natgillin/translations-raw huggingface dataset:
I 2 randomiserede, dobbeltblinde, parallelgruppe-studier indgik tidligere antikoagulansbehandlede patienter.
Two randomized, parallel group, double-blind studies were performed in patients previously treated with anticoagulation therapy.
Pradaxa indeholder det aktive stof dabigatranetexilat, og hører til en gruppe lægemidler, der kaldes antikoagulantia (blodfortyndende lægemidler).
Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants.
Beholder: Når beholderen er åbnet, skal medicinen anvendes i løbet af højst 4 måneder.
Bottle: Once opened, the medicine must be used within 4 months.
Der findes ingen data vedrørende brugen af Pradaxa til patienter, der har gennemgået operation for hoftefraktur.
There is no data on the use of Pradaxa in patients undergoing hip fracture surgery.
I tilfælde af blødningskomplikationer skal behandlingen med Pradaxa seponeres og kilden til blødningen undersøges.
In the event of haemorrhagic complications, Pradaxa treatment must be discontinued and the source of bleeding investigated.
Tabel 9: Antal undersøgte patienter, maksimal daglig dosis i fase III-studier Indikation
Table 9: Number of patients studied, maximum daily dose in phase III studies Indication
I de 3 aktivt-kontrollerede DVT/LE fase III-studier blev der rapporteret en højere frekvens af MI hos patienter, der fik dabigatranetexilat, end hos dem, der fik warfarin; i de to korterevarende studier RECOVER and RE-COVER II henholdsvis 0,4 % vs. 0,2 % og i det længerevarende RE-MEDY-studie 0,8 % vs. 0,1 %.
In the three active controlled DVT/PE phase III studies, a higher rate of MI was reported in patients who received dabigatran etexilate than in those who received warfarin: 0.4% vs. 0.2% in the shortterm RE-COVER and RE-COVER II studies; and 0.8% vs. 0.1% in the long-term RE-MEDY trial.
Pradaxa bør anvendes med forsigtighed ved tilstande med en øget risiko for blødning eller ved samtidig brug af lægemidler, der påvirker hæmostasen ved at hæmme trombocytaggregationen.
Pradaxa should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation.
Ved korte behandlingsforløb (mindst 3 måneder) afvejes mod forbigående risikofaktorer (fx nylig operation, traume, immobilisering) og ved længerevarende behandlingsforløb mod permanente risikofaktorer eller idiopatisk DVT eller LE.
Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.
Hvis behandlingen først kan begynde dagen efter operationen, skal du begynde med at tage 2 kapsler én gang dagligt.
If the treatment cannot be started until the day after surgery, dosing should be started with 2 capsules once a day.
Samtidig anvendelse kontraindiceret (se pkt.
Concomitant use contraindicated (see section 4.3)
Patienter i samtidig behandling med verapamil*, amiodaron, kinidin
Patients who receive concomitant verapamil*, amiodarone, quinidine
Tabel 10: Antal undersøgte patienter, maksimal daglig dosis i fase III-studier Indikation
Table 10: Number of patients studied, maximum daily dose in phase III studies Indication
Fra 6 timer før næste planlagte dosis skal den glemte dosis ikke tages.
From 6 hours prior to the next scheduled dose on, the missed dose should be omitted.
Ingen dosisjustering er nødvendig (se pkt 5.2).
No dose adjustment is necessary (see section 5.2).
Nøje observation af tegn på blødning anbefales hos patienter, der samtidigt behandles med NSAID (se pkt.
Close observation for signs of bleeding is recommended in patients concomitantly treated with NSAIDs (see section 4.5).
De efterfølgende dage er absorptionen af dabigatran hurtig med Cmax opnået 2 timer efter lægemiddeladministration.
On subsequent days absorption of dabigatran is rapid with peak plasma concentrations attained 2 hours after medicinal product administration.
