FrancophonIA/ELRC3.0 huggingface dataset:
English: The first study involved a total of 2,101 patients who had had a knee replacement operation.
Danish: Det første studie omfattede i alt 2.101 patienter, der havde fået udskiftet et knæ.
English: Side effects reported with Pradaxa are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Pradaxa vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Pradaxa, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Pradaxa, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The company that makes Pradaxa will provide an educational pack for all doctors who are expected to prescribe the medicine, to increase awareness of the risk of bleeding and provide guidance on how to manage it.
Danish: Den virksomhed, der fremstiller Pradaxa, skal sørge for informationsmateriale til alle læger, der forventes at ordinere lægemidlet, for at øge bevidstheden om risikoen for blødning og give instruktioner i, hvordan denne risiko skal håndteres.
English: Prevention of blood clots or stroke in patients at risk of stroke
Danish: Forebyggelse af blodpropper eller slagtilfælde hos patienter med risiko for slagtilfælde
English: Although the studies showed a small higher risk of heart problems with Pradaxa than with warfarin, the benefits of Pradaxa were still considered to outweigh its risks.
Danish: Selvom studierne har vist en lidt højere risiko for hjerteproblemer ved Pradaxa end ved warfarin, anses fordelene ved Pradaxa stadig at opveje risiciene.
English: Patients will also receive an alert card summarising key safety information on the medicine.
Danish: Patienterne skal derudover have udleveret et patientkort med de vigtigste sikkerhedsoplysninger om lægemidlet.
English: One of these studies compared Pradaxa with warfarin and the other compared Pradaxa with placebo (a dummy treatment).
Danish: I det ene af disse studier blev Pradaxa sammenlignet med warfarin, og i det andet studie blev Pradaxa sammenlignet med placebo (et ikke-virksomt stof).
English: Pradaxa contains the active substance dabigatran etexilate.
Danish: Pradaxa indeholder det aktive stof dabigatranetexilat.
English: Since certain patients who take Pradaxa are at increased risk of bleeding, a number of precautions were included in the prescribing information.
Danish: Da nogle patienter, der får Pradaxa, har øget risiko for blødning, er der angivet en række forholdsregler i ordinationsoplysningerne.
English: These clots, present in conditions such as deep vein thrombosis (DVT), can be dangerous if they move to another part of the body such as the lungs.
Danish: Disse blodpropper, der ses ved tilstande som f.eks. dyb venetrombose, kan være farlige, hvis de flytter sig til andre dele af kroppen, f.eks. lungerne.
English: It blocks a substance called thrombin, which is central to the process of blood clotting.
Danish: Det blokerer stoffet trombin, der er centralt for blodets koagulation.
English: Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating (clotting).
Danish: Dabigatran er et antikoagulans (blodfortyndende lægemiddel), hvilket betyder, at det hæmmer blodets koagulation og dermed dannelsen af blodpropper.
English: Patients who have atrial fibrillation are also at risk of blood clots which can travel to the brain and cause a stroke.
Danish: Patienter med atrieflimren har også risiko for at få blodpropper, der kan føres til hjernen og forårsage et slagtilfælde.
English: Pradaxa compared well with warfarin in reducing the risk of strokes in patients with atrial fibrillation without increasing the risk of major bleeding.
Danish: Pradaxa klarede sig godt i sammenligning med warfarin i forhold til at reducere risikoen for slagtilfælde hos patienter med atrieflimren uden at øge risikoen for større blødningshændelser.
English: When Pradaxa is used long term in patients with non-valvular atrial fibrillation, or when it is used in patients with DVT or PE, kidney function should be assessed at least once a year if their kidney function is mildly to moderately reduced or if they are over 75 years old.
Danish: Når Pradaxa anvendes til langtidsbehandling hos patienter med ikke-valvulær atrieflimren eller hos patienter med dyb venetrombose eller lungeemboli, bør nyrefunktionen vurderes mindst én gang om året, hvis deres nyrefunktion er let til moderat nedsat, eller hvis de er over 75 år gamle.
English: The active substance in Pradaxa, dabigatran etexilate, is a ‘prodrug' of dabigatran.
Danish: Det aktive stof i Pradaxa, dabigatranetexilat, er et såkaldt prodrug for dabigatran.
English: The effect of Pradaxa in preventing blood clots in patients who have undergone a hip or knee replacement is comparable to that of enoxaparin.
Danish: Pradaxas effekt til forebyggelse af blodpropper hos patienter, der har fået udskiftet en hofte eller et knæ, er sammenlignelig med enoxaparins effekt.
