FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose reductions are recommended for patients who receive concomitantly verapamil (see table 2 above and sections 4.4 and 4.5).
Danish: Der anbefales en dosisreduktion til patienter, der samtidig får verapamil (se tabel 2 ovenfor og pkt.
English: - Belly ache or stomach ache - Indigestion - Difficulty in swallowing - Fluid exiting a wound - Fluid exiting a wound after an operation
Danish: - mavesmerter - fordøjelsesbesvær - besvær med at synke - sårvæske - sårvæske efter operation.
English: INFORMATION IN BRAILLE Pradaxa 110 mg (only applicable for folding box, not applicable for bottle label)
Danish: INFORMATION I BRAILLESKRIFT Pradaxa 110 mg (kun på karton, ikke på etiket)
English: Hazard ratio vs. warfarin (95% confidence interval)
Danish: Hazard ratio vs. warfarin (95 % konfidensinterval)
English: Pradaxa 150 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Danish: Pradaxa 150 mg, hårde kapsler, fås også i polypropylen-(plastik-)beholdere med 60 hårde kapsler.
English: The trials, demonstrated that treatment with dabigatran etexilate 150 mg twice daily was non-inferior to the treatment with warfarin ( non-inferiority margin for RE-COVER and RE-COVER II: 3.6 for risk difference and 2.75 for hazard ratio).
Danish: Studierne viste, at dabigatranetexilat 150 mg 2 gange dagligt er non-inferior til warfarin (noninferioritet for RE-COVER og RE-COVER II var 3,6 i risiko-forskel og 2,75 for hazard ratio).
English: When a loading dose of 180 mg ticagrelor was given 2 hours after 110 mg dabigatran etexilate (in steady state), the increase of dabigatran AUCτ,ss and Cmax,ss was reduced to 1.27-fold and 1.23-fold, respectively, compared with dabigatran etexilate given alone.
Danish: Når en initialdosis på 180 mg ticagrelor blev givet 2 timer efter 110 mg dabigatranetexilat (i steady state), blev forøgelsen af dabigatran-AUCτ,ss ogCmax,ss reduceret henholdsvis 1,27 gange og 1,23 gange sammenlignet med dabigatranetexilat alene.
English: There is very limited clinical experience in patients with a body weight < 50 kg or > 110 kg at the recommended posology.
Danish: Der er meget begrænset klinisk erfaring mht. behandling med den anbefalede dosering hos patienter med en vægt på mindre end 50 kg eller mere end 110 kg. I henhold til de tilgængelige kliniske og kinetiske data er det ikke nødvendigt med en dosisjustering (se pkt.
English: Table 8: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Danish: Tabel 8: Interaktioner med antikoagulantia og trombocytfunktionshæmmere
English: ulcer in the gullet) - Inflammation of the gullet and stomach - Reflux of gastric juice into the gullet - Belly ache or stomach ache - Indigestion - Difficulty in swallowing - Fluid exiting a wound - Fluid exiting a wound after an operation
Danish: sår i spiserøret) - betændelse i spiserør og mave - sure opstød - mavesmerter - fordøjelsesbesvær - besvær med at synke - sårvæske - sårvæske efter operation.
English: Immune system disorder Drug hypersensitivity
Danish: Immunsystemet Lægemiddeloverfølsomhed
English: The presence of lesions, conditions, procedures and/or pharmacological treatment (such as NSAIDs, antiplatelets, SSRIs and SNRIs, see section 4.5), which significantly increase the risk of major bleeding requires a careful benefit-risk assessment.
Danish: Forekomst af læsioner, tilstande, procedurer og/eller farmakologisk behandling (såsom NSAID, antitrombotiske midler, SSRI og SNRI, se pkt.
