FrancophonIA/ELRC3.0 huggingface dataset:
English: One year endpoint
Danish: Endepunkt ved ét år
English: The nature of the infections was generally similar in natalizumab- and placebo-treated patients.
Danish: Typen af infektioner hos natalizumab-behandlede patienter lignede generelt typen af infektioner hos placebo-behandlede patienter.
English: Uncommon side effects that may affect up to 1 in 100 people:
Danish: Ikke almindelige bivirkninger (påvirker op til 1 ud af 100 personer):
English: Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least 6 weeks later) developed in approximately 6% of patients.
Danish: Cirka 6 % af patienterne udviklede persisterende anti-natalizumab antistoffer (én positiv test bekræftet ved gentagelse af testen mindst 6 uger senere).
English: After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended.
Danish: Efter fortynding med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske anbefales omgående anvendelse.
English: Other opportunistic infections have been reported with use of TYSABRI, primarily in patients with Crohn's disease who were immunocompromised or where significant co-morbidity existed, however increased risk of other opportunistic infections with use of the medicinal product in patients without these co-morbidities cannot currently be excluded.
Danish: Der er indberettet andre opportunistiske infektioner i forbindelse med brugen af TYSABRI, primært hos patienter med Crohns sygdom hvor patienterne var immunkompromitterede, eller hvor der forelå signifikant co-morbiditet.
English: Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ml).
Danish: Hvert 15 ml hætteglas med koncentrat til infusionsvæske indeholder 300 mg natalizumab (20 mg/ml).
English: What TYSABRI looks like and contents of the pack TYSABRI is a clear, colourless to slightly cloudy liquid.
Danish: TYSABRI er en klar, farveløs til lettere uigennemsigtig væske.
English: Hepatic events
Danish: Hepatiske bivirkninger
English: Hypersensitivity reactions usually occurred during the infusion or within the 1-hour period after the completion of the infusion (See section 4.4).
Danish: Overfølsomhedsreaktioner optrådte sædvanligvis under infusionen eller inden for én time efter at infusionen var gennemført (Se pkt.
English: Inspect the TYSABRI vial for particles prior to dilution and administration.
Danish: Undersøg TYSABRI hætteglasset for partikler inden fortynding og indgivelse.
English: Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI (see section 4.8).
Danish: Alvorlige, livstruende og til tider dødelige tilfælde er efter markedsføring blevet rapporteret hos patienter med multipel sklerose i behandling med TYSABRI (se pkt.
English: After dilution for use, this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Danish: Efter fortynding indeholder dette lægemiddel 17,7 mmol (svarende til 406 mg) natrium per dosis.
English: When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Danish: Når opløsningen er fortyndet (se sektion 6.6), indeholder infusionsvæsken cirka 2,6 mg natalizumab/ml.
English: Rare, serious cases of anaemia and haemolytic anaemia have been reported in patients treated with TYSABRI in post-marketing observational studies.
Danish: Alvorlig anæmi og hæmolytisk anæmi er i sjældne tilfælde rapporteret fra observationsstudier efter markedsføring hos patienter behandlet med Tysabri.
English: Studies have not been conducted to examine the effects of renal or hepatic impairment.
Danish: Der er ikke gennemført forsøg til undersøgelse af virkningerne ved nyre- eller leverinsufficiens.
English: • Inspect the TYSABRI vial for particles prior to dilution and administration.
Danish: • Undersøg TYSABRI hætteglasset for partikler inden fortynding og indgivelse.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TYSABRI 300 mg concentrate for solution for infusion natalizumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) TYSABRI 300 mg koncentrat til infusionsvæske, opløsning natalizumab
English: TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Danish: TYSABRI-behandling skal initieres og kontinuerligt overvåges af speciallæger med erfaring i diagnosticering og behandling af neurologiske tilstande på hospitaler med let adgang til MR-scanning.
English: Progressive multifocal leukoencephalopathy (PML).
Danish: Progressiv multifokal leukoencefalopati (PML).
