FrancophonIA/ELRC3.0 huggingface dataset:
English: A group of symptoms caused by a serious infection of the brain including: - Changes in personality and behaviour such as confusion, delirium or loss of consciousness, seizures (fits), headache, nausea / vomiting, stiff neck, extreme sensitivity to bright light, fever, rash (anywhere on the body).
Danish: En gruppe symptomer forårsaget af en alvorlig infektion i hjernen, herunder: - Ændringer i personlighed og adfærd såsom forvirring, konfusion eller bevidsthedstab, krampeanfald, hovedpine, kvalme/opkastning, nakkestivhed, ekstrem følsomhed for skarpt lys, feber, udslæt (hvor som helst på kroppen).
English: Efficacy as monotherapy has been evaluated in one randomised, double-blind, placebo-controlled study lasting 2 years (AFFIRM study) in relapsing-remitting MS patients who had experienced at least 1 clinical relapse during the year prior to entry and had a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.
Danish: Effekten som monoterapi er blevet evalueret i et randomiseret, dobbeltblindet, placebokontrolleret studie over 2 år (AFFIRM studiet) med relapsing-remitterende MS-patienter, der havde oplevet mindst ét klinisk attak i året forud for deres indtræden i forsøget, og som havde en score på mellem 0 og 5 på Kurtzke-skalaen (Expanded Disability Status Scale - EDSS).
English: In the sub-group of patients indicated for treatment of rapidly evolving relapsing remitting MS (patients with 2 or more relapses and 1 or more Gd+ lesion), the annualised relapse rate was 0.282 in the TYSABRI treated group (n = 148) and 1.455 in the placebo group (n = 61) (p <0.001).
Danish: I undergruppen af patienter, der var indiceret til behandling af hurtigt udviklende relapsingremitterende MS (patienter med 2 eller flere attakker eller 1 eller flere Gd+ læsioner), var den årlige attakhyppighed 0,282 i den TYSABRI behandlede gruppe (n= 148) og 1,455 i placebo-gruppen (n= 61) (p <0,001).
English: Mean number of new or newlyenlarging T2-hyperintense lesions
Danish: Gennemsnitligt antal nye eller nyligt forstørrede T2-hyperintense læsioner
English: These occurred in 23.1% of MS patients treated with natalizumab (placebo: 18.7%).
Danish: Sådanne reaktioner optrådte hos 23,1 % af de MS-patienter, der blev behandlet med natalizumab (placebo: 18,7 %).
English: Cases of asymptomatic PML based on MRI and positive JCV DNA in the cerebrospinal fluid have been reported.
Danish: Der er indberettet tilfælde med asymptomatisk PML baseret på MR-scanninger og positiv JCV DNA i cerebrospinalvæske.
English: • Adult patients aged 18 years and over with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Danish: • Voksne patienter i alderen 18 år og derover med hurtigt udviklende svær relapsing-remitterende multipel sklerose, defineret som 2 eller flere invaliderende attakker på ét år og med 1 eller flere gadolinium-forstærkede læsioner set ved MR-hjernescanning eller en signifikant stigning i T2-læsionsbyrden sammenlignet med en tidligere nylig MR-scanning.
English: Completing 1 years Completing 2 years
Danish: Randomiseret Fuldførte 1 år Fuldførte 2 år
English: Symptoms can include; walking problems, numbness in the face, arms or legs, problems seeing things, tiredness, feeling off-balance or light headed, bladder and bowel problems, difficulty in thinking and concentrating, depression, acute or chronic pain, sexual problems, and stiffness and muscle spasms.
Danish: Symptomer kan omfatte: gangproblemer; følelsesløshed i ansigt, arme eller ben; problemer med at se ting; træthed; en følelse af at være ude af balance eller opløftet; blære- og tarmproblemer; besvær med at tænke og koncentrere sig; depression; akut eller kronisk smerte; seksuelle problemer samt stivhed og muskelspasmer.
English: In 2-year controlled clinical trials in MS patients, hypersensitivity reactions occurred in up to 4% of patients.
Danish: I 2-års kontrollerede kliniske forsøg med MS-patienter forekom der overfølsomhedsreaktioner hos op til 4 % af patienterne.
English: After 2 years all patients should be re-informed about the risk of PML with TYSABRI.
Danish: Efter 2 år skal alle patienter geninformeres om risikoen for PML ved behandling med TYSABRI.
