FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 3 or higher neutropenia, thrombocytopenia, and anaemia present after Day 93 occurred in 11%, 7%, and 3% of patients, respectively.
Danish: Grad 3 eller højere neutropeni, trombocytopeni og anæmi, som er til stede efter dag 93, forekom hos henholdsvis 11 %, 7 % og 3 % af patienterne.
English: No concurrent CRS
Danish: Ingen samtidig CRS
English: The PRAC considers that the product information of axicabtagene ciloleucel should be amended to reflect the risk of spinal cord oedema, myelitis and quadriplegia associated with axicabtagene ciloleucel therapy.
Danish: PRAC vurderer, at produktinformationen for axicabtagene ciloleucel skal opdateres for at afspejle risikoen for rygmarvsødem, myelitis og tetraplegi i forbindelse med behandling med axicabtagene ciloleucel.
English: After the first 10 days following the infusion, the patient should be monitored at the physician's discretion.
Danish: Efter de første 10 dage efter infusionen skal patienten monitoreres efter lægens skøn.
English: Grade 3 or higher neutropenia (including febrile neutropenia), anaemia, and thrombocytopenia occurred in 80%, 45%, and 40% of patients, respectively.
Danish: Grad 3 eller højere neutropeni (herunder febril neutropeni), anæmi og trombocytopeni forekom hos hhv. 80 %, 45 % og 40 % af patienterne.
English: - Decreased levels of sodium, phosphate, or potassium which will show up on blood tests.
Danish: Reducerede niveauer af natrium, fosfat eller kalium, hvilket påvises i blodprøver.
English: YESCARTA 0.4 - 2 x 108 cells dispersion for infusion
Danish: YESCARTA 0,4 - 2 x 108 celler infusionsvæske, dispersion
English: Hypogammaglobulinaemia has been very commonly observed in patients treated with YESCARTA.
Danish: Hypogammaglobulinæmi er meget almindeligt observeret hos patienter behandlet med YESCARTA.
English: Grading assessment
Danish: Bedømmelse af grad
English: - Failure of the kidneys causing your body to hold onto fluid which can be serious or life threatening.
Danish: Nyresvigt, hvilket betyder, at kroppen bevarer væske, hvilket kan være alvorligt eller livstruende.
English: This medicine contains genetically modified human blood cells.
Danish: Dette lægemiddel indeholder genetisk modificerede humane blodceller.
English: Administer methylprednisolone 1000 mg intravenously per day for 3 days; if improves, then manage as above.
Danish: Administrér methylprednisolon 1000 mg intravenøst dagligt i 3 dage; ved bedring behandles som beskrevet ovenfor.
English: Treatment algorithms have been developed to ameliorate the neurologic adverse reactions experienced by patients on YESCARTA.
Danish: Behandlingsalgoritmer er blevet udviklet for at modvirke de neurologiske bivirkninger, som opleves af patienter i behandling med YESCARTA.
English: To prepare YESCARTA, patient's own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment linked to CD28 co-stimulatory domain and CD3-zeta signalling domain.
Danish: YESCARTA fremstilles ved at høste en patients egne T-celler og genetisk modificere dem ex vivo ved retroviral transduktion, så de udtrykker en kimær antigenreceptor (CAR) bestående af et murint anti-CD19 enkeltkæde variabelt fragment forbundet med CD28 co-stimulerende domæne og CD3-zeta signaleringsdomæne.
English: The most common signs or symptoms associated with neurologic adverse reactions included encephalopathy (58%), headache (40%), tremor (31%), dizziness (21%), aphasia (18%), and delirium (17%).
Danish: De mest almindelige tegn og symptomer forbundet med neurologiske bivirkninger inkluderede encefalopati (58 %), hovedpine (40 %), rysten (31 %), svimmelhed (21 %), afasi (18 %) og delirium (17 %).
English: The median peak level of anti-CD19 CAR T cells in the blood (Cmax) was 38.3 cells/µL (range: 0.8 to 1513.7 cells/μL), which decreased to a median of 2.1 cells/µL by 1 month (range: 0 to 167.4 cells/μL) and to a median of 0.4 cells/µL by 3 months (range: 0 to 28.4 cells/μL) after YESCARTA infusion.