English: Hypromellose Dimeticone 350
Danish: Kapselindhold vinsyre akaciegummi hypromellose dimeticon 350 talcum hydroxypropylcellulose
English: Treated patients Major bleeding events
Danish: Behandlede patienter Alvorlig blødning
English: Haemorrhagic stroke Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value % refers to yearly event rate
Danish: Hazard ratio sammenlignet med warfarin (95 % CI) p-værdi % refererer til den årlige event rate
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR BLISTER for 110 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FOLDEÆSKE TIL BLISTER til 110 mg
English: For patients with NVAF treated for prevention of stroke and systemic embolism with 150 mg dabigatran etexilate twice daily,
Danish: For patienter med NVAF, der fik 150 mg dabigatranetexilat 2 gange dagligt til forebyggelse af apopleksi og systemisk emboli, gjaldt følgende:
English: - The black printing ink contains shellac, iron oxide black and potassium hydroxide.
Danish: - Den sorte tryksværte består af shellac, sort jernoxid (E172) og kaliumhydroxid.
English: There is no relevant use of Pradaxa in the paediatric population for the indication of primary prevention of venous thromboembolic events in patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Danish: Det er ikke relevant at anvende Pradaxa til indikationen primær forebyggelse af venøs tromboemboli (VTE) efter elektiv hofte-eller knæalloplastik i den pædiatriske population.
English: The table 11 shows bleeding events broken down to major and any bleeding in the pivotal study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation.
Danish: Tabel 11 viser blødninger opdelt på alvorlige og alle blødninger i det pivotale studie, der undersøgte forebyggelse af tromboembolisk apopleksi og systemisk emboli hos patienter med atrieflimren.
English: Dose reductions are recommended for patients who receive concomitantly verapamil (see table 1 above and sections 4.4 and 4.5).
Danish: Der anbefales en dosisreduktion til patienter, der samtidig får verapamil (se tabel 1 ovenfor og pkt.
English: Boehringer Ingelheim Sp.zo.o.
Danish: Boehringer Ingelheim Sp. z o.o.
English: A coagulation test (see section 4.4) may help to identify patients with an increased bleeding risk caused by excessive dabigatran exposure.
Danish: 4.4) kan hjælpe til at identificere patienter med øget blødningsrisiko som følge af for høj dabigatraneksponering.
English: Data for adjudicated major bleeding endpoints are shown in table 12 below.
Danish: De data, der vedrører endepunktet blødninger, og som er vurderet til at være alvorlige, fremgår af tabel 12.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Pradaxa nøjagtig efter lægens anvisning.
English: Primary prevention of venous thromboembolism in orthopaedic surgery
Danish: Primær forebyggelse af venøs tromboemboli ved ortopædkirurgi
English: INFORMATION IN BRAILLE Pradaxa 150 mg (only applicable for folding box, not applicable for bottle label)
Danish: INFORMATION I BRAILLESKRIFT Pradaxa 150 mg (kun på karton, ikke på etiket)
English: Composite of major VTE (including PE and proximal DVT, whatever symptomatic or asymptomatic detected by routine venography) and VTE-related mortality constituted a secondary end-point and is considered of better clinical relevance.
Danish: Et sekundært endepunkt, som betragtes med større klinisk relevans, var kombinationen af alvorlig VTE (inklusive lungeemboli og proksimal DVT påvist ved rutine-flebograf, hvad enten VTE var symptomatisk eller asymptomatisk) og VTE-relateret død.
English: When a single dose of 75 mg dabigatran etexilate was coadministered simultaneously with a loading dose of 180 mg ticagrelor, the dabigatran AUC and Cmax were increased by 1.73-fold and 1.95-fold, respectively.
Danish: Administration af en enkelt dosis af 75 mg dabigatranetexilat og en initialdosis af ticagrelor på 180 mg førte til en stigning i AUC og Cmax for dabigatran på hhv.
English: If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately.
Danish: Kontakt straks lægen, hvis du får en blødning, som du ikke kan stoppe eller der opstår tegn på længerevarende eller kraftig blødning, usædvanlig svaghed, træthed, bleghed, svimmelhed, hovedpine eller uforklarlig hævelse.
English: -if an operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction): it is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
Danish: - hvis en operation involverer et kateter eller en injektion i rygmarven (f.eks. for epidural eller spinal anæstesi eller smertelindring)
English: Pradaxa 150 mg twice daily
Danish: Pradaxa 150 mg 2 gange dagligt
English: There are no clinical data of the effect of dabigatran on infants during breast-feeding.
