FrancophonIA/ELRC3.0 huggingface dataset:
English: • Present the results of the TOUCH analysis which showed clinically and statistically significant reduction in PML risk in patients who are treated with EID (dosing interval 6 weeks) compared to Standard interval dosing (dosing interval 4 weeks).
Danish: • Fremlægge resultaterne af TOUCH-analysen, som viste klinisk og statistisk signifikant reduktion af PML-risikoen hos patienter, der bliver behandlet med EID (doseringsinterval på 6 uger), sammenlignet med dosering med standardintervallet (doseringsinterval på 4 uger).
English: The active substance is natalizumab.
Danish: Aktivt stof: natalizumab.
English: JC virus also causes JCV granule cell neuronopathy (GCN) which has been reported in patients treated with TYSABRI.
Danish: JC-virus forårsager også JCV-granularcelle-neuronopati (GCN), som er blevet indberettet hos patienter behandlet med TYSABRI.
English: • That the aim of the treatment initiation form is to provide patients with information on PML
Danish: • At formålet med formularen til behandlingsstart er at give patienterne information om PML og IRIS
English: TYSABRI is contraindicated in combination with other DMTs (see section 4.3).
Danish: TYSABRI er kontraindiceret i kombination med andre DMT'er (se pkt.
English: Acute retinal necrosis (ARN) is a rare fulminant viral infection of the retina caused by the family of herpes viruses (e.g. varicella zoster).
Danish: Akut retinal nekrose (ARN) er en sjælden fulminant viral infektion af retina forårsaget af herpes-virus (f.eks. varicella zoster).
English: Patients with a treatment history of immunosuppressant medications are at increased risk for PML.
Danish: Patienter med tidligere behandling med immunsupprimerende lægemidler har en øget risiko for PML.
English: • If you have antibodies to the JC virus in your blood.
Danish: • Hvis du har antistoffer til JC virus i blodet.
English: Patients should be re-informed about the risk factors for PML, like duration of treatment, immunosuppressant use prior to receiving TYSABRI and the presence of antiJohn Cunningham virus (JCV) antibodies (see section 4.4.
Danish: Patienterne bør igen informeres om risikofaktorerne for PML som behandlingsvarighed, brug af immunsupprimerende lægemidler inden behandlingen med TYSABRI samt tilstedeværelse af anti-John Cunningham-virus-antistof (JCV) (se pkt.
English: This should be considered if you are on a controlled sodium diet.
Danish: Dette skal tages i betragtning, hvis du er på en natriumfattig diæt.
English: In 2-year controlled clinical trials in MS patients TYSABRI treatment was associated with increases in circulating lymphocytes, monocytes, eosinophils, basophils and nucleated red blood cells.
Danish: Ved kontrollerede kliniske studier over 2 år blev TYSABRI-behandling associeret med stigning i cirkulerende lymfocytter, monocytter, eosinofile granulocytter, basofile granulocytter og kerneholdige røde blodlegemer.
English: Clinical neurologic deterioration in patients with PML and/or JCV GCN may be caused by JCVmediated destruction of CNS tissue, or upon restoration of immune function, by an intracerebral immune inflammatory reaction known as immune reconstitution inflammatory syndrome (IRIS).
Danish: Klinisk neurologisk forværring hos patienter med PML og/eller JCV GCN kan skyldes JCV-medieret nedbrydning af CNS-væv eller, ved genetablering af immunfunktionen, en intracerebral immuninflammatorisk reaktion kaldet immunrekonstitutionssyndrom (IRIS).
English: PML usually leads to severe disability or death (see section 4.4).
Danish: PML fører sædvanligvis til alvorligt funktionstab eller død (se pkt.
English: Consistent with the pharmacological activity of natalizumab, altered trafficking of lymphocytes was seen as white blood cell increases as well as increased spleen weights in most in vivo studies.
Danish: I overensstemmelse med den farmakologiske aktivitet af natalizumab viste ændringer i transporten af lymfocytter sig som en stigning i antallet af hvide blodlegemer såvel som en forøget miltvægt i de fleste in vivo studier.
English: • Reminder to read the package leaflet carefully before starting Tysabri
Danish: • Påmindelse om at læse indlægssedlen grundigt inden opstart af TYSABRI
English: Currently available evidence suggests that the risk of PML is low at an index equal to or below 0.9 and increases substantially above 1.5 for patients who have been on treatment with TYSABRI for longer than 2 years.
