FrancophonIA/ELRC3.0 huggingface dataset:
English: A large number of PK/PD studies were reviewed together with data from clinical experience and the CHMP considered the available data to be sufficient to support revisions of the indication for both parenteral and inhalation use products, in line with clinical experience and current therapeutic guidelines.
Danish: Der blev gennemgået en lang række farmakokinetiske/farmakodynamiske undersøgelser foruden data fra kliniske erfaringer, og CHMP fandt de foreliggende data tilstrækkelige til at støtte en revision af indikationen for både parenterale lægemidler og inhalationslægemidler i henhold til de kliniske erfaringer og gældende behandlingsvejledninger.
English: • the CHMP considered the available data to be sufficient to support revisions of the indication for both parenteral use and inhalation use medicinal products, in line with clinical experience and current therapeutic guidelines
Danish: • CHMP fandt de foreliggende data tilstrækkelige som grundlag for revision af indikationerne for lægemidler til parenteral brug og inhalationsbrug i henhold til de kliniske erfaringer og gældende behandlingsvejledninger.
English: In conclusion, the CHMP is of the opinion that the benefit-risk of the polymyxin-based products included in the scope of this procedure remains positive, provided that changes, as applicable, are made to their product information as set out in Annex III to the opinion.
Danish: Som konklusion er CHMP af den opfattelse, at benefit/risk-forholdet for de polymyxinbaserede lægemidler omfattet af denne procedure fortsat er positivt under forudsætning af de respektive ændringer i produktoplysningerne, som fremgår af bilag III til udtalelsen.
English: Having reviewed all available data, the CHMP considered that CMS and colistin represent a crucial therapeutic option in the armamentarium available to prescribers in the context of the treatment of infections caused by multi-drug resistant Gram-negative pathogens.
Danish: Efter gennemgang af alle foreliggende data fandt CHMP, at CMS og colistin er en essentiel del af de ordinerende lægers våben mod infektioner med multiresistente gramnegative patogener.
English: • the CHMP made extensive revisions to the SmPC to reflect current pharmacokinetic and pharmacodynamic data, including an update of the EUCAST breakpoints and the list of susceptible species,
Danish: • CHMP foretog omfattende revisioner af produktresuméet, for at dette skal modsvare de nuværende farmakokinetiske og farmakodynamiske data, herunder ajourføringer af EUCASTafskæringspunkterne og fortegnelsen over følsomme arter.
English: Limited therapeutic options have led to an increased clinical use of colistin, a polymyxin antibiotic developed over 50 years ago and which has retained activity against a number of multi-drug resistant pathogens.
Danish: Begrænsede behandlingsmuligheder har ført til øget klinisk anvendelse af colistin, et polymyxinantibiotikum, der er udviklet for mere end 50 år siden, men har bibeholdt aktiviteten mod en række multiresistente patogener, muligvis fordi det kun anvendes parenteralt i begrænset omfang, fordi der findes sikre behandlingsmuligheder, der er mindre neurotoksiske og nefrotoksiske.
English: Whereas
Danish: Ud fra følgende betragtninger:
English: The CHMP reviewed the optimal way of expressing the strength and dose of polymyxin-containing products and was of the opinion that given the established use of international units (IU) in EU clinical practice and in the European and British Pharmacopoeia, the EU product information for CMS should continue to be expressed in IU.
Danish: Udvalget fandt, at internationale enheder (IE) fortsat burde anvendes i produktoplysningerne for CMS på baggrund af den almindeligt anerkendte anvendelse heraf i klinisk praksis i EU og i Ph Eur.
English: Content (concentration)
Danish: Indhold (Koncentration) Paknings-størrelse
English: These are your last remaining tablets.
Danish: Disse tabletter er de sidste, du har tilbage.
English: Lixiana is used in adults to:
Danish: Lixiana anvendes til voksne til at:
English: Special populations Assessment of renal function:
Danish: Specielle populationer Vurdering af nyrefunktionen:
English: Lixiana can be initiated or continued in patients who may require cardioversion.
Danish: Lixiana kan initieres eller fortsættes hos patienter, der kan have brug for kardiovertering.
English: Or scan the QR code with your smartphone:
Danish: Eller scan QR-koden med din smartphone:
English: It is very important to take Lixiana before and after the operation exactly at the times you have been told by your doctor.
