natgillin/translations-raw huggingface dataset:
Patienter, som er anti-JCV-antistof-positive, har en øget risiko for at udvikle PML sammenlignet med patienter, som er anti-JCV antistof-negative. 
Patients who are anti-JCV antibody positive are at an increased risk of developing PML compared to patients who are anti-JCV antibody negative.
En yderligere virkningsmekanisme af natalizumab kan være at undertrykke igangværende inflammatoriske reaktioner i de syge væv ved at hæmme interaktionen af α4-udtrykkende leukocytter med deres respektive ligander i den ekstracellulære matrix og på parenkymceller. 
A further mechanism of action of natalizumab may be to suppress ongoing inflammatory reactions in diseased tissues by inhibiting the interaction of α4-expressing leukocytes with their ligands in the extracellular matrix and on parenchymal cells.
Under behandling med TYSABRI blev der observeret mindre reduktioner i hæmoglobinniveauet (gennemsnitlig reduktion 0,6 g/dl), hæmatokrit (gennemsnitlig reduktion 2 %) og antallet af røde blodlegemer (gennemsnitlig reduktion 0,1 x 106/l). 
During treatment with TYSABRI, small reductions in haemoglobin (mean decrease 0.6 g/dl), haematocrit (mean decrease 2%) and red blood cell counts (mean decrease 0.1 x 106/l) were seen.
• Hvert enkelt hætteglas er til engangsbrug. 
• Each vial is for single-use only.
Det fortyndede lægemiddel skal anvendes så hurtigt som muligt og inden for 8 timer efter fortynding. 
The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution.
Det aktive stof er natalizumab. 
The active substance is natalizumab.
Læger skal evaluere hvert enkelt tilfælde for at fastslå, hvorvidt der er tegn på en immunkompromitteret tilstand, inden behandling med TYSABRI påbegyndes (se pkt. 
Physicians must evaluate each individual case to determine whether there is evidence of an immunocompromised state prior to commencing treatment with TYSABRI (see section 4.3).
• Dato for behandlingsstart 
• Date treatment started
Ved kontrollerede kliniske forsøg over 2 år blev TYSABRI-behandling associeret med stigning i cirkulerende lymfocytter, monocytter, eosinofile granulocytter, basofile granulocytter og kerneholdige røde blodlegemer. 
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.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 x 15 ml hætteglas 
PHARMACEUTICAL FORM AND CONTENTS concentrate for solution for infusion 1 x 15 ml vial
Det er vigtigt, at De har indlægssedlen og patientinformationskortet på Dem under behandlingsforløbet og i 6 måneder efter den sidste dosis TYSABRI, da bivirkninger kan forekomme selv efter, at De er ophørt med behandlingen. 
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.
• Smerte eller ubehag i brystet 
• Chest pain or discomfort
Dette skal tages i betragtning, hvis De er på en natriumfattig diæt. 
This should be considered if you are on a controlled sodium diet.
Hvis behandlingen skal fortsætte længere end 24 måneder: Nødvendigheden af at informere patienterne om den øgede risiko for PML og forsyne patienterne med en kopi af formularen til fortsat behandling o Risiko for andre opportunistiske infektioner o Nødvendigheden af at informere den nationalt ansvarlige myndighed om alle tilfælde af 
o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o Possibility of other opportunistic infections o The need to inform the National Competent Authority about any cases of PML
Natalizumab er et rekombinant humaniseret anti-α4-integrin antistof, produceret i en murin cellelinje ved rekombinant DNA-teknologi. 
Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a murine cell line by recombinant DNA technology.
Anti-JCV-antistof-analyser 
Anti-JCV antibody testing
Natalizumab binder sig specifikt til α4β1 integrinet og blokerer derved interaktionen med dets kognate receptor, vaskulært celleadhæsionsmolekyle-1 (VCAM-1) og ligand osteopontin, og et variant domæne (alternatively spliced) af fibronektin, connecting segment-1 (CS-1). 