English: Relapses in previous 12 months, median (range)
Danish: Attakker i forudgående 12 måneder ,median (område) EDSS-baseline, median (område)
English: Rate ratio 0.32 CI95% 0.26 ; 0.40
Danish: Hyppighedsforhold 0,32 CI95% 0,26 ; 0,40
English: TYSABRI 300 mg concentrate for solution for infusion natalizumab
Danish: TYSABRI 300 mg koncentrat til infusionsvæske, opløsning natalizumab
English: The presence of persistent antinatalizumab antibodies increased natalizumab clearance approximately 3-fold, consistent with reduced serum natalizumab concentrations observed in persistently antibody-positive patients, (see section 4.8).
Danish: Det svarede til de reducerede serum natalizumab koncentrationer, der blev observeret hos patienter, der var persisterende antistof-positive (se pkt.
English: Estimates of the total natalizumab removal after 3 plasma exchanges (over a 5-8 day interval) was approximately 70-80%.
Danish: Estimeringer af den totale fjernelse af natalizumab efter tre plasmafereser (over en periode på 5-8 dage) var cirka 70-80 % sammenlignet med 40 % i tidligere forsøg, hvor målingerne blev foretaget efter afbrydelse af natalizumab over en lignende observationsperiode.
English: NAME OF THE MEDICINAL PRODUCT TYSABRI 300 mg concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN TYSABRI 300 mg koncentrat til infusionsvæske, opløsning
English: TYSABRI must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: TYSABRI må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Known active malignancies, except for patients with cutaneous basal cell carcinoma.
Danish: Dette gælder dog ikke patienter med kutant basalcelle-karcinom.
English: Each vial of TYSABRI contains 2.3 mmol (or 52 mg) of sodium.
Danish: Hvert hætteglas med TYSABRI indeholder 2,3 mmol (eller 52 mg) natrium.
English: VCAM-1, CS-1 and osteopontin that mediates the firm adhesion and transmigration of leukocytes into the brain parenchyma and may perpetuate the inflammatory cascade in CNS tissue.
Danish: Når det drejer sig om inflammation i centralnervesystemet (CNS) ved MS, er det interaktionen mellem α4β1 og VCAM-1, CS-1 og osteopontin, der medierer den faste adhæsion og transmigration af leukocytter ind i hjerneparenkymet og dermed foranlediger den uophørlige inflammatoriske kaskade i CNS væv.
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 admini-strationen.
English: Two year endpoint
Danish: Endepunkt ved to år
English: 4.5 Interaction with other medicinal products and other forms of interaction TYSABRI is contraindicated in combination with beta-interferons or glatiramer acetate (see section
Danish: TYSABRI er kontraindiceret i kombination med beta-interferoner eller glatirameracetat (se pkt.
English: • Sore throat and runny or blocked up nose
Danish: • Ondt i halsen og løbende eller tilstoppet næse
English: Mean number of Gd-enhancing lesions
Danish: Gennemsnitligt antal Gdforstærkede læsioner
English: Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.
Danish: Natalizumab er en selektiv adhæsionsmolekyleinhibitor, der binder sig til α4-subunitten på humane integriner.
English: If you miss your usual dose of TYSABRI, arrange with your doctor to receive it as soon as you can. You can then continue to receive your dose of TYSABRI every 4 weeks.
Danish: Hvis De glemmer at få Deres sædvanlige dosis TYSABRI, skal De aftale med Deres læge at få den så hurtigt som muligt.
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Danish: Efter fortynding med 100 ml natriumchlorid 9 mg/ml (0,9 %) indeholder lægemidlet 17,7 mmol (eller 406 mg) natrium per dosis.
English: What TYSABRI contains
Danish: TYSABRI indeholder:
English: Hypersensitivity to natalizumab or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for natalizumab eller over for et eller flere af hjælpestofferne angivet i pkt.
English: Use aseptic technique when preparing TYSABRI solution for intravenous infusion.
Danish: Brug aseptisk teknik, når TYSABRI opløsningen klargøres til intravenøs (i.v.)