English: • Prescriber name, signature and date
Danish: • Den ordinerende læges navn, underskrift og dato
English: • Severe anaemia (decrease in your red blood cells which can make your skin pale and can make you feel breathless or lacking energy)
Danish: • Alvorlig anæmi (nedsat antal røde blodlegemer, som kan medføre bleghed, åndenød og manglende energi)
English: If you have previously not been treated with immunosuppressants and have received TYSABRI for 2 years or longer, the level of your anti-JCV antibody response may be associated with the risk of getting PML.
Danish: Hvis De ikke tidligere er blevet behandlet med immunsuppressive lægemidler og er blevet behandlet med TYSABRI i 2 år eller mere, kan niveauet af Deres anti-JCV-antistof-respons være associeret til risikoen for at få PML.
English: In patients with PML a reaction known as IRIS (Immune Reconstitution Inflammatory Syndrome) is likely to occur after treatment for PML, as TYSABRI is removed from your body.
Danish: Hos patienter med PML vil en reaktion, der kaldes immunrekonstitutionssyndrom (Immune Reconstitution Inflammatory Syndrome, IRIS), sandsynligvis optræde efter behandling af PML, når TYSABRI fjernes fra kroppen.
English: Natalizumab showed no effects on in vitro assays of α4-integrin-positive tumour line proliferation or cytotoxicity.
Danish: Natalizumab udviste ingen virkninger på in vitro prøver af α4-integrin-positiv tumor linje proliferation eller cytotoksicitet.
English: • Patient alert card
Danish: • Patientinformationskort
English: For the estimation of PML risk in the different patient subgroups, please refer to the Physician Information and Management Guidelines.
Danish: For vurdering af PML-risikoen i de forskellige patientundergrupper henvises til Information til lægen og Retningslinjer for behandling.
English: In clinical trials, herpes infections (Varicella-Zoster virus, Herpes-simplex virus) occurred slightly more frequently in natalizumab-treated patients than in placebo-treated patients.
Danish: I kliniske forsøg forekom herpesinfektioner (varicella-zoster-virus, herpes simplex-virus) en anelse hyppigere hos patienter behandlet med natalizumab end hos placebo-behandlede patienter.
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.
English: TYSABRI is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following patient groups:
Danish: TYSABRI er indiceret som en monoterapeutisk sygdomsmodificerende behandling af meget aktiv relapsing-remitterende multipel sklerose (MS) hos følgende patientgrupper:
English: • Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Danish: • Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: If a woman becomes pregnant while taking TYSABRI, discontinuation of the medicinal product should be considered.
Danish: Hvis en kvinde bliver gravid, mens hun får TYSABRI, bør det overvejes at seponere lægemidlet.
English: Anti-JCV antibody negative patients may still be at risk of PML for reasons such as a new JCV infection, fluctuating antibody status or a false negative test result.
Danish: Anti-JCV antistofnegative patienter kan stadig være i risiko for PML af grunde såsom en ny JCV infektion, svingende antistof status eller et falsk negativt testresultat.
English: • You may not be able to use TYSABRI if you are currently receiving or have previously received medicines that affect your immune system, e.g. mitoxantrone or cyclophosphamide.
Danish: • De vil muligvis ikke kunne anvende TYSABRI, hvis De i øjeblikket får eller tidligere har fået, lægemidler, der påvirker immunsystemet, f.eks. mitoxantron eller cyclophosphamid.
English: Since patients who have received an initial short exposure to TYSABRI and then had an extended period without treatment are at a higher risk of developing anti-natalizumab antibodies and/or hypersensitivity upon redosing, the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, the patient should not receive further treatment with TYSABRI.
Danish: Da patienter, der kortvarigt er blevet eksponeret for TYSABRI og derefter har haft en længerevarende periode uden behandling, har en højere risiko for at udvikle antistoffer mod natalizumab og/eller overfølsomhed ved readministration, bør tilstedeværelse af antistoffer evalueres, og hvis disse forbliver positive ved en bekræftende test efter mindst 6 uger, bør patienten ikke modtage yderligere behandling med TYSABRI.
English: Antibodies were detected on only one occasion in an additional 4% of patients.
Danish: Enkeltstående tilfælde af antistofpåvirkning sås hos yderligere 4 % af patienterne.
English: TYSABRI must not be administered as a bolus injection.
Danish: TYSABRI må ikke indgives som en bolusinjektion.
English: All physicians who intend to prescribe TYSABRI must ensure they are familiar with the Physician Information and Management Guidelines.
Danish: Enhver læge, der påtænker at ordinere TYSABRI, skal sikre sig kendskab til indholdet i informationen til lægen og behandlingsvejledningen.
English: Remove flip-off cap from the vial.
Danish: Tag flip-off hætten af hætteglasset.
English: Following reconstitution of the immune system in immunocompromised patients with PML improved outcome has been seen.
