FrancophonIA/ELRC3.0 huggingface dataset:
English: Haemodialysis, started two hours after administration of a single dose of apixaban 5 mg, decreased apixaban AUC by 14% in these ESRD subjects, corresponding to an apixaban dialysis clearance of 18 mL/min.
Danish: Hæmodialyse, som blev påbegyndt to timer efter administration af en enkelt dosis apixaban på 5 mg, reducerede apixabans AUC med 14% hos forsøgspersoner med terminal nyresygdom, hvilket svarer til en dialyseclearance for apixaban på 18 ml/min.
English: The overall incidence of adverse reactions related to bleeding with apixaban was 10% in the apixaban vs enoxaparin studies.
Danish: Den samlede bivirkningsfrekvens relateret til blødning pga. apixaban var 10% i apixaban- versus enoxaparinstudierne.
English: Coadministration of apixaban 10 mg with atenolol 100 mg did not have a clinically relevant effect on the pharmacokinetics of apixaban.
Danish: Samtidig behandling med apixaban 10 mg og atenolol 100 mg viste ingen klinisk relevant effekt på farmakokinetikken for apixaban.
English: Eliquis has not been shown to impair your ability to drive or use machines.
Danish: Eliquis påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Each 2.5 mg film-coated tablet contains 51.43 mg lactose (see section 4.4).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver 2,5 mg filmovertrukken tablet indeholder 51,43 mg lactose (se pkt.
English: AMPLIFY STUDY
Danish: AMPLIFY-STUDIET
English: Each tablet contains 2.5 mg of apixaban.
Danish: Hver tablet indeholder 2,5 mg apixaban.
English: When prevention of recurrent DVT and PE is indicated, the 2.5 mg twice daily dose should be initiated following completion of 6 months of treatment with apixaban 5 mg twice daily or with another anticoagulant, as indicated in Table 1 below (see also section 5.1)
Danish: Hvis forebyggelse af recidiverende DVT og LE er indiceret, bør behandlingen med en dosis på 2,5 mg oralt to gange dagligt initieres efter afsluttet 6 måneders behandling med apixaban 5 mg to gange dagligt eller med et andet antikoagulans, som anvist i tabel 1 (se også pkt.
English: In the apixaban vs warfarin study the incidence of ISTH major gastrointestinal bleeds (including upper GI, lower GI, and rectal bleeding) with apixaban was 0.76%/year.
Danish: I apixaban versus warfarinstudiet var incidensen af ISTH major gastrointestinal blødning (inklusive øvre gastrointestinal, nedre gastrointestinal og rektal blødning) 0,76%/år med apixaban.
English: Eliquis is used in adults: - to prevent a blood clot from forming in the heart in patients with an irregular heart beat (atrial fibrillation) and at least one additional risk factor.
Danish: Eliquis anvendes til voksne: - til at forebygge blodpropper i hjertet hos patienter med uregelmæssig hjerterytme (atrieflimren) og mindst en yderligere risikofaktor.
English: The recommended dose of apixaban for the prevention of recurrent DVT and PE is 2.5 mg taken orally twice daily.
Danish: Den anbefalede dosis af apixaban til forebyggelse af recidiverende DVT og LE er 2,5 mg oralt to gange dagligt.
English: Table 3 below shows the predicted steady state exposure and anti-Factor Xa activity for each indication.
Danish: Tabel 3 viser den forventede eksponering ved steady state og anti-faktor Xa-aktivitet for hver indikation.
English: Table 3: Predicted Apixaban Steady-state Exposure and Anti-Xa Activity
Danish: Tabel 3: Forventet eksponering ved steady state og anti-Xa‑aktivitet
English: Bleeding: - in your brain or in your spinal column - in your lungs
Danish: Blødning: - i hjernen eller rygsøjlen - i lungerne
English: Stroke or systemic embolism* 51 (1.62) Stroke Ischaemic or unspecified Haemorrhagic Systemic embolism Stroke, systemic embolism,
Danish: Apopleksi eller systemisk emboli* Apopleksi Iskæmisk eller uspecificeret Hæmoragisk Systemisk emboli Apopleksi, systemisk emboli,
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin
Danish: Filmovertræk Lactosemonohydrat Hypromellose (E464) Titandioxid (E171) Triacetin
English: To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs
Danish: Til behandling af blodpropper i blodårerne i benene og blodårerne i lungerne
English: After 2 days of coadministration of Eliquis with VKA therapy, an INR should be obtained prior to the next scheduled dose of Eliquis.
