FrancophonIA/ELRC3.0 huggingface dataset:
English: The Hazard Ratio (Edoxaban 60 mg vs. warfarin) for the primary endpoint in the centres with a lower average time of INR in the target range (INR TTR) for warfarin was 0.73 - 0.80 for the lowest 3 quartiles (INR TTR ≤ 57.7% to ≤ 73.9%).
Danish: Hazard Ratio (edoxaban 60 mg vs. warfarin) for det primære endepunkt i centre med en lavere gennemsnitlig tid for INR i målområdet (INR TTR) for warfarin var 0,73 - 0,80 for de 3 laveste kvartiler (INR TTR ≤ 57,7 % til ≤ 73,9 %).
English: The patient should not take double the prescribed dose on the same day to make up for a missed dose.
Danish: Patienten må ikke tage en dosis, der er dobbelt så stor som den ordinerede, på den samme dag som erstatning for den glemte dosis.
English: OTHER MON, TUE, WED, THU, FRI, SAT, SUN
Danish: ANDET Man., Tirs., Ons., Tors., Fre., Lør., Søn.
English: No dose reduction is required for concomitant use of amiodarone, quinidine or verapamil (see section
Danish: Ingen dosisreduktion er nødvendig ved anvendelse sammen med amiodaron, quinidin eller verapamil (se pkt.
English: Common other adverse reactions for edoxaban were anaemia, rash and abnormal liver function tests.
Danish: Andre almindelige bivirkninger ved edoxaban var anæmi, udslæt og unormale leverfunktionsprøver.
English: • Bleeding from a surgical wound following an operation
Danish: • Blødning fra et operationssår efter en operation
English: Interaction with other medicinal products affecting haemostasis Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.
Danish: Interaktion med andre lægemidler, der påvirker hæmostasen Anvendelse sammen med lægemidler, der påvirker hæmostasen, kan øge risikoen for blødninger.
English: a The event rate (%/yr) is calculated as number of events/subject-year exposure.
Danish: a Hændelsesraten (%/år) er beregnet som antal hændelser/personårs-eksponering.
English: Switching to and from Roteas
Danish: Skift til og fra Roteas
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 omfatte nuværende eller nylige ulcerationer i mave-tarm-kanalen, tilstedeværelse af maligne tumorer med høj blødningsrisiko, nylige cerebrale eller spinale skader, nyligt gennemgået hjerne-, spinal- eller øjenkirurgi, nylig intrakraniel blødning, kendte eller formodede øsofagusvaricer,
English: b The event rate (%/yr) is calculated as number of events/subject-year exposure.
Danish: b Hændelsesraten (%/år) er beregnet som antal hændelser/personårs-eksponering.
English: In animal reproduction studies, rabbits showed increased incidence of gallbladder variations at a dosage of 200 mg/kg which is approximately 65 times the maximum recommended human dose (MRHD) of 60 mg/day based on total body surface area in mg/m2.
Danish: I dyrereproduktionsstudier viste kaniner en øget forekomst af galdeblærevariationer ved en dosering på 200 mg/kg, hvilket er ca. 65 gange den maksimalt anbefalede, humane dosis (maximum recommended human dose, MRHD) på 60 mg/dag baseret på det totale legemsoverfladeareal i mg/m2.
English: Secondary efficacy endpoints included: Composite of stroke, SEE, and cardiovascular (CV) mortality; major adverse cardiovascular event (MACE), which is the composite of non-fatal MI, non-fatal stroke, non-fatal SEE, and death due to CV cause or bleeding; composite of stroke, SEE, and all-cause mortality.
Danish: De sekundære endepunkter for virkningen omfattede: Sammensætningen af apopleksi, SEE og kardiovaskulær (CV) mortalitet, større kardiovaskulære bivirkninger (major adverse cardiovascular event, MACE), som er sammensætningen af ikke-dødelig MI, ikke-dødelig apopleksi, ikke-dødelig SEE og dødsfald, der skyldes en CV årsag eller blødning; sammensætningen af apopleksi, SEE og mortalitet af alle årsager.