Danish: Det er yderst vigtigt, at du tager Lixiana før og efter operationen på præcist de tidspunkter, som lægen har angivet.
English: Lixiana can be taken with or without food.
Danish: Lixiana kan tages sammen med eller uden mad.
English: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥1/10), almindelig (≥1/100 til < 1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Safety in patients with NVAF in ENGAGE AF-TIMI 48
Danish: Sikkerhed hos patienter med NVAF i ENGAGE AF-TIMI 48
English: erythromycin, or ketoconazole.
Danish: erythromycin eller ketoconazol.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 June 2015
Danish: Dato for første markedsføringstilladelse: 19. juni 2015
English: □ Either in the morning □ Or at noon □ Or in the evening For more information please visit: www.dspatient.eu
Danish: □ Enten om morgenen □ Eller ved middagstid □ Eller om aftenen Yderligere oplysninger kan findes på: www.dspatient.eu
English: Do not take Lixiana if you are pregnant or breast-feeding.
Danish: Tag ikke Lixiana hvis du er gravid eller ammer.
English: No dose modification is necessary when Lixiana is administered with digoxin.
Danish: Ingen dosismodifikation er nødvendig, når Lixiana administreres sammen med digoxin.
English: If you become pregnant while you are taking Lixiana, immediately tell your doctor, who will decide how you should be treated.
Danish: Hvis du bliver gravid, mens du tager Lixiana, skal du straks fortælle det til lægen, som vil bestemme, hvilken behandling, du skal have.
English: The same information is also available on the following URL: www.dspatient.eu.
Danish: De samme oplysninger kan også fås via følgende URL: www.dspatient.eu.
English: There is a potential for inadequate anticoagulation during the transition from Lixiana to VKA.
Danish: Der er mulighed for utilstrækkelig antikoagulation ved overgangen fra Lixiana til VKA.
English: Most patients (85%) should be able to achieve an INR ≥ 2.0 within 14 days of concomitant administration of Lixiana and VKA.
Danish: Det bør være muligt for de fleste patienter (85 %) at opnå en INR ≥ 2,0 i løbet af 14 dage med administration af Lixiana sammen med VKA.
English: Detailed information on this product is available by scanning the QR Code below with a smartphone.
Danish: Detaljerede oplysninger om dette præparat kan fås ved at scanne QR-koden nedenfor med en smarttelefon.
English: Prior to launch of Lixiana in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før lancering af Lixiana i hver enkelt medlemsstat skal indehaveren af markedsføringstilladelsen være enig med den relevante nationale myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: Lixiana 15 mg is not indicated as monotherapy, as it may result in decreased efficacy.
Danish: Lixiana 15 mg er ikke indiceret til monoterapi, da det kan føre til nedsat virkning.
English: Anti-FXa activity by CrCL category
Danish: Anti-FXa-aktivitet pr. CrCl-kategori
English: Periodic hepatic monitoring is recommended for patients on Lixiana treatment beyond 1 year.
Danish: Der anbefales periodisk leverovervågning for patienter i behandling med Lixiana længere end 1 år.
English: Tell your doctor immediately if you have taken too many Lixiana tablets.
Danish: Fortæl det straks til din læge, hvis du har taget for mange tabletter med Lixiana.
English: • That all patients should be provided with a Patient alert card and be counselled about: The signs or symptoms of bleeding and when to seek attention from a healthcare provider Importance of treatment compliance Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals that they are taking Lixiana if they need to have any surgery or invasive procedure
Danish: • At alle patienter skal forsynes med et patientkort og rådgives om: Tegn og symptomer på blødning, og hvornår de skal søge hjælp hos en læge eller sundhedspersonale Vigtigheden af at overholde behandlingen Nødvendigheden af at have patientkortet på sig hele tiden Nødvendigheden af at informere læger eller sundhedspersonale om, at de tager Lixiana, hvis de skal have foretaget en operation eller et invasivt indgreb
English: If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Lixiana.
Danish: Hvis der er en mulighed for, at du kan blive gravid, skal du anvende en pålidelig præventionsmetode, mens du tager Lixiana.
English: Do not take Lixiana:
Danish: Tag ikke Lixiana:
English: If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Lixiana at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body.