Det bør tillige overvejes at administrere trombocytkoncentrater ved trombocytopeni, eller hvis langtidsvirkende trombocythæmmende lægemidler har været anvendt.
Consideration should also be given to administration of platelet concentrates in cases where thrombocytopenia is present or long acting antiplatelet medicinal products have been used.
Patienter kan forblive på Pradaxa i forbindelse med kardiovertering.
Patients can stay on Pradaxa while being cardioverted.
Patienter med risiko for blødning
Patients at risk of bleeding
I RE-SONATE-studiet, som sammenlignede dabigatranetexilat med placebo, var frekvensen af MI 0,1% for patienter i dabigatranetexilat-armen og 0,2% for patienter i placebo-armen.
In the RE-SONATE study, which compared dabigatran etexilate to placebo, the rate of MI was 0.1% for patients who received dabigatran etexilate and 0.2% for patients who received placebo
- forhindre blodpropper i hjernen (apopleksi) og i andre blodkar i kroppen, hvis du har en form for uregelmæssig hjerterytme, der kaldes non-valvulær atrieflimren, og mindst en yderligere risikofaktor.
prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.
Da dabigatran hovedsageligt udskilles via nyrerne, skal tilstrækkelig diurese opretholdes.
Since dabigatran is excreted predominantly by the renal route adequate diuresis must be maintained.
I RE-MEDY, som er et warfarinkontrolleret studie, indgik patienter tidligere behandlet i 3 til 12 måneder og med behov for yderligere antikoagulansbehandling og i RE-SONATE, som er et placebokontrolleret studie, indgik patienter tidligere behandlet i 6 til 18 måneder med vitamin Kantagonist.
RE-MEDY, warfarin controlled study, enrolled patients already treated for 3 to 12 months with the need for further anticoagulant treatment and RE-SONATE, the placebo controlled study, enrolled patients already treated for 6 to 18 months with Vitamin K inhibitors.
Nedsat leverfunktion og anden leversygdom, som forventes at have indvirkning på overlevelsen, er kontraindiceret (se pkt.
Hepatic impairment or liver disease expected to have any impact on survival is contraindicated (see section 4.3).
Hvis du har glemt at tage Pradaxa
If you forget to take Pradaxa
Efter oral indtagelse absorberes dabigatranetexilat hurtigt og omdannes til dabigatran via esterasekatalyseret hydrolyse i plasma og i leveren.
After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase-catalysed hydrolysis in plasma and in the liver.
I de kliniske studier blev mukosale blødninger (f.eks. gastrointestinale, urogenitale) hyppigere observeret under langvarig behandling med Pradaxa, sammenlignet med VKA-behandling.
In the clinical studies mucosal bleedings (e.g. gastrointestinal, genitourinary) were seen more frequently during long term Pradaxa treatment compared with VKA treatment.
Procedurer, som f.eks. spinal anæstesi, kan kræve en helt upåvirket hæmostatisk funktion.
Procedures such as spinal anaesthesia may require complete haemostatic function.
Nyrefunktion (CrCL i ml/min)
Renal function (CrCL in mL/min)
Hos næsten halvdelen (45,8 %) af RE-LY patienterne var CrCl > 50- < 80 ml/min.
Almost half (45.8 %) of the RE-LY patients had a CrCL > 50-< 80 mL/min.
Kontakt straks lægen, hvis du får en alvorlig allergisk reaktion, som medfører vejrtrækningsbesvær eller svimmelhed.
Tell your doctor immediately, if you experience a serious allergic reaction which causes difficulty in breathing or dizziness.
Effekten blev progressivt mindsket ved administration af en verapamilformulering med forlænget frigivelse (stigning i Cmax med omkring 1,9 gange og i AUC med omkring 1,7 gange) eller administration af flere doser verapamil (stigning i Cmax med omkring 1,6 gange og i AUC med omkring 1,5 gange).
The effect was progressively decreased with administration of an extended release formulation (increase of Cmax by about 1.9-fold and AUC by about 1.7-fold) or administration of multiple doses of verapamil (increase of Cmax by about 1.6-fold and AUC by about 1.5-fold).