Danish: 38,3 celler/mikrol (interval: 0,8 til 1513,7 celler/mikrol), hvilket aftog til et gennemsnit på 2,1 celler/mikrol efter 1 måned (interval: 0 til 167,4 celler/mikrol) og til et gennemsnit på 0,4 celler/mikrol efter 3 måneder (interval 0 til 28,4 celler/mikrol) efter infusion med YESCARTA.
English: Leukopenia Neutropenia Anaemia
Danish: Leukopeni Neutropeni Anæmi
English: - Feeling sick, constipation, diarrhoea, pain in the stomach or being sick.
Danish: Kvalme, forstoppelse, diarré, mavesmerter eller opkastning.
English: Concurrent CRS
Danish: Samtidig CRS
English: Thirty were found to have double expressor DLBCL (overexpression of both MYC and BCL-2 protein); 5 were found to have HGBCL with MYC, BCL-2 or BCL-6 gene rearrangement (double- and triple-hit); and 2 were found to have HGBCL not otherwise specified.
Danish: Tredive havde dobbeltekspression af DLBCL (overekspression af både MYC og BCL-2 protein), 5 havde HGBCL med re-arrangement af genet MYC, BCL-2 eller BCL-6 (dobbelt og tredobbelt hit) og 2 havde HGBCL som ikke var specificeret på anden vis. Seksogtres patienter var evaluerbare for cell-of-origin klassifikationer (germinalcenter B-celletype [GCB] eller aktiveret B-celletype [ABC]).
English: 17.4 (11.6, NE) 17.4 (11.6, NE) NE (12.8, NE)
Danish: 17,4 (11,6; NE)
English: Patients should be monitored at least daily for 10 days at the qualified healthcare facility following infusion for signs and symptoms of neurologic toxicity.
Danish: Patienterne skal som minimum monitoreres dagligt i de første 10 dage på den kvalificerede klinik efter infusionen for tegn og symptomer på neurologisk toksicitet.
English: Continue corticosteroids use until the event is Grade 1 or less, then taper over 3 days.
Danish: Fortsæt behandling med kortikosteroider, indtil hændelsen er grad 1 eller lavere, nedtrap derefter over 3 dage.
English: CRS grading and management guidance
Danish: Tabel 1: Vejledning til bedømmelse og behandling af CRS
English: Motor dysfunction Pain in extremity Back pain Arthralgia Muscle pain
Danish: Motorisk dysfunktion Smerter i ekstremitet Rygsmerter Artralgi
English: Each bag of YESCARTA contains 300 mg sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver pose med YESCARTA indeholder 300 mg natrium.
English: - Extreme tiredness.
Danish: Ekstrem træthed.
English: •Update reports:
Danish: •Endelig rapport med studieresultater:
English: It is unknown whether YESCARTA is excreted in human milk or transferred to the breast-feeding child. Breast-feeding women should be advised of the potential risk to the breast-fed child.
Danish: Det er ukendt, om YESCARTA udskilles i human mælk eller overføres til det ammede spædbarn.
English: Continue dexamethasone use until the event is Grade 1 or less, then taper over 3 days.
Danish: Fortsæt brug af dexamethason, indtil hændelsen er Grad 1 eller lavere, nedtrap derefter over 3 dage.
English: - Lung infection.
Danish: Lungeinfektion.
English: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (CAR) with a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg.
Danish: Autologe T-celler transduceret med retroviral vektor, der koder en anti-CD19 CD28/CD3-zeta kimærisk antigenreceptor (CAR) med en måldosis på 2 x 106 anti-CD19 CAR-positive, levedygtige T-celler/kg.
English: • A lymphodepleting chemotherapy regimen consisting of cyclophosphamide 500 mg/m2 intravenous and fludarabine 30 mg/m2 intravenous should be administered on the 5th, 4th, and 3rd day before infusion of YESCARTA.