Danish: Efter 2 dages samtidig behandling med Eliquis og VKA skal INR-værdi indhentes inden den næste planlagte dosis af Eliquis.
English: Apixaban is not recommended for the treatment of DVT and PE in patients receiving concomitant systemic treatment with strong inducers of both CYP3A4 and P-gp since efficacy may be compromised (see section 4.4).
Danish: Apixaban anbefales ikke til behandling af DVT og LE hos patienter, der får samtidig systemisk behandling med potente induktorer af både CYP3A4 og P-gp, da virkningen kan være kompromitteret (se pkt.
English: The overall discontinuation rate due to adverse reactions was 1.8% for apixaban and 2.6% for warfarin in the ARISTOTLE study.
Danish: Den samlede frekvens af afbrudt behandling på grund af bivirkninger relateret til behandlingen var 1,8% for apixaban og 2,6% for warfarin i ARISTOTLE‑studiet.
English: The relationship between apixaban plasma concentration and anti-FXa activity is approximately linear over a wide dose range of apixaban.
Danish: Sammenhængen mellem apixabans plasmakoncentration og anti‑faktor Xaaktivitet er tilnærmelsesvis lineær over et bredt dosisinterval for apixaban.
English: Immune system disorders Hypersensitivity, allergic oedema and Anaphylaxis
Danish: Overfølsomhed, allergisk ødem og anafylaksi
English: In controlled clinical trials, orally-administered apixaban in healthy subjects at doses up to 50 mg daily for 3 to 7 days (25 mg twice daily (bid) for 7 days or 50 mg once daily (od) for 3 days) had no clinically relevant adverse effects.
Danish: I kontrollerede kliniske forsøg med oralt indgivet apixaban til raske personer i doser op til 50 mg dagligt i 3-7 dage (25 mg 2 gange dagligt i 7 dage eller 50 mg 1 gang dagligt i 3 dage) blev der ikke set klinisk relevante bivirkninger.
English: The following side effects are known if you take Eliquis to prevent a blood clot from forming in the heart in patients with an irregular heart beat and at least one additional risk factor.
Danish: Følgende bivirkninger er kendte bivirkninger, når man tager Eliquis til at forebygge blodpropper i hjertet hos patienter med uregelmæssig hjerterytme og mindst en yderligere risikofaktor.
English: Enoxaparin 40 mg sc once daily 35 ± 3 d p-value Apixaban 2.5 mg po twice daily 12 ± 2 d
Danish: Enoxaparin 40 mg sc en gang dagligt 35 ± 3 d p-værdi Apixaban 2.5 mg oralt to gange dagligt 12 ± 2 d
English: Adjudicated ISTH major gastrointestinal bleeding occurred in 1 (0.1%) apixaban-treated patient at the 5 mg twice daily dose, no patients at the 2.5 mg twice daily dose, and 1 (0.1%) placebo-treated patient.
Danish: Bekræftet ISTH større gastrointestinal blødning forekom hos 1 (0,1%) af de apixaban‑behandlede patienter, som fik dosen på 5 mg dagligt, hos ingen af patienterne, som fik dosen på 2,5 mg dagligt, og hos 1 (0,1%) af patienterne, som fik placebo.
English: Fatal
Danish: Dødelige
English: Fertility Studies in animals dosed with apixaban have shown no effect on fertility (see section 5.3).
Danish: Fertilitet Forsøg på dyr der blev doseret med apixaban viste ingen effekt på fertiliteten.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 5 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER 5 mg
English: In non-valvular atrial fibrillation patients taking apixaban for the prevention of stroke and systemic embolism, the results demonstrate a less than 1.7-fold fluctuation in peak-to-trough levels.