Danish: Der findes ingen kliniske data for effekten af Pradaxa på nyfødte, der ammes.
English: ulcer in the gullet) - Inflammation of the gullet and stomach - Reflux of gastric juice into the gullet - Vomiting - Difficulty in swallowing - Unusual laboratory test results on liver function
Danish: sår i spiserøret) - betændelse i spiserør og mave - sure opstød - opkastning - besvær med at synke - unormale prøveresultater for leverfunktionen.
English: Concomitant administration of P-gp inhibitors (see table 6) is expected to result in increased dabigatran plasma concentrations.
Danish: Samtidig administration af P-gpinhibitorer (se tabel 6) forventes at resultere i en øget dabigatran plasmakoncentration.
English: Hazard ratio vs warfarin (95% confidence interval) non-inferiority margin Patients with event at 18 months Cumulative risk at
Danish: Behandlede patienter Recidiverende symptomatisk VTE og VTE-relateret død Hazard ratio vs warfarin (95 % konfidensinterval) Non-inferioritetsmargin Patienter med bivirkning ved 18 måneder
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 150 mg hard capsules
Danish: LÆGEMIDLETS NAVN Pradaxa 150 mg, hårde kapsler
English: Table 7: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Danish: Tabel 7: Interaktioner med antikoagulantia og trombocytfunktionshæmmere
English: DVT/PE treatment and DVT/PE prevention
Danish: DVT/LEbehandling og forebyggelse af recidiver
English: Post procedural haemorrhage
Danish: Drænage efter procedure
English: Concomitant administration of P-gp inhibitors (see table 7) is expected to result in increased dabigatran plasma concentrations.
Danish: Samtidig administration af P-gpinhibitorer (se tabel 7) forventes at resultere i en øget dabigatran plasmakoncentration.
English: - if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
Danish: - hvis du tager dronedaron, som er medicin til behandling af en unormal hjerterytme - hvis du tager et kombinationspræparat med glecaprevir og pibrentasvir, et antiviralt lægemiddel,
English: Concomitant administration of P-gp inducers is expected to result in decreased dabigatran plasma concentrations, and should be avoided (see sections 4.5 and 5.2).
Danish: Plasmakoncentrationen af dabigatran forventes at falde ved samtidig administration med P-gpinduktorer, og bør derfor undgås (se pkt.
English: Check with your doctor if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om eller føler dig usikker på.
English: Concomitant administration of P-gp inhibitors (see table 5) is expected to result in increased dabigatran plasma concentrations.
Danish: Samtidig administration af P-gpinhibitorer (se tabel 5) forventes at resultere i en øget dabigatran plasmakoncentration.
English: Rare (may affect up to 1 in 1,000 people): - Bleeding - Bleeding may happen in the brain, from a surgical incision, from the site of entry of an injection or from the site of entry of a catheter into a vein
Danish: Sjældne bivirkninger (kan forekomme hos højst 1 ud af 1.000 brugere): - blødning kan forekomme efter operation, fra et injektionssted, eller fra det sted, hvor et kateter går ind i venen eller i hjernen.
English: Table 10: Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopaedic surgery studies
Danish: Tabel 10: Analyse af alvorlig VTE og VTE-relateret mortalitet i behandlingsperioden i de ortopædkirurgiske studier RE-MODEL og RE-NOVATE
English: Table 5: Discontinuation rules before invasive or surgical procedures
Danish: Tabel 5: Seponeringsregler før invasive/kirurgiske procedurer
English: In phase I studies the exposure (AUC) of dabigatran after the oral administration of Pradaxa is approximately 2.7-fold higher in volunteers with moderate renal insufficiency (CrCL between 30-50 mL/min) than in those without renal insufficiency.
Danish: I fase I-studier var eksponering (AUC) af dabigatran efter oral administration af Pradaxa er ca. 2,7 gange højere hos frivillige, med moderat nedsat nyrefunktion (CrCL mellem 30-50 ml/min) end hos dem uden nedsat nyrefunktion.