English: Treatment and prevention of DVT and PE
Danish: Behandling og forebyggelse af dyb venetrombose og lungeemboli
English: Two main studies in over 5,100 adults with symptoms of DVT or PE, and who were initially treated with an injectable anticoagulant, compared Pradaxa with warfarin.
Danish: I to hovedstudier hos over 5.100 voksne med symptomer på dyb venetrombose eller lungeemboli, og som initialt blev behandlet med et injicerbart blodfortyndende lægemiddel, blev Pradaxa sammenlignet med warfarin.
English: How is Pradaxa used?
Danish: Hvordan anvendes Pradaxa?
English: Prevention of blood clots after hip or knee replacement
Danish: Forebyggelse af blodpropper efter udskiftning af en hofte eller et knæ
English: It must not be used in patients taking any other anticoagulant medicine, except when the anticoagulant medicine is being switched or when heparin (another anticoagulant medicine) is being used in specific medical procedures.
Danish: Pradaxa må ikke anvendes hos patienter, der får anden blodfortyndende medicin, bortset fra ved skift til anden blodfortyndende medicin, eller hvor heparin (et andet blodfortyndende lægemiddel) anvendes ved specifikke medicinske procedurer.
English: • preventing stroke and the formation of clots in adults who have an abnormal heartbeat called ‘nonvalvular atrial fibrillation' and are considered to be at risk of stroke;
Danish: • forebyggelse af slagtilfælde og blodpropdannelse hos voksne, der har såkaldt ikke-valvulær atrieflimren (unormalt hjerteslag), og som vurderes at have risiko for slagtilfælde
English: • preventing the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee;
Danish: • forebyggelse af blodpropdannelse i venerne hos voksne, der har fået udskiftet en hofte eller et knæ
English: In addition, the overall benefit of Pradaxa in the treatment and prevention of DVT and PE is comparable to that of warfarin.
Danish: Derudover er de overordnede fordele ved Pradaxa til behandling og forebyggelse af dyb venetrombose og lungeemboli sammenlignelige med warfarins overordnede fordele.
English: For the full list of all side effects reported with Pradaxa, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Pradaxa fremgår af indlægssedlen.
English: Pradaxa was as effective as warfarin in reducing formation of blood clots in the veins (DVT) or lungs (PE), or blood-clot-related death during treatment.
Danish: Pradaxa var lige så effektivt som warfarin til at reducere dannelsen af blodpropper i venerne (dyb venetrombose) eller lungerne (lungeemboli) samt forekomsten af blodproprelaterede dødsfald under behandling.
English: Pradaxa must not be used in patients who have severely reduced kidney function, who are currently bleeding significantly or who have a condition putting them at significant risk of major bleeding.
Danish: Pradaxa må ikke gives til patienter, der har svært nedsat nyrefunktion, der har aktuel kraftig blødning, eller som har en sygdom, der betyder, at de har betydelig risiko for større blødningshændelser.
English: Pradaxa (220 or 150 mg a day) was as effective as enoxaparin (an anticoagulant given by injection) in preventing formation of blood clots or death in patients who had undergone hip or knee replacement in two main studies.
Danish: I to hovedstudier var Pradaxa (220 eller 150 mg pr. dag) lige så effektivt som enoxaparin (et blodfortyndende lægemiddel, der indgives ved injektion) til at forebygge dannelsen af blodpropper eller dødsfald hos patienter, der havde fået udskiftet en hofte eller et knæ.
English: What benefits of Pradaxa have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Pradaxa?
English: • treating deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (PE, a clot in a blood vessel supplying the lungs) in adults, and preventing these conditions from occurring again.
Danish: • behandling af dyb venetrombose (blodprop i en dyb vene, typisk i benet) og lungeemboli (blodprop i en lunge-arterie) hos voksne samt forebyggelse af ny dyb venetrombose og lungeemboli.
English: How does Pradaxa work?
Danish: Hvordan virker Pradaxa?
English: The proportion of patients who had a stroke or other problems caused by blood clots each year was around 1.5% for patients taking 110 mg Pradaxa (183 patients out of 6,015) and 1.1% for patients taking 150 mg Pradaxa (135 out of 6,076), compared with 1.7% for patients taking warfarin (203 out of 6,022).
