FrancophonIA/ELRC3.0 huggingface dataset:
English: TYSABRI is a clear, colourless to slightly cloudy liquid.
Danish: TYSABRI er en klar, farveløs til lettere uigennemsigtig væske.
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 studie med aber var antallet af aborter fordoblet hos natalizumab-behandlede (30 mg/kg) grupper i forhold til matchende kontrolgrupper.
English: Do not use this medicine if you notice particles in the liquid and/or the liquid in the vial is discoloured.
Danish: Brug ikke lægemidlet, hvis du bemærker partikler i væsken, og/eller hvis væsken i hætteglasset er misfarvet.
English: • Reminder to keep the card with them for 6 months after the last dose of Tysabri
Danish: • Påmindelse om at have kortet på sig i 6 måneder efter den sidste dosis TYSABRI
English: • TYSABRI must be diluted before it is given to you.
Danish: • TYSABRI skal fortyndes, inden du får det.
English: The safety and efficacy of TYSABRI in combination with other immunosuppressive and antineoplastic therapies have not been fully established.
Danish: Sikkerheden og effekten af TYSABRI i kombination med andre immunosuppressive og antineoplastiske behandlinger er ikke blevet udførligt undersøgt.
English: Discussion of PML in TYSABRI Treated Patients
Danish: Drøftelse af PML hos patienter i behandling med TYSABRI
English: If you have all three risks described above your chance of getting PML is higher.
Danish: Hvis du har alle de tre risikofaktorer, der er beskrevet ovenfor, er din risiko for at få PML større.
English: The decision to suspend TYSABRI at any stage may be based on the initial clinical presentation, MRI findings, the evolution of symptoms or signs and/or the response to corticosteroid treatment.
Danish: Beslutningen om at afbryde TYSABRI på et hvilket som helst stadie kan baseres på den indledende kliniske præsentation, MR-fund, udviklingen af symptomer eller tegn og/eller responset på kortikosteroidbehandling.
English: Patients should not be tested for anti-JCV antibodies within 2 weeks of PLEX due to removal of antibodies from the serum, or within 6 months of IVIg (i.e. 6 months = 5x half-life for immunoglobulins).
Danish: Patienter bør ikke testes for anti-JCV-antistoffer inden for 2 uger efter PLEX på grund af fjernelse af antistoffer fra serum eller inden for 6 måneder efter IVIg (dvs. 6 måneder svarende til 5x halveringstiden for immunoglobuliner).
English: Your doctor may repeat this blood test while you are on TYSABRI treatment to check if anything has changed.
Danish: Din læge kan gentage denne blodprøve, mens du er i behandling med TYSABRI, for at undersøge, om noget har ændret sig.
English: Some cases have occurred in patients with central nervous system (CNS) herpes infections (e.g. herpes meningitis and encephalitis).
Danish: Nogle tilfælde er opstået hos patienter med herpes-infektioner i centralnervesystemet (CNS) (f.eks. herpes meningitis og herpes encephalitis).
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Danish: Du vil også finde denne information i det patientinformationskort, som din læge har givet dig.
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 studier 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: 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 reduceret, 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: Serious adverse events were evaluated in 621 MS paediatric patients included in a meta-analysis (see also Section 5.1).
Danish: Alvorlige bivirkninger blev evalueret hos 621 pædiatriske patienter med MS inkluderet i en metaanalyse (se også pkt.
English: • Severe allergy (hypersensitivity)
Danish: • Svær allergi (overfølsomhed)
English: PML is associated with an uncontrolled increase of the JC virus in the brain, although the reason for this increase in some patients treated with TYSABRI is unknown.
Danish: PML er forbundet med en ukontrolleret forøgelse af John Cunningham virus (JCV) i hjernen, selv om grunden til denne forøgelse hos nogle patienter, der behandles med TYSABRI, er ukendt.
English: During extended pre-registration trials, two cases of PML were reported in MS patients and a full safety evaluation revealed one further case in a clinical trial patient with Crohn's Disease.
Danish: I længerevarende studier inden udstedelse af markedsføringstilladelsen blev der indberettet to tilfælde af PML hos MS-patienter, og i en komplet sikkerhedsevaluering blev der identificeret ét yderligere tilfælde i et klinisk studie hos en patient med Crohns sygdom.
English: 15 ml concentrate in a vial (type I glass) with a stopper (chlorobutyl rubber) and a seal (aluminium) with a flip-off cap.
Danish: 15 ml koncentrat i et hætteglas (type I glas) med en prop (chlorbutylgummi) og en forsegling (aluminium) med flip-off hætte.
English: Package leaflet: Information for the patient TYSABRI 300 mg concentrate for solution for infusion natalizumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten TYSABRI 300 mg koncentrat til infusionsvæske, opløsning natalizumab Dette lægemiddel er underlagt supplerende overvågning.
