FrancophonIA/ELRC3.0 huggingface dataset:
English: A population pharmacokinetics analysis was conducted on samples from over 1,100 MS patients receiving doses ranging from 3 to 6 mg/kg natalizumab.
Danish: En populations-farmakokinetisk analyse blev gennemført med prøver fra mere end 1.100 MS-patienter, som fik doser fra 3 til 6 mg/kg natalizumab.
English: You should discuss with your doctor if TYSABRI is the most suitable treatment for you before you start taking TYSABRI and when you have been taking TYSABRI for more than two years.
Danish: De bør drøfte med Deres læge, om behandling med TYSABRI er den mest hensigtsmæssige behandling for Dem, inden De starter med at få TYSABRI, og hvis De har fået TYSABRI i mere end to år.
English: • If you are allergic to natalizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis De er allergisk over for natalizumab eller et af de øvrige indholdsstoffer i TYSABRI (angivet i punkt 6).
English: Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months
Danish: Fortsat behandling bør overvejes nøje hos patienter, som ikke udviser tegn på terapeutisk gavn efter 6 måneders behandling.
English: PML may lead to severe disability or death.
Danish: PML kan føre til svære funktionstab (invaliditet) eller død.
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Danish: De vil også finde denne information i det patientinformationskort, som Deres læge har givet Dem.
English: In patients considered at high risk treatment with TYSABRI should only be continued if the benefits outweigh the risks.
Danish: Hos patienter, som regnes for at have en høj risiko, bør behandling med TYSABRI kun fortsættes, hvis fordelene ved behandling overstiger risiciene.
English: The rate of defects corresponds to the defect rates reported in other pregnancy registries involving MS patients.
Danish: Dette antal svarer til, hvad der er rapporteret i andre graviditetsregistre for MS-patienter.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27th June 2006
Danish: Dato for første markedsføringstilladelse: 27. juni 2006 Dato for seneste fornyelse:
English: Resources for the management of hypersensitivity reactions should be available.
Danish: Ressourcer til håndtering af overfølsomhedsreaktioner skal være tilgængelige.
English: If you have all three risks described above your chance of getting PML is higher.
Danish: Hvis De har alle de tre risikofaktorer, der er beskrevet ovenfor, er Deres risiko for at få PML større.
English: The risk for hypersensitivity was greatest with early infusions and in patients re-exposed to TYSABRI following an initial short exposure (one or two infusions) and extended period (three months or more) without treatment.
Danish: Risikoen for overfølsomhed var størst i forbindelse med de første infusioner og hos patienter re-eksponeret for TYSABRI efter en indledende kortvarig eksponering (en eller to infusioner) og en længerevarende periode (tre måneder eller mere) uden behandling.
English: TYSABRI stops the cells that cause inflammation from going into your brain.
Danish: TYSABRI forhindrer de celler, der forårsager betændelsen, i at trænge ind i hjernen.
English: Based on how patients treated with TYSABRI are currently monitored at national level, the Marketing Authorisation Holder (MAH) shall discuss and agree with the National Competent Authorities measures to enhance further this monitoring (e.g. registries, post-marketing surveillance studies) as appropriate.
Danish: Afhængigt af hvordan TYSABRI-behandlede patienter på nuværende tidspunkt monitoreres nationalt, skal indehaveren af markedsføringstilladelsen og de nationalt ansvarlige myndigheder drøfte og aftale foranstaltninger for yderligere at fremme denne monitorering på passende vis (f.eks. registre, overvågningsstudier efter markedsføringen).
English: • The presence of anti-JCV antibodies.
Danish: • Tilstedeværelse af anti-JCV-antistof.
English: Tell your doctor immediately if you have, or think you have, any sort of infection (see side effects).
Danish: Infektioner Fortæl det straks til lægen, hvis De har eller tror, De har, en infektion (se bivirkninger).
English: Elevations in neutrophils were not seen.
Danish: Der blev ikke observeret stigning i neutrofile granulocytter.
English: Adverse reactions reported with natalizumab with an incidence of 0.5% greater than reported with placebo are shown below.
Danish: Bivirkninger, som blev indberettet i forbindelse med natalizumab med en incidens på 0,5 % højere end indberettet for placebo, er vist nedenfor.
English: TYSABRI is for intravenous use.
Danish: TYSABRI er til intravenøs anvendelse
English: If particles are observed and/or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.
Danish: Hvis der observeres partikler, og/eller hvis væsken i hætteglasset ikke er farveløs, klar til let opaliserende, må hætteglasset ikke anvendes.