Danish: Aktuel tilgængelig viden tyder på, at risikoen for PML er lav ved en indeksværdi, der er lig med eller under 0,9, og stiger betydeligt ved værdier over 1,5 hos patienter, som har været i behandling med TYSABRI i mere end 2 år.
English: • You must not use TYSABRI if you are being treated with other medicines to treat your MS disease
Danish: • Du må ikke bruge TYSABRI, hvis du er i behandling med andre lægemidler til behandling af MS.
English: concentrate for solution for infusion 1 x 15 ml vial
Danish: Koncentrat til infusionsvæske, opløsning 1 x 15 ml hætteglas
English: Following clinical diagnosis of ARN, discontinuation of TYSBABRI should be considered in these patients.
Danish: Efter en klinisk diagnose af ARN bør det overvejes at seponere TYSABRI hos disse patienter.
English: Irrespective of the presence or absence of PML risk factors, heightened clinical vigilance for PML should be maintained in all patients treated with TYSABRI and for 6 months following discontinuation of therapy.
Danish: Uanset om patienten har risikofaktorer for PML eller ej, bør der udvises øget klinisk overvågning for PML hos alle patienter i behandling med TYSABRI og i 6 måneder efter seponering af behandlingen.
English: Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%).
Danish: I løbet af studiernes 2 års varighed rapporterede 43,5 % af de patienter, der blev behandlet med natalizumab, bivirkninger (placebo: 39,6 %).
English: No studies have been performed to evaluate the efficacy and safety of TYSABRI when switching patients from DMTs with an immunosuppressant effect.
Danish: Der er ikke udført studier for at evaluere TYSABRIs virkning og sikkerhed i forbindelse med skift fra en sygdomsmodificerende behandling (DMT) med immunsuppressiv virkning.
English: • If you do not have antibodies to the JC virus in your blood OR
Danish: • du ikke har antistoffer mod JC-virusset i dit blod, ELLER
English: For further information, refer to the Physician Information and Management Guidelines.
Danish: For yderligere oplysninger henvises der til Information til lægen og Retningslinjer for behandling.
English: Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies (see sections 4.4 and 4.8).
Danish: Patienter med øget risiko for opportunistiske infektioner, herunder immunkompromitterede patienter (inklusive patienter, der aktuelt får immunsuppressiv behandling, eller patienter, som er immunkompromitterede pga. tidligere behandling) (se pkt.
English: Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a murine cell line by recombinant DNA technology.
Danish: Natalizumab er et rekombinant humaniseret anti-α4-integrin-antistof, produceret i en murin cellelinje ved rekombinant DNA-teknologi.
English: Keep the leaflet and Alert Card with you during treatment and for six months after the last dose of TYSABRI, since side effects may occur even after you have stopped treatment.
Danish: Det er vigtigt, at du har indlægssedlen og patientinformationskortet på dig under behandlingsforløbet og i 6 måneder efter den sidste dosis TYSABRI, da bivirkninger kan forekomme selv efter, at du er ophørt med behandlingen.
English: After 2 years of treatment, patients should be reinformed about the risks of TYSABRI, especially the increased risk of Progressive Multifocal Leukoencephalopathy (PML), and should be instructed together with their caregivers on early signs and symptoms of PML.
Danish: Efter 2 års behandling skal patienterne igen informeres om risici ved behandling med TYSABRI, især den forøgede risiko for at udvikle progressiv multifokal leukoencefalopati (PML), og patienterne og deres omsorgsgivere skal informeres om tidlige tegn og symptomer på PML.
English: When switching from dimethyl fumarate, the washout period should be sufficient for lymphocyte count to recover before treatment with TYSABRI is started.
Danish: Når der skiftes fra dimethylfumarat, skal udvaskningsperioden være tilstrækkelig lang til, at lymfocyttallet er normaliseret, før behandlingen med TYSABRI startes.
English: Insert the syringe needle into the vial through the centre of the rubber stopper and remove 15 ml concentrate for solution for infusion.
Danish: Stik sprøjtenålen ind i hætteglasset gennem midten af gummiproppen, og udtræk 15 ml koncentrat til infusionsvæske, opløsning.
English: In Phase 3 MS clinical trials, concomitant treatment of relapses with a short course of corticosteroids was not associated with an increased rate of infection.
Danish: I kliniske fase III-studier med MS-patienter var samtidig behandling af attakker med kortvarig kortikosteroid ikke associeret med øget hyppighed af infektioner.
English: In a pre-specified, retrospective analysis of US anti-JCV antibody positive TYSABRI patients (TOUCH registry), the risk of PML was compared between patients treated with the approved dosing interval and patients treated with extended interval dosing as identified in the last 18 months of exposure (EID, average dosing intervals of approximately 6 weeks).