Danish: 500 mg/m2 og intravenøs fludarabin 30 mg/m2 som skal administreres på 5., 4. og 3. dagen inden infusion af YESCARTA.
English: Local biosafety guidelines should be followed for unused medicinal products or waste material.
Danish: Gældende lokale retningslinjer vedrørende biosikkerhed for sådanne produkter skal følges i forbindelse med ikke anvendte lægemidler eller affaldsmateriale.
English: Accordingly, healthcare professionals should take appropriate precautions (wearing gloves and glasses) when handling leukapheresis material or YESCARTA to avoid potential transmission of infectious diseases.
Danish: Sundhedspersonale, der håndterer YESCARTA, skal derfor tage hensigtsmæssige forholdsregler (bruge handsker og øjenværn), når de håndterer leukaferesemateriale eller YESCARTA for at undgå mulig overførsel af smitsomme sygdomme.
English: Primary central nervous system (CNS) lymphoma
Danish: Primært lymfom i centralnervesystemet (CNS)
English: • Inspect the product bag for any breaches of container integrity before thawing.
Danish: • Efterse posen med produkt for brud inden optøning.
English: • Verify the patient ID again to match the patient identifiers on the YESCARTA bag.
Danish: • Kontrollér igen, at patient-ID'et matcher patientidentifikationerne på posen med YESCARTA.
English: Counsel patients to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion and to seek immediate medical attention should signs or symptoms of CRS occur.
Danish: Tilråd patienterne at blive nær en kvalificeret klinik i mindst 4 uger efter infusionen og at søge omgående lægehjælp, hvis de oplever tegn eller symptomer på CRS.
English: lightheadedness, fluid in the lungs, which may be severe and can be fatal (all symptoms of a condition called cytokine release syndrome).
Danish: Feber, kulderystelser, nedsat blodtryk, der kan forårsage symptomer, såsom svimmelhed, fortumlethed, væske i lungerne, hvilket kan være alvorligt og muligvis dødeligt (alle er symptomer på en tilstand kaldet cytokin release syndrom).
English: • Paracetamol 500-1,000 mg given orally and diphenhydramine 12.5 to 25 mg intravenous or oral
Danish: • Paracetamol 500-1000 mg administreret oralt og diphenhydramin 12,5 til 25 mg administreret intravenøst eller oralt (eller tilsvarende) cirka 1 time inden infusion af YESCARTA anbefales.
English: Among 73 patients with evaluable samples at baseline, 40% had detectable B-cells; the B-cell aplasia observed in the majority of patients at baseline was attributed to prior therapies.
Danish: Blandt 73 patienter med evaluerbare prøver ved baseline havde 40 % påviselige B-celler.
English: Hypersensitivity Histiocytosis Haematophagic
Danish: Hypersensitivitet Hæmatofagisk histiocytose
English: YESCARTA comprises human autologous T cells.
Danish: YESCARTA består af humane autologe T-celler.
English: - Hypersensitivity.
Danish: Overfølsomhed.
English: Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions, or hypotension) including from preceding chemotherapies.
Danish: • Vedvarende alvorlige bivirkninger (især lungereaktioner, hjertereaktioner eller hypotension),
English: - Decreased levels of calcium which will show up on blood tests.
Danish: Reducerede niveauer af calcium, hvilket påvises i blodprøver.
English: - Decreased levels of albumin which will show up on blood tests.
Danish: Nedsatte niveauer af albumin, hvilket påvises i blodprøver.
English: The median time to onset was 5 days (range: 1 to 17 days).
Danish: Den gennemsnitlige tid til symptomstart var 5 dage (mellem 1 og 17 dage).
English: If you think you may be allergic, ask your doctor for advice.
Danish: Spørg lægen om råd, hvis du tror, du er allergisk.
English: - Increased levels of bilirubin reporting on how your liver is working, which will show up on blood tests.
Danish: Øgede niveauer af bilirubin, hvilket påvises i blodprøver og fortæller, hvordan din lever fungerer.
English: Counsel patients to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion and to seek immediate medical attention should signs or symptoms of neurologic toxicity occur.