Danish: Hvis der er brug for, at din unormale hjerterytme bringes tilbage til en normal rytme ved hjælp af en procedure, der kaldes kardiovertering, skal du tage Lixiana på de tidspunkter, din læge fortæller dig, for at forebygge blodpropper i hjernen og andre blodkar i kroppen.
English: A 4 hour haemodialysis session reduced total edoxaban exposures by less than 9%.
Danish: En 4-timers hæmodialyse reducerede den total eksponering for edoxaban med under 9 %.
English: Discontinuation for surgery and other interventions
Danish: Seponering med henblik på kirurgi og andre indgreb
English: • Lixiana may increase the risk of bleeding.
Danish: • Lixiana kan øge blødningsrisikoen.
English: • Do not stop taking Lixiana without consulting your doctor as this can increase your risk of developing a blood clot.
Danish: • Hold ikke op med at tage Lixiana uden at kontakte lægen, da det kan øge din risiko for at udvikle en blodprop.
English: Cardioversion should be performed no later than 12 hours after the dose of Lixiana on the day of the procedure.
Danish: Kardiovertering skal udføres højst 12 timer efter dosen af Lixiana på dagen for proceduren.
English: This method is recommended when assessing patients' CrCL prior to and during Lixiana treatment.
Danish: Denne metode anbefales, når patienternes CrCl vurderes før og under behandlingen med Lixiana.
English: Lixiana contains the active substance edoxaban and belongs to a group of medicines called anticoagulants.
Danish: Lixiana indeholder det aktive stof edoxaban og tilhører en gruppe lægemidler, som kaldes antikoagulantia.
English: • The need to inform Health Care Professionals that they are taking Lixiana if they need to have any surgery or invasive procedure
Danish: • Nødvendigheden af at informere læger eller sundhedspersonale om, at de tager Lixiana, hvis de skal have foretaget en operation eller et invasivt indgreb
English: • Guidance on switching from or to Lixiana treatment
Danish: • Vejledning i skift fra eller til Lixiana-behandling
English: Once an INR ≥ 2.0 is achieved, Lixiana should be discontinued.
Danish: Når INR ≥ 2,0 er opnået, skal Lixiana seponeres.
English: Talk to your doctor or pharmacist before taking Lixiana,
Danish: Kontakt lægen eller apotekspersonalet, før du tager Lixiana,
English: Please consult your doctor for a new prescription of Lixiana.
Danish: Kontakt venligst lægen for en ny recept på Lixiana.
English: A QR Code and the following text may be printed on the inner lid of the carton: Lixiana should be taken once daily and ideally at the same time every day Take as recommended by your doctor:
Danish: En QR-kode og den følgende tekst kan være trykt på indersiden af kartonens låg: Lixiana skal tages én gang dagligt og ideelt på samme tidspunkt hver dag Tages som anbefalet af din læge:
English: Do not stop taking Lixiana without talking to your doctor first, because Lixiana treats and prevents serious conditions.
Danish: Du må ikke holde op med at tage Lixiana uden først at kontakte lægen, da Lixiana behandler og forebygger alvorlige sygdomme.
English: - if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6) - if you are actively bleeding - if you have a disease or condition that increases the risk of serious bleeding
Danish: - hvis du er allergisk over for edoxaban eller et af de øvrige indholdsstoffer i Lixiana (angivet i punkt 6) - hvis du har en aktiv blødning - hvis du har en sygdom eller tilstand, som øger risikoen for alvorlig blødning
English: Lixiana is not recommended in children and adolescents under 18 years of age.
Danish: Lixiana bør ikke anvendes til børn og unge under 18 år.
English: After 14 days it is recommended that Lixiana is discontinued and the VKA continued to be titrated to achieve an INR between 2 and 3.
Danish: Efter 14 dage anbefales det at seponere Lixiana og fortsætte med at titrere VKA for at opnå en INR fra 2 til 3.
English: The programme is also aimed at ensuring that the healthcare professionals who intend to prescribe Lixiana are aware of the Patient alert card and that the card is to be given to and reviewed with all patients treated with Lixiana.
Danish: Programmets mål er også at sikre, at læger og sundhedspersonale, der planlægger at ordinere Lixiana, er bekendt med patientkortet, og at kortet udleveres til og gennemgås sammen med alle patienter, der behandles med Lixiana.
English: Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that edoxaban passes the placenta, Lixiana is contraindicated during pregnancy (see section 4.3).