English: - Film coat:
Danish: - Filmovertræk:
English: Safety and efficacy of edoxaban have not been established in pregnant women.
Danish: Edoxabans sikkerhed og virkning er ikke klarlagt hos gravide kvinder.
English: The median subject-year exposure was 15,471, and 15,840 for the 60 mg and 30 mg treatment groups, respectively; and the median subject-year follow-up was 19,191 and 19,216 for the 60 mg and 30 mg treatment groups, respectively.
Danish: Medianen for eksponeringen i personår var hhv.15.471 og 15.840 for behandlingsgrupperne med 60 mg og 30 mg, og medianen for opfølgning i personår var hhv. 19.191 og 19.216 for behandlingsgrupperne med 60 mg og 30 mg.
English: The primary efficacy outcome consisted of a composite of all stroke, SEE, MI and CV mortality.
Danish: Det primære virkningsudfald bestod af det sammensatte udfald af alle tilfælde af apopleksi, SEE, MI og CV-mortalitet.
English: The use of Roteas with other P-gp inhibitors including HIV protease inhibitors has not been studied.
Danish: Anvendelsen af Roteas sammen med andre P-gp-hæmmere, herunder hiv-proteasehæmmere, er ikke undersøgt.
English: Roteas 15 mg is only to be used when changing from Roteas 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3.
Danish: Roteas 15 mg må kun anvendes ved skift fra Roteas 30 mg til en K-vitaminagonist (f.eks. warfarin) (se pkt.
English: Like other similar medicines (medicines to reduce blood clotting), Roteas may cause bleeding which may potentially be life-threatening.
Danish: Roteas kan som andre lignende lægemidler (lægemidler, der reducerer blodstørkningen) forårsage blødninger, som evt. kan være livstruende.
English: • Bleeding from the nose
Danish: • Blødning fra næsen
English: The primary safety endpoint was clinically relevant bleeding (major or clinically relevant non-major).
Danish: Det primære endepunkt for sikkerhed var klinisk relevant blødning (svær eller klinisk relevant ikke svær).
English: Management should be individualised according to the severity and location of the haemorrhage.
Danish: Behandlingen tilpasses individuelt efter blødningens sværhedsgrad og sted.
English: Co-administration of high dose ASA (325 mg) increased the steady state Cmax and AUC of edoxaban by 35% and 32%, respectively.
Danish: Administration af ASA i høj dosis (325 mg) forhøjede steady-state Cmax og AUC for edoxaban med hhv. 35 % og 32 %.
English: Please consult the Summary of Product Characteristics (SmPC) for more information.
Danish: Se venligst produktresuméet for yderligere oplysninger.
English: Tables 7, 8 and 9 show major, fatal and intracranial bleedings, respectively, by creatinine clearance category in NVAF patients in ENGAGE AF-TIMI 48.
Danish: Tabel 7, 8 og 9 viser henholdsvis større, dødelige og intrakraniale blødninger pr. kreatininclearancekategori hos NVAF-patienter i ENGAGE AF-TIMI 48.
English: Roteas, like other anticoagulants, is recommended to be used with caution in patients with increased risk of bleeding.
Danish: Ligesom andre antikoagulantia bør Roteas anvendes med forsigtighed hos patienter med en øget blødningsrisiko.
English: • Details of the population potentially at higher risk of bleeding
Danish: • Oplysninger om den population, der potentielt har den største blødningsrisiko
English: Your doctor will need to do blood measurements and will instruct you when to stop taking Roteas.
Danish: Det er nødvendigt for din læge at tage blodprøver og vil instruere dig i, hvornår du skal holde op med at tage Roteas.
English: How to take Roteas).
Danish: Sådan skal du tage Roteas).
English: In clinical pharmacology studies, healthy subjects received rivaroxaban 20 mg once daily, dabigatran 150 mg twice daily, or apixaban 5 mg twice daily, followed by a single dose of edoxaban 60 mg on Day 4.
Danish: I kliniske farmakologistudier fik raske personer rivaroxaban 20 mg en gang dagligt, dabigatran 150 mg to gange dagligt eller apixaban 5 mg to gange dagligt efterfulgt af en enkelt dosis edoxaban 60 mg på dag 4.