Danish: Andelen af patienter pr. år, der fik et slagtilfælde eller andre problemer forårsaget af blodpropper, var ca. 1,5 % for de patienter, der fik 110 mg Pradaxa (183 ud af 6.015), og 1,1 % for de patienter, der fik 150 mg Pradaxa (135 ud af 6.076), sammenholdt med 1,7 % for de patienter, der fik warfarin (203 ud af 6.022).
English: Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in their leg veins.
Danish: Patienter, der får udskiftet en hofte eller et knæ, har høj risiko for at få blodpropper i venerne i benet.
English: In all patients, kidney function should also be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected.
Danish: Desuden bør nyrefunktionen vurderes hos alle patienter inden påbegyndelse af behandling for at udelukke patienter med svært nedsat nyrefunktion.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pradaxa have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pradaxa.
English: Another two studies looked at the prevention of VTE or PE in around 4,200 adults with symptoms of recurring blood clots and who were on long-term treatment with anticoagulants.
Danish: 4.200 voksne med symptomer på tilbagefald af blodpropper, og som var i langtidsbehandling med blodtyndende medicin.
English: During the treatment period, blood clots were detected in 36% of the patients taking 220 mg Pradaxa (183 out of 503), compared with 38% of the patients receiving enoxaparin (193 out of 512).
Danish: I behandlingsperioden sås blodpropper hos 36 % af de patienter, der fik 220 mg Pradaxa (183 ud af 503), sammenholdt med 38 % af de patienter, der fik enoxaparin (193 ud af 512).
English: In the second study, blood clots or blood-clot-related death occurred in 0.4% (3 out of 681) of patients treated with Pradaxa, compared with 5.6% (37 out of 662) of patients treated with placebo.
Danish: I det andet studie sås blodpropper eller blodproprelaterede dødsfald hos 0,4 % af de patienter, der fik Pradaxa (3 ud af 681), sammenholdt med 5,6 % af de patienter, der fik placebo (37 ud af 662).
English: During the treatment period, blood clots were detected in 6% of the patients taking 220 mg Pradaxa (53 out of 880), compared with 7% of the patients receiving enoxaparin (60 out of 897).
Danish: I behandlingsperioden sås blodpropper hos 6 % af de patienter, der fik 220 mg Pradaxa (53 ud af 880), sammenholdt med 7 % af de patienter, der fik enoxaparin (60 ud af 897).
English: In the first study, blood clots or blood-clot-related death occurred in 1.8% (26 out of 1,430) of patients treated with Pradaxa, compared with 1.3% (18 out of 1,426) of patients treated with warfarin.
Danish: I det første studie sås blodpropper eller blodproprelaterede dødsfald hos 1,8 % af de patienter, der fik Pradaxa (26 ud af 1.430), sammenholdt med 1,3 % af de patienter, der fik warfarin (18 ud af 1.426).
English: Blood clots or blood-clot-related death occurred in 2.7% (68 out of 2,553) of patients treated with Pradaxa, compared with 2.4% (62 out of 2,554) of patients treated with warfarin.
Danish: Blodpropper eller blodproprelaterede dødsfald sås hos 2,7 % af de patienter, der fik Pradaxa (68 ud af 2.553), sammenholdt med 2,4 % af de patienter, der fik warfarin (62 ud af 2.554).
English: Pradaxa (110 mg or 150 mg twice a day) was as effective as warfarin (another anticoagulant given by mouth) in preventing stroke or a blood clot blocking blood vessels in other parts of the body in a study of patients with non-valvular atrial fibrillation who were considered to be at risk of stroke.
Danish: I et studie hos patienter med ikke-valvulær atrieflimren, der vurderedes at have risiko for slagtilfælde, var Pradaxa (110 mg eller 150 mg to gange dagligt) lige så effektivt som warfarin (et andet blodfortyndende lægemiddel, der indgives gennem munden) til at forebygge slagtilfælde eller blodpropper i blodårerne i andre dele af kroppen.
English: • life-time maximum dose
Danish: • maksimal livstidsdosis
English: The Marketing Authorisation Holders of Novantrone and associated names shall submit for assessment to the Reference Member State a Risk Management Plan containing key elements as described in the CHMP assessment report.
Danish: Indehaverne af markedsføringstilladelse for Novantrone og relaterede navne forelægger en risikostyringsplan for referencemedlemsstaten med de hovedelementer, der er beskrevet i CHMP's vurderingsrapport.