• Periodiske, opdaterede sikkerhedsforanstaltnnger (PSUR'er)
• Periodic Safety Update Reports
Pradaxa påvirker ikke evnen til at køre bil eller betjene maskiner.
Pradaxa has no known effects on the ability to drive or use machines.
Hyppigheden af alvorlig blødning og andre blødningstilfælde var i overensstemmelse med den, der blev set i RE-LY.
The rates of outcome events including, major bleed and other bleeding events were consistent with those seen in RE-LY.
Ved intolerans for Pradaxa, bør patienterne instrueres i straks at kontakte deres behandlende læge for at blive omstillet til alternative behandlingsmuligheder for forebyggelse af apopleksi og systemisk emboli i forbindelse med atrieflimren eller for DVT/LE.
In case of intolerability to Pradaxa, patients should be instructed to immediately consult their treating physician in order to be switched to alternate acceptable treatment options for prevention of stroke and systemic embolism associated with atrial fibrillation or for DVT/PE.
Antallet af alvorlige blødninger med denne dosis var sammenligneligt med warfarin.
Major bleeding rates with this dose were comparable to warfarin.
Ved samtidig indtagelse af Pradaxa og pantoprazol så man et fald i dabigatran-AUC på ca. 30 %.
Pantoprazole When Pradaxa was co-administered with pantoprazole, a decrease in the dabigatran AUC of approximately 30 % was observed.
Doser af Pradaxa ud over det anbefalede udsætter patienten for forøget risiko for blødning.
Pradaxa doses beyond those recommended expose the patient to increased risk of bleeding.
Alle GI-blødninger *HR er ikke mulig at beregne, da der ikke forekom nogen hændelse i nogen af behandlingerne.
Any GI bleeds *HR not estimable as there is no event in either one treatment
• En specifik antidot (Praxbind ®) er tilgængelig (der henvises til produktresuméer for Pradaxa ® og
• A specific reversal agent (Praxbind ®) is available (please refer to the Summary of Product
Generelt kan det antages, at disse mål for antikoagulationsaktiviteten kan reflektere dabigatranniveauerne og være en hjælp til vurdering af blødningsrisikoen.
In general, it can be assumed that these measures of anti-coagulant activity may reflect dabigatran levels and can provide guidance for the assessment of bleeding risk, i.e. exceeding the 90
Dette studie viste, at dobbeltterapi med dabigatranetexilat og en P2Y12-antagonist reducerede blødningsrisikoen signifikant vs. warfarin trippelterapi, med non-inferioritet for de samlede tromboemboliske hændelser, hos patienter med atrieflimren, der gennemgik PCI med stenting.
This study demonstrated that dual-therapy with dabigatran etexilate and a P2Y12 antagonist significantly reduced the risk of bleeding vs. warfarin triple-therapy with non-inferiority for composite of thromboembolic events in patients with atrial fibrillation who underwent a PCI with stenting.
Ved samtidig indtagelse af Pradaxa og 600 mg amiodaron som enkeltdosis, forblev absorptionsgraden og absorptionshastigheden af amiodaron og dets aktive metabolit DEA praktisk taget uændret.
Amiodarone When Pradaxa was co-administered with a single oral dose of 600 mg amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged.
Sjælden Traumer, forgiftninger og behandlingskomplikationer Traumatisk blødning
Rare Injury, poisoning and procedural complications Traumatic haemorrhage
De anførte blødningshændelser inkluderer alle blødninger registreret fra første indtagelse af Pradaxa eller warfarin efter ophør af parenterel behandling (kun oral behandlingsperiode).
Bleeding events for both treatments are counted from the first intake of Pradaxa or warfarin after the parenteral therapy has been discontinued (oral only treatment period).
Patienter, der gennemgår kateterablation for atrieflimren
Patients undergoing catheter ablation for atrial fibrillation
Derfor bør der ikke foretages INR-måling.