English: Edoxaban 60 mg was non-inferior to warfarin for the primary efficacy endpoint of stroke or SEE (upper limit of the 97.5% CI of the HR was below the pre-specified non-inferiority margin of 1.38) (Table 4).
Danish: 60 mg var non-inferior i forhold til warfarin for det primære endepunkt for virkning apopleksianfald eller SEE (øvre grænse for 97,5 % CI for HR var under den præspecificerede non-inferioritetsmargin på 1,38) (tabel 4).
English: • Pregnancy and breast-feeding (see section 4.6).
Danish: • Graviditet og amning (se pkt.
English: Patients undergoing cardioversion:
Danish: Patienter, der gennemgår kardiovertering (hjertestød):
English: Digoxin: Edoxaban 60 mg once daily on days 1 to 14 with coadministration of multiple daily doses of digoxin 0.25 mg twice daily (days 8 and 9) and 0.25 mg once daily (days 10 to 14) increased the Cmax of edoxaban by 17%, with no significant effect on AUC or renal clearance at steady state.
Danish: Digoxin: Edoxaban 60 mg en gang dagligt på dag 1 til 14 med samtidig administration af flere daglige doser digoxin 0,25 mg to gange dagligt (dag 8 og 9) og 0,25 mg en gang dagligt (dag 10 til 14) forhøjede Cmax for edoxaban med 17 % uden nogen signifikant virkning på AUC eller nyreclearance ved steady-state.
English: They come in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1, or 100 x 1 film-coated tablets.
Danish: De leveres i blisters i kartoner med 10, 14, 28, 30, 56, 60, 84, 90, 98 eller 100 filmovertrukne tabletter eller blisters i enhedsdoser i kartoner med 10 x 1, 50 x 1, eller 100 x 1 filmovertrukne tabletter.
English: Your doctor will need to do blood measurements and will instruct you when to start taking Roteas.
Danish: Det er nødvendigt for din læge at tage blodprøver og vil instruere dig i, hvornår du skal begynde at tage Roteas.
English: Patients undergoing cardioversion
Danish: Patienter, der gennemgår kardiovertering
English: The duration of therapy for treatment of DVT and PE (venous thromboembolism, VTE), and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Danish: Behandlingsvarigheden for behandling af DVT og LE (venøs tromboembolisme, VTE), og forebyggelse af recidiverende VTE bør tilpasses individuelt efter omhyggelig afvejning af fordele ved behandling mod risikoen for blødning (se pkt.
English: The edoxaban clinical programme for atrial fibrillation was designed to demonstrate the efficacy and safety of two dose groups of edoxaban compared to warfarin for the prevention of stroke and systemic embolism in subjects with nonvalvular atrial fibrillation and at moderate to high risk of stroke and systemic embolic events (SEE).
Danish: Det kliniske program med edoxaban ved atrieflimren var designet for at påvise virkning og sikkerhed af to dosisgrupper af edoxaban sammenlignet med warfarin til forebyggelse af apopleksi og systemisk emboli hos personer med non-valvulær atrieflimren og med en moderat til høj risiko for apopleksi og systemiske emboliske hændelser (systemic embolic events, SEE).
English: The primary safety outcome was a composite of major and CRNM bleeding.
Danish: Det primære sikkerhedsudfald var det sammensatte udfald af tilfælde af svær og CRNM-blødning.
English: • problems with the blood vessels in your brain or spinal column
Danish: • problemer med blodårerne i hjerne eller rygsøjle
English: The efficacy results for pre-specified major subgroups (with dose reduction as required), including age, body weight, gender, status of renal function, prior stroke or TIA, diabetes and P-gp inhibitors were generally consistent with the primary efficacy results for the overall population studied in the trial.
Danish: Resultaterne for virkning for præspecificerede større undergrupper (med dosisreduktion som påkrævet), herunder alder, legemsvægt, køn, nyrefunktionsstatus, tidligere apopleksi eller TIA, diabetes og P-gp-hæmmere var generelt i overensstemmelse med de primære virkningsresultater for den samlede population, der blev undersøgt i studiet.