English: Disease exacerbations or infusion related events may indicate the development of antibodies against natalizumab.
Danish: Sygdomsforværring eller infusionsrelaterede hændelser kan indikere udvikling af antistoffer mod natalizumab.
English: METHOD OF ADMINISTRATION Dilute before infusion.
Danish: ADMINISTRATIONSMETODE Fortyndes inden infusion.
English: Before you start treatment with TYSABRI, it is important that you and your doctor have discussed the benefits you would expect to receive from this treatment and the risks that are associated with it.
Danish: Det skal De vide, før De begynder at tage TYSABRI Inden De påbegynder behandlingen med TYSABRI, er det vigtigt, at De og Deres læge har diskuteret, hvilke fordele De kan forvente at få af denne behandling, og hvilke risici der er forbundet med behandlingen.
English: • TYSABRI must be diluted before it is given to you.
Danish: • TYSABRI skal fortyndes, inden De får det.
English: Your doctor may repeat this blood test while you are on TYSABRI treatment to check if anything has changed.
Danish: Deres læge kan gentage denne blodprøve, mens De er i behandling med TYSABRI, for at undersøge, om noget har ændret sig.
English: The majority of patients did not interrupt natalizumab therapy during infections and recovery occurred with appropriate treatment.
Danish: Størstedelen af patienterne fortsatte natalizumab-behandlingen under en infektion og restituerede under passende behandling.
English: In a study in monkeys, the number of abortions was doubled in the natalizumab 30 mg/kg treatment groups versus matching control groups.
Danish: I et forsøg med aber var antallet af aborter fordoblet hos natalizumab-behandlede (30 mg/kg) grupper i forhold til matchende kontrolgrupper.
English: The interaction between α4β1 and its targets is an important component of pathological inflammation in the brain and disruption of these interactions leads to reduced inflammation.
Danish: Interaktionen mellem α4β1 og dets bindingssteder (targets) er en vigtig komponent i den patologiske inflammation i hjernen, og blokering af disse interaktioner medfører reduceret inflammation.
English: 15 ml concentrate in a vial (type I glass) with a stopper (bromobutyl rubber) and a seal (aluminium) with a flip-off cap.
Danish: 15 ml koncentrat i et hætteglas (Type I glas) med en prop (bromobutylgummi) og en forsegling (aluminium) med flip-off hætte.
English: In 2-year controlled clinical trials in MS patients, an infusion-related event was defined as an adverse event occurring during the infusion or within 1 hour of the completion of the infusion.
Danish: I 2-års kontrollerede kliniske forsøg med MS-patienter var en infusionsrelateret reaktion defineret som en uønsket hændelse, der opstod under infusionen eller inden for én time efter, at infusionen var tilendebragt.
English: TYSABRI 300 mg is administered by intravenous infusion once every 4 weeks.
Danish: TYSABRI 300 mg indgives som intravenøs infusion én gang hver 4. uge.
English: • Information for medical or healthcare professionals on how to prepare and administer TYSABRI is provided at the end of this leaflet.
Danish: • Information til læger og sundhedspersonale, om hvordan TYSABRI klargøres og indgives, findes sidst i denne indlægsseddel.
English: If a decision is made to stop treatment with natalizumab, the physician needs to be aware that natalizumab remains in the blood, and has pharmacodynamic effects (e.g increased lymphocyte counts) for approximately 12 weeks following the last dose.
Danish: Hvis det besluttes at standse behandlingen med natalizumab, bør lægen erindre, at natalizumab forbliver i blodet og har farmakodynamiske virkninger (f.eks. forhøjet lymfocyttal) i cirka 12 uger efter den sidste dosisindgift.
English: In cynomolgus monkeys treated with natalizumab until parturition, low levels of natalizumab were detected in the breast milk of some animals.
Danish: Hos cynomolgus-aber, der blev behandlet med natalizumab indtil fødsel, blev lave niveauer af natalizumab påvist i brystmælken hos nogle af dyrene.
English: In post-marketing experience, there have also been reports of eosinophilia (eosinophil count >1,500/mm3) without clinical symptoms.
Danish: Efter markedsføring er der indberettet eosinofili (eosinofiltal > 1.500 mm3) uden kliniske symptomer.
English: This is because patients who received one or two doses of TYSABRI and then had a gap in treatment of three months or more, were more likely to have an allergic reaction when resuming treatment.
