FrancophonIA/ELRC3.0 huggingface dataset:
English: The treatment initiation form should contain the following elements:
Danish: Formularen til behandlingsstart skal indeholde følgende:
English: PML is a rare infection of the brain.
Danish: PML er en sjælden infektionssygdom i hjernen.
English: • If you have previously taken a medicine called an immunosuppressant.
Danish: • Hvis De tidligere er blevet behandlet med et lægemiddel, der kaldes et immunsuppressivt lægemiddel.
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 De måske bemærke symptomerne pludseligt inden for nogle få timer, eller De vil opleve, at symptomerne udvikler sig langsomt over flere dage.
English: TYSABRI is not recommended for use in patients aged over 65 due to a lack of data in this population.
Danish: TYSABRI anbefales ikke til brug hos patienter over 65 år på grund af mangel på data i denne alderspopulation.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene til fremsendelse af periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel er angivet på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og eventuelle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Signs of a possible liver problem:
Danish: Tegn på mulige leverproblemer:
English: • Yellowing of your skin or the whites of your eyes
Danish: • Gulfarvning af huden eller det hvide i øjnene
English: IRIS may lead to your condition getting worse, including worsening of brain function.
Danish: IRIS kan medføre, at Deres tilstand bliver værre, herunder at Deres hjernefunktion forringes.
English: Of these, 581 patients received a fixed 300 mg dose as monotherapy.
Danish: Af disse fik 581 patienter en fastsat 300 mg dosis som monoterapi.
English: In other clinical trials, cases of additional opportunistic infections have been reported, some of which were fatal.
Danish: I andre kliniske forsøg er der indberettet tilfælde af yderligere opportunistiske infektioner, hvoraf nogle var dødelige.
English: Continuous dosing with TYSABRI is important, especially during the first few months of treatment.
Danish: Uafbrudt behandling med TYSABRI er vigtig, især de første par måneder af behandlingen.
English: RESULTS Annual relapse rate After one year (primary endpoint) After two years One year
Danish: RESULTATER Årlig attakhyppighed Efter ét år (primært endepunkt) Efter to år Ét år
English: After 2 years continued therapy should be considered only following a reassessment of the potential for benefit and risk.
Danish: Efter 2 år bør fortsat behandling kun ske efter en revurdering af mulige fordele og risici.
English: Monotherapy; randomised double-blind placebo-controlled parallel-group trial for 120 weeks
Danish: Monoterapi; randomiseret dobbeltblindet placebokontrolleret parallelgruppe forsøg over 120 uger
English: Proportion progressed1(24-week confirmation)
Danish: Andel med progression 1(24ugers bekræftelse)
English: A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.
Danish: En ”nonresponder” kan også defineres som en patient med uændret eller øget attakhyppighed eller løbende svære attakker sammenlignet med det forudgående år.
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 Deres læge, hvis De er gravid, hvis De har formodning om, at De er gravid, eller hvis De planlægger at blive gravid.
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 hjælpere om deres behandling, da disse kan opdage symptomer, som patienten ikke selv er opmærksom på.
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Danish: Det er vigtigt, at De gemmer patientinformationskortet og viser det til deres partner eller hjælpere.
English: This active ingredient is called a monoclonal antibody.
Danish: Dette aktive stof kaldes et monoklonalt antistof.
English: However, observation over longer treatment periods is required before any effect of natalizumab on malignancies can be excluded.
Danish: Imidlertid kræves der observation over længere behandlingsperioder, inden effekten af natalizumab på udvikling af malignitet kan udelukkes.
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 De får TYSABRI, vil De muligvis ikke bemærke nogen forbedring; men TYSABRI kan alligevel virke ved at forebygge forværring i Deres MS.
English: TYSABRI is used to treat multiple sclerosis (MS).
Danish: TYSABRI anvendes til behandling af multipel sklerose (MS).
English: When the symptoms flare up, it is called a relapse (also known as an exacerbation or an attack).
Danish: Når symptomerne blusser op, kaldes det et attak (også kendt som en eksacerbation eller et relaps).
English: No information on the severity of the relapses before inclusion of patients in the study is available.
Danish: Der er ingen information tilgængelig vedrørende sværheden af patienternes attakker inden deres inklusion i studiet.
English: PML usually leads to severe disability or death (see section 4.4).
Danish: PML fører sædvanligvis til alvorligt funktionstab eller død (se sektion 4.4).
English: These antibodies are a sign that you have been infected by JC virus.
Danish: Disse antistoffer er tegn på, at De har haft en JC-virus-infektion.
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 sektion 4.8).
English: No effects on abortion rates were noted in any other study.
Danish: Der er ikke blevet observeret virkninger på abortraterne i noget andet forsøg.