English: Roteas film-coated tablets edoxaban
Danish: Roteas filmovertrukne tabletter edoxaban
English: • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
Danish: • betændelseshæmmende midler og smertestillende lægemidler (f.eks. naproxen eller acetylsalicylsyre)
English: Haemodialysis does not significantly contribute to edoxaban clearance (see section 5.2).
Danish: Hæmodialyse bidrager ikke signifikant til clearance af edoxaban (se pkt.
English: The median study drug exposure for both the edoxaban 60 mg and 30 mg treatment groups was 2.5 years.
Danish: Medianen for eksponering for studielægemidlet for både edoxaban 60 mg- og 30 mgbehandlingsgrupperne var 2,5 år.
English: Roteas is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 4.3).
Danish: Roteas er kontraindiceret hos patienter med leversygdom, der er forbundet med koagulopati og en klinisk relevant blødningsrisiko (se pkt.
English: Edoxaban 60 mg (30 mg dose reduced) resulted in a lower rate of cardiovascular mortality compared to warfarin [HR (95% CI): 0.86 (0.77, 0.97)].
Danish: Edoxaban 60 mg (30 mg dosisreduceret) førte til en lavere hyppighed for kardiovaskulær mortalitet sammenlignet med warfarin [HR (95 % CI): 0,86 (0,77; 0,97)].
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.
Danish: Det skal besluttes, om amning skal ophøre eller behandling seponeres.
English: Concomitant use of edoxaban with ciclosporin, dronedarone, erythromycin, or ketoconazole requires dose reduction to 30 mg once daily.
Danish: Anvendelse af edoxaban sammen med ciclosporin, dronedaron, erythromycin eller ketoconazol kræver en dosisreduktion til 30 mg en gang dagligt.
English: a The primary efficacy endpoint is adjudicated symptomatic recurrent VTE (i.e., the composite endpoint of DVT, non-fatal PE, and fatal PE).
Danish: a Det primære endepunkt for virkning er adjudikeret symptomatisk, recidiverende VTE (det vil sige det sammensatte endepunkt med DVT, ikke-dødelig LE og dødelig LE).
English: In a pre-specified subgroup analysis of PE subjects 447 (30.6%) and 483 (32.2%) of edoxaban and warfarin treated subjects, respectively, were identified as having PE and NT-proBNP ≥ 500 pg/mL.
Danish: I en præspecificeret undergruppeanalyse af personer med LE blev 447 (30,6 %) og 483 (32,2 %) af personerne i behandling med hhv. edoxaban og warfarin identificeret som havende LE og NTproBNP ≥ 500 pg/ml.
English: • St John's Wort, a herbal product used for anxiety and mild depression
Danish: • prikbladet perikon, et naturlægemiddel, der anvendes mod angst og let depression
English: Co-administration of protonpump inhibitors had no relevant impact on edoxaban exposure.
Danish: Samtidig administration af protonpumpehæmmere gav ingen relevant påvirkning af eksponeringen for edoxaban.
English: • Abnormal liver blood tests
Danish: • Unormale leverblodprøver
English: Effects of coagulation markers when switching from rivaroxaban, dabigatran, or apixaban to edoxaban
Danish: Virkningen af koagulationsmarkører, når der skiftes fra rivaroxaban, dabigatran eller apixaban til edoxaban
English: NSAIDs: Co-administration of naproxen and edoxaban increased bleeding time relative to either medicine alone.
Danish: NSAID'er: Administration af naproxen sammen med edoxaban forøgede blødningstiden i forhold til administration af begge lægemidler hver for sig.
English: Elderly No dose reduction is required (see section 5.2).
Danish: Ældre Ingen dosisreduktion er nødvendig (se pkt.
English: Table 11 summarises adjudicated bleeding events for the safety analysis set on-treatment period.
Danish: Tabel 11 opsummerer bedømte blødningshændelser for analysesættet for sikkerhed i behandlingsperioden.
English: Pharmocokinetic/pharmacodynamic relationship(s) PT, INR, aPTT and Anti-factor Xa correlate linearly with edoxaban concentrations.