Danish: Dette skyldes, at patienter, der fik én eller to behandlinger med TYSABRI og derefter ingen behandling i en periode på tre måneder eller mere, havde større sandsynlighed for at få en allergisk reaktion, når behandlingen blev genoptaget.
English: If, after approximately 6 months of therapy, persistent antibodies are suspected, either due to reduced efficacy or due to occurrence of infusion-related events, they may be detected and confirmed with a subsequent test 6 weeks after the first positive test.
Danish: Hvis der, efter cirka 6 måneders behandling, er mistanke om persisterende antistoffer, enten på grund af nedsat effekt eller på grund af forekomsten af infusionsrelaterede bivirkninger, kan de påvises og bekræftes ved en efterfølgende test 6 uger efter den første positive test.
English: TYSABRI is contraindicated in children and adolescents below the age of 18 years (see section 4.3).
Danish: TYSABRI er kontraindiceret til børn under 18 år (se pkt.
English: The pharmacokinetics of natalizumab in paediatric MS patients or in patients with renal or hepatic insufficiency has not been studied.
Danish: Farmakokinetikken af natalizumab hos pædiatriske MS-patienter eller hos patienter med nyre- eller leverinsufficiens er ikke blevet undersøgt.
English: Do not use TYSABRI
Danish: Brug ikke TYSABRI
English: The effect of plasma exchange on natalizumab clearance and pharmacodynamics was evaluated in a study of 12 MS patients.
Danish: Virkningen af plasmaferese på natalizumab-clearance og -farmakodynamik er evalueret i et forsøg med 12 MS-patienter.
English: Prescribers should be aware of the possibility that other opportunistic infections may occur during TYSABRI therapy and should include them in the differential diagnosis of infections that occur in TYSABRI-treated patients.
Danish: Ordinerende læger bør være opmærksomme på muligheden for, at der kan optræde andre opportunistiske infektioner under TYSABRI-behandlingen og bør inkludere disse i differentialdiagnostiseringen af infektioner, der optræder hos TYSABRI-behandlede patienter.
English: • That the aim of the treatment initiation form is to provide patients with information on PML and IRIS
Danish: • At formålet med formularen til behandlingsstart er at give patienterne information om PML og
English: Patients can switch directly from beta interferon or glatiramer acetate to natalizumab providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia.
Danish: Patienter kan skifte direkte fra beta interferon eller glatirameracetat til natalizumab, forudsat at der ikke er relevante behandlingsrelaterede abnorme fund f.eks. neutropeni.
English: Infections including other opportunistic infections
Danish: Infektioner, herunder andre opportunistiske infektioner
English: The treatment continuation form should contain the elements of the treatment initiation form and, in addition, a statement that the risks of PML increase with duration of treatment and that treatment beyond 24 months carries additional risk.
Danish: Formularen til fortsat behandling skal indeholde elementerne fra formularen til behandlingsstart og desuden en redegørelse for, at risikoen for PML øges med behandlingsvarigheden, og at behandling ud over 24 måneder medfører en yderligere risiko.
English: Current evidence suggests that the risk of PML is low at an index equal to or below 0.9 and increases substantially above 1.5 for patients who have been on treatment with TYSABRI for longer than 2 years (see the Physician Information and Management Guidelines for further information).
Danish: Aktuel viden tyder på, at risikoen for PML er lav ved en indeksværdi, der er lig med eller under 0,9, og stiger betydeligt ved værdier over 1,5 hos patienter, som har været i behandling med TYSABRI i mere end 2 år (se Information til lægen og Retningslinjer for behandling for yderligere information).
English: • You will also find this information in the Patient Alert Card you have been given by your doctor.
Danish: • De kan også finde denne information i patientinformationskortet, som lægen har givet Dem.
English: Short courses of corticosteroids can be used in combination with TYSABRI.
Danish: Kortvarig kortikosteroid-behandling kan anvendes i kombination med TYSABRI.
English: TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses.
Danish: TYSABRI øger risikoen for at udvikle encephalitis og meningitis forårsaget af herpes simplex- og varicella-zoster-virus.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with TYSABRI in one or more subsets of the paediatric population in multiple sclerosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med TYSABRI i en eller flere undergrupper af den pædiatriske population med multipel sklerose (se pkt.
English: Patients treated with TYSABRI must be given the patient alert card and be informed about the risks of the medicinal product (see also package leaflet).
Danish: Patienter behandlet med TYSABRI skal have udleveret patientinformationskortet, og skal informeres om risici ved behandling med lægemidlet (se også indlægssedlen).