Specifically, natalizumab binds to the α4β1 integrin, blocking the interaction with its cognate receptor, vascular cell adhesion molecule-1 (VCAM-1), and ligands osteopontin, and an alternatively spliced domain of fibronectin, connecting segment-1 (CS-1).
Kombination med beta-interferoner eller glatirameracetat. 
Combination with beta-interferons or glatiramer acetate.
Blokering af disse molekylære interaktioner forhindrer transmigration af mononukleære leukocytter gennem endotelet ind i inflammeret parenkymalt væv. 
Disruption of these molecular interactions prevents transmigration of mononuclear leukocytes across the endothelium into inflamed parenchymal tissue.
Der bør monitoreres for udvikling af IRIS, som har vist sig inden for få dage til flere uger efter plasmaferese hos TYSABRI-behandlede patienter med PML, og der skal iværksættes passende behandling af den associerede inflammation under patientens bedring fra PML (se informationen til lægen og behandlingsvejledningen for yderligere oplysninger). 
Monitoring for development of IRIS, which has occurred within days to several weeks after plasma exchange in TYSABRI treated patients with PML, and appropriate treatment of the associated inflammation during recovery from PML should be undertaken (see the Physician Information and Management Guidelines for further information).
• Den fortyndede opløsning skal infunderes intravenøst over 1 time med en hastighed på cirka 2 ml/minut. 
• The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
Varigheden af behandlingen med TYSABRI inden frembrud af infektion varierede fra nogle få måneder og op til flere år (se pkt. 
The duration of treatment with TYSABRI prior to onset ranged from a few months to several years (see section 4.4).
Hvis den fortyndede opløsning ikke anvendes omgående, skal den opbevares ved 2 ˚C -8 ˚C og infunderes inden for 8 timer efter fortynding. 
If not used immediately, the diluted solution must be stored at 2˚C - 8˚C and infused within 8 hours of dilution.
Stigning fra baseline i lymfocytter, monocytter, eosinofile granulocytter og basofile granulocytter varierede inden for området fra 35 % til 140 % for individuelle celletyper. 
Increases from baseline for lymphocytes, monocytes, eosinophils and basophils ranged from 35% to 140% for individual cell types but mean cell counts remained within normal ranges.
• De ikke har antistoffer mod JC-virusset i Deres blod, ELLER 
• If you do not have antibodies to the JC virus in your blood OR
TYSABRI indeholder natrium 
TYSABRI contains sodium
Ressourcer til håndtering af overfølsomhedsreaktioner og adgang til MR skal være tilgængelige. 
Resources for the management of hypersensitivity reactions and access to MRI should be available.
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 hjælpere skal informeres om tidlige tegn og symptomer på PML. 
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.
I tilfælde af signifikant leverskade bør TYSABRI afbrydes. 
In cases of significant liver injury TYSABRI should be discontinued.
I løbet af forsøgenes 2 års varighed rapporterede 43,5 % af de patienter, der blev behandlet med natalizumab, bivirkninger (placebo: 39,6 %). 
Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%).
Hazard ratio for progression af handikapudvikling var 0,36 (95 % CI: 0,17; 0,76) p=0,008. 
Hazard ratio for disability progression was 0.36 (95% CI: 0.17, 0.76) p = 0.008.
Spontane, alvorlige bivirkninger med leverskade er blevet rapporteret i post-marketingfasen. 
Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase.
PML bør betragtes som en differentialdiagnose hos enhver MS-patient i behandling med TYSABRI, som har neurologiske symptomer og/eller nye læsioner set på MR-scanninger. 
PML should be considered as a differential diagnosis in any MS patient taking TYSABRI presenting with neurological symptoms and/or new brain lesions in MRI.
Hvis en patient, der behandles med TYSABRI, udvikler en opportunistisk infektion, skal behandlingen med lægemidlet afbrydes permanent. 
If a patient receiving TYSABRI develops an opportunistic infection, dosing of the medicinal product must be permanently discontinued.
Opbevares i køleskab (2 °C-8 °C). 
Store in a refrigerator (2˚C - 8˚C).
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. 
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.
• Hvis De tager enten beta-interferon eller glatirameracetat. 