Danish: Efter genetablering af immunsystemet hos immunkompromitterede patienter med PML har man observeret bedring hos patienterne.
English: A case of cryptosporidium diarrhoea was reported in MS clinical trials.
Danish: Et tilfælde af cryptosporidium-diaré blev indberettet i kliniske forsøg med MS-patienter.
English: In 10% of patients antibodies against natalizumab were detected in 2-year controlled clinical trials in MS patients.
Danish: Hos 10 % af patienterne blev der påvist antistoffer mod natalizumab i 2-års kontrollerede kliniske forsøg med MS-patienter.
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 immunsuppressive lægemidler inden behandlingen med TYSABRI samt tilstedeværelse af anti-John Cunningham-virus-antistof (JCV) (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg of natalizumab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder 20 mg natalizumab.
English: No clastogenic or mutagenic effects of natalizumab were observed in the Ames or human chromosomal aberration assays.
Danish: Der blev ikke observeret klastogene eller mutagene virkninger af natalizumab i Ames tests eller human kromosomaberrationstests.
English: In post-marketing experience, there have been reports of hypersensitivity reactions which have occurred with one or more of the following associated symptoms: hypotension, hypertension, chest pain, chest discomfort, dyspnoea, angioedema, in addition to more usual symptoms such as rash and urticaria.
Danish: Efter markedsføringen har der været indberetninger om overfølsomhedsreaktioner, hvor der optrådte et eller flere af følgende associerede symptomer: hypotension, hypertension, smerte i brystet, ubehag i brystet, dyspnø og angioødem ud over de mere sædvanlige symptomer som udslæt og urticaria.
English: Only body weight and the presence of anti-natalizumab antibodies were found to influence natalizumab disposition.
Danish: Kun legemsvægt og tilstedeværelse af anti-natalizumab antistoffer viste sig at påvirke natalizumab fordelingen.
English: Physicians should refer to the Physician Information and Management Guidelines for further information on managing the risk of PML in TYSABRI-treated patients.
Danish: Læger henvises til Information til lægen og Retningslinjer for behandling for yderligere information om håndtering af risikoen for PML hos TYSABRI-behandlede patienter.
English: Warnings and precautions Talk to your doctor before using TYSABRI.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før De får TYSABRI.
English: Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI (see also section
Danish: Lægen skal derfor sikre sig, at sådanne patienter ikke er immunkompromitterede, inden behandling med TYSABRI påbegyndes (se også pkt.
English: The analysis explored the effects of selected covariates including body weight, age, gender, hepatic and renal function, and presence of anti-natalizumab antibodies upon pharmacokinetics.
Danish: Analysen så på virkninger på farmakokinetikken af udvalgte kovariater inklusive legemsvægt, alder, køn, nyre- og leverfunktion samt tilstedeværelse af anti-natalizumab antistoffer.
English: PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation.
Danish: PML er blevet indberettet efter seponering af TYSABRI hos patienter, hvor fundene ikke tydede på PML på seponeringstidspunktet.
English: Patients with a treatment history of immunosuppressant medicinal products are at increased risk for PML.
Danish: Patienter med en behandlingsanamnese med immunsuppressive lægemidler har øget risiko for at udvikle PML.
English: IRIS is thought to result from the restoration of immune function in patients with PML, which can lead to serious neurological complications and may be fatal.
Danish: IRIS menes at være forårsaget af genetablering af immunfunktionen hos patienter med PML, hvilket kan medføre alvorlige neurologiske komplikationer med risiko for letal udgang.
English: In studies conducted in mice, growth and metastasis of melanoma and lymphoblastic leukaemia tumour cells was not increased by the administration of natalizumab.
Danish: I dyreforsøg med mus blev vækst og metastasering af melanom og lymfoblastiske leukæmitumorceller ikke forøget ved administration af natalizumab.
English: Testing for serum anti-JCV antibody prior to initiating TYSABRI therapy or in patients receiving the medicinal product with an unknown antibody status is recommended.
Danish: Testning for serum-anti-JCV-antistof anbefales før initiering af behandling med TYSABRI og hos patienter, der får lægemidlet og har ukendt antistof-status.
English: Physicians must discuss the benefits and risks of TYSABRI therapy with the patient and provide them with a Patient Alert Card.
Danish: Læger skal diskutere fordele og risici ved TYSABRI behandlingen med patienten og de skal give patienten et patientinformationskort.
English: • If you have antibodies to the JC virus in your blood.
Danish: • Hvis De har antistoffer til JC virus i blodet.
English: In these cases the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, treatment should be discontinued, as persistent antibodies are associated with a substantial decrease in efficacy of TYSABRI and an increased incidence of hypersensitivity reactions (see section 4.8).