Danish: På grund af den mulige reproduktionstoksicitet, den intrinsiske blødningsrisiko og beviset for, at edoxaban krydser placenta, er Lixiana kontraindiceret under graviditeten (se pkt.
English: The MAH shall ensure that in each Member State where Lixiana is marketed, all healthcare professionals who are expected to use Lixiana are provided with the following educational material:
Danish: Indehaveren af markedsføringstilladelsen skal i hver medlemsstat, hvor Lixiana markedsføres, sikre, at alle læger og alt sundhedspersonale, der forventes at anvende Lixiana, forsynes med følgende uddannelsesmateriale:
English: For all patients undergoing cardioversion: Confirmation should be sought prior to cardioversion that the patient has taken Lixiana as prescribed.
Danish: For alle patienter, der gennemgår kardiovertering: Før kardiovertering skal patienten bekræfte, at Lixiana er taget som ordineret.
English: You have been prescribed Lixiana, an anticoagulant medicine, which thins your blood and helps prevent you from suffering blood clots.
Danish: Du har fået ordineret Lixiana, et antikoagulerende lægemiddel, som fortynder blodet og hjælper med til at forhindre, at du får blodpropper.
English: • Lixiana is an oral anticoagulant factor Xa inhibitor.
Danish: • Lixiana er en oral antikoagulant faktor Xa-hæmmer.
English: Lixiana has been prescribed at a once-daily dose of:
Danish: Lixiana er blevet ordineret med en dosis én gang dagligt på:
English: Lixiana Discontinue the VKA and start Lixiana when the international normalised ratio (INR) is ≤ 2.5.
Danish: Seponer VKA og start behandling med Lixiana, når international normalised ratio (INR) er ≤ 2,5.
English: Intravenous unfractionated heparin (UFH): Discontinue the infusion and start Lixiana 4 hours later.
Danish: Intravenøst, ufraktioneret heparin (UFH): Seponer infusionen, og start behandling med Lixiana 4 timer senere.
English: The educational programme is aimed at mitigating the risk of serious bleeds or haemorrhage in patients treated with Lixiana by ensuring prescriber awareness and providing guidance on appropriate patient selection, correct dosing as well as management of the risk.
Danish: Uddannelsesprogrammets mål er at reducere risikoen for alvorlige blødninger eller hæmoragi hos patienter, der behandles med Lixiana, ved at sikre, at den person, der skal ordinere medicinen, er bekendt med denne risiko, og give vejledning i passende patientudvælgelse, korrekt dosering samt håndtering af risikoen.
English: The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see section 5.1).
Danish: Den anbefalede dosis er 60 mg edoxaban en gang dagligt efter indledende anvendelse af parenteral antikoagulation i mindst 5 dage (se pkt.
English: The safety and efficacy of Lixiana in children and adolescents less than 18 years of age have not been established.
Danish: Lixianas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: The primary safety endpoint was major bleeding.
Danish: Det primære endepunkt for sikkerhed var svær blødning.
English: If oral medicinal products cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant and then switch to oral once daily Lixiana (see section 4.2).
Danish: Hvis der ikke kan indtages orale lægemidler i løbet af eller efter det kirurgiske indgreb, bør det overvejes at administrere parenteral antikoagulation og derefter skifte til oral behandling med Lixiana en gang dagligt (se pkt.
English: In deciding whether a procedure should be delayed until 24 hours after the last dose of Lixiana, the increased risk of bleeding should be weighed against the urgency of the intervention.
Danish: Når det skal besluttes, om et indgreb skal udskydes til 24 timer efter den sidste dosis Lixiana, skal den forhøjede blødningsrisiko afvejes mod, hvor akut der behøves et indgreb.
English: Do not stop taking Lixiana unless advised by your doctor.
Danish: Du må ikke holde op med at tage Lixiana, medmindre lægen råder dig til det.
English: Edoxaban is a substrate for the efflux transporter P-glycoprotein (Pgp), but not a substrate for uptake transporters such as organic anion transporter polypeptide OATP1B1, organic anion transporters OAT1 or OAT3 or organic cation transporter OCT2.
Danish: Edoxaban er et substrat for efflux-transporterproteinet P-glykoprotein (P-gp), men det er ikke et substrat for optagelsestransportproteiner, såsom organisk aniontransportprotein-polypeptid OATP1B1, organisk aniontransportprotein OAT1 eller OAT3 eller organisk kationtransportprotein OCT2.
English: If any of the above apply to you, tell your doctor before taking Lixiana, because the effect of Lixiana may be reduced.
Danish: Hvis noget af det ovenstående gælder for dig, skal du fortælle det til lægen, før du tager Lixiana, da Lixianas virkning kan blive nedsat.
English: • Please read the Patient Information Leaflet found inside each pack of Lixiana.
Danish: • Læs indlægssedlen, der findes i alle pakninger med Lixiana.
English: 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: Your doctor will determine when to restart Lixiana.
Danish: Din læge vil bestemme, hvornår Lixiana skal genstartes.
English: If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, Lixiana should be stopped as soon as possible and preferably at least 24 hours before the procedure.
Danish: Hvis antikoagulation skal seponeres for at nedsætte blødningsrisikoen ved kirurgiske indgreb eller andre procedurer, bør Lixiana stoppes så snart som muligt, og helst mindst 24 timer før indgrebet.
English: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).
Danish: Forebyggelse af apopleksi og systemisk emboli hos voksne patienter med non-valvulær atrieflimren (NVAF) med en eller flere risikofaktorer, såsom kongestivt hjertesvigt, hypertension, alder ≥ 75 år, diabetes mellitus, tidligere apopleksi eller transitorisk iskæmisk anfald (TIA).
English: No dose reduction is required (see section 5.2).
Danish: Ingen dosisreduktion er nødvendig (se pkt.
English: QR code to be included
Danish: QR-kode indsættes
English: Tell your doctor before taking Lixiana, because these medicines may increase the effects of Lixiana and the chance of unwanted bleeding.
Danish: Fortæl det altid lægen, før du tager Lixiana, da disse lægemidler kan øge virkningen af Lixiana og risikoen for uønsket blødning.
English: If you take more Lixiana than recommended, you may have an increased risk of bleeding.
Danish: Hvis du tager mere Lixiana end anbefalet, kan du have en øget blødningsrisiko.
English: All ICHs reported on the Adjudicated Cerebrovascular and Non-Intracranial bleed eCRF forms confirmed by the adjudicators are included in ICH counts.
Danish: Alle ICH'er, der blev rapporteret på eCRFformularerne Adjudicated Cerebrovaskular and Non-Intracranial bleed , og blev bekræftet af bedømmerne, er inkluderet i ICH-antallet.
English: Table 12 below shows the edoxaban anti-Factor Xa activity by CrCL category for each indication.
Danish: Tabel 12 nedenfor viser anti-faktor Xa-aktiviteten for edoxaban pr. CrCl-kategori for hver indikation.
English: Due to the pharmacological mode of action, the use of Lixiana may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in post haemorrhagic anaemia.
Danish: På grund af Lixianas farmakologiske virkningsmekanisme kan brugen af Lixiana være forbundet med en øget risiko for okkult eller synlig blødning fra alle væv eller organer, hvilket kan medføre posthæmoragisk anæmi.
English: Anticoagulants, antiplatelets, NSAIDs and SSRIs/SNRIs
Danish: Antikoagulantia, antitrombotiske midler, NSAID'er og SSRI'er/SNRI'er
English: If possible, Lixiana should be stopped at least 24 hours before an operation.
Danish: Hvis det er muligt, skal behandlingen med Lixiana stoppes mindst 24 timer før en operation.
English: Lixiana has no or negligible influence on the ability to drive and use machines.
Danish: Lixiana påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Interaction with other medicinal products affecting haemostasis
Danish: Interaktion med andre lægemidler, der påvirker hæmostasen
English: For life-threatening bleeding that cannot be controlled with the measures such as transfusion or haemostasis, the administration of a 4-factor prothrombin complex concentrate (PCC) at 50 IU/kg has been shown to reverse the effects of Lixiana 30 minutes after completing the infusion.
Danish: For livstruende blødninger, der ikke kan kontrolleres ved behandling med transfusion eller hæmostase, har administrationen af 4-faktor protrombinkomplekskoncentrat (prothrombin complex concentrate, PCC) med 50 IE pr. kg vist sig at reversere virkningen af Lixiana 30 minutter efter infusionen er gennemført.