• If you are taking either beta-interferon or glatiramer acetate.
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 forsøg. 
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.
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 med f.eks. mitoxantron eller cyclophosphamid, se også pkt. 
Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies, e.g. mitoxantrone or cyclophosphamide, see also sections 4.4 and 4.8).
10. Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer. 
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Hvis der er tvivl, bør yderligere evaluering overvejes, herunder MR-scanning helst med kontrast (sammenlignes med baseline MR inden behandlingen), analyse af cerebrospinalvæsken for JC DNA samt gentagen neurologisk vurdering, som beskrevet i informationen til lægen og i behandlingsvejledningen (se afsnittet Rådgivende vejledning). 
If any doubt exists, further evaluation, including MRI scan preferably with contrast (compared with pre-treatment baseline MRI), CSF testing for JC Viral DNA and repeat neurological assessments, should be considered as described in the Physician Information and Management Guidelines (see educational guidance).
Inden for hver enkelt gruppe med samme hyppighed skal bivirkningerne opstilles efter, hvor alvorlige de er. 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Natriumdihydrogenphosphatmonohydrat; dinatriumphosphatheptahydrat; natriumchlorid; polysorbat 80 (E433); og vand til injektionsvæsker. 
LIST OF EXCIPIENTS sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
Denne indlægsseddel blev senest ændret { måned ÅÅÅÅ }. 
This leaflet was last revised in {MM/YYYY}.
Derved kan natalizumab undertrykke inflammatorisk aktivitet på sygdomsstedet og hæmme yderligere rekruttering af immunceller ind i inflammeret væv. 
As such, natalizumab may act to suppress inflammatory activity present at the disease site, and inhibit further recruitment of immune cells into inflamed tissues.
Der blev ikke observeret forskel i hyppighed eller art af malignitet mellem natalizumab- og placebo-behandlede patienter i løbet af 2 års behandling. 
No differences in incidence rates or the nature of malignancies between natalizumab- and placebo-treated patients were observed over 2 years of treatment.
Yderligere infusionsrelaterede reaktioner der var associeret med persisterende antistoffer omfattede rigor, kvalme, opkastning og rødmen (se pkt. 
Additional infusion-related reactions associated with persistent antibodies included rigors, nausea, vomiting and flushing (see section 4.4).
Hvis der er mistanke om opportunistisk infektion, skal TYSABRI seponeres, indtil mistanken er afkræftet ved yderligere evalueringer. 
If an opportunistic infection is suspected, dosing with TYSABRI is to be suspended until such infections can be excluded through further evaluations.
I kliniske fase III-studier hos MS-patienter var samtidig behandling af attakker med kortvarig kortikosteroid ikke associeret med en øget hyppighed af infektioner. 
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.
6.6) skal infusionen indgives over cirka 1 time, og patienterne skal observeres under infusionen og i 1 time efter infusionen for tegn og symptomer på overfølsomhedsreaktioner. 
After dilution (see section 6.6), the infusion is to be administered over approximately 1 hour and patients are to be observed during the infusion and for 1 hour after the completion of the infusion for signs and symptoms of hypersensitivity reactions.
Rådgivende vejledning 
Educational guidance
I placebo-kontrollerede forsøg med 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. 
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%).
4.8, hvordan bivirkninger indberettes. 
See section 4.8 for how to report adverse reactions
Blokaden hæmmer yderligere rekruttering af immunceller til inflammeret væv og reducerer derved nydannelse eller forstørrelse af MS-læsioner. 
MS and inhibits further recruitment of immune cells into inflamed tissue, thus reducing the formation or enlargement of MS lesions.
For opbevaringsforhold efter fortynding af lægemidlet, se pkt. 
For storage conditions after dilution of the medicinal product see section 6.3.
Hændelser, der blev indberettet hyppigere i forbindelse med natalizumab end med placebo, omfattede svimmelhed, kvalme, urticaria og rigor. 
Events reported more commonly with natalizumab than with placebo included dizziness, nausea, urticaria and rigors.