Danish: Hos patienter med non‑valvulær atrieflimren, der tager apixaban til forebyggelse af apopleksi og systemisk emboli, viser resultaterne et udsving på mindre end 1,7 gange mellem højeste og laveste serumkoncentration.
English: In patients taking apixaban for the treatment of DVT and PE or prevention of recurrent DVT and PE, the results demonstrate a less than 2.2-fold fluctuation in peak-to-trough levels.
Danish: Hos patienter, der tager apixaban til behandling af DVT og LE eller forebyggelse af recidiverende DVT og LE, viser resultaterne et udsving på mindre end 2,2 gange mellem højeste og laveste serumkoncentration.
English: What Eliquis contains
Danish: Eliquis indeholder:
English: Apixaban showed a reduction in recurrent symptomatic VTE or VTE- related death across the different levels of center TTR; within the highest quartile of TTR according to center, the relative risk for apixaban vs enoxaparin/warfarin was 0.79 (95% CI, 0.39, 1.61).
Danish: Apixaban viste en reduktion af recidiverende symptomatisk VTE eller VTE‑relateret død på tværs af de forskellige niveauer af center-TTI; for centre i den højeste kvartil af TTI var den relative risiko for apixaban versus enoxaparin/warfarin 0,79 (95% CI 0,39-1,61).
English: In the study, apixaban was statistically superior to enoxaparin/warfarin in the primary safety endpoint [Relative Risk 0.31, 95% confidence interval (0.17, 0.55), P-value <0.0001] (see Table 11).
Danish: I studiet var apixaban statistisk superior til enoxaparin/warfarin i det primære sikkerhedsendepunkt [relativ risiko 0,31; 95% konfidensinterval (0,17-0,55), p < 0,0001] (se tabel 11).
English: The following side effects are known if you take Eliquis to treat or prevent re-occurrence of blood clots in the veins of your legs and blood clots in the blood vessels of your lungs.
Danish: Følgende bivirkninger er kendte bivirkninger, når man tager Eliquis til behandling eller forebyggelse af nye blodpropper i blodårerne i benene eller lungerne.
English: Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
Danish: Forebyggelse af venøs tromboemboli (VTE) hos voksne patienter ved elektiv hofte- eller knæalloplastik.
English: In the study, apixaban was statistically superior to enoxaparin/warfarin in the primary safety endpoint [Relative Risk 0.31, 95% confidence interval (0.17, 0.55), P-value < 0.0001] (see Table 9).
Danish: I studiet var apixaban statistisk superior til enoxaparin/warfarin i det primære sikkerhedsendepunkt [relativ risiko 0,31; 95% konfidensinterval (0,17-0.55), p < 0,0001] (se tabel 9).
English: The recommended dose of apixaban is 2.5 mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL (133 micromole/L).
Danish: Den anbefalede dosis apixaban er 2,5 mg indtaget oralt to gange dagligt hos patienter med NVAF og med mindst to af følgende karakteristika: alder ≥ 80 år, kropsvægt ≤ 60 kg eller serumkreatinin ≥ 1,5 mg/dl (133 mikromol/l).
English: Apixaban exposure parameters exhibit low to moderate variability reflected by a within-subject and inter-subject variability of ~20% CV and ~30% CV, respectively.
Danish: Variationen i apixabans eksponeringsparameter er lav til moderat på ca. 20 % CV og ca. 30 % CV for henholdsvis den intraindividuelle og inter‑individuelle variation.
English: The following side effects are known if you take Eliquis to prevent blood clots from forming after hip or knee replacement operations.
Danish: Følgende bivirkninger er kendte bivirkninger, når man tager Eliquis til at forebygge blodpropper efter en knæ- eller hofteoperation.
English: Respiratory tract haemorrhage
Danish: Blødning fra respirationsveje
English: For oral use
Danish: Oral anvendelse.
English: Apixaban showed a reduction of stroke and systemic embolism compared to warfarin across the different levels of center TTR; within the highest quartile of TTR according to center, the hazard ratio for apixaban vs warfarin was 0.73 (95% CI, 0.38, 1.40).