Danish: I en forudspecificeret, retrospektiv analyse af amerikanske anti-JCV-antistof-positive TYSABRIpatienter (TOUCH-register) blev risikoen for PML sammenlignet mellem patienter, der fik behandling med det godkendte doseringsinterval, og patienter, der fik behandling med forlænget doseringsinterval som identificeret i de sidste 18 måneders eksponering (extended interval dosing (EID), gennemsnitlige doseringsintervaller på cirka 6 uger).
English: The highest incidence of adverse reactions identified from placebo-controlled trials in multiple sclerosis patients with natalizumab given at the recommended dose, are reported as dizziness, nausea, urticaria and rigors associated with infusions.
Danish: De hyppigst indberettede bivirkninger, identificeret i placebokontrollerede studier hos patienter med multipel sklerose, hvor natalizumab blev givet ved den anbefalede dosis, er svimmelhed, kvalme, urticaria og rigor associeret med infusioner.
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 pkt.
English: In postmarketing experience, rare cases of ARN have been observed in patients receiving TYSABRI.
Danish: Efter markedsføring er der blevet observeret sjældne tilfælde af ARN hos patienter, der har fået TYSABRI.
English: A case of cryptosporidium diarrhoea was reported in MS clinical trials.
Danish: Et tilfælde af cryptosporidium-diaré blev indberettet i kliniske studier med MS-patienter.
English: Interim analysis of results (as of May 2015) from the ongoing TYSABRI Observational Program (TOP), a phase 4, multicentre, single-arm study (n=5770) demonstrated that patients switching from beta interferon (n= 3255) or glatiramer acetate (n= 1384) to TYSABRI showed a sustained, significant decrease in annualised relapse rate (p< 0.0001).
Danish: Interimanalyse af resultaterne (maj 2015) fra det igangværende TYSABRI-observationsprogram (TOP), et fase IV-multicenterstudie med en enkelt arm (n = 5.770) viste, at patienter, der skiftede fra beta-interferon (n = 3.255) eller glatirameracetat (GA) (n = 1.384) til TYSABRI havde en vedvarende, signifikant reduktion i den årlige attakhyppighed (p< 0,0001).
English: In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo: 1,135), adverse events leading to discontinuation of therapy occurred in 5.8% of patients treated with natalizumab (placebo: 4.8%).
Danish: I placebo-kontrollerede studiermed 1.617 MS-patienter, der blev behandlet med natalizumab i op til 2 år (placebo: 1.135), forekom der hos 5,8 % af de natalizumab-behandlede patienter (placebo: 4,8 %) bivirkninger, der førte til afbrydelse af behandlingen.
English: Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μg/ml to 29 μg/ml.
Danish: Gennemsnitlig middelværdi for steady state minimumskoncentrationer af natalizumab over behandlingsperioden lå mellem 23 μg/ml og 29 μg/ml.
English: sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
Danish: Natriumdihydrogenphosphatmonohydrat; dinatriumphosphatheptahydrat; natriumchlorid; polysorbat 80 (E433); og vand til injektionsvæsker.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1)
Danish: • Patienter med højaktiv sygdom trods et fuldstændigt og tilstrækkeligt behandlingsforløb med mindst en sygdomsmodificerende behandling (disease modifying therapy, DMT) (se pkt.
English: Consistent with efficacy results observed for patients switching from beta interferon or glatiramer acetate to TYSABRI, for patients switching from fingolimod (n=147) to TYSABRI, a significant decrease in annualised relapse rate (ARR) was observed, which remained stable over 2 years, and mean EDSS scores remained similar from baseline to Year 2.
Danish: I overensstemmelse med virkningsresultater observeret for patienter, der skiftede fra beta-interferon eller GA til TYSABRI, blev der for patienter, der skiftede fra fingolimod (n = 147) til TYSABRI, observeret en signifikant reduktion i årlig attakhyppighed (ARR), som var stabil over en periode på 2 år, og de gennemsnitlige EDSS-scorer var sammenlignelige fra baseline til år 2.
English: In one study in guinea pigs, a small reduction in pup survival was noted.
Danish: I ét studie med marsvin blev der observeret en lille reduktion i overlevelsesraten hos afkommet.