English: The Marketing Authorisation Holder(s) shall ensure that in each Member State where Novantrone and associated names are marketed, all healthcare professional (HCP) and patients/carers who are expected to prescribe and dispense or use Novantrone in treatment of multiple sclerosis have access to/are provided with the following educational package:
Danish: Indehaveren (indehaverne) af markedsføringstilladelse sikrer, at i hver medlemsstat, hvor Novantrone og relaterede navne markedsføres, har alle sundhedspersoner og patienter/omsorgsgivere, der forventes at ordinere og dispensere eller anvende Novantrone til behandling af multipel sklerose, adgang til/får udleveret følgende informationspakke:
English: • Novantrone could cause cardiotoxicity o need for echocardiogram or multiple-gated acquisition (MUGA) evaluation of the left-ventricular ejection fraction (LVEF) prior to administration of each dose and yearly for up to 5 years after the end of therapy.
Danish: • Novantrone kan medføre kardiotoksicitet o nødvendigheden af et ekkokardiogram eller bestemmelse ved multiple-gated acquisition (MUGA) af venstre ventrikels uddrivningsfraktion før administration af hver dosis og årligt i indtil 5 år efter afslutningen af behandlingen.
English: • signs and symptoms of cardiotoxicity and haematotoxicity
Danish: • tegn og symptomer på kardiotoksicitet og hæmatotoksicitet
English: • evaluation of the left-ventricular ejection fraction (LVEF)
Danish: • bestemmelse af venstre ventrikels uddrivningsfraktion
English: • Novantrone could cause haematotoxicity, including secondary acute myeloid leukaemia and myelodysplastic syndrome o the need for monitoring at the start and prior to each treatment administration
Danish: • Novantrone kan medføre hæmotoksicitet, herunder sekundær akut myeloid leukæmi og myelodysplastisk syndrom o nødvendigheden af overvågning ved behandlingens påbegyndelse og før hver administration af behandlingen checkliste til sundhedspersoner med følgende hovedelementer:
English: • key signs and symptoms regarding cardiotoxicity and haematotoxicity
Danish: • vigtigste tegn og symptomer på kardiotoksicitet og hæmatotoksicitet
English: • Information on the need of regular monitoring, and when it should be carried out, for cardiotoxicity and haematotoxicity
Danish: • information om nødvendigheden af regelmæssig overvågning for kardiotoksicitet og hæmatotoksicitet, og hvornår den bør foretages patientkort med følgende hovedelementer:
English: • full blood count including platelets
Danish: • fuldstændig blodtælling, herunder trombocytter skriftlig information til patienterne med følgende hovedelementer:
English: HCP brochure including the following key-elements:
Danish: brochure til sundhedspersoner, der indeholder følgende hovedelementer:
English: The expected recruitment period is 18 months.
Danish: Forventet rekrutteringsperiode er 18 måneder.
English: Show them the package.
Danish: Vis dem pakningen.
English: The final study report will be available 6 months after the last patient visit in the study.
Danish: Den endelige study report vil være tilgængelig 6 måneder efter sidste patientbesøg i undersøgelsen.
English: Do not take more tablets than your doctor has recommended.
Danish: Tag ikke flere tabletter end lægen har anbefalet.
English: Remember to take your medicine.
Danish: Husk at tage medicinen.
English: Take ADARTREL once a day by mouth, every day at about the same time each day.
Danish: Tag Adartrel en gang daglig, hver dag og omtrent på samme tidspunkt hver dag.
English: Your doctor will decide on the dose you need to take each day and you should follow the doctor's instructions.
Danish: Lægen vil afgøre hvilken dosis du skal tage hver dag, og du bør altid følge lægens anvisninger.
English: Ropirinol has been granted a marketing authorisation by France on 30 June 2004.
Danish: Der blev udstedt en markedsføringstilladelse for Ropirinol af Frankrig den 30. juni 2004.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ADARTREL (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF ADARTREL (se bilag I)
English: Module 5 - Clinical
Danish: Modul 5 - Clinical
English: ADARTREL is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Danish: Adartrel er ikke anbefalet til brug hos børn under 18 år p.g.a. mangel på data vedrørende sikkerhed og effekt.
English: You can take ADARTREL with or without food.
Danish: Adartrel kan tages sammen med eller uden mad.
English: The bioavailability of ropinirole varies greatly between individuals.
Danish: Biotilgængeligheden af ropinirol varierer betydeligt mellem individer.
English: Treatment initiation (week 1)
Danish: Behandlingsinitiering (uge 1)
English: Undesirable effects should be closely monitored.
Danish: Bivirkninger skal følges nøje.