Danish: Apixaban gav en reduktion af apopleksi og systemisk emboli sammenlignet med warfarin på tværs af de forskellige niveauer af center TTI; i den højeste kvartil af TTI i forhold til center var hazard ratio for apixaban versus warfarin 0,73 (95% CI, 0,38, 1,40).
English: There was no statistically significant difference in the incidence of major + CRNM, minor, and all bleeding between the apixaban 2.5 mg twice daily and placebo treatment groups (see Table 11).
Danish: Der var ingen statistisk signifikant forskel i incidensen af major + CRNM, minor og alle blødninger mellem behandlingsgrupperne, der fik apixaban 2,5mg dagligt og placebo (se tabel 11).
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Hududslæt
English: Inducers of CYP3A4 and P-gp
Danish: CYP3A4- og P-gp-induktorer
English: In patients taking apixaban for the prevention of VTE following hip or knee replacement surgery, the results demonstrate a less than 1.6-fold fluctuation in peak-to-trough levels.
Danish: Hos patienter, der tager apixaban til forebyggelse af VTE efter hofte- eller knæalloplastik viser resultaterne et udsving på mindre end 1,6 gange mellem højeste og laveste serumkoncentration.
English: There was no statistically significant difference in the incidence of major + CRNM, minor, and all bleeding between the apixaban 2.5 mg twice daily and placebo treatment groups (see Table 13).
Danish: Der var ingen statistisk signifikant forskel i incidensen af major + CRNM, minor og alle blødninger mellem behandlingsgrupperne, der fik apixaban 2,5 mg dagligt og placebo (se tabel 13).
English: The recommended dose is one tablet of Eliquis 2.5 mg twice a day if: - you have severely reduced kidney function - two or more of the following apply to you: - your blood test results suggest poor kidney function (value of serum creatinine is 1.5 mg/dL (133 micromole/L) or greater) - you are 80 years old or older - your weight is 60 kg or lower.
Danish: Den anbefalede dosis er en Eliquis 2,5 mg tablet to gange dagligt, hvis: - De har svært nedsat nyrefunktion - To eller flere af følgende punkter gælder for Dem: - Deres blodprøver tyder på, at De har nedsat nyrefunktion (Deres serumkreatinin-tal er 1,5 mg/dl (133 mikromol/l) eller mere) - De er 80 år eller derover - De vejer 60 kg eller derunder.
English: Nonfatal PE†
Danish: Ikke‑dødelig
English: Apix 5.0 mg vs.
Danish: Apix 5,0 mg vs. placebo
English: The dosing regimen should be reduced to 2.5 mg apixaban given twice daily for at least 2.5 days (5 single doses) if the patient meets the criteria for dose reduction (see above sections Dose reduction and Renal impairment).
Danish: Dosisregimet skal reduceres til en dosis på 2,5 mg apixaban to gange dagligt i mindst 2,5 dage (5 enkeltdoser), hvis patienten opfylder kriterierne for dosisreduktion (se Dosisreduktion og Nedsat nyrefunktion ovenfor).
English: Each 5 mg film-coated tablet contains 102.86 mg lactose (see section 4.4).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver 5 mg filmovertrukken tablet indeholder 102,86 mg lactose (se pkt.
English: Electrical and/or pharmacologic cardioversion was conducted after at least 5 doses of 5 mg twice daily apixaban (or 2.5 mg twice daily in selected patients (see section 4.2)) or at least 2 hours after a 10 mg loading dose (or a 5 mg loading dose in selected patients (see section 4.2)) if earlier cardioversion was required.
Danish: Der blev udført elektrisk og/eller farmakologisk kardiovertering efter mindst 5 doser af 5 mg apixaban to gange dagligt (eller 2,5 mg to gange dagligt til udvalgte patienter (se pkt.
English: In the VTEt studies, the overall incidence of adverse reactions related to bleeding with apixaban was 15.6% in the apixaban vs enoxaparin/warfarin study and 13.3% in the apixaban vs placebo study (see section 5.1).