English: • Speak with your partner or caregivers and inform them about your treatment.
Danish: • Fortæl Deres partner eller hjælpere om behandlingen.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: De ikke-kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet og genotoksicitet.
English: These studies showed no evidence of teratogenic effects or effects on growth of offspring.
Danish: Disse forsøg viste ingen tegn på teratogene virkninger eller virkninger på væksten af afkommet.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning hos patienter, der er på en kontrolleret natriumdiæt.
English: These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon or glatiramer acetate.
Danish: Disse patienter kan defineres som patienter, der ikke har responderet på et fuldstændigt og tilstrækkeligt behandlingsforløb (sædvanligvis behandling i mindst et år) med et beta-interferon eller glatirameracetat.
English: • Swelling of your face, lips or tongue
Danish: • Hævelse af ansigt, læber eller tunge
English: The Marketing Authorisation Holder must, following discussions and agreement with the National Competent Authorities in each Member State where TYSABRI is marketed, ensure that all physicians who intend to prescribe TYSABRI are provided with a physician pack containing the following elements:
Danish: Indehaveren af markedsføringstilladelsen skal efter drøftelser og aftale med de nationalt ansvarlige myndigheder i de medlemsstater, hvor TYSABRI markedsføres, sikre, at alle læger, der påtænker at ordinere TYSABRI, forsynes med en lægepakke, der indeholder følgende:
English: The MAH shall implement agreed measures for monitoring within a time frame agreed with the National Competent Authorities.
Danish: Indehaveren af markedsføringstilladelsen skal implementere de aftalte foranstaltninger vedrørende monitorering inden for en tidsramme, som er aftalt med de nationalt ansvarlige myndigheder.
English: MS causes inflammation in the brain that damages the nerve cells.
Danish: MS forårsager betændelse i hjernen, hvilket beskadiger nervecellerne.
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 De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De får dette lægemiddel.
English: A few patients have had an allergic reaction to TYSABRI.
Danish: Nogle få patienter har fået en allergisk reaktion mod TYSABRI.
English: It is considered unlikely that natalizumab will affect fertility performance in humans following the maximum recommended dose.
Danish: Det anses for usandsynligt, at natalizumab vil påvirke fertiliteten hos mennesker ved den anbefalede maksimumdosis.
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: 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 Deres læge gentage blodprøven regelmæssigt for at undersøge, om noget har ændret sig, hvis:
English: − An unexplained fever
Danish: − Feber af ukendt årsag
English: Infections, including PML and opportunistic infections
Danish: Infektioner, inklusive PML og opportunistiske infektioner
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 immunsuppressive virkninger.
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 immunsuppressive midler, så der gives tilstrækkelig tid til, at immunsystemets funktion genetableres.
English: Pack size of one vial per carton.
Danish: Pakkestørrelse ét hætteglas per karton.
English: • If you have been treated for more than 2 years and you have a lower level of JCV antibodies in your blood.
Danish: • De er blevet behandlet i mere end 2 år og har et lavt niveau af JCV-antistoffer i Deres blod.
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 immunsuppresive lægemidler.
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 Deres behandling, og ikke kun til Deres neurolog.
English: If PML or JCV GCN is suspected, further dosing must be suspended until PML has been excluded.
Danish: Hvis der er mistanke om PML eller JCV GCN, skal yderligere administration suspenderes, indtil PML er blevet udelukket.
English: However, the risk of hypersensitivity reactions should be considered for every infusion administered.
Danish: Risikoen for overfølsomhedsreaktioner bør imidlertid tages i betragtning, hver gang der gives infusion.
English: MRI (0-2 years) Median % change in T2hyperintense lesion volume
Danish: MR (0-2 år) Median % ændring i T2hyperintense læsioners volumen
English: These medicinal products have the potential to cause prolonged immunosuppression, even after dosing is discontinued.
Danish: Disse lægemidler kan potentielt forårsage langvarig immunsuppression, selv efter at behandlingen er afbrudt.
English: MRI screening for PML
Danish: MR-screening for PML
English: The risk of PML with TYSABRI is higher:
Danish: Risikoen for PML i forbindelse med brug af TYSABRI er større:
English: The physician information about TYSABRI shall contain the following key elements:
Danish: Informationen til lægen om TYSABRI skal indeholde følgende hovedelementer:
English: All changes in haematological variables returned to pre-treatment values, usually within 16 weeks of last dose of the medicinal product and the changes were not associated with clinical symptoms.
Danish: Alle ændringer i hæmatologiske parametre vendte sædvanligvis tilbage til niveauerne før behandlingen inden for 16 uger efter den sidste indgivelse af lægemidlet, og ændringerne var ikke associerede med kliniske symptomer.