Therefore INR tests should not be performed.
In vitro viser tacrolimus en hæmmende effekt på P-gp, som svarer til effekten af itraconazol og ciclosporin.
Tacrolimus has been found in vitro to have a similar level of inhibitory effect on Pgp as that seen with itraconazole and cyclosporine.
Dette eksplorative studie viste, at dabigatranetexilat blev forbundet med en signifikant reduktion i hyppigheden af MBE ved ablation sammenlignet med INRjusteret warfarin.
This exploratory study showed that dabigatran etexilate was associated with a significant reduction in MBE rate compared with INR-adjusted warfarin in the setting of ablation.
Gennem de yderligere 2,5 års behandling i RELY-ABLE, med en maksimal eksponering på over 6 år (total eksponering i RELY + RELY-ABLE) bekræftedes langtids-sikkerhedsprofilen for dabigatranetexilat for begge studiedoser, hhv. 110 mg to gange dagligt og 150 mg to gange dagligt.
During the additional 2.5 years of treatment in RELY-ABLE, with a maximum exposure of over 6 years (total exposure in RELY + RELY-ABLE), the long-term safety profile of dabigatran etexilate was confirmed for both test doses 110 mg b.i.d.
Det primære mål med dette studie var at fastslå, om dabigatranetexilat var non-inferior til warfarin i at reducere forekomsten af det sammensatte endepunkt af apopleksi og systemisk emboli.
The primary objective in this study was to determine if dabigatran etexilate was non-inferior to warfarin in reducing the occurrence of the composite endpoint stroke and systemic embolism.
SSRI og SNRI øgede risikoen for blødning i alle behandlingsarmene i et fase III klinisk studie, der sammenlignede dabigatran med warfarin til forebyggelse af apopleksi hos patienter med atrieflimren (RE-LY).
SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in all treatment groups of a phase III clinical trial comparing dabigatran to warfarin for stroke prevention in atrial fibrillation patients (RE-LY).
Ved en initialdosis på 300 mg eller 600 mg clopidogrel steg dabigatran AUCτ,ss og Cmax,ss med omkring 30-40 % (se pkt.
With a loading dose of 300 mg or 600 mg clopidogrel, dabigatran AUCτ,ss and Cmax,ss were increased by about 30-40 % (see section 4.4) .
I studiet oplevede 2 patienter (22,1 %) lette behandlingsrelaterede bivirkninger (gastroøsofageal reflux/abdominalsmerter; abdominalt ubehag) og 1 patient (11,1 %) oplevede en ikke-relateret alvorlig bivirkning (tilbagevendende VTE i benet) i post-behandlingsperioden > 3 dage efter ophør af dabigatranetexilatbehandling.
On treatment 2 (22.1 %) patients experienced mild related adverse events (gastrooesophageal reflux / abdominal pain; abdominal discomfort) and 1 (11.1 %) patient experienced a not related serious adverse event (recurrent VTE of the leg) in the post treatment period > 3 days after stop of dabigatran etexilate.
• Ved større blødninger skal behandling med Pradaxa ® straks stoppes.
• In case of major bleeding events, Pradaxa ® must be stopped immediately.
I behandlingperioden på 174,0 dage med fast dabigatrandosis blev koagulationen ikke monitoreret.
The duration of treatment with fixed dose of dabigatran was 174.0 days without coagulation monitoring.
Enkelt kapsel med 75 mg Pradaxa
single capsule of 75 mg Pradaxa
I tillæg til tilstrækkelig klinisk overvågning, er det derfor vigtigt at teste hæmoglobin/hæmatokrit i laboratoriet, for at detektere okkult blødning.
Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit is of value to detect occult bleeding.
Patienter med høj risiko for død i forbindelse med operation, og hvor væsentlige risikofaktorer for udvikling af tromboemboli er til stede
Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events
I dette tilfælde skal behandling med Pradaxa midlertidigt stoppes, da der er en øget risiko for blødning under og kort efter en operation.