English: Package leaflet: Information for the patient Pradaxa 75 mg hard capsules dabigatran etexilate
Danish: Indlægsseddel: Information til patienten Pradaxa 75 mg, hårde kapsler dabigatranetexilat
English: As part of the descriptive analysis, TIMI (Thrombolysis In Myocardial Infarction) major bleeding events was lower in both dabigatran etexilate dual-therapy groups than in the warfarin triple-therapy group: 14 events (1.4%) in the dabigatran etexilate 110 mg dual-therapy group as compared with 37 events (3.8%) in the warfarin triple-therapy group (HR 0.37; 95% CI 0.20, 0.68; P=0.002) and 16 events (2.1%) in the dabigatran etexilate 150 mg dual-therapy group as compared with 30 events (3.9%) in the corresponding warfarin triple-therapy group (HR 0.51; 95% CI 0.28, 0.93; P=0.03).
Danish: Som en del af den beskrivende analyse var TIMI (trombolyse ved myokardieinfarkt) større blødningshændelser lavere i begge grupper med dabigatranetexilat dobbeltterapi, end i gruppen med warfarin trippelterapi: 14 hændelser (1,4 %) i gruppen med dabigatranetexilat 110 mg dobbeltterapi, sammenlignet med 37 hændelser (3,8 %) i gruppen med warfarin trippelterapi (HR 0,37; 95 % CI 0,20; 0,68; P=0,002), og 16 hændelser (2,1 %) i gruppen med dabigatranetexilat 150 mg dobbeltterapi, sammenlignet med 30 hændelser (3,9 %) i den tilsvarende gruppe med warfarin trippelterapi (HR 0,51; 95 % CI 0,28; 0,93; P=0,03).
English: treat blood clots in the veins of your legs and lungs and to prevent blood clots from reoccurring in the vein of your legs and lungs.
Danish: - behandle blodpropper i vener i ben og lunger og til at forebygge sådanne nye blodpropper.
English: How to take Pradaxa
Danish: Sådan skal du tage Pradaxa
English: Capsules with light blue, opaque cap and white, opaque body of size 0 filled with yellowish pellets.
Danish: Kapslen: Uigennemsigtig lyseblå top og uigennemsigtig hvid bund, størrelse 0 og indeholdende gullige pellets.
English: • Mild to moderate P-gp inhibitor co-medication (e.g. amiodarone, verapamil, quinidine and ticagrelor; see section 4.5)
Danish: • Samtidig administration af milde til moderate P-gp-inhibitorer (f.eks. amiodaron, verapamil, kinidin og ticagrelor, se pkt.
English: Table 6: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Danish: Tabel 6: Interaktioner med antikoagulantia og trombocytfunktionshæmmere
English: th percentile of dabigatran plasma concentrations measured at trough (10-16 hours after the previous dose) was about 200 ng/mL,
Danish: • 90-percentilen for dabigatran-plasmakoncentrationerne ved trough (10-16 timer efter den forrige dosis) var ca. 200 ng/ml,
English: Patients with moderate renal impairment (CrCL 30-50 mL/min)
Danish: Patienter med moderat nedsat nyrefunktion (CrCL 30-50 ml/min)
English: 95% confidence interval Symptomatic DVT 95% confidence interval Symptomatic PE 95% confidence interval VTE-related deaths 95% confidence interval Unexplained deaths 95% confidence interval All-cause deaths 95% confidence interval
Danish: Risikoforskel vs. Warfarin (%) 95 % konfidensinterval Non-inferioritetsmargin Sekundære virkningsendepunkter Recidiverende symptomatisk VTE og død uanset årsag 95 % konfidensinterval Symptomatisk DVT 95 % konfidensinterval Symptomatisk LE 95 % konfidensinterval VTE-relateret død 95 % konfidensinterval Død uanset årsag 95 % konfidensinterval
English: Table 13: Bleeding events in a study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation
Danish: Tabel 13: Blødningsrelaterede hændelser fra et studie, der undersøgte forebyggelse af tromboembolisk apopleksi og systemisk emboli hos patienter med atrieflimren.