Danish: I VTEt‑studierne var den samlede bivirkningsfrekvens relateret til blødning pga. apixaban 15,6% i apixaban- versus enoxaparin/warfarinstudiet og 13,3% i apixaban- versus placebostudiet (se pkt.
English: Coadministration of single doses of apixaban (10 mg) and naproxen (500 mg), a commonly used NSAID, did not have any effect on the naproxen AUC or Cmax.
Danish: Samtidig indgivelse af en enkelt dosis apixaban (10 mg) og naproxen (500 mg), som er et almindelig anvendt NSAID, påvirkede ikke naproxens AUC eller Cmax.
English: Prevention of VTE (VTEp): elective hip or knee replacement surgery The recommended dose of apixaban is 2.5 mg taken orally twice daily.
Danish: Forebyggelse af VTE (VTEp): elektiv hofte- eller knæalloplastik Den anbefalede dosis er 2,5 mg apixaban indtaget oralt 2 gange dagligt.
English: No dose adjustment for apixaban is required during concomitant therapy with such medicinal products, however in patients receiving concomitant systemic treatment with strong inducers of both CYP3A4 and P-gp apixaban should be used with caution for the prevention of VTE in elective hip or knee replacement surgery, for the prevention of stroke and systemic embolism in patients with NVAF and for the prevention of recurrent DVT and PE.
Danish: Justering af apixabandosis er ikke nødvendig ved samtidig behandling med disse lægemidler, men hos patienter der får samtidig systemisk behandling med potente induktorer af både CYP3A4 og P‑gp bør apixaban anvendes med forsigtighed til forebyggelse af VTE ved elektiv hofte- eller knæalloplastik, til forebyggelse af apopleksi og systemisk emboli hos patienter med NVAF og til forebyggelse af recidiverende DVT og LE.
English: The recommended dose is one tablet of Eliquis 2.5 mg twice a day if:
Danish: Den anbefalede dosis er en Eliquis 2,5 mg tablet to gange dagligt, hvis:
English: Patients with elevated liver enzymes alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2 x ULN or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Danish: Patienter med forhøjede leverenzymer alanin‑aminotransferase (ALAT)/aspartat‑aminotransferase (ASAT) > 2 gange øvre normalværdi eller total‑bilirubin ≥ 1,5 x øvre normalværdi blev ekskluderet fra de kliniske forsøg.
English: Coadministration of a single dose of apixaban (10 mg) and atenolol (100 mg), a common beta-blocker, did not alter the pharmacokinetics of atenolol.
Danish: Samtidig indgivelse af en enkeltdosis apixaban (10 mg) og atenolol (100 mg), som er en almindelig beta-blokker, påvirkede ikke atenolols farmakokinetikf.
English: - Film coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).
Danish: - Filmovertræk: lactosemonohydrat , hypromellose (E464), titandioxid (E171), triacetin, rød jernoxid (E172).
English: In the NVAF studies, the overall incidence of adverse reactions related to bleeding with apixaban was 24.3% in the apixaban vs warfarin study and 9.6% in the apixaban vs acetylsalicylic acid study.
Danish: I NVAF‑studierne var den samlede bivirkningsfrekvens relateret til blødning pga. apixaban 24,3% i apixaban versus warfarin studiet og 9,6% i apixaban- versus acetylsalicylsyrestudiet.
English: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) The recommended dose of apixaban is 5 mg taken orally twice daily.
Danish: Forebyggelse af apopleksi og systemisk emboli hos patienter med non-valvulær atrieflimren (NVAF) Den anbefalede dosis apixaban er 5 mg indtaget oralt to gange dagligt.
English: Subjects received either apixaban 2.5 mg given orally twice daily (po bid) or enoxaparin 40 mg administered subcutaneously once daily (sc od).
Danish: Patienterne fik enten apixaban 2,5 mg apixaban indgivet oralt 2 gange dagligt eller enoxaparin 40 mg indgivet subkutant 1 gang dagligt.
English: The concomitant use of Eliquis with antiplatelet agents increases the risk of bleeding (see section 4.5).
Danish: Samtidig anvendelse af Eliquis og thrombocythæmmende midler øger blødningsrisikoen (se pkt.