Danish: Tilråd patienter at blive nær en kvalificeret klinik i mindst 4 uger efter infusionen og at søge omgående lægehjælp, hvis de oplever tegn eller symptomer på neurologisk toksicitet.
English: Neurologic adverse reactions
Danish: Neurologiske bivirkninger
English: - have kidney problems.
Danish: - Har nyreproblemer.
English: Other medicines and YESCARTA
Danish: Brug af anden medicin sammen med YESCARTA
English: Each patient-specific single infusion bag contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg.
Danish: Hver enkelt patientspecifik infusionspose indeholder en dispersion med anti-CD19 CAR T-celler i cirka 68 ml for en måldosis med 2 x 106 anti-CD19 CAR-positive, levedygtige T-celler/kg.
English: It is not known if YESCARTA has the potential to be transferred to the foetus.
Danish: 5.3) Det vides ikke, om YESCARTA kan overføres til fosteret.
English: • Once thawed, YESCARTA is stable at room temperature (20 °C-25 °C) for up to 3 hours.
Danish: • Efter optøning er YESCARTA stabil ved stuetemperatur (20 °C-25 °C) i op til 3 timer.
English: Delirium Anxiety
Danish: Delirium Angst
English: - Heart failure.
Danish: Hjertesvigt.
English: Adverse drug reactions identified with YESCARTA
Danish: Tabel 3: Bivirkninger identificeret med YESCARTA
English: YESCARTA 0.4 - 2 x 108 cells dispersion for infusion axicabtagene ciloleucel (CAR+ viable T cells) For intravenous use only.
Danish: YESCARTA, 0,4 - 2 x 108 celler infusionsvæske, dispersion axicabtagene ciloleucel (CAR+ levedygtige T-celler) Kun til intravenøs anvendelse.
English: Store frozen in vapour phase of liquid nitrogen ≤ -150˚C.
Danish: Opbevares nedfrosset i dampformen af flydende kvælstof ≤ -150 °C.
English: (b) Refer to Table 2 for management of neurologic adverse reactions.
Danish: Tabel 2: Vejledning til bedømmelse og behandling af neurologiske bivirkninger
English: Spinal cord oedema was reported, in the context of neurologic toxicity in the post-marketing setting.
Danish: Rygmarvsødem i forbindelse med neurologisk toksicitet blev rapporteret efter markedsføring.
English: Each patient specific single infusion bag of YESCARTA contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg body weight (range: 1 x 106 - 2 x 106 cells/kg), with a maximum of 2 x 108 anti-CD19 CAR T cells.
Danish: Hver enkelt patientspecifik infusionspose med YESCARTA indeholder en dispersion af anti-CD19 CAR T-celler i cirka 68 ml dispersion for at opnå en måldosis på 2 x 106 anti-CD19 CAR-positive, levedygtige T-celler/kg legemsvægt (interval: 1 x 106 - 2 x 106 celler/kg), og maksimum 2 x 108 antiCD19 CAR T-celler.
English: How YESCARTA is given
Danish: Sådan gives YESCARTA
English: YESCARTA 0.4 - 2 x 108 cells dispersion for infusion axicabtagene ciloleucel (CAR+ viable T cells)
Danish: YESCARTA, 0,4 - 2 x 108 celler infusionsvæske, dispersion axicabtagene ciloleucel (CAR+ levedygtige T-celler
English: Febrile neutropenia has been observed in patients after YESCARTA infusion (see section 4.8) and may be concurrent with CRS.
Danish: Febril neutropeni er blevet observeret hos patienter efter infusion med YESCARTA (se pkt.
English: Store frozen in vapour phase of liquid nitrogen ≤ -150 °C until thawed for use.
Danish: Skal opbevares nedfrosset i dampformen af flydende kvælstof ved ≤ -150 °C indtil det optøs til brug.
English: YESCARTA, an engineered autologous T-cell immunotherapy product, binds to CD19 expressing cancer cells and normal B cells.
Danish: Det binder til kræftceller, som udtrykker CD19, og til normale B-celler.