In this case Pradaxa will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation.
Der observeredes ingen andre påvirkninger af fertiliteten hos hundyr.
No other effects on female fertility were observed.
Efter oral administration omdannes dabigatranetexilat hurtigt og fuldstændigt til den i plasma aktive form dabigatran.
After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma.
Perkutan koronar intervention (PCI) med stenting (SPAF) Patienter med non-valvulær atrieflimren, der gennemgår PCI med stenting, kan behandles med Pradaxa i kombination med trombocythæmmende midler, efter der er opnået hæmostase (se pkt.
Percutaneous coronary intervention (PCI) with stenting (SPAF) Patients with non valvular atrial fibrillation who undergo a PCI with stenting can be treated with Pradaxa in combination with antiplatelets after haemostasis is achieved (see section 5.1).
P-gp-inhibitorer
P-gp inhibitors
30 x 1 hårde kapsler
30 x 1 hard capsule
Henholdsvis 22,9 % og 22,5 % af patienterne havde CrCL > 50-< 80 ml/min, og henholdsvis 4,1 % og 4,8 % havde CrCL mellem 30 og 50 ml/min i RE-MEDY- og RE-SONATEstudierne.
22.9 % and 22.5 % of the patients had a CrCL > 50-< 80 mL/min, and 4.1 % and 4.8 % had a CrCL between 30 and 50 mL/min in the RE-MEDY and RE-SONATE studies.
- Det aktive stof hedder dabigatran.
- The active substance is dabigatran.
Tabel 23-25 viser resultater af de primære sikkerhedsendepunkter i relevante delpopulationer:
Tables 23-25 display results of the primary efficacy and safety endpoint in relevant sub-populations:
• Blisterfolien må kun fjernes, når der er behov for en kapsel.
• The blister foil should only be peeled off, when a hard capsule is required.
I et af de kliniske studier var hyppigheden af hjerteanfald numerisk højere med Pradaxa end med warfarin.
In a clinical trial the rate of heart attacks with Pradaxa was numerically higher than with warfarin.
RE-SONATE viste, at dabigatranetexilat var superior overfor placebo til forebyggelse af recidiverende symptomatisk DVT/LE inklusive uforklarlig død i behandlingsperioden (p<0,0001), med en risikoreduktion på fra 5,6 % til 0,4 % (relativ risikoreduktion på 92 % baseret på hazard ratio).
RE-SONATE demonstrated dabigatran etexilate was superior to placebo for the prevention of recurrent symptomatic DVT/PE events including unexplained deaths, with a risk reduction from 5.6 % to 0.4 % (relative risk reduction 92 % based on hazard ratio ) during the treatment period (p<0.0001).
• Folien på bagsiden fjernes, og kapslen kan tages ud.
• The backing foil should be peeled off and the capsule can be removed.
Hvis du har taget for meget Pradaxa, øges risikoen for blødning.
Taking too much Pradaxa increases the risk of bleeding.
Under anden fase af et non-interventionsstudie (GLORIA-AF) blev der prospektivt indsamlet data for sikkerhed og virkning hos nydiagnosticerede NVAF-patienter på dabigatranetexilat i daglig klinisk praksis.
A non-interventional study (GLORIA-AF) prospectively collected (in its second phase) safety and effectiveness data in newly diagnosed NVAF patients on dabigatran etexilate in a real-world setting.
60 x 1 hårde kapsler
60 x 1 hard capsule
Et uforklarligt fald i hæmoglobin og/eller hæmatokrit eller blodtryk bør føre til udredning for en evt. blødningskilde.
An unexplained fall in haemoglobin and/or haematocrit or blood pressure should lead to a search for a bleeding site.
Hos patienter med moderat nedsat nyrefunktion (CrCL 30-50 ml/min) er den anbefalede dosis af Pradaxa også 300 mg som 1 kapsel a 150 mg 2 gange dagligt.