English: • You will also find this information in the Patient Alert Card you have been given by your doctor.
Danish: • Du kan også finde denne information i patientinformationskortet, som lægen har givet dig.
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 studier - 3 med marsvin og 2 med cynomolgus aber.
English: In the postmarketing setting, the risk of PML has been well characterized over the first 6 years of treatment with the identification of different levels of PML risk in different patient subgroups.
Danish: Efter markedsføringen er risikoen for PML velbeskrevet over de første 6 års behandling med identificering af forskellige PMLrisikoniveauer hos forskellige patientundergrupper.
English: Sodium chloride Polysorbate 80 (E433) Water for injections
Danish: Polysorbat 80 (E433) Vand til injektionsvæsker
English: Use of plasmapheresis (PLEX) or intravenous immunoglobulin (IVIg) can affect meaningful interpretation of serum antiJCV antibody testing.
Danish: Anvendelsen af plasmaferese (PLEX) eller intravenøs immunglobulin (IVIg) kan påvirke en korrekt fortolkning af serum-anti-JCV-antistoftestning.
English: No cases of PML were identified in the meta-analysis, however, PML has been reported in natalizumab treated paediatric patients in the post-marketing setting.
Danish: Ingen tilfælde af PML blev identificeret i meta-analysen, men PML er dog blevet rapporteret hos natalizumab-behandlede pædiatriske patienter efter markedsføring.
English: - 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: - 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: The interim analysis showed a lower risk of PML in patients treated with EID (hazard ratio = 0.06 95% CI of hazard ratio = 0.01- 0.22).
Danish: Interimanalysen viste en lavere risiko for PML hos patienter, der fik behandling med EID (hazard ratio = 0,06 95 % CI for hazard ratio = 0,01-0,22).
English: o Description of PML and incidence.
Danish: o Beskrivelse af PML og incidens.
English: As the actual duration of these effects is unknown, initiating treatment with TYSABRI after alemtuzumab is not recommended unless the benefits clearly outweigh the risks for the individual patient.
Danish: Da den reelle virkningsvarighed er ukendt, anbefales det ikke at påbegynde behandling med TYSABRI efter alemtuzumab, medmindre fordelene for den enkelte patient klart opvejer risiciene.
English: The clinical worsening is a result of local inflammatory reaction, including oedema, and manifests as a worsening of neurological symptoms including hemiparesis, ataxia, speech abnormalities, visual disturbance, cognitive/behavioural changes and seizure (dependent on the site of IRIS).
Danish: Den kliniske forværring skyldes en lokal inflammatorisk reaktion, herunder ødem, og manifesterer sig som en forværring af neurologiske symptomer, herunder hemiparese, ataksi, taleforstyrrelser, synsforstyrrelser, kognitive/adfærdsmæssige forandringer og krampeanfald (afhængigt af stedet for IRIS).
English: In order to improve traceability of biological medicinal products, the product name (Tysabri) and batch number of the administered product should be clearly recorded.
Danish: 10. For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts navn (TYSABRI) og batchnummer tydeligt registreres.
English: In patients treated with TYSABRI, IRIS has occurred within days to several weeks after TYSABRI removal by plasma exchange (PLEX) or immunoabsorption (IA).
Danish: Hos patienter i behandling med TYSABRI er der set IRIS inden for dage til flere uger efter fjernelse af TYSABRI via plasmaferese (PLEX) eller immunabsorption (IA).
English: A post-marketing meta-analysis was conducted using data from 621 paediatric MS patients treated with TYSABRI (median age 17 years, range was 7-18 years, 91% aged ≥14 years).
Danish: Efter markedsføring blev der udført en meta-analyse med data fra 621 pædiatriske patienter med MS, der blev behandlet med TYSABRI (medianalder 17 år, interval 7-18 år, 91 % ≥14 år.
English: A Complete Blood Count (CBC, including lymphocytes) is recommended prior to initiating TYSABRI to ensure that immune effects of the previous therapy (i.e. cytopenia) have resolved.
Danish: Komplet blodtælling (CBC inklusive lymfocytter) anbefales, før TYSABRI-behandling initieres, for at sikre, at virkningen af den tidligere behandling på immunsystemet (dvs. cytopeni) er ophørt.
English: TYSABRI is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups:
Danish: TYSABRI er indiceret som monoterapi til sygdomsmodificerende behandling af voksne med meget aktiv relapsing-remitterende multipel sklerose (MS) hos følgende patientgrupper:
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 studier med MS-patienter var infektionshyppigheden cirka 1,5 per patient-år hos både natalizumab- og placebo-behandlede patienter.