English: Thrombosis Capillary leak syndrome
Danish: Trombose Kapillær lækagesyndrom
English: Gently mix the contents of the bag while thawing.
Danish: Bland forsigtigt posens indhold under optøning.
English: What you need to know before you are given YESCARTA
Danish: Det skal du vide, før du får YESCARTA Modtag ikke YESCARTA
English: A total of 108 patients were treated with YESCARTA in a phase 1/2 open-label, multicentre, singlearm study in patients with relapsed or refractory aggressive B-cell NHL.
Danish: DLBCL, PMBCL og DLBCL transformeret fra follikulært lymfom (ZUMA-1) I alt 108 patienter blev behandlet med YESCARTA i et fase 1/2, ublindet, enarmet, multicenterstudie med patienter med recidiveret eller refraktær aggressiv B-celle NHL.
English: Spinal cord oedema Myelitis
Danish: Rygmarvsødem Myelitis Tetraplegi
English: Hypocalcaemia Hypoalbuminaemia
Danish: Hypokalcæmi Hypoalbuminæmi
English: Ataxia Neuropathy Seizure
Danish: Neuropati Krampeanfald Dyskalkuli Myokloni
English: HCP Educational program
Danish: Uddannelsesprogram til sundhedspersonale
English: Kite Pharma EU B.V. Science Park 406
Danish: Science Park 406
English: Patients were not required to be followed after they progressed; thus, the majority of patients with evaluable samples were responders.
Danish: Således var størstedelen af patienter med evaluerbare prøver responderende patienter.
English: How you are given YESCARTA
Danish: Sådan får du YESCARTA
English: Respiratory, thoracic and mediastinal disorders Very common
Danish: Knogler, led, muskler og bindevæv Meget almindelig
English: - Increased levels of liver enzymes which will show up on blood tests.
Danish: Øgede niveauer af leverenzymer, hvilket påvises i blodprøver.
English: Dyspnoea Hypoxia Pleural effusion
Danish: Dyspnø Hypoxi Pleuraekssudat
English: Kite Pharma EU B.V. Science Park 408
Danish: Science Park 408
English: - Muscle and joint pain, back pain.
Danish: Muskel- og ledsmerter, rygsmerter.
English: • Look for signs of infection; any infection will be treated before you are given YESCARTA.
Danish: En eventuel infektion vil blive behandlet, inden du får indgivet
English: Vomiting Constipation Abdominal pain Dry mouth
Danish: Kvalme Opkastning Forstoppelse Mavesmerter Mundtørhed
English: - Anxiety.
Danish: Synkebesvær.
English: What you need to know before you are given YESCARTA 3.
Danish: Virkning og anvendelse Det skal du vide, før du får YESCARTA Sådan gives YESCARTA Bivirkninger
English: Rash
Danish: Race
English: Not applicable 47.7 (38.2, 56.7) Not applicable 50.5 (40.4, 59.7)
Danish: NE (0,4; 17,3) NE (0,4; 29,5) NE (0,4; 17,3) NE (0,4; 29,5)
English: Quadriplegia
Danish: Kulderystelser
English: Encephalopathy Headache Tremor
Danish: Encefalopati Hovedpine Rysten Svimmelhed Afasi
English: Per Grade 2
Danish: Som grad 2
English: A.
Danish: NE)
English: - Muscle spasms.
Danish: Muskelspasmer.
English: •Final report of study results: December 2038
Danish: December 2038
English: Dizziness Aphasia
Danish: Nyrer og urinveje
English: Further information on Mayzent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Mayzent.
Danish: Yderligere information om Mayzent findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Mayzent.
English: Other information about Mayzent
Danish: Andre oplysninger om Mayzent
English: Mayzent is available as tablets and should be taken once a day.
Danish: Mayzent fås som tabletter og bør tages én gang dagligt.
English: As for all medicines, data on the use of Mayzent are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Mayzent løbende overvåget.
English: The maintenance dose is either 1 mg or 2 mg daily, depending on how quickly the patient's body can process the medicine.
Danish: Vedligeholdelsesdosen er enten 1 mg eller 2 mg dagligt afhængigt af, hvor hurtigt patientens krop optager lægemidlet.