De hyppigst indberettede bivirkninger, identificeret i placebokontrollerede forsøg hos patienter med multipel sklerose, hvor natalizumab blev givet ved den anbefalede dosis, er svimmelhed, kvalme, urticaria og rigor associeret med infusioner. 
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.
• Åndedrætsbesvær 
• Difficulty breathing
Hvis en patient udvikler PML, skal behandlingen med TYSABRI afbrydes permanent. 
If a patient develops PML the dosing of TYSABRI must be permanently discontinued.
Spontane tilfælde af alvorlige leverskader, øgede leverenzymer, hyperbilirubæmi er blevet rapporteret i post-marketing fasen (se pkt. 
Spontaneous cases of serious liver injuries, increased liver enzymes, hyperbilirubinaemia have been reported during the post marketing phase (see section 4.4).
Symptomerne på JCV GCN ligner symptomerne på PML (f.eks. cerebellart syndrom). 
Symptoms of JCV GCN are similar to symptoms of PML (i.e. cerebellar syndrome).
Er De i tvivl, så spørg lægen. 
- If you have any further questions, ask your doctor.
Sjældne bivirkninger (påvirker op til 1 ud af 1.000 personer): 
Rare side effects that may affect up to 1 in 1,000 people:
Leukocytmigration over BBB involverer interaktion mellem adhæsionsmolekyler på de inflammatoriske celler og adhæsionsmolekylerne på karvæggens endotelceller. 
Leukocyte migration across the BBB involves interaction between adhesion molecules on inflammatory cells and endothelial cells of the vessel wall.
o Beskrivelse af MR-scanningsprotokollen til baseline, rutinemæssig screening og ved mistanke om PML o Anti-JCV-antistof-analyser, frekvens af analyserne, fortolkning af kvalitative og kvantitative resultater, seroforekomst af JCV-antistoffer og serokonversionsrate over tid o Monitoreringsstrategi efter seponering af behandlingen med TYSABRI o Nødvendigheden af at informere patienterne om fordele og risici ved behandling med TYSABRI og forsyne patienterne med: En kopi af formularen til behandlingsstart Et patientinformationskort, der indeholder en basistekst ifølge aftale med CHMP 
o Description of MRI protocols for baseline, routine screening and in case of PML suspicion o Anti-JCV antibody testing, frequency of testing, interpretation of qualitative and quantitative results, seroprevalence of JCV-antibodies and seroconversion rate over time o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
Blokade af de molekylære interaktioner mellem α4β1 og dets bindingssteder (targets) reducerer den inflammatoriske aktivitet, der er til stede i hjernen hos MS-patienter. 
Blockade of the molecular interactions of α4β1 with its targets reduces inflammatory activity present in the brain in
Gennemsnitlig middelværdi for steady-state minimumskoncentrationer af natalizumab over behandlingsperioden lå mellem 23 μg/ml og 29 μg/ml. 
Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μg/ml to 29 μg/ml.
• TYSABRI må ikke blandes med andre lægemidler eller opløsningsmidler. 
• TYSABRI must not be mixed with other medicinal products or diluents.
Tag altid denne medicin nøjagtigt efter lægens anvisning. 
Always use this medicine exactly as your doctor has told you.
Der er ikke gennemført studier af evnen til at føre motorkøretøj og betjene maskiner under behandling med TYSABRI. 
No studies on the effects on the ability to drive and use machines have been performed with TYSABRI.
Brugen af TYSABRI er blevet associeret med en øget risiko for PML, en opportunistisk infektion forårsaget af JC-virus, som kan være letal eller resultere i svære funktionstab. 
Progressive Multifocal Leukoencephalopathy (PML) Use of TYSABRI has been associated with an increased risk of PML, an opportunistic infection caused by JC virus, which may be fatal or result in severe disability.
I litteraturen er der rapporteret forbigående let til moderat trombocytopeni og anæmi hos børn af kvinder behandlet med TYSABRI i tredje trimester af graviditeten. 
Cases from published literature reported transient mild to moderate thrombocytopenia and anaemia observed in infants born to women exposed to TYSABRI in their third trimester of pregnancy.