Danish: I disse tilfælde bør det evalueres, om der er antistoffer til stede, og hvis disse forbliver positive ved en bekræftende test efter mindst seks uger, bør behandlingen afbrydes, da persisterende antistoffer associeres med en væsentlig nedsættelse af TYSABRIs effekt og en øget forekomst af overfølsomhedsreaktioner (se pkt.
English: • If your doctor has told you that you have PML (progressive multifocal leukoencephalopathy).
Danish: • Hvis Deres læge har fortalt Dem, at De lider af progressiv multifokal leukoencefalopati (PML).
English: You should discuss with your doctor whether you choose to breast-feed or to use TYSABRI.
Danish: De skal tale med Deres læge om, hvorvidt De skal vælge at amme eller at få TYSABRI.
English: However, given that dizziness has been commonly reported, patients who experience this adverse reaction should be advised not to drive or use machines until it has resolved.
Danish: Men i betragtning af at der hyppigt er indberettet svimmelhed, bør patienter, der oplever denne bivirkning, informeres om ikke at føre motorkøretøj eller betjene maskiner, før svimmelheden er forsvundet.
English: Cases of JCV GCN have also been reported during postmarketing use of TYSABRI.
Danish: Der er også indberettet tilfælde af JCV GCN efter markedsføring af TYSABRI.
English: Patients who are anti-JCV antibody positive are at an increased risk of developing PML compared to patients who are anti-JCV antibody negative.
Danish: Patienter, som er anti-JCV-antistof-positive, har en øget risiko for at udvikle PML sammenlignet med patienter, som er anti-JCV antistof-negative.
English: 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.
Danish: 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.
English: 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.
Danish: 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).
English: • Each vial is for single-use only.
Danish: • Hvert enkelt hætteglas er til engangsbrug.
English: The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution.
Danish: Det fortyndede lægemiddel skal anvendes så hurtigt som muligt og inden for 8 timer efter fortynding.
English: The active substance is natalizumab.
Danish: Det aktive stof er natalizumab.
English: 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).
Danish: Læger skal evaluere hvert enkelt tilfælde for at fastslå, hvorvidt der er tegn på en immunkompromitteret tilstand, inden behandling med TYSABRI påbegyndes (se pkt.
English: • Date treatment started
Danish: • Dato for behandlingsstart
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 forsøg over 2 år blev TYSABRI-behandling associeret med stigning i cirkulerende lymfocytter, monocytter, eosinofile granulocytter, basofile granulocytter og kerneholdige røde blodlegemer.
English: PHARMACEUTICAL FORM AND CONTENTS concentrate for solution for infusion 1 x 15 ml vial
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 x 15 ml hætteglas
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 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.
English: • Chest pain or discomfort
Danish: • Smerte eller ubehag i brystet
English: This should be considered if you are on a controlled sodium diet.
Danish: Dette skal tages i betragtning, hvis De er på en natriumfattig diæt.
English: 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
Danish: 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
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: Anti-JCV antibody testing
Danish: Anti-JCV-antistof-analyser
English: 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).
Danish: 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).
English: Combination with beta-interferons or glatiramer acetate.
Danish: Kombination med beta-interferoner eller glatirameracetat.
English: Disruption of these molecular interactions prevents transmigration of mononuclear leukocytes across the endothelium into inflamed parenchymal tissue.
Danish: Blokering af disse molekylære interaktioner forhindrer transmigration af mononukleære leukocytter gennem endotelet ind i inflammeret parenkymalt væv.
English: 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).
Danish: 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).
English: • The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
Danish: • Den fortyndede opløsning skal infunderes intravenøst over 1 time med en hastighed på cirka 2 ml/minut.
English: The duration of treatment with TYSABRI prior to onset ranged from a few months to several years (see section 4.4).
Danish: Varigheden af behandlingen med TYSABRI inden frembrud af infektion varierede fra nogle få måneder og op til flere år (se pkt.
English: If not used immediately, the diluted solution must be stored at 2˚C - 8˚C and infused within 8 hours of dilution.
Danish: Hvis den fortyndede opløsning ikke anvendes omgående, skal den opbevares ved 2 ˚C -8 ˚C og infunderes inden for 8 timer efter fortynding.
English: 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.
Danish: Stigning fra baseline i lymfocytter, monocytter, eosinofile granulocytter og basofile granulocytter varierede inden for området fra 35 % til 140 % for individuelle celletyper.
English: • If you do not have antibodies to the JC virus in your blood OR
Danish: • De ikke har antistoffer mod JC-virusset i Deres blod, ELLER