English: Cases of PML have been reported from clinical trials, post-marketing observational studies and postmarketing passive surveillance.
Danish: Tilfælde af PML er blevet rapporteret fra kliniske forsøg, fra observationsstudier efter markedsføringen og i forbindelse med passiv overvågning efter markedsføringen.
English: Given that efficacy may be reduced or the incidence of hypersensitivity or infusion-related reactions may be increased in a patient with persistent antibodies, treatment should be discontinued in patients who develop persistent antibodies.
Danish: Da effekten kan være redu-ceret, eller hyppigheden af overfølsomhed eller infusionsrelaterede reaktioner kan være forøget hos en patient med persisterende antistoffer, bør behandlingen afbrydes hos patienter, der udvikler persisterende antistoffer.
English: In a randomised, open label study of 60 patients with relapsing MS there was no significant difference in the humoral immune response to a recall antigen (tetanus toxoid) and only slightly slower and reduced humoral immune response to a neoantigen (keyhole limpet haemocyanin) was observed in patients who were treated with TYSABRI for 6 months compared to an untreated control group.
Danish: I et randomiseret, åbent studie med 60 patienter med relapsing MS blev der ikke observeret nogen signifikant forskel i humoral immunrespons på et recall-antigen (tetanustoksoid) og kun en lidt langsommere og reduceret humoral immunrespons på et neoantigen (keyhole limpet haemocyanin) hos patienter, der blev behandlet med TYSABRI i seks måneder sammenlignet med en ubehandlet kontrolgruppe.
English: The effect of natalizumab on reproduction was evaluated in 5 studies, 3 in guinea pigs and 2 in cynomolgus monkeys.
Danish: Virkningerne af natalizumab på reproduktion blev evalueret i 5 forsøg - 3 med marsvin og 2 med cynomolgus aber.
English: Before initiation of treatment with TYSABRI, a recent (usually within 3 months) MRI should be available as a reference, and be repeated at least on a yearly basis.
Danish: Inden behandling med TYSABRI påbegyndes, skal en nylig gennemført (sædvanligvis inden for 3 måneder) MR-scanning være tilgængelig som reference, og MR-scanningen skal gentages mindst en gang om året.
English: In such cases where TYSABRI therapy was discontinued the elevated eosinophil levels resolved.
Danish: I de tilfælde, hvor behandling med TYSABRI blev seponeret, faldt de forhøjede eosinofil-niveauer.
English: • Confirmation of patient understanding of the risks of PML and that they have received a copy of the form and a patient alert card
Danish: • Bekræftelse af, at patienten forstår risikoen for at udvikle PML, og at patienten har modtaget en kopi af formularen samt et patientinformationskort
English: Proportion progressed1(12-week confirmation; primary outcome)
Danish: Handikapudvikling Andel med progression1(12ugers bekræftelse; primært resultat)
English: Data from clinical trials, a prospective pregnancy registry, post-marketing cases and available literature do not suggest an effect of TYSABRI exposure on pregnancy outcomes.
Danish: Data fra kliniske forsøg, fra et prospektivt graviditetsregister, fra tilfælde efter markedsføring og fra litteraturen tyder ikke på, at TYSABRI påvirker fostret.
English: Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial Magnetic Resonance Image (MRI) or at least 1 Gadolinium-enhancing lesion.
Danish: Patienterne skal have oplevet mindst 1 attak i det forudgående år, mens de var i behandling, og have mindst 9 T2-hyperintense læsioner påvist ved kraniel magnetisk resonansscanning (MR-scanning) eller mindst 1 gadolinium-forstærket læsion.
English: The anti-JCV antibody assay (ELISA) should not be used to diagnose PML.
Danish: Anti-JCV-antistoftesten (ELISA) bør ikke benyttes til at diagnosticere PML.
English: Once the clinician has excluded PML and/or JCV GCN (if necessary, by repeating clinical, imaging and/or laboratory investigations if clinical suspicion remains), dosing of TYSABRI may resume.
Danish: Så snart lægen har udelukket PML og/eller JCV GCN (om nødvendigt ved gentagelse af kliniske undersøgelser, scanning og/eller laboratorieundersøgelser, hvis der stadig er klinisk mistanke om PML), kan behandling med TYSABRI genoptages.
English: Dilute before infusion.
Danish: Fortyndes inden infusion.
English: You should remain aware for symptoms that might arise for up to 6 months after stopping TYSABRI treatment.