English: Other experience with ropinirole
Danish: Anden erfaring med ropinirol
English: - you give up or start smoking while taking ADARTREL.
Danish: • hvis du stopper eller begynder på at ryge mens du tager Adartrel.
English: The amended SPC is endorsed by the CHMP.
Danish: Det ændrede produktresumé vedtages af CHMP.
English: You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work for you.
Danish: Du bør fortsætte med at tage din medicin selvom du ikke får det bedre, da det kan tage et antal uger inden den virker.
English: Ropinirole may be taken with food, to improve gastrointestinal tolerance.
Danish: Ropinirol kan tages sammen med mad for at forbedre gastrointestinal tolerance.
English: No clinically significant effect on the QT interval was observed.
Danish: Der blev ingen klinisk signifikant effekt observeret på QT-intervallet.
English: The patient's response to ropinirole should be evaluated after 3 months treatment (see section 5.1).
Danish: Patientens respons på ropinirol bør evalueres efter 3 måneders behandling (se afsnit 5.1).
English: The increase in dosage should be gradual and titrated against the symptomatic response.
Danish: Dosisforøgelse bør være gradvis og titreres mod det symptomatiske respons.
English: The adverse events that are specific to RLS patients, such as augmentation and rebound effects have been discussed.
Danish: De bivirkninger, der er specifikke for RLS-patienter, såsom augmentation og reboundeffekter, er blevet drøftet.
English: Due to the risk of hypotension, patients with severe cardiovascular disease (in particular coronary insufficiency) should be treated with caution.
Danish: På grund af risiko for hypotension, bør patienter med alvorlig kardiovaskulær sygdom (specielt hjerteinsufficiens) behandles med forsigtighed.
English: Very rarely, cases of altered liver function (abnormal blood tests) have been reported.
Danish: Meget sjældent er der set ændret leverfunktion (unormale blodprøver).
English: In patients over 65 years of age, a reduction in the systemic clearance of ropinirole by about 30% is possible.
Danish: Hos patienter over 65 år er reduktion af den systemiske clearance af ropinirol med omkring 30% mulig.
English: Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved.
Danish: Efter behandlingsinitiering øges daglig dosis indtil optimal terapeutisk respons opnås.
English: The elimination half-life of ropinirole is 6 hours on average.
Danish: Eliminationshalveringstiden for ropinirol er gennemsnitlig 6 timer.
English: Tell your doctor if you notice any side effects and they worry you.
Danish: Fortæl lægen hvis du oplever bivirkninger som bekymrer dig.
English: Do not use ADARTREL after the expiry date which is stated on the carton.
Danish: Anvend ikke efter udløbsdatoen, som er angivet på æsken flasken.
English: In clinical studies most patients were of Caucasian origin.
Danish: Størstedelen af patienterne i de kliniske forsøg var af kaukasisk oprindelse.
English: If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Danish: Hvis behandlingen afbrydes i mere end et par dage bør re-initiering ske med dosistitrering som beskrevet ovenfor.
English: Patients who are intolerant to lactose should note that each ADARTREL tablet contains a small amount of lactose.
Danish: Patienter der er intolerante over for laktose, skal lægge mærke til, at hver Adartrel tablet indeholder en lille mængde lactose.
English: The use of ADARTREL in children with Restless Legs Syndrome has not been studied and therefore ADARTREL is not usually prescribed in patients under 18 years of age.
Danish: Brug af Adartrel til børn med Restless Legs Syndrome er ikke undersøgt og derfor ordineres Adartrel normalt ikke til børn under 18 år.
English: Important information about some of the ingredients of ADARTREL
Danish: Vigtige oplysninger om visse af indholdsstofferne i Adartrel
English: - you are taking ADARTREL and the doctor is going to prescribe you any other medicine.
Danish: • du får Adartrel, og lægen vil ordinere dig anden medicin.
English: Before the end of a mutual recognition procedure, Spain and the Netherlands, presented to the EMEA a referral considering that this medicinal product might present a risk to public health since they were of the opinion that safety and efficacy in long-term treatment of ropinirole in restless legs syndrome had not been demonstrated.
Danish: Inden afslutningen af den gensidige anerkendelses-procedure indbragte Spanien og Nederlandene en sag for EMEA ud fra den betragtning, at dette lægemiddel muligvis udgør en risiko for folkesundheden, eftersom sikkerhed og virkning for ropinirol til langtidsbehandling af Restless Legs Syndrome (RLS) efter deres opfattelse ikke er påvist.