English: 2) Intravenous methylprednisolone (1 g/d for 3 or 5 d) with oral taper over 2 months
Danish: 1) Oral prednison 1,5 mg/kg/dag × 2 uger med nedtrapning over 2 måneder 2) Intravenøs methylprednisolon (1 g/dag i 3 eller 5 dage) med oral nedtrapning over 2 måneder
English: Patient alert card
Danish: Patientinformationskort
English: The pharmacokinetics of natalizumab in paediatric MS patients has not been established.
Danish: Natalizumabs farmakokinetiker ikke klarlagt hos pædiatriske MS-patienter.
English: Initiating treatment with TYSABRI after alemtuzumab is generally not recommended.
Danish: Behandling med TYSABRI bør normalt ikke påbegyndes efter alemtuzumab.
English: Your doctor may switch you directly from another medicine for MS to TYSABRI if there are no signs of abnormalities caused by your previous treatment.
Danish: Du vil få TYSABRI af en læge, der har erfaring i behandling af MS. Din læge kan skifte dig direkte fra et andet lægemiddel for MS til TYSABRI, hvis der ikke er tegn på abnormaliteter forårsaget af din tidligere behandling.
English: The pharmacokinetics of natalizumab in patients with renal or hepatic insufficiency has not been studied.
Danish: Natalizumabs farmakokinetik er ikke blevet undersøgt hos patienter med nyre- eller leverinsufficiens.
English: Efficacy has been modelled for patients who switch to longer dosing after ≥1 year of approved TYSABRI dosing and who did not experience a relapse in the year prior to switching.
Danish: Virkningen hos patienter, der skifter til længere doseringintervaller efter ≥1 års behandling med den godkendte dosering af TYSABRI, og som ikke oplever recidiv i året op til skiftet, er modelleret.
English: Your doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
Danish: Din læge vil overvåge dig under infusionen og i en time herefter for at kontrollere, om der opstår allergiske reaktioner.
English: • Present data from PK/PD/efficacy modelling from the RESTORE study which indicates that risk of return of MS disease activity more likely with increased body weight (>80kg) or longer dosing intervals (>7 weeks).
Danish: • Fremlægge data fra farmakokinetisk/farmakodynamisk/virkningsrelateret modellering fra RESTORE-studiet, som tyder på, at risikoen for tilbagevenden af MS-sygdomsaktivitet er mere sandsynlig ved høj legemsvægt (>80 kg) eller længere doseringsintervaller (>7 uger).
English: For storage conditions after dilution of the medicinal product see section 6.3.
Danish: Opbevaringsforhold efter fortynding af lægemidlet, se pkt.
English: Each ml of concentrate contains 20 mg of natalizumab.
Danish: Hver ml koncentrat indeholder 20 mg natalizumab.
English: Reductions in female guinea pig fertility were observed in one study at doses in excess of the human dose; natalizumab did not affect male fertility.
Danish: Nedsat fertilitet blev observeret i ét studie med marsvinehunner ved doser, der overskred dosis hos mennesker; natalizumab påvirkede ikke fertiliteten hos hanner.
English: In clinical trials, TYSABRI approximately halved the progression of the disabling effects of MS and also decreased the number of MS attacks by about two-thirds.
Danish: I kliniske studier har TYSABRI cirka halveret udviklingen af invaliderende virkninger, som var forårsaget af MS.
English: Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on TYSABRI treatment or for up to 6 months after stopping TYSABRI treatment, it is very important that you speak to your doctor as soon as possible.
Danish: Derfor er det meget vigtigt, at du taler med din læge så hurtigt som muligt, hvis du tror, at din MS bliver værre, eller hvis du bemærker nye symptomer, mens du er i behandling med TYSABRI eller i op til 6 måneder efter behandlingen med TYSABRI er stoppet.
English: Short courses of steroids used to treat relapses were not associated with increased infections in clinical trials.
Danish: Kortvarig steroidbehandling af attakker blev i kliniske studier ikke associeret med en øget forekomst af infektioner.
English: Concurrent treatment with immunosuppressants
Danish: Samtidig behandling med immunsuppressiva
English: • Visually inspect the diluted medicinal product for particles or discolouration prior to administration.
Danish: • Undersøg det fortyndede lægemiddel visuelt for partikler eller misfarvning inden administrationen.
English: Contents of the pack and other information What TYSABRI contains
Danish: Pakningsstørrelser og yderligere oplysninger TYSABRI indeholder:
English: The washout period should be sufficient for lymphocyte count to recover before treatment with TYSABRI is started.
Danish: Udvaskningsperioden skal være tilstrækkelig lang til, at lymfocyttallet er normaliseret, før behandlingen med TYSABRI startes.