English: What measures are being taken to ensure the safe and effective use of Mayzent?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mayzent?
English: The most common side effects with Mayzent (which may affect more than 1 in 10 people) are headache and hypertension (high blood pressure).
Danish: De hyppigste bivirkninger ved Mayzent (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine og forhøjet blodtryk.
English: The European Medicines Agency therefore decided that Mayzent should only be used in patients whose disease is active with signs of inflammation.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at Mayzent kun bør anvendes hos patienter, hvis sygdom er aktiv med tegn på inflammation.
English: This is determined by the use of a blood or saliva test to measure the activity of the patient's liver enzyme CYP2C9.
Danish: Dette afgøres ved hjælp af en blod- eller spytprøve, der viser aktiviteten af patientens CYP2C9-leverenzym.
English: Why is Mayzent authorised in the EU?
Danish: Hvorfor er Mayzent godkendt i EU?
English: Mayzent must also not be used in patients who have inherited a gene known as CYP2C9*3 from both parents, which makes them unable to process the medicine fast enough.
Danish: Mayzent må heller ikke anvendes hos patienter, der har arvet genet CYP2C9*3 fra begge forældre, da det gør, at de ikke kan optage lægemidlet hurtigt nok.
English: Mayzent must also not be used in patients with cancer and certain immune disorders due to its effect on the immune system.
Danish: Mayzent må heller ikke anvendes hos patienter med kræft og visse immunforstyrrelser på grund af dets indvirkning på immunsystemet.
English: An overview of Mayzent and why it is authorised in the EU
Danish: En oversigt over Mayzent, og hvorfor det er godkendt i EU
English: The Agency therefore decided that Mayzent's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Mayzent opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Mayzent are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Mayzent vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: What are the risks associated with Mayzent?
Danish: Hvilke risici er der forbundet med Mayzent?
English: The materials will include a guide for patients with key safety information about Mayzent, as well as a pregnancy reminder card for women who can become pregnant.
Danish: Materialerne skal omfatte en vejledning til patienter med vigtig sikkerhedsinformation om Mayzent samt et påmindelseskort til kvinder, der kan blive gravide.
English: Mayzent was shown to be effective at delaying the progression of the disease in a 3-year main study involving 1,651 patients with secondary progressive MS, of whom 779 had active disease with a relapse within 2 years or other signs of inflammation in scans.
Danish: Mayzent blev påvist at være effektivt til at udskyde sygdomsprogression i et 3-årigt hovedstudie, der omfattede 1.651 patienter med sekundær progressiv multipel sklerose, hvoraf 779 havde aktiv sygdom med et attak inden for 2 år eller andre tegn på inflammation i henhold til scanninger.
English: It must not be used in patients who have recently had a stroke and in patients with certain heart disorders (because of its effects on heart rate and blood pressure), severe liver disorders and in pregnant women and women who can become pregnant and are not using effective contraception.
Danish: Det må heller ikke bruges hos patienter, der for nylig har haft et slagtilfælde, patienter med visse hjertesygdomme (på grund af indvirkningen på hjerterytmen og blodtrykket), patienter med alvorlige leversygdomme, gravide kvinder eller kvinder, som kan blive gravide og ikke bruger sikker prævention.
English: What is Mayzent and what is it used for?
Danish: Hvad er Mayzent, og hvad anvendes det til?
English: Disease progression was defined as worsening of the disease that is independent from a relapse and is maintained over at least 3 months, as assessed using a standard scale called EDSS.
Danish: Sygdomsprogression blev defineret som en forværring af sygdommen, uafhængigt af attakker, der vedvarer i mindst 3 måneder som vurderet på den såkaldte EDSS-standardskala.
English: The medicine must also not be used in patients who previously had certain severe infections (known as progressive multifocal leukoencephalopathy or cryptococcal meningitis).
Danish: Lægemidlet må heller ikke anvendes hos patienter, der tidligere har haft visse alvorlige infektioner (progressiv multifokal leukoencefalopati eller kryptokokmeningitis).