English: IRIS is generally suspected when patients with PML exhibit signs of clinical worsening usually, but not always, accompanied by gadolinium enhancement of PML lesions with or without mass effect on brain MRI.
Danish: IRIS mistænkes generelt, når patienter med PML udviser tegn på klinisk forværring, som oftest, men ikke altid, er ledsaget af gadolinium-forstærkede PML-læsioner med eller uden masseeffekt på MR-hjernescanning.
English: o Management of PML o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
Danish: o Behandling af PML o Monitoreringsstrategi efter seponering af behandling med TYSABRI o Nødvendigheden af at informere patienterne om fordele og risici ved behandling med TYSABRI og forsyne dem med:
English: When switching patients from another DMT to TYSABRI, the half-life and mode of action of the other therapy must be considered in order to avoid an additive immune effect whilst at the same time minimising the risk of disease reactivation.
Danish: Når patienter skifter fra en anden sygdomsmodificerende behandling (DMT) til TYSABRI, skal halveringstiden og virkningsmekanismen af den anden behandling tages i betragtning for at undgå en additiv virkning på immunsystemet, mens risikoen for sygdomsreaktivering samtidig skal minimeres.
English: Use of TYSABRI has been associated with an increased risk of PML, an opportunistic infection caused by JC virus, which may be fatal or result in severe disability.
Danish: Brugen af TYSABRI er blevet associeret med en øget risiko for PML, en opportunistisk infektion forårsaget af JC-virus, som kan være letal eller resultere i svære funktionstab.
English: Pack size of one vial per carton.
Danish: Pakningsstørrelse: et hætteglas per karton.
English: • Patients 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: • Patienter 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: In 2-year controlled clinical trials in MS patients, hypersensitivity reactions occurred in up to 4% of patients.
Danish: I 2-års kontrollerede kliniske studier med MS-patienter forekom der overfølsomhedsreaktioner hos op til 4 % af patienterne.
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 du ikke tidligere er blevet behandlet med immunsupprimerende lægemidler og er blevet behandlet med TYSABRI i 2 år eller mere, kan niveauet af dit anti-JCV-antistof-respons være associeret til risikoen for at få PML.
English: Tell your doctor if you are taking or have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: Within this analysis, a limited subset of patients with data available prior to treatment (158 of the 621 patients) demonstrated a reduction in ARR from 1.466 (95% CI 1.337, 1.604) prior to treatment to 0.110 (95% CI 0.094, 0.128).
Danish: I denne analyse viste en begrænset delgruppe af patienter med tilgængelige data før behandling (158 ud af de 621 patienter) en reduktion i ARR fra 1,466 (95 % CI 1,337; 1,604) før behandling til 0,110 (95 % CI
English: Although JC viral load in the CSF might be expected to decline in the setting of IRIS, it is also possible that due to the breakdown of the blood brain barrier (BBB) and release of JCV from cells lysed during IRIS, it can be increased.
Danish: Selvom JC-virusbelastningen i CSF kan forventes at falde i forbindelse med IRIS, er det også muligt, at den stiger som følge af nedbrydningen af blodhjernebarrieren (BBB) og frigivelsen af JCV fra celler, der bliver lyseret i forbindelse med IRIS.
English: Current pharmacokinetic/pharmacodynamic statistical modelling and simulation indicate that the risk of MS disease activity for patients switching to longer dosing intervals may be higher for patients with body weight >80kg or those with dosing intervals ≥7 weeks.
Danish: Nuværende farmakokinetisk/farmakodynamisk statistisk modellering og simulering tyder på, at risikoen for MS-sygdomsaktivitet hos patienter, der skifter til længere doseringsintervaller, kan være højere hos patienter med en legemsvægt >80 kg eller hos dem med doseringsintervaller ≥7 uger.
English: o Description of MRI protocols for baseline, routine screening and in case of PML suspicion o Anti-JCV antibody testing, frequency of testing, interpretation of qualitative and quantitative results, seroprevalence of JCV-antibodies and seroconversion rate over time o Diagnosis and prognosis of symptomatic and asymptomatic PML
Danish: o Beskrivelse af MR-scanningsprotokollen til baseline, rutinemæssig screening og ved mistanke om PML o Anti-JCV-antistof-analyser, frekvens af analyserne, fortolkning af kvalitative og kvantitative resultater, seroforekomst af JCV-antistoffer og serokonversionsrate over tid o Diagnosticering af og prognose for symptomatisk og asymptomatisk PML
English: Prior treatment with immunosuppressive or immunomodulatory therapies
Danish: Tidligere behandling med immunsuppressiv eller immunmodulerende terapi
English: Pharmacotherapeutic group: Selective immunosuppressive agents, ATC code: L04AA23 Pharmacodynamic effects
Danish: Farmakoterapeutisk klassifikation: Selektivt immunsupprimerende middel, ATC-kode: L04AA23.