English: Symptoms might arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML.
Danish: Der kan opstå symptomer, som du måske ikke selv bliver opmærksom på som for eksempel ændringer i humør eller opførsel, hukommelsessvigt, besvær med at tale eller kommunikere.
English: In anti-JCV antibody positive patients, extended interval dosing of TYSABRI (average dosing interval of approximately 6 weeks) is suggested to be associated with a lower PML risk compared to approved dosing.
Danish: Hos anti-JCV-antistof-positive patienter tyder det på, at dosering af TYSABRI med forlænget interval (gennemsnitligt doseringsinterval på cirka 6 uger) er forbundet med en lavere PML-risiko sammenlignet med godkendt dosering.
English: In post marketing experience, serious, life-threatening, and sometimes fatal cases of encephalitis and meningitis caused by herpes simplex or varicella zoster have been reported in multiple sclerosis patients receiving TYSABRI.
Danish: Alvorlige, livstruende og til tider dødelige tilfælde af encephalitis og meningitis forårsaget af herpes-simplexeller varicella-zoster virus er efter markedsføring blevet rapporteret hos patienter med multipel sklerose i behandling med TYSABRI.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om TYSABRI på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: What you need to know before you use TYSABRI
Danish: Det skal du vide, før du begynder at bruge TYSABRI
English: Suspension of TYSABRI therapy, for short duration (days or weeks), is not expected to compromise therapeutic efficacy based on the pharmacodynamics of the drug.
Danish: Med udgangspunkt i lægemidlets farmakodynamik forventes kortvarig afbrydelse (dage eller uger) af behandlingen med TYSABRI ikke at kompromittere den terapeutiske virkning.
English: TYSABRI 300 mg concentrate for solution for infusion
Danish: TYSABRI 300 mg koncentrat til infusionsvæske, opløsning
English: • Do not breast-feed whilst using TYSABRI.
Danish: • Du må ikke amme, mens du får TYSABRI.
English: • Immunosuppressant use prior to receiving TYSABRI.
Danish: • Brugen af immunsupprimerende lægemidler inden behandling med TYSABRI.
English: In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML (i.e. the risk is greater in those with a high antibody index compared to those with a low index).
Danish: Hos anti-JCV-antistof-positive patienter i behandling med TYSABRI, som ikke tidligere er blevet behandlet med immunsupprimerende lægemidler, er niveauet af anti-JCV-antistofrespons (indeks) forbundet med risikoniveauet for PML (dvs. risikoen er større hos patienter med et højt antistof-indeks end hos patienter med et lavt indeks).
English: o A stratification of the risk of developing PML based on the identified risk factors and presentation of the PML risk in a given time interval of treatment as well as the cumulative PML risk o PML risk estimates algorithm summarizes PML risk by anti- John Cunningham virus (JCV) antibody status, prior IS use and duration of treatment (by year of treatment) and stratifies this risk by index value when applicable.
Danish: o At risikoen for PML øges ved forlænget behandlingsvarighed, og at behandling ud over 24 måneder medfører en yderligere risiko og andre faktorer associeret med en øget risiko for at udvikle PML Tilstedeværelse af anti-JC-virus-antistoffer Niveau af antistof-respons (indeks) for patienter, som ikke tidligere er blevet behandlet med immunsupprimerende lægemidler Immunsuppressiv behandling inden behandling med TYSABRI o Stratificering i forhold til risikoen for at udvikle PML baseret på de identificerede risikofaktorer og risikoen for udvikling af PML inden for et givet behandlingsinterval samt den kumulative risiko for udvikling af PML o PML-risikoestimeringsalgoritmen opsummerer PML-risikoen efter anti-John Cunningham-virus (JCV)-antistof-status, tidligere brug af immunsupprimerende lægemidler og behandlingsvarighed (efter behandlingsår) og stratificerer denne risiko efter indeksværdi, hvis relevant.
English: Breast-feeding should be discontinued during treatment with TYSABRI.
Danish: Amning skal ophøre under behandling med TYSABRI.
English: Proportion progressed1(24-week confirmation)
Danish: AFFIRM studiet: Overordnede rammer og resultater Andel med progression 1(24ugers bekræftelse)
English: • Details of the patient, treating doctor and date Tysabri was started
Danish: • En påmindelse om hvor bivirkninger indberettes • Patientoplysninger, behandlende læge og dato for opstart af TYSABRI
English: Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ml).
Danish: Hvert 15 ml hætteglas med koncentrat indeholder 300 mg natalizumab (20 mg/ml).