English: Cartons containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated aluminium unit dose blisters.
Danish: En pakning indeholder 10 x 1, 30 x 1, 60 x 1 som perforerede aluminiums enkeltdosis-blistre.
English: Table 13: Half-life of total dabigatran in healthy subjects and subjects with impaired renal function.
Danish: Tabel 13: Halveringstid for total dabigatran hos raske og hos patienter med nedsat nyrefunktion.
English: For the primary safety endpoint of major bleeding there was an interaction of treatment effect and age.
Danish: Alder havde en indvirkning på det primære sikkerhedsendepunkt alvorlig blødning.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR BLISTER for 150 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FOLDEÆSKE TIL BLISTER til 150 mg
English: Table 10: Adverse reactions
Danish: Tabel 10: Bivirkninger
English: PHARMACEUTICAL FORM AND CONTENTS 50x1 hard capsules.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 50 x 1 hårde kapsler.
English: Iron oxide black (E172) Potassium hydroxide
Danish: Sort tryksværte shellac sort jernoxid (E 172) kaliumhydroxid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én hård kapsel indeholder 75 mg dabigatranetexilat (som mesilat).
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 75 mg hard capsules dabigatran etexilate
Danish: LÆGEMIDLETS NAVN Pradaxa 75 mg hårde kapsler dabigatranetexilat
English: In the pooled studies the primary safety endpoints of major bleeding, major or clinically relevant bleeding and any bleeding were significantly lower than warfarin at a nominal alpha level of 5 %.
Danish: Tabel 12 viser blødninger forekommet under behandling af DVT og LE i de poolede data fra registreringsstudierne RE-COVER og RE-COVER II, hvor forekomsten af de primære sikkerhedsendepunkter alvorlig blødning, alvorlig (MBE) eller klinisk relevant blødning (CRBE) og alle blødninger var signifikant lavere end for warfarin ved et nominelt alfa-niveau på 5 %.
English: - if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g.,
Danish: (angivet i punkt 6) - hvis du har svært nedsat nyrefunktion - hvis du bløder - hvis du har en sygdom i et af dine organer, som øger risikoen for alvorlig blødning (f.eks.
English: Both dabigatran etexilate dual-therapy groups had lower rates of intracranial hemorrhage than the corresponding warfarin triple-therapy group: 3 events (0.3%) in the 110 mg dabigatran etexilate dual-therapy group as compared with 10 events (1.0%) in the warfarin triple-therapy group (HR 0.30; 95% CI 0.08, 1.07; P=0.06) and 1 event (0.1%) in the 150 mg dabigatran etexilate dual-therapy group as compared with 8 events (1.0%) in the corresponding warfarin triple-therapy group (HR 0.12; 95% CI 0.02, 0.98; P=0.047).
Danish: Begge grupper med dabigatranetexilat dobbeltterapi havde lavere hyppigheder af intrakraniel blødning end den tilsvarende gruppe med warfarin trippelterapi: 3 hændelser (0,3 %) i gruppen med 110 mg dabigatranetexilat dobbeltterapi, sammenlignet med 10 hændelser (1,0 %) i gruppen med warfarin trippelterapi (HR 0,30; 95 % CI 0,08; 1,07; P=0,06), og 1 hændelse (0,1 %) i gruppen med 150 mg dabigatranetexilat dobbeltterapi, sammenlignet med 8 hændelser (1,0 %) i den tilsvarende gruppe med warfarin trippelterapi (HR 0,12; 95 % CI 0,02; 0,98; P=0,047).
English: Major bleeding event/clinical relevant bleeds
Danish: Alvorlig blødning/klinisk relevant blødning
English: Data for the major VTE and VTE-related mortality endpoint were homogeneous with regards to the primary efficacy endpoint and are shown in table 10.
Danish: De data, der vedrører alvorlig VTE og VTE-relateret død er sammenlignelige mht det primære endepunkt.