English: Anti-JCV antibody testing should not be performed during, or for at least two weeks following, plasma exchange due to the removal of antibodies from the serum.
Danish: Anti-JCVantistoftestning bør ikke udføres under eller mindre end to uger efter plasmaudskiftning på grund af fjernelse af antistoffer fra serum.
English: Physicians should counsel patients on the importance of uninterrupted dosing, particularly in the early months of treatment (see hypersensitivity).
Danish: Lægerne bør informere patienterne om vigtigheden af, at behandlingen ikke afbrydes, især i de første måneder af behandlingen (se Overfølsomhed).
English: Do not use if it is discoloured or if foreign particles are seen.
Danish: Produktet må ikke anvendes, hvis det er misfarvet, eller hvis der observeres fremmede partikler.
English: • Patient details, signature and date
Danish: • Patientoplysninger, underskrift og dato
English: Anaphylactic/anaphylactoid reactions occurred in less than 1% of patients receiving TYSABRI.
Danish: Anafylaktiske/anafylaktoide reaktioner forekom hos mindre end 1 % af de patienter, der fik TYSABRI.
English: Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine).
Danish: Nogle patienter kan have været eksponeret for immunsuppressive lægemidler (f.eks. mitoxantron, cyclophosphamid, azathioprin).
English: Two years
Danish: To år
English: Patients are to be observed during the infusion and for 1 hour after the completion of the infusion (see section 4.8).
Danish: Patienterne skal observeres under infusionen og i 1 time efter at infusionen er tilendebragt (se sektion 4.8).
English: • Treatment duration, especially beyond 2 years.
Danish: • Behandlingens varighed, især hvis behandlingen varer mere end 2 år.
English: PML is associated with an uncontrolled increase of the JC virus in the brain, although the reason for this increase in some patients treated with TYSABRI is unknown.
Danish: PML er forbundet med en ukontrolleret forøgelse af JC-virus i hjernen, selv om grunden til denne forøgelse hos nogle patienter, der behandles med TYSABRI, er ukendt.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført iAppendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: These reactions usually occurred during the infusion or up to 1 hour after completion of the infusion.
Danish: Disse reaktioner optrådte sædvanligvis under infusionen eller op til 1 time efter, at infusionen var tilendebragt.
English: Diluted solution: After dilution, immediate use is recommended.
Danish: Efter fortynding anbefales omgående anvendelse.
English: Colourless, clear to slightly opalescent solution.
Danish: Farveløs, klar til let opaliserende opløsning.
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, e.g. mitoxantrone or cyclophosphamide).
Danish: • Hvis Deres læge fortæller Dem, at De har et alvorligt problem med Deres immunsystem (for eksempel på grund af en sygdom såsom HIV, eller på grund af et lægemiddel, De tager eller tidligere har taget, f.eks. mitoxantron eller cyclophosphamid).
English: Starting other therapies during this interval will result in a concomitant exposure to natalizumab.
Danish: Påbegyndelse af andre behandlinger i dette tidsinterval vil resultere i en samtidig eksponering for natalizumab.
English: If herpes encephalitis or meningitis occurs, the medicinal product should be discontinued, and appropriate treatment for herpes encephalitis or meningitis should be administered.
Danish: Hvis herpes encephalitis eller meningitis opstår, skal lægemidlet seponeres og passende behandling for herpes encephalitis eller meningitis administreres.
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 forsøg ikke associeret med sikkerhedsrisici.
English: In MS, lesions are believed to occur when activated T-lymphocytes cross the blood-brain barrier (BBB).
Danish: I MS menes det, at læsioner opstår, når aktiverede T-lymfocytter krydser blodhjernebarrieren (blood-brain barrier - BBB).
English: Following the repeat intravenous administration of a 300 mg dose of natalizumab to MS patients, the mean maximum observed serum concentration was 110 ± 52 μg/ml.
Danish: Efter gentagen intravenøs administration af en 300 mg dosis natalizumab til MS-patienter var den observerede middelværdi for den maksimale serumkoncentration 110 ± 52 μg/ml.
English: Therefore, it is recommended that newborns of women exposed to the medicinal product during the third trimester of pregnancy are monitored for potential haematological abnormalities.
Danish: Det anbefales derfor, at børn af kvinder behandlet med lægemidlet i tredje trimester observeres for potentielle hæmatologiske abnormiteter.
English: Patients and physicians should continue to follow the same monitoring protocol and be alert for any new signs or symptoms that may be suggestive of PML for approximately 6 months following discontinuation of TYSABRI.
Danish: Patienter og læger skal fortsætte med at følge den samme monitoreringsprotokol og være opmærksomme på eventuelle nye tegn eller symptomer, der kan tyde på PML, i cirka 6 måneder efter seponering af TYSABRI.