English: • Summary of Product Characteristics and Package Leaflet
Danish: • Produktresumé og indlægsseddel
English: Relapse rate derived variables / MRI-derived variables
Danish: Progression i EDSS Sekundære endepunkter Afledte variabler fra attakhyppighed / afledte variabler fra MR Patienter
English: • Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: • Tilfør de 15 ml koncentrat til infusionsvæske- til 100 ml natriumklorid 9 mg/ml (0,9 %) injektionsopløsning.
English: Progressive Multifocal Leukoencephalopathy (PML)
Danish: Progressiv multifokal leukoencefalopati (PML)
English: Due to this increased risk of developing PML, the benefits and risks of TYSABRI treatment should be individually reconsidered by the specialist physician and the patient; patients must be monitored at regular intervals throughout and should be instructed together with their caregivers on early signs and symptoms of PML.
Danish: På grund af den øgede risiko for at udvikle PML bør fordele og risici ved TYSABRI-behandling genovervejes for den enkelte patient ved drøftelse mellem speciallægen og patienten.
English: • Patients with a high anti-JCV antibody index who have received more than 2 years of
Danish: • Patienter med et højt anti-JCV-antistof-indeks, som er blevet behandlet i mere end 2 år med TYSABRI, og som ikke tidligere er blevet behandlet med immunsuppressive lægemidler.
English: Infections
Danish: virus-infektion
English: Rate ratio 0.33 CI95% 0.26 ; 0.41
Danish: Hyppighedsforhold 0,33 CI95% 0,26 ; 0,41
English: Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Tilfør de 15 ml koncentrat til infusionsvæske til 100 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske.
English: Concurrent use of these agents with TYSABRI may increase the risk of infections, including opportunistic infections, and is contraindicated (see section 4.3).
Danish: Brug af disse midler samtidig med anvendelse af TYSABRI kan øge risikoen for infektioner, inklusive opportunistiske infektioner.
English: Your doctor can decide whether TYSABRI is not working properly for you by testing your blood and will stop TYSABRI, if necessary.
Danish: Deres læge kan ved hjælp af en blodprøve finde ud af, om TYSABRI ikke virker, som det skal for Dem.
English: If you miss your dose of TYSABRI
Danish: Hvis De har glemt at tage TYSABRI
English: - Keep this leaflet and the Patient Alert Card. You may need to read them again.
Danish: - Gem indlægssedlen og patientinformationskortet.
English: When diluted, the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Danish: Når opløsningen er fortyndet indeholder infusionsvæsken cirka 2,6 mg/ml natalizumab.
English: • Information on PML and IRIS including the risk of developing PML during TYSABRI treatment stratified by prior treatment with immunosuppressants and JC virus infection.
Danish: • Information om PML og IRIS herunder risikoen for at udvikle PML under TYSABRI
English: Platelet counts were also reduced in offspring born to mothers treated with natalizumab until parturition, however there was no evidence of anaemia in these offspring.
Danish: Blodpladetal var ligeledes reduceret hos afkom født af hunner, der var blevet behandlet med natalizumab indtil fødslen.
English: After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Efter at infusionen er gennemført, gennemskylles i.v.-slangen med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske.
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) the medicinal product contains 17.7 mmol (or 406 mg) sodium.
Danish: Når lægemidlet er fortyndet med 100 ml natriumchlorid 9 mg/ml (0,9 %) indeholder det 17,7 mmol (sv.t.
English: Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride
Danish: Natriumdihydrogenphosphatmonohydrat Dinatriumphosphatheptahydrat Natriumchlorid
English: • Fever
Danish: • Feber • Træthed
English: Anaemia and haemolytic anaemia
Danish: Anæmi og hæmolytisk anæmi
English: A condition called JCV GCN (JC virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI.
Danish: JC-virus forårsager også JCV-granularcelle-neuronopati (GCN), som er blevet indberettet hos patienter behandlet med TYSABRI.