English: Change of anticoagulant treatment
Danish: Skift i blodfortyndende medicinsk behandling
English: Package leaflet: Information for the patient Pradaxa 110 mg hard capsules dabigatran etexilate
Danish: Indlægsseddel: Information til patienten Pradaxa 110 mg, hårde kapsler dabigatranetexilat
English: Each hard capsule contains 75 mg dabigatran etexilate (as mesilate).
Danish: Én hård kapsel indeholder 75 mg dabigatranetexilat (som mesilat).
English: Table 17: Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopaedic surgery studies.
Danish: Tabel 17: Analyse af alvorlig VTE og VTE-relateret mortalitet i behandlingsperioden i de ortopædkirurgiske studier RE-MODEL og RE-NOVATE
English: Data for the major VTE and VTE-related mortality endpoint were homogeneous with regards to the primary efficacy endpoint and are shown in table 17.
Danish: De data, der vedrører alvorlig VTE og VTE-relateret død er sammenlignelige mht. det primære endepunkt.
English: In phase I studies the exposure (AUC) of dabigatran after the oral administration of Pradaxa is approximately 2.7-fold higher in volunteers with moderate renal insufficiency (CrCL between 30 and 50 mL/min) than in those without renal insufficiency.
Danish: I fase-I studie var eksponering (AUC) af dabigatran efter oral administration af Pradaxa er ca. 2,7 gange højere hos frivillige med moderat nedsat nyrefunktion (CrCL mellem 30 og 50 ml/min) end hos dem uden nedsat nyrefunktion.
English: You can continue to take Pradaxa if your heart beat needs to be restored to normal by a procedure called cardioversion.
Danish: Hvis dit hjerteslag skal vende tilbage til normalen, ved en procedure kaldet kardiovertering, kan du fortsætte med at tage Pradaxa.
English: Subjects randomized Major bleeding Intracranial bleeding GI bleeding Fatal bleeding Minor bleeding Any bleeding
Danish: Livstruende blødning Alvorlig blødning/klinisk relevant blødning Alle blødninger Alle GI blødninger
English: The trials, demonstrated that treatment with dabigatran etexilate 150 mg twice daily was non-inferior to the treatment with warfarin (non-inferiority margin for RE-COVER, and RE-COVER II: 3.6 for risk difference and 2.75 for hazard ratio).
Danish: Studierne viste, at dabigatranetexilat 150 mg 2 gange dagligt er non-inferior til warfarin noninferioritet for RE-COVER og RE-COVER II var 3,6 i risiko forskel og 2,75 for hazard ratio
English: No data aPTT [x-fold upper limit of normal] > 1.3 INR
Danish: Ingen data aPTT [x gange øvre normalgrænse] INR
English: Table 7: Other interactions
Danish: Andre interaktioner Tabel 7: Andre interaktioner
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR 75 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL 75 mg
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 110 mg hard capsules dabigatran etexilate
Danish: LÆGEMIDLETS NAVN Pradaxa 110 mg hårde kapsler dabigatranetexilat
English: Carton containing 6 blister strips (60 x 1) in perforated aluminium unit dose white blisters.
Danish: Pakning, der indeholder 6 hvide blisterkort (60 x 1) som perforerede aluminiums enkeltdosis-blistre.
English: The Boehringer Ingelheim logo is printed on the cap and “R110” on the body of the capsule.
Danish: Boehringer Ingelheims logo er trykt på hætten, og ”R110” på bunden af kapslen.
English: Renal and urinary disorders Genitourological haemorrhage, including haematuria
Danish: Nyrer og urinveje Urogenital blødning, inklusive hæmaturi
English: • Moderate renal impairment (30-50 mL/min
Danish: • Moderat nedsat nyrefunktion (30-50 ml/min CrCL)
English: In patients treated for prevention of recurrent of DVT and PE with 150 mg dabigatran etexilate twice daily no pharmacokinetic data are available.
Danish: Der foreligger ingen farmakokinetiske data for patienter i forebyggende behandling for recidiverende DVT og LE med 150 mg dabigatranetexilat 2 gange dagligt.