Opportunistiske infektioner blev også påvist hos MS-patienter behandlet med TYSABRI som monoterapi (se pkt. 
Opportunistic infections were also detected in MS patients treated with TYSABRI as a monotherapy (see section 4.8).
Disse ændringer var associeret med forøget ekstramedullær hæmatopoiese i milten, thymus atrofi og nedsat hepatisk hæmatopoiese. 
These changes were associated with increased splenic extramedullary haematopoiesis, thymic atrophy and decreased hepatic haematopoiesis.
Natalizumab blokerer interaktionen af α4β7 integrinet med det mukosale addressin celleadhæsionsmolekyle-1 
Natalizumab blocks the interaction of α4β7 integrin with the mucosal addressin cell adhesion molecule-1 (MadCAM-1).
Den fortyndede opløsning skal infunderes intravenøst over 1 time med en hastighed på cirka 2 ml/minut. 
The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
Nogle patienter, som tidligere har haft en abnorm leverfunktionstest, har oplevet en forværring af de abnorme leverværdier, mens de fik TYSABRI. 
Some patients with a past medical history of an abnormal liver test have experienced an exacerbation of abnormal liver test while on TYSABRI.
JC-virus forårsager også JCVgranularcelle-neuronopati (GCN), som er blevet indberettet hos patienter behandlet med TYSABRI. 
JC virus also causes JCV granule cell neuronopathy (GCN) which has been reported in patients treated with TYSABRI.
I ét forsøg med marsvin blev der observeret en lille reduktion i overlevelsesraten hos afkommet. 
In one study in guinea pigs, a small reduction in pup survival was noted.
Anti-JCV-antistof-analyser giver information, der kan understøtte risikostratifikation ved TYSABRIbehandling. 
Anti-JCV antibody testing provides supportive information for risk stratification of TYSABRI treatment.
Hvert enkelt hætteglas er til engangsbrug. 
Each vial is for single-use only.
Deres læge vil overvåge Dem under infusionen og i en time herefter for at kontrollere, om der opstår allergiske reaktioner. 
Your doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
TYSABRI må ikke blandes med andre lægemidler eller opløsningsmidler. 
TYSABRI must not be mixed with other medicinal products or diluents.
I kliniske forsøg har TYSABRI cirka halveret udviklingen af invaliderende virkninger, som var forårsaget af MS. 
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.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse. 
METHOD AND ROUTE(S) OF ADMINISTRATION
Kortvarig steroidbehandling af attakker blev i kliniske forsøg ikke associeret med en øget forekomst af infektioner. 
Short courses of steroids used to treat relapses were not associated with increased infections in clinical trials.
Amning bør afbrydes under behandling med TYSABRI. 
Breast-feeding should be discontinued during treatment with TYSABRI.
For yderligere information om anti-JCV-antistof-analyser henvises der til Information til lægen og Retningslinjer for behandling. 
For further information on anti-JCV antibody testing please see Physician Information and Management Guidelines.
Patienter, som har alle tre risikofaktorer for PML (dvs. er anti-JCV-antistof-positive og har fået mere end 2 års behandling med TYSABRI og tidligere har fået immunsuppressiv behandling) har en betydeligt højere risiko for at udvikle PML. 
Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML.
Symptomerne på JCV GCN ligner symptomerne på PML. 
The symptoms of JCV GCN are similar to PML.
IRIS optræder hos næsten alle TYSABRI-behandlede patienter med PML efter seponering eller fjernelse af lægemidlet, f.eks. i forbindelse med plasmaferese (se pkt. 
IRIS occurs in almost all TYSABRI PML patients after withdrawal or removal of the medicinal product, e.g. by plasma exchange (see section 5.2).
Hvis det fortyndede lægemiddel opbevares ved 2°C - 8°C (må ikke nedfryses), skal man lade opløsningen få stuetemperatur inden infusionen. 
If the diluted medicinal product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Undersøg det fortyndede lægemiddel visuelt for partikler eller misfarvning inden administrationen. 
Visually inspect the diluted medicinal product for particles or discolouration prior to administration.