English: These symptoms may be caused by an infection of the brain (encephalitis) or its covering layer (meningitis).
Danish: Disse symptomer kan være forårsaget af en infektion i hjernen (encephalitis) eller i hjernehinden (meningitis).
English: The impact of plasma exchange on the restitution of lymphocyte migration and ultimately its clinical usefulness is unknown.
Danish: Betydningen af plasmaferese på genetablering af lymfocytmigration og dermed dens kliniske anvendelighed er ukendt.
English: PML and IRIS (Immune Reconstitution Inflammatory Syndrome)
Danish: PML og immunrekonstitutionssyndrom (Immune Reconstitution Inflammatory Syndrome, IRIS)
English: • The symptoms of PML may be similar to an MS relapse (e.g. weakness or visual changes).
Danish: • Symptomerne på PML kan ligne et MS-attak (f.eks. svækkelse eller synsændringer).
English: In a few patients who use TYSABRI, over time the body's natural defence may stop TYSABRI from working properly (the body develops antibodies to TYSABRI).
Danish: Hos nogle få patienter, som anvender TYSABRI, vil kroppens naturlige forsvar i løbet af nogen tid forhindre TYSABRI i at virke efter hensigten (kroppen udvikler antistoffer mod TYSABRI).
English: All changes were observed at doses in excess of the human dose and were reversed upon clearance of natalizumab.
Danish: Alle ændringer blev observeret ved doser, der overskred den humane dosis, og var reversible efter clearance af natalizumab.
English: • Adult patients aged 18 years and over with high disease activity despite treatment with a betainterferon or glatiramer acetate.
Danish: • Voksne patienter i alderen 18 år og derover med høj sygdomsaktivitet trods behandling med et beta-interferon eller glatirameracetat.
English: TYSABRI contains the active substance (natalizumab).
Danish: TYSABRI indeholder det aktive stof (natalizumab).
English: If there are signs of treatment-related abnormalities these must return to normal before treatment with natalizumab is started.
Danish: Hvis der er behandlings-relaterede abnorme fund, skal disse normaliseres, inden behandling med natalizumab påbegyndes.
English: TYSABRI will be given to you by a doctor experienced in the treatment of MS.
Danish: De vil få TYSABRI af en læge, der har erfaring i behandling af MS.
English: Do not use this medicine if you notice particles in the liquid and/or the liquid in the vial is discoloured.
Danish: Brug ikke dette lægemiddel, hvis De ser partikler i væsken, og/eller hvis væsken i hætteglasset er misfarvet.
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 De modtage et patientinformationskort, der indeholder vigtig sikkerhedsinformation, som De skal kende, inden De får TYSABRI (udtales ty-SA-bri), og som De skal være opmærksom på under behandlingen med TYSABRI.
English: Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, doubleblind studies.
Danish: Data vedrørende sikkerheden og effekten efter 2 års behandling med natalizumab er genereret fra kontrollerede, dobbeltblindede studier.
English: This should be carefully considered on a case-by-case basis, and a wash-out period of natalizumab might be appropriate.
Danish: Dette bør overvejes nøje på individuel basis, sammen med hensigtsmæssigheden af en udvaskningsperiode af natalizumab.
English: Persistent antibodies were associated with a substantial decrease in the effectiveness of TYSABRI and an increased incidence of hypersensitivity reactions.
Danish: Persisterende antistoffer var associeret med en væsentlig nedsættelse af effekten af TYSABRI og en øget forekomst af overfølsomhedsreaktioner.
English: Re-testing of anti-JCV antibody negative patients every 6 months is recommended.
Danish: Det anbefales at teste anti-JCV-antistof-negative patienter hver 6. måned.
English: The mechanism for elimination and results from population pharmacokinetics suggest that dose adjustment would not be necessary in patients with renal or hepatic impairment.
Danish: Eliminationsmekanismen og resultater fra populations-farmakokinetiske undersøgelser tyder på, at dosisjustering ikke vil være nødvendig hos patienter med nyre- eller leverinsufficiens.
English: The patients were randomised with a 2:1 ratio to receive TYSABRI 300 mg (n = 627) or placebo (n = 315) every 4 weeks for up to 30 infusions.
Danish: Patienterne blev randomiseret i forholdet 2:1 til at modtage TYSABRI 300 mg (n = 627) eller placebo (n = 315) hver 4. uge med op til 30 infusioner.
English: The safety and efficacy of TYSABRI in combination with other immunosuppressive and antineoplastic therapies have not been fully established.
Danish: Sikkerheden og effekten af TYSABRI i kombination med andre immunosuppressive og antineoplas-tiske behandlinger er ikke blevet udførligt undersøgt.