For patients with moderate renal impairment (CrCL 30-50 mL/min) the recommended dose of Pradaxa is also 300 mg taken as one 150 mg capsule twice daily.
Opfølgningsstudiet for RE-LY (RELY-ABLE) indsamlede yderligere sikkerhedsoplysninger fra en gruppe patienter i fortsat behandling med samme dosis dabigatranetixilat som i RE-LY studiet.
The RE-LY extension study (RELY-ABLE) provided additional safety information for a cohort of patients which continued the same dose of dabigatran etexilate as assigned in the RE-LY trial.
Andre patienter med en øget blødningsrisiko
Other patients at increased risk of bleeding
I lyset af den lange halveringstid for amiodaron kan en interaktion forekomme i flere uger efter ophør med amiodaron (se pkt.
In view of the long half-life of amiodarone the potential for an interaction may exist for weeks after discontinuation of amiodarone (see sections 4.2 and 4.4).
Intrakraniel blødning GI blødning Letal blødning Mindre blødning Alle blødninger
Intracranial bleeding GI bleeding Fatal bleeding Minor bleeding Any bleeding
Der foreligger ingen data for behandling med Pradaxa 110 mg to gange dagligt.
There are no data available for 110 mg twice daily Pradaxa treatment.
Dette kan inkludere aktuel eller nylig gastrointestinal ulceration, maligne neoplasmer med høj risiko for blødning, nylig hjerne- eller rygmarvsskade, nylig hjerne-, rygmarvs- eller øjenoperation, nylig intrakraniel blødning, øsofagusvaricer eller mistanke herom, arteriovenøse malformationer, vaskulære aneurismer eller større intraspinale eller intracerebrale vaskulære abnormaliteter
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
Tabel 18-19 viser resultater af de primære sikkerhedsendepunkter i relevante delpopulationer:
Tables 18-19 display results of the primary efficacy and safety endpoint in relevant sub-populations:
Forekomsten af visse blødninger (MBE/CRBE; enhver blødning) var signifikant lavere ved et nominelt alfa-niveau på 5 % hos patienter, som fik Pradaxa, sammenlignet med patienter behandet med warfarin.
Some bleeding events (MBEs/CRBEs; any bleeding) were significantly lower at a nominal alpha level of 5% in patients receiving Pradaxa as compared with those receiving warfarin.
Kontakt din læge, hvis du har eller har haft en sygdom, især:
Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:
Hvis ikke andet er udtrykkeligt beskrevet, bør der være tæt klinisk overvågning (nøje observation for tegn på blødning eller anæmi), når dabigatran gives samtidig med stærke P-gp-inhibitorer.
If not otherwise specifically described, close clinical surveillance (looking for signs of bleeding or anaemia) is required when dabigatran is co-administered with strong P-gp inhibitors.
Patienter med gastritis, øsofagitis or gastroøsofageal refluks
Patients with gastritis, esophagitis or gastroesophageal reflux
Pradaxas sikkerhed er blevet evalueret i et pivotalt studie, der undersøgte forebyggelse af apopleksi og systemisk emboli hos patienter med atrieflimren, i 2 aktivt kontrollerede studier med DVT/LEbehandling, og i 1 aktivt kontrolleret forebyggende DVT/LE-studie.
The safety of Pradaxa has been evaluated in a pivotal study investigating the prevention of stroke and systemic embolism in patients with atrial fibrillation, in two active controlled DVT/PE treatment trials and in one active controlled DVT/PE prevention trial.
Clopidogrel Hos unge, raske mænd medførte samtidig administration af dabigatranetexilat og clopidogrel ikke yderligere forlængelse af kapillær blødning i forhold til clopidogrel monoterapi.
Clopidogrel In young healthy male volunteers, the concomitant administration of dabigatran etexilate and clopidogrel resulted in no further prolongation of capillary bleeding times compared to clopidogrel monotherapy.