Danish: Farmakokinetiske/farmakodynamiske forhold PT, INR, aPTT og anti-faktor-Xa korrelerer lineært med edoxabankoncentrationerne.
English: What you need to know before you take Roteas
Danish: Det skal du vide, før du begynder at tage Roteas
English: Adverse reactions were experienced by 2,256 (32.2%) of the patients treated with edoxaban 60 mg (30 mg dose reduced) in the ENGAGE AF-TIMI 48 study and 1,249 (30.3%) in the Hokusai-VTE study.
Danish: Der blev oplevet bivirkninger hos 2.256 (32,2 %) af patienterne i behandling med edoxaban 60 mg (30 mg dosisreduceret) I ENGAGE AF-TIMI 48-studiet og hos 1.249 (30,3 %) i Hokusai-VTE-studiet.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with edoxaban in one or more subsets of the paediatric population in prevention of arterial thrombosis, treatment of thromboembolism and prevention of thromboembolism (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med edoxaban i alle undergrupper af den pædiatriske population ved forebyggelse af arterietrombose, behandling af tromboembolisme og forebyggelse af tromboembolisme (se pkt.
English: • some medicines for treatment of epilepsy (e.g. phenytoin, carbamazepine, phenobarbital)
Danish: • visse former for medicin til behandling af epilepsi (f.eks. fenytoin, carbamazepin, phenobarbital)
English: - If your body weight is 60 kg or lower, the recommended dose is one 30 mg tablet once daily.
Danish: - Hvis din legemsvægt er 60 kg eller derunder, er den anbefalede dosis en tablet med 30 mg en gang dagligt.
English: Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding, as judged to be appropriate.
Danish: Ud over den kliniske overvågning kan det derfor være af værdi at undersøge hæmoglobin/hæmatokrit for at opdage okkult blødning, hvis det skønnes nødvendigt.
English: During the overall study period in the ITT population (analysis set to show superiority), adjudicated stroke or SEE occurred in 296 subjects in the edoxaban 60 mg group (1.57% per year), and 337 subjects in the warfarin group (1.80% per year).
Danish: I løbet af den samlede studieperiode i ITT-populationen (analysesæt til at vise superioritet) forekom adjudikeret apopleksi eller SEE hos 296 personer i edoxaban 60 mg-gruppen (1,57 % pr. år) og 337 personer i warfaringruppen (1,80 % pr. år).
English: All ICHs reported on the Adjudicated Cerebrovascular and Non-Intracranial bleed eCRF forms confirmed by the adjudicators are included in ICH counts.
Danish: formularerne Adjudicated Cerebrovaskular and Non-Intracranial bleed , og blev bekræftet afbedømmerne, er inkluderet i ICH-antallet.
English: In the warfarin group, the median TTR (time in therapeutic range, INR 2.0 to 3.0) was 65.6%.
Danish: I warfaringruppen var medianen for TTR (tid i det terapeutiske interval, INR 2,0 til 3,0) 65,6 %.
English: Laboratory coagulation parameters
Danish: Koagulationsparametre i laboratoriundersøgelser
English: Naproxen had no effect on the Cmax and AUC of edoxaban.
Danish: Naproxen havde ingen virkning på Cmax og AUC for edoxaban.
English: After taking renal function and body weight into account, age had no additional clinically significant effect on edoxaban pharmacokinetics in a population pharmacokinetic analysis of the pivotal Phase 3 study in NVAF (ENGAGE AF-TIMI 48).
Danish: Efter der er taget hensyn til nyrefunktionen og legemsvægten, havde alderen ingen yderligere klinisk signifikant virkning på farmakokinetikken for edoxaban i en populationsfarmakokinetisk analyse af det pivotale fase III-studie af NVAF (ENGAGE AF-TIMI 48).
English: Platelet inhibitors: In ENGAGE AF-TIMI 48 concomitant use of thienopyridines (e.g. clopidogrel) monotherapy was permitted and resulted in increased clinically relevant bleeding although with a lower risk of bleeding on edoxaban compared to warfarin (see section 4.4).
