natgillin/translations-raