FrancophonIA/ELRC3.0 huggingface dataset:
English: • The longer that you are on treatment especially if you have been on treatment for more than two years.
Danish: • Jo længere tid du er i behandling - især hvis du har været i behandling i mere end to år.
English: Information about extended interval dosing (EID)
Danish: Information om forlænget doseringsinterval (EID)
English: Within the limitations of these data, there were no new safety signals identified in this patient population.
Danish: Under hensyntagen til begrænsningerne i disse data blev der ikke identificeret nye sikkerhedssignaler hos denne patientpopulation.
English: A group of symptoms caused by a serious infection of the brain including:
Danish: En gruppe symptomer forårsaget af en alvorlig infektion i hjernen, herunder:
English: Serious cases of ARN, either affecting one or both eyes, led to blindness in some patients.
Danish: Alvorlige tilfælde af ARN, der enten påvirkede det ene eller begge øjne, førte til blindhed hos nogle patienter.
English: • Increase or decrease in your blood pressure (your doctor or nurse will notice this if they are monitoring your blood pressure).
Danish: • Blodtryksstigning eller blodtryksfald (dette vil din læge eller sygeplejerske opdage, hvis de overvåger dit blodtryk).
English: • If your doctor tells you that you have a serious problem with your immune system (due to disease for example, HIV or due to a medicine you are taking or have previously taken
Danish: • Hvis din læge fortæller dig, at du har et alvorligt problem med dit immunsystem (for eksempel på grund af en sygdom såsom HIV, eller på grund af et lægemiddel, du tager eller tidligere har taget).
English: • Switching usually occurred after 1 year (median of 25 standard interval doses) in the secondary definition
Danish: • Skift skete som regel efter 1 år (gennemsnitligt 25 standardintervaldoser) i den sekundære definition.
English: • It is important to continue with your medicine for as long as you and your doctor decide that it is helping you.
Danish: • Det er vigtigt, at du fortsætter med din medicin, så længe din læge mener, at det er gavnligt for dig.
English: After dilution, immediate use is recommended.
Danish: Efter fortynding anbefales omgående anvendelse.
English: The diagnosis and management of IRIS is a controversial issue and there is no consensus concerning its treatment.
Danish: Diagnosticering og håndtering af IRIS er et kontroversielt emne, og der er ingen konsensus vedrørende behandling af IRIS.
English: Severe sequelae can occur including coma and death.
Danish: Svære sequelae kan forekomme, herunder koma og død.
English: The following steroid regimens have been reported for the treatment of IRIS in the literature:
Danish: Der er rapporteret om følgende steroidregimer til behandling af IRIS i litteraturen:
English: To switch from some MS medicines, your doctor may advise you to wait for a certain time to ensure that most of the previous medicine has left your body.
Danish: Ved skift fra visse MS-lægemidler kan lægen råde dig til at vente i en vis periode for at sikre, at det meste af den tidligere medicin er ude af kroppen.
English: Do not use this medicine after the expiry date stated on the label and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og æsken.
English: Without an accelerated elimination procedure, clearance of teriflunomide from plasma can take from several months up to 2 years.
Danish: Uden en accelereret eliminationsprocedure kan clearance af teriflunomid fra plasma tage fra flere måneder til op til 2 år.
English: No effects on abortion rates were noted in any other study.
Danish: Der er ikke blevet observeret virkninger på abortraterne i noget andet studie.
English: Speak to your doctor or nurse immediately if you notice any of the following Symptoms of serious infections including:
Danish: Tal omgående med din læge eller sygeplejerske, hvis du bemærker noget af følgende Symptomer på alvorlige infektioner, herunder:
English: • If you have an active cancer (unless it is a type of skin cancer called basal cell carcinoma).
Danish: • Hvis du har aktiv kræft (medmindre det er den type hudkræft, som kaldes basalcelle karcinom).
English: Signs of allergy to TYSABRI, during or shortly after your infusion:
Danish: Tegn på allergi over for TYSABRI under eller kort tid efter din infusion:
English: For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: − differentiation between PML and MS
Danish: − differentiering mellem PML og MS
English: • Reminder not to start Tysabri if there is a serious problem with their immune system
Danish: • Påmindelse om ikke at starte på TYSABRI, hvis der er et alvorligt problem med deres immunsystem
English: The symptoms of MS vary from patient to patient, and you may experience some or none of them.
Danish: Symptomerne fra MS varierer fra patient til patient, og du vil måske opleve nogle af dem eller måske ingen.
English: • Yellowing of your skin or the whites of your eyes • Unusual darkening of the urine.
Danish: • Gulfarvning af huden eller det hvide i øjnene • Usædvanlig mørkfarvning af urinen.
English: Mean EDSS scores remained stable over 5 years.
Danish: Gennemsnitlige EDSS-scorer var stabile over en periode på 5 år.
English: Side effects are listed below by how commonly they have been reported in clinical trials:
Danish: Bivirkningerne er opstillet nedenfor efter hvor hyppigt, de er blevet indberettet i kliniske studier:
English: • The need to inform the National Competent Authority about any cases of PML
Danish: • Nødvendigheden af at informere den nationalt ansvarlige myndighed om alle tilfælde af PML
English: IRIS may lead to your condition getting worse, including worsening of brain function.
Danish: IRIS kan medføre, at din tilstand bliver værre, herunder at din hjernefunktion forringes.
English: Speak to your doctor as soon as possible if you think you have an infection.
Danish: Tal med din læge så hurtigt som muligt, hvis du mener, at du har en infektion.
English: • Do not use TYSABRI if you are pregnant unless you have discussed this with your doctor.
Danish: • Brug ikke TYSABRI, hvis du er gravid, medmindre du har talt med din læge om dette.
English: The majority (85%) of patients dosed with EID had received the approved dosing for ≥1 year prior to switching to EID.
Danish: Størstedelen (85 %) af de patienter, der fik behandling med EID, havde fået den godkendte dosering i ≥1 år, før de skiftede til EID.
English: Monotherapy; randomised double-blind placebo-controlled parallel-group trial for 120 weeks
Danish: Monoterapi; randomiseret dobbeltblindet placebokontrolleret parallelgruppe studie over 120 uger
English: • A reminder regarding serious infections and the need to speak to their doctor if they have severe persistent infection
Danish: • En påmindelse vedrørende alvorlige infektioner og nødvendigheden af at kontakte lægen, hvis de har/får svær, vedvarende infektion
English: Anti-JCV antibody prevalence in the EU was reported as ranging from 48.8% to 69.5% in the EU in a cross sectional study of MS patients irrespective of treatment.
Danish: Prævalensen af anti-JCV-antistoffer blev rapporteret at variere fra 48,8 % til 69,5 % i EU i et tværgående studie af MS-patienter uanset behandling.
English: No prospective clinical studies have been completed to validate these findings.
Danish: Der er ikke gennemført prospektive kliniske studier til validering af disse fund.
English: • If you have previously taken a medicine called an immunosuppressant.
Danish: • Hvis du tidligere er blevet behandlet med et lægemiddel, der kaldes et immunsuppressivt lægemiddel.
English: Before you start treatment with TYSABRI, it is important that you and your doctor have discussed the benefits you would expect to receive from this treatment and the risks that are associated with it.
Danish: Inden du påbegynder behandlingen med TYSABRI, er det vigtigt, at du og din læge har diskuteret, hvilke fordele du kan forvente at få af denne behandling, og hvilke risici der er forbundet med behandlingen.
English: When a relapse occurs, you may notice the symptoms suddenly, within a few hours, or slowly progressing over several days.
Danish: Når der optræder et attak, vil du måske bemærke symptomerne pludseligt inden for nogle få timer, eller du vil opleve, at symptomerne udvikler sig langsomt over flere dage.
English: In other clinical trials, cases of additional opportunistic infections have been reported, some of which were fatal.
Danish: I andre kliniske studier er der indberettet tilfælde af yderligere opportunistiske infektioner, hvoraf nogle var dødelige.
English: • Reminder to show the card to any doctor involved with their treatment
Danish: • Påmindelse om at vise kortet til alle læger, der er involveret i deres behandling
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Danish: Patienterne bør ligeledes rådes til at informere deres partner eller omsorgsgivere om deres behandling, da disse kan opdage symptomer, som patienten ikke selv er opmærksom på.
English: • Inform about an ongoing study assessing the efficacy, tolerability and safety of switching to EID after at least 12 months on approved dosing.
Danish: • Informere om et igangværende studie til vurdering af virkningen, tolerabiliteten og sikkerheden ved skift til EID efter mindst 12 måneders behandling med den godkendte dosering.
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Danish: Det er vigtigt, at du gemmer patientinformationskortet og viser det til din partner eller dine hjælpere.
English: However, it has recently been suggested that corticosteroids may be useful to treat IRIS, particularly in patients with severe to life-threatening IRIS (Tan et al., 2009, Clifford et al., 2010).
Danish: For nylig er det imidlertid blevet antydet, at kortikosteroider kan være nyttige til behandling af IRIS, især hos patienter med svær til livstruende IRIS (Tan et al., 2009, Clifford et al., 2010).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: • Reminder of the approved dosing; cross reference to EU SmPC
Danish: • Påmindelse om den godkendte dosering; krydsreference til EU-produktresumé
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Danish: Sørg for omgående at fortælle det til din læge, hvis du er gravid, har mistanke om, at du er gravid, eller hvis du planlægger at blive gravid.
English: 1 case of herpes meningitis was reported in the meta-analysis.
Danish: Et tilfælde af herpes meningitis blev rapporteret i meta-analysen.
English: When you receive TYSABRI you might not notice any improvement, but TYSABRI may still be working to prevent your MS becoming worse.
Danish: Når du får TYSABRI, vil du muligvis ikke bemærke nogen forbedring; men TYSABRI kan alligevel virke ved at forebygge forværring i din MS.
English: Monitoring for potential signs of return of MS disease activity in patients switching dosing intervals.
Danish: Monitorering for potentielle tegn på tilbagevenden af MS-sygdomsaktivitet hos patienter, der skifter doseringsinterval.
English: These antibodies are a sign that you have been infected by JC virus.
Danish: Disse antistoffer er tegn på, at du har haft en JC-virus-infektion.
English: These studies showed no evidence of teratogenic effects or effects on growth of offspring.
Danish: Disse studier viste ingen tegn på teratogene virkninger eller virkninger på væksten af afkommet.
English: • Speak with your partner or caregivers and inform them about your treatment.
Danish: • Fortæl din partner eller dine omsorgsgivere om behandlingen.
English: As scientific and medical knowledge, including both diagnostic criteria and management of IRIS is rapidly evolving, please contact Medical affairs in your country for the most up to date information on treatment recommendations.
Danish: Da den videnskabelige og medicinske viden, herunder både diagnostiske kriterier og håndtering af IRIS, er i hurtig udvikling, bedes du kontakte de nationale sundhedsmyndigheder for at få de sidste nye oplysninger om behandlingsanbefalinger.
English: • If you are taking medicines that suppress or modulate the immune system including other medicines used to treat MS disease.
Danish: • Hvis du tager lægemidler, der undertrykker eller påvirker (modulerer) immunsystemet, herunder andre lægemidler til behandling af MS.
English: The limited sample size and shorter duration of TYSABRI exposure for this subgroup of patients should be considered when interpreting these data.
Danish: Det begrænsede antal patienter og den kortere varighed af TYSABRI-eksponeringen for denne patientundergruppe skal tages i betragtning, når disse data tolkes.
English: Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Danish: Vis patientinformationskortet til alle læger, der er involveret i din behandling, og ikke kun til din neurolog.
English: Analysis of STRATIFY JCV showed the prevalence of anti-JCV antibodies to be approximately 55%.
Danish: En analyse af STRATIFY JCV viste, at prævalensen af anti-JCV-antistoffer var cirka 55 %.
English: An accelerated elimination procedure as defined in the teriflunomide Summary of Product Characteristics is recommended or alternatively washout period should not be shorter than 3.5 months.
Danish: En accelereret eliminationsprocedure anbefales som defineret i produktresuméet for teriflunomid, eller alternativt skal udvaskningsperioden være minimum 3,5 måneder.
English: 1 Progression of disability was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS >=1.0 sustained for 12 or 24 weeks or at least a 1.5 point increase on the EDSS from a baseline EDSS =0 sustained for 12 or 24 weeks.
Danish: 1 Progression af handikapudvikling var defineret som mindst 1,0 point stigning i EDSS fra en baseline EDSS >=1,0 fortsat i 12 eller 24 uger eller mindst 1,5 point stigning i EDSS fra en baseline EDSS =0 fortsat i 12 eller 24 uger.
English: In the MS population, anti-JCV antibody prevalence increased with age and was lower in women than in men in all cohorts tested.
Danish: I MS-populationen steg prævalensen af anti-JCV-antistoffer med alderen, og den var lavere hos kvinder end hos mænd i alle undersøgte kohorter.
English: Care should be taken with patients who have previously received immunosuppressants to allow sufficient time for immune function recovery to occur.
Danish: Der bør udvises forsigtighed hos patienter, som tidligere har modtaget immunsupprimerende midler, så der gives tilstrækkelig tid til, at immunsystemets funktion genetableres.
English: • If you have been treated for more than 2 years and you have a lower level of JCV antibodies in your blood.
Danish: • du er blevet behandlet i mere end 2 år og har et lavt niveau af JCV-antistoffer i dit blod.
English: Therefore, following PLEX or IA, periodic clinical monitoring of patients, including MRI monitoring, may be useful for the early detection of IRIS.
Danish: Efter PLEX eller IA kan periodisk klinisk monitorering af patienterne, herunder MR-monitorering, derfor være nyttig med henblik på tidlig påvisning af IRIS.
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts navn og batchnummer tydeligt registreres.
English: o Information provided regarding - In all cases where further investigation of change in neurological status or change in brain MRI is indicated, TYSABRI must be suspended and not restarted until non MS pathology has been confidently excluded.
Danish: o Information gives vedrørende - I alle tilfælde, hvor yderligere undersøgelse af en ændring i neurologisk status eller en ændring i MR-hjernescanning er indiceret, skal TYSABRI afbrydes og ikke genoptages, før ikke-MS-patologi er blevet udelukket med sikkerhed.
English: The safety and efficacy of TYSABRI in children and adolescents up to 18 years have not been established.
Danish: TYSABRIs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: o Confirmation that TYSABRI should be permanently discontinued if PML is confirmed.
Danish: o Bekræftelse af, at TYSABRI bør seponeres permanent, hvis PML bliver bekræftet.
English: For those with a lower risk of PML, your doctor may repeat the test regularly to check if anything has changed if:
Danish: Ved lav risiko for at få PML kan din læge gentage blodprøven regelmæssigt for at undersøge, om noget har ændret sig, hvis:
English: Use of these medicinal products soon after the discontinuation of natalizumab may lead to an additive immunosuppressive effect.
Danish: Brugen af sådanne lægemidler kort tid efter afbrydelse af behandling med natalizumab kan føre til additive immunsupprimerende virkninger.
English: If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor is required to decide if a switch to TYSABRI is appropriate for you.
Danish: Hvis du er blevet behandlet med alemtuzumab, er det nødvendigt med en grundig vurdering og diskussion med lægen for at beslutte, om det er hensigtsmæssigt for dig at skifte til TYSABRI.
English: The mean ± SD steady-state clearance was 13.1 ± 5.0 ml/h, with a mean ± SD half-life of 16 ± 4 days.
Danish: Middelværdi ± SD steady state clearance var 13,1 ± 5,0 ml/t, med en middelværdi ± SD halveringstid på 16 ± 4 dage.
English: Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine).
Danish: Nogle patienter kan have været eksponeret for immunsupprimerende lægemidler (f.eks. mitoxantron, cyclophosphamid, azathioprin).
English: Alemtuzumab has profound prolonged immunosuppressive effects.
Danish: Alemtuzumab har en markant langvarig immunsuppressiv virkning.
English: − A copy of the treatment initiation form
Danish: − En kopi af formularen til behandlingsstart
English: • A description of PML, potential symptoms and management of PML
Danish: • En beskrivelse af PML, potentielle symptomer og behandling af PML
English: • If you are allergic to natalizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for natalizumab eller et af de øvrige indholdsstoffer i TYSABRI (angivet i punkt 6).
English: • You may not be able to use TYSABRI if you are currently receiving or have previously received medicines that affect your immune system
Danish: • Du vil muligvis ikke kunne bruge TYSABRI, hvis du i øjeblikket får eller tidligere har fået, lægemidler, der påvirker immunsystemet.
English: The efficacy of TYSABRI when administered with EID has not been established, and therefore the benefit/risk balance of EID is unknown (see section 4.4).
Danish: Virkningen af TYSABRI, når det administreres som EID, er ikke klarlagt, og derfor er benefit/risk-forholdet for EID ukendt (se pkt.
English: If you miss your dose of TYSABRI
Danish: Hvis du har glemt din dosis TYSABRI
English: • Reminder to show the card to patients and caregivers and provides a list of symptoms that may be associated with the development of PML
Danish: • Påmindelse om at vise kortet til patienter og omsorgsgivere og udlevere en liste over symptomer, som kan være relateret til udviklingen af PML
English: No data are available in MS patients regarding concomitant exposure with immunosuppressant medication.
Danish: Der er ingen tilgængelige data fra MS-patienter vedrørende samtidig eksponering med immunsupprimerende lægemidler.
English: For medicinal products such as interferon and glatiramer acetate, concomitant exposure of this duration was not associated with safety risks in clinical trials.
Danish: For lægemidler som interferon og glatirameracetat blev samtidig eksponering af denne varighed i kliniske studier ikke associeret med sikkerhedsrisici.
English: If further deterioration occurs during steroid taper and this is judged to be due to continuing or new inflammatory reactions a further course of higher dose steroids may be necessary.
Danish: Hvis der ses yderligere forværring under steroidnedtrapningen, og dette vurderes at skyldes fortsatte eller nye inflammatoriske reaktioner, kan det være nødvendigt med endnu en kur med højere doser steroider.
English: Tell your doctor immediately if you have, or think you have, any sort of infection (see side effects).
Danish: Fortæl det straks til lægen, hvis du har eller tror, du har, en infektion (se bivirkninger).
English: In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
Danish: Foruden denne indlægsseddel vil du modtage et patientinformationskort, der indeholder vigtig sikkerhedsinformation, som du skal kende, inden du får TYSABRI (udtales ty-SA-bri), og som du skal være opmærksom på under behandlingen med TYSABRI.
English: Although the inflammatory reaction following immune reconstitution may be a necessary step to remove JCV-infected cells, it may become necessary to treat the active immune reaction to prevent potential damage caused by IRIS (Talan 2009; Elston and Thacker 2009) and can be life-threatening and may therefore require management in an intensive care unit.
Danish: Selvom den inflammatoriske reaktion efter immunrekonstitution kan være et nødvendigt skridt for at fjerne JCV-inficerede celler, kan det blive nødvendigt at behandle den aktive immunreaktion for at forebygge potentiel skade som følge af IRIS (Talan 2009; Elston og Thacker 2009), og kan være livstruende og kan derfor kræve behandling på en intensivafdeling.
English: ARN has been observed in patients being administered TYSABRI and can be potentially blinding.
Danish: ARN er blevet observeret hos patienter, der har fået administreret TYSABRI, og kan evt. føre til blindhed.
English: You should discuss with your doctor if TYSABRI is the most suitable treatment for you before you start taking TYSABRI and when you have been taking TYSABRI for more than two years.
Danish: Du bør drøfte med din læge, om behandling med TYSABRI er den mest hensigtsmæssige behandling for dig, inden du starter med at få TYSABRI, og hvis du har fået TYSABRI i mere end to år.
English: The treatment reported in these cases included anti-viral therapy and in some cases, surgery (see section 4.4).
Danish: Behandlingen omfattede antiviral behandling og i nogle tilfælde kirurgi (se pkt.
English: The effect of plasma exchange on natalizumab clearance and pharmacodynamics was evaluated in a study of 12 MS patients.
Danish: Virkningen af plasmaferese på natalizumabs clearance og farmakodynamik er evalueret i et studie med 12 MS-patienter.
English: Hypersensitivity reactions have been associated with TYSABRI, including serious systemic reactions (see section 4.8).
Danish: Overfølsomhedsreaktioner er blevet associeret med TYSABRI, herunder alvorlige systemiske reaktioner (se pkt.
English: Patients presenting with eye symptoms such as decreased visual acuity, redness and painful eye should be referred for retinal screening for ARN.
Danish: Patienter med øjensymptomer, såsom nedsat synsskarphed, røde eller smertende øjne, bør henvises til retinal screening for ARN.