Danish: Trombocythæmmere: I ENGAGE AF-TIMI 48 var samtidig anvendelse af monoterapi med thienopyridiner (f.eks. clopidogrel) tilladt og førte til klinisk relevante blødninger, selvom der var en lavere blødningsrisiko med edoxaban sammenlignet med warfarin (se pkt.
English: Anticoagulants, antiplatelets, NSAIDs and SSRIs/SNRIs Anticoagulants: Co-administration of edoxaban with other anticoagulants is contraindicated due to increased risk of bleeding (see section 4.3).
Danish: Antikoagulantia, antitrombotiske midler, NSAID'er og SSRI'er/SNRI'er Antikoagulantia: Administration af edoxaban sammen med andre antikoagulantia er kontraindiceret på grund af den forhøjede blødningsrisiko (se pkt.
English: In the warfarin group, the median TTR (time in therapeutic range, INR 2.0 to 3.0) was 68.4%.
Danish: I warfaringruppen var den mediane TTR (tid i terapeutisk interval, INR 2,0 til 3,0) 68,4 %.
English: - If you have impaired kidney function, the dose may be reduced to one 30 mg tablet once daily by your doctor.
Danish: - Hvis du har nedsat nyrefunktion, kan din læge reducere dosis til en tablet med 30 mg en gang dagligt.
English: Population PK modeling indicates that exposure approximately doubles in patients with severe renal impairment (CrCL 15 - 29 mL/min) relative to patients with normal renal function.
Danish: Populationsfarmakokinetisk modellering indikerer, at eksponeringerne omtrent fordobles hos patienter med svært nedsat nyrefunktion (CrCl 15 - 29 ml/min.)
English: Prosthetic heart valves and moderate to severe mitral stenosis Edoxaban has not been studied in patients with mechanical heart valves, in patients during the first 3 months after implantation of a bioprosthetic heart valve, with or without atrial fibrillation, or in patients with moderate to severe mitral stenosis.
Danish: Edoxaban er ikke blevet undersøgt hos patienter med mekaniske hjerteklapper, i løbet af de første 3 måneder efter implantation af en bioprostetisk hjerteklap, med eller uden atrieflimren eller hos patienter med moderat til svær mitralstenose.
English: As a result of FXa inhibition, edoxaban also prolongs clotting time in tests such as prothrombin time (PT), and activated partial thromboplastin time (aPTT).
Danish: Som et resultat af FXa-hæmningen forlænger edoxaban også størkningstiden i tests, såsom protrombintid (PT) samt aktiveret partiel tromboplastintid (aPTT).
English: In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitors: ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine, or verapamil resulted in increased plasma concentrations of edoxaban.
Danish: I farmakokinetiske (PK) studier førte administration af edoxaban sammen med P-gp-hæmmerne ciclosporin, dronedaron, erythromycin, ketoconazol, quinidin eller verapamil til forhøjede plasmakoncentrationer af edoxaban.
English: Low Body Weight
Danish: Lav legemsvægt
English: From
Danish: Fra
English: • some medicines for fungal infections (e.g. ketoconazole)
Danish: • visse lægemidler mod svampeinfektioner (f.eks. ketoconazol)
English: The results for all-cause mortality (adjudicated deaths) in Hokusai-VTE were 136 (3.3%) for subjects taking edoxaban 60 mg (30 mg dose reduced) as opposed to 130 (3.2%) for warfarin.
Danish: Resultaterne for mortalitet af alle årsager (bedømte dødsfald) i Hokusai-VTE var 136 (3,3 %) for personer, der tog edoxaban 60 mg (30 mg dosisreduceret), i modsætning til 130 (3,2 %) for warfarin.
English: Gender No dose reduction is required (see section 5.2).
Danish: Køn Ingen dosisreduktion er nødvendig (se pkt.
English: The co-administration of Roteas with ASA in elderly patients should be used cautiously because of a potentially higher bleeding risk (see section 4.5).
Danish: Administration af Roteas sammen med ASA hos ældre patienter bør finde sted med forsigtighed på grund af en potentielt højere blødningsrisiko (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS 10 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 10 filmovertrukne tabletter