Danish: De bør være opmærksom påat der kan opstå symptomer i op til 6 måneder efter De er stoppet med TYSABRI-behandlingen.
English: • You must not use TYSABRI if you are being treated with other medicines to treat your MS, such as beta-interferons or glatiramer acetate.
Danish: • De må ikke få TYSABRI, hvis De er i behandling med andre lægemidler til behandling af MS, som f.eks. beta-interferoner eller glatirameracetat.
English: There is no evidence of a specific pattern of birth defects with TYSABRI.
Danish: Der er ikke påvist et specifikt mønster for misdannelser relateret til TYSABRI.
English: Mean number of T1-hypointense lesions
Danish: Gennemsnitligt antal T1hypointense læsioner
English: In 2-year controlled clinical trials in MS patients, the rate of infection was approximately 1.5 per patient-year in both natalizumab- and placebo-treated patients.
Danish: I 2-års kontrollerede kliniske forsøg med MS-patienter var infektionshyppigheden cirka 1,5 per patient-år hos både natalizumab- og placebo-behandlede patienter.
English: MRI evaluations for T1-weighted gadolinium (Gd)-enhancing lesions and T2-hyperintense lesions were performed annually.
Danish: Magnetisk resonans scanning (MR) evalueringer for T1-vægtede gadolinium (Gd)-forstærkede læsioner og T2-hyperintense læsioner blev udført årligt.
English: Concurrent or prior treatment with immunosuppressants
Danish: Samtidig eller tidligere behandling med immunsuppressiva
English: • Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
Danish: • Bekræftelse af, at lægen har drøftet risikoen for at udvikle PML og IRIS, hvis behandlingen afbrydes på grund af mistanke om PML
English: These medicines are for MS and cannot be used with TYSABRI (see Using other medicines, below).
Danish: Disse lægemidler er til behandling af MS og kan ikke anvendes sammen med TYSABRI (se afsnittet nedenfor ”Anvendelse af anden medicin”).
English: More frequent MRIs (e.g. on a 3 to 6 monthly basis) using an abbreviated protocol should be considered for patients at higher risk of PML.
Danish: Hyppigere MR-scanninger (f.eks. hver 3. til 6. måned) vha, en forkortet protokol skal overvejes til patienter med høj risiko for PML.
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: Pharmacotherapeutic group: Selective immunosuppressive agents, ATC code: L04AA23 Pharmacodynamic effects
Danish: Farmakoterapeutisk klassifikation: Selektivt immunsuppressivt middel, ATC-kode: L04AA23.
English: Natalizumab is excreted in human milk.
Danish: Natalizumab udskilles i human mælk.
English: Retesting low index patients who have no history of prior immunosuppressant use every 6 months once they reach the 2 year treatment point is recommended.
Danish: Det anbefales at teste patienter med lavt indeks, som ikke tidligere er blevet behandlet med immunsuppressive lægemidler, hver 6. måned, når de når tidspunktet for 2 års behandling.
English: Patients should be monitored as appropriate for impaired liver function, and be instructed to contact their physician in case signs and symptoms suggestive of liver injury occur, such as jaundice and vomiting.
Danish: Patienterne bør overvåges for nedsat leverfunktion og instrueres om at kontakte deres læge i tilfælde af tegn og symptomer, der tyder på leverskade, såsom gulsot og opkastning.
English: There have been cases of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI.
Danish: Der har været tilfælde, hvor en sjælden hjerneinfektion, kaldet progressiv multifokal leukoencefalopati (PML), er forekommet hos patienter, der har fået TYSABRI.
English: The physician should be particularly alert to symptoms suggestive of PML or JCV GCN that the patient may not notice (e.g. cognitive, psychiatric symptoms or cerebellar syndrome).
Danish: Lægen bør være særlig på vagt over for symptomer, der kunne tyde på PML eller JCV GCN, og som patienten muligvis ikke lægger mærke til (f.eks. kognitive, psykiatriske symptomer eller cerebellart syndrom).
English: The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction and, if so, whether these symptoms are typical of MS or possibly suggestive of PML or JCV GCN.
Danish: Lægen bør evaluere patienten for at fastslå, om symptomerne er tegn på neurologisk dysfunktion, og i så fald, hvorvidt disse symptomer er typiske for MS, eller om de kan være tegn på PML eller JCV GCN.
English: • Physician information about TYSABRI
Danish: • Information til lægen om TYSABRI
English: • Treatment initiation and treatment continuation forms
Danish: • Formularer til behandlingsstart og til fortsat behandling