English: No recommendation on a posology can be made.
Danish: Der kan ikke gives nogen anbefalinger vedrørende dosering.
English: o Patients, their partners and care givers are advised of symptoms that may be indicative of early PML and the need for counseling on the need to be vigilant for these symptoms while on TYSABRI treatment, and also for approximately 6 months after the last dose of TYSABRI (PML has also been reported up to 6 months following the last dose of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation).
Danish: o Patienter, deres partnere og omsorgsgivere informeres om symptomer, som kan være tegn på tidlig PML, og om behovet for rådgivning om nødvendigheden af at være opmærksom på disse symptomer under behandlingen med TYSABRI og i cirka 6 måneder efter den sidste dosis TYSABRI (der er også rapporteret om PML op til 6 måneder efter den sidste dosis TYSABRI hos patienter, hos hvem der ikke blev fundet tegn på PML på tidspunktet for seponering).
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 studier forekom herpesinfektioner (varicella-zoster-virus, herpes simplex-virus) en anelse hyppigere hos patienter behandlet med natalizumab end hos placebo-behandlede patienter.
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 studier, fra observationsstudier efter markedsføringen og i forbindelse med passiv overvågning efter markedsføringen.
English: Your doctor should do a blood test in order to test for abnormalities and whether you have antibodies to the JC virus.
Danish: Lægen bør tage en blodprøve for at teste for abnormaliteter og for at undersøge, om du har antistoffer mod JC-virus.
English: • Reminder no to take any other long-term medicines for MS while receiving Tysabri
Danish: • Påmindelse om ikke at få anden længerevarende behandling med andre lægemidler mod MS, mens de får TYSABRI
English: • Possibility of other opportunistic infections
Danish: • Risiko for andre opportunistiske infektioner
English: Following discontinuation of fingolimod, lymphocyte count progressively returns to normal range within 1 to 2 months after stopping therapy.
Danish: Efter seponering af fingolimod vender lymfocyttallet gradvist tilbage til normalområdet i løbet af 1 til 2 måneder.
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 dyrestudier med mus blev vækst og metastasering af melanom og lymfoblastiske leukæmitumorceller ikke forøget ved administration af natalizumab.
English: If utilising extended interval dosing, caution is required because the efficacy of extended interval dosing has not been established and the associated benefit risk balance is currently unknown (see section 5.1).
Danish: Hvis der anvendes forlænget doseringsinterval, skal der udvises forsigtighed, idet virkningen ved dosering med forlænget interval ikke er klarlagt, og det associerede benefit/risk-forhold er ukendt på nuværende tidspunkt (se pkt.
English: Patients can switch directly from beta interferon or glatiramer acetate to TYSABRI providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia and, lymphopenia.
Danish: Patienter kan skifte direkte fra beta interferon eller glatirameracetat til TYSABRI, forudsat at der ikke er relevante behandlingsrelaterede abnorme fund f.eks. neutropeni eller lymfopeni.
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 studiet, og som havde en score på mellem 0 og 5 på Kurtzke-skalaen (Expanded Disability Status Scale - EDSS).
English: You should remain aware for symptoms that might arise for up to 6 months after stopping TYSABRI treatment.
Danish: Du bør være opmærksom på at der kan opstå symptomer i op til 6 måneder efter du er stoppet med TYSABRI-behandlingen.
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: 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 immunsupprimerende lægemidler, hver 6. måned, når de når tidspunktet for 2 års behandling.
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 studier, fra et prospektivt graviditetsregister, fra tilfælde efter markedsføring og fra litteraturen tyder ikke på, at TYSABRI påvirker fostret.
English: You should discuss with your doctor whether you choose to breast-feed or to use TYSABRI.
Danish: Du skal tale med din læge om, hvorvidt du skal vælge at amme eller at bruge TYSABRI.
English: • If your doctor has told you that you have PML (progressive multifocal leukoencephalopathy).
Danish: • Hvis din læge har fortalt dig, at du lider af progressiv multifokal leukoencefalopati (PML).
English: Talk to your doctor before using TYSABRI.
Danish: Kontakt lægen, før du bruger TYSABRI.
English: Caution regarding potential concomitant immune effects is required when switching patients from teriflunomide to TYSABRI.
Danish: Der skal udvises forsigtighed med hensyn til mulige samtidige virkninger på immunsystemet, når patienterne skifter fra teriflunomid til TYSABRI.
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 studier med MS-patienter.
English: These medicines cannot be used with TYSABRI (see Using other medicines, below).
Danish: Disse lægemidler kan ikke anvendes sammen med TYSABRI (se afsnittet nedenfor ”Anvendelse af anden medicin”).