvikling af en blodprop kan være større, hvis De stopper behandlingen for tidligt.
English: Both apixaban and enoxaparin were given for 32-38 days in the ADVANCE-3 study and for 10-14 days in the ADVANCE-2 study.
Danish: Både apixaban og enoxaparin blev givet i 32‑38 dage i ADVANCE‑3‑forsøget og i 10‑14 dage i ADVANCE‑2‑forsøget.
English: Please complete this section or ask your doctor to do it Name:
Danish: Du skal udfylde disse felter eller bede din læge om at gøre det Navn:
English: - Take the dose as soon as you remember and: - take the next dose of Eliquis at the usual time - then continue as normal.
Danish: - tag dosen så snart De kommer i tanke om det og: - tag den næste dosis på det sædvanlige tidspunkt - fortsæt som normalt
English: If a blood clot travels from your leg to your lungs, it can block blood flow causing breathlessness, with or without chest pain.
Danish: Hvis en blodprop bevæger sig fra benet til lungerne, kan det medføre åndenød med eller uden brystsmerter.
English: † Secondary endpoint.
Danish: † Sekundært endepunkt.
English: * All the bleeding criteria included surgical site bleeding 1 Includes events occurring after first dose of enoxaparin (pre-surgery) 2 Includes events occurring after first dose of apixaban (post-surgery)
Danish: * Alle blødningskriterierne inkluderer blødning i operationssåret 1 Omfatter hændelser efter første dosis af enoxaparin (før operation) 2 Omfatter hændelser efter første dosis af apixaban (efter operation)
English: In the event of haemorrhagic complications, treatment must be discontinued and the source of bleeding investigated.
Danish: I tilfælde af hæmoragiske komplikationer skal behandlingen stoppes og kilden til blødningen findes.
English: Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors, ATC code: B01AF02
Danish: Farmakoterapeutisk klassifikation: Antitrombotiske midler, direkte faktor Xa-hæmmere, ATC‑kode: B01AF02
English: The primary safety endpoint was major bleeding.
Danish: Det primære sikkerhedsendepunkt var major blødning.
English: Eliquis contains lactose (a type of sugar) and sodium
Danish: Eliquis indeholder lactose (en type sukker) og natrium
English: Film-coated tablet (tablet)
Danish: Filmovertrukne tabletter (tabletter)