English: Coadministration of apixaban with rifampicin, a strong inducer of both CYP3A4 and P-gp, led to an approximate 54% and 42% decrease in mean apixaban AUC and Cmax, respectively.
Danish: Samtidig indtagelse af apixaban og rifampicin (en kraftig CYP3A4 og P-gp-induktor), medførte et fald i det gennemsnitlige AUC og Cmax for apixaban på henholdsvis ca. 54 % og 42 %.
English: In patients with creatinine clearance < 15 mL/min, or in patients undergoing dialysis, there is no clinical experience therefore apixaban is not recommended (see sections 4.2 and 5.2).
Danish: Der foreligger ingen klinisk erfaring for patienter med kreatininclearance < 15 ml/min og for patienter, som er i dialyse, og derfor bør apixaban ikke anvendes hos disse patienter (se pkt.
English: The mean age was 69.9 years, the mean CHADS2 score was 2.0 and 13.6% of patients had prior stroke or TIA.
Danish: Gennemsnitsalderen var 69,9 år, gennemsnitlig CHADS2-score var 2,0, og 13,6% af patienterne havde tidligere haft apopleksi eller TIA.
English: Apixaban inhibits free and clot-bound factor Xa, and prothrombinase activity.
Danish: Apixaban hæmmer frit og fibrinbundet faktor Xa samt protrombinaseaktivitet.
English: Musculoskeletal and connective tissue disorders Muscle haemorrhage
Danish: Knogler, led, muskler og bindevæv Muskelblødning
English: - Bleeding: - in your lungs or your throat - into the space behind your abdominal cavity - into a muscle
Danish: - Blødning: - i lunger eller hals - i rummet bag bughulen - i en muskel
English: Apix 2.5 mg vs.
Danish: Apix 2,5 mg vs. placebo
English: VTE or all-cause death
Danish: VTE eller død uanset årsag
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Eliquis bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Elderly patients Increasing age may increase haemorrhagic risk (see section 5.2).
Danish: Ældre patienter Stigende alder kan medføre øget blødningsrisiko (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg apixaban.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 2,5 mg apixaban.
English: Interaction with inducers of both CYP3A4 and P-gp The concomitant use of Eliquis with strong CYP3A4 and P-gp inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to a ~50% reduction in apixaban exposure.
Danish: Interaktion med både CYP3A4- og P-gp-induktorer Samtidig brug af Eliquis med kraftige CYP3A4- og P-gp‑induktorer (f.eks. rifampicin, phenytoin, carbamazepin, phenobarbital eller perikon (Hypericum perforatum)) kan føre til ca. 50 % reduktion i eksponering til apixaban.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 2.5 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER 2,5 mg
English: The recommended dose is one tablet of Eliquis 5 mg twice a day.
Danish: Den anbefalede dosis er en Eliquis 5 mg tablet to gange dagligt.
English: Post-surgery treatment period Major
Danish: Behandlingsperiode efter operation 2 Alvorlige
English: For the prevention of VTE in elective hip or knee replacement surgery (VTEp), the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt), apixaban is to be used with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min) (see sections 4.2 and
Danish: Til forebyggelse af VTE ved elektiv hofte- eller knæalloplastik (VTEp), til behandling af DVT, behandling af LE og forebyggelse af recidiverende DVT og LE (VTE) skal apixaban anvendes med forsigtighed til patienter med svært nedsat nyrefunktion (kreatininclearance 15-29 ml/min) (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg apixaban.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 5 mg apixaban.
English: 5 mg twice daily
Danish: 5 mg to gange dagligt
English: The mean age was 69.1 years, the mean CHADS2 score was 2.1 and 18.9% of patients had prior stroke or TIA.
Danish: Gennemsnitsalderen var 69,1 år, gennemsnitlig CHADS2-score var 2,1, og 18,9% af patienterne havde haft forudgående apopleksi eller TIA.
English: Enoxaparin 40 mg sc once daily 35 ± 3 d
Danish: Enoxaparin 40 mg sc en gang dagligt 35 ± 3 d