English: Your doctor may test your blood to check if you have antibodies to the JC virus before you start treatment with TYSABRI.
Danish: Inden De påbegynder behandling med TYSABRI, vil lægen muligvis tage en blodprøve for at undersøge, om De har antistoffer mod JC-virus i blodet.
English: A study in pregnant cynomolgus monkeys demonstrated natalizumab-related changes in the foetus that included mild anaemia, reduced platelet counts, increased spleen weights and reduced liver and thymus weights.
Danish: Ændringerne omfattede mild anæmi, reduceret blodpladetal, øget miltvægt og reduceret lever- og thymusvægt.
English: Other medicines and TYSABRI Tell your doctor if you are taking or have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, hvis De bruger anden medicin eller har gjort det for nylig.
English: There are no studies on the effects of TYSABRI on the ability to drive and use machines.
Danish: Der foreligger ingen studier af TYSABRIs indvirkning på evnen til at føre motorkøretøj eller betjene maskiner, men hvis De oplever svimmelhed, som er en almindelig bivirkning, må De ikke køre bil eller betjene maskiner..
English: Stopping TYSABRI therapy
Danish: TYSABRIs natriumindhold
English: How to use TYSABRI
Danish: Sådan skal De tage TYSABRI
English: What you need to know before you use TYSABRI
Danish: Det skal De vide, før De begynder at tage TYSABRI Sådan skal De tage TYSABRI Bivirkninger
English: MedDRA System Organ Class Adverse reaction
Danish: MedDRA-systemorganklasse Bivirkninger
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 Diagnosis and prognosis of symptomatic and asymptomatic PML differentiation between PML and MS
Danish: • 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 immunsuppressive 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 Diagnosticering af og prognose for symptomatisk og asymptomatisk PML differentiering mellem PML og MS o PML-behandlingsalgoritme o Anbefalingen, at patienterne bør MR-scannes på følgende tidspunkter: Inden for 3 måneder inden behandlingsstart med TYSABRI Årligt under behandling med TYSABRI Hyppigere MR-scanninger (f.eks. hver 3. til 6. måned) af patienter med høj risiko for udvikling af PML Ved det første tegn på ethvert symptom, der indikerer muligheden for PML.
English: • Being sick (vomiting)
Danish: • Kløende udslæt (nældefeber)
English: • Severe allergy (hypersensitivity) • Progressive multifocal leukoencephalopathy (PML)
Danish: • Progressiv multifokal leukoencefalopati (PML)
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Danish: Koncentrat til fortynding med opløsning til infusion.
English: • Tiredness
Danish: • Ledsmerte
English: − Weight loss
Danish: Fortyndet opløsning:
English: Discontinue administration of TYSABRI and initiate appropriate therapy at the first symptoms or signs of hypersensitivity.
Danish: Ved symptomer eller tegn på overfølsomhed skal indgivelsen af TYSABRI afbrydes, og passende behandling påbegyndes.
English: − Headache
Danish: − Hovedpine
English: • Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk and other factors associated with an increased risk for the development of PML
Danish: • Information om, at atypiske/opportunistiske infektioner, især PML, kan optræde i forbindelse med TYSABRI-behandling, herunder:
English: Intravenous use.
Danish: infusion.
English: − Severe diarrhoea
Danish: − Kortåndethed
English: Latvija
Danish: filiāle Latvijā
English: Patients who have experienced a hypersensitivity reaction must be permanently discontinued from treatment with TYSABRI.
Danish: Behandlingen med TYSABRI skal afbrydes permanent for patienter, som har oplevet en overfølsomhedsreaktion.
English: Each vial contains 2.3 mmol (or 52 mg) sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder 2,3 mmol (eller 52 mg) natrium.
English: Dizziness
Danish: − Sløvhed
English: Sodium phosphate, monobasic, monohydrate, Sodium phosphate, dibasic, heptahydrate, Sodium chloride (see section 2 ‘TYSABRI contains sodium'), Polysorbate 80 (E433)
Danish: 2 ‘TYSABRI indeholder natrium') Polysorbat 80 (E433)
English: At the first sign of any symptoms indicative of the possibility of PML.
Danish: Det kan være nødvendigt, at Deres læge undersøger disse symptomer nøjere for at udelukke PML.
English: Sodium content in TYSABRI
Danish: Brug af anden medicin sammen med TYSABRI
English: Unopened vial:
Danish: Uåbnede hætteglas:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Optimark on 23 July 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Optimark den 23. juli 2007.
English: Optimark gadoversetamide
Danish: Optimark gadoversetamid
English: The recommended dose is 0.2 ml per kilogram body weight.
Danish: Den anbefalede dosis er 0,2 ml pr. kg legemsvægt.
English: The full EPAR for Optimark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Optimark findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Optimark.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Optimark.
English: It is given as an injection into a vein, usually a vein in an arm.
Danish: Det gives som en injektion i en vene, sædvanligvis en vene i en arm.
English: The scans were analysed by three radiologists (doctors specialised in carrying out and interpreting scans of the body).
Danish: Scanningerne blev analyseret af tre radiologer (læger specialiseret i at udføre og fortolke scanninger af kroppen).
English: The radiologists did not know what treatment the patient had received beforehand, to make sure that the studies' findings were as accurate as possible.
Danish: Radiologerne vidste ikke, hvilken behandling patienten havde fået inden, så man var sikker på at få så nøjagtige undersøgelsesresultater som muligt.
English: In addition, the company will provide annual reviews of cases of NSF and conduct a study on the accumulation of gadolinium in the bone.
Danish: Virksomheden vil desuden hvert år fremlægge en gennemgang af NSF-tilfælde og gennemføre en undersøgelse af ophobningen af gadolinium i knoglerne.
English: Optimark is for diagnostic use.
Danish: Optimark er til diagnostisk brug.
English: Patients who have moderate problems with their kidneys should only receive Optimark if their doctor has carefully balanced the benefits and risks of using it.
Danish: Patienter, som har moderate problemer med deres nyrer, bør kun tage Optimark, hvis deres læge nøje har foretaget en afvejning af fordele og risici ved brug heraf.
English: These patients should receive no more than one dose of Optimark during each MRI scan, and there should be a gap of at least a week between each Optimark injection.
Danish: Disse patienter bør højst få en dosis Optimark under hver MRI-scanning, og der skal være et interval på mindst en uge mellem hver Optimark-injektion.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Optimark.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Optimark skal anvendes.
English: Other information about Optimark:
Danish: Andre oplysninger om Optimark
English: Optimark should only be given by a doctor who has experience in using MRI.
Danish: Optimark bør kun gives af læger med erfaring i anvendelse af MRI.
English: What measures are being taken to ensure the safe and effective use of Optimark?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Optimark?
English: The company that markets Optimark will ensure that all healthcare professionals who are expected to use this medicine are informed that it should not be used in children below 2 years as the effect of the medicine in this age group, such as its effect on immature kidneys, has not been studied.
Danish: Virksomheden, der markedsfører Optimark, sikrer, at alt sundhedspersonale, som forventes at ordinere dette lægemiddel, er informeret om, at det ikke må anvendes til børn under to år, da lægemidlets virkning hos denne aldersgruppe (f.eks. virkningen på ikke fuldt udviklede nyrer) endnu ikke er undersøgt.
English: Each scan's clarity was scored on a four-point scale.
Danish: For hver scanning blev billedets klarhed bedømt på en 4pointsskala.
English: It must not be used in patients who have severely reduced kidney function, in patients who have had or are about to have a liver transplant, or in babies aged less than four weeks, due to a risk of a condition called nephrogenic systemic fibrosis (NSF).
Danish: Det må ikke anvendes til patienter med alvorlige nyreproblemer, patienter, som har fået eller skal have en levertransplantation, eller til spædbørn under fire uger på grund af risiko for en sygdom, der hedder nefrogen systemisk fibrose (NSF).
English: For more information about treatment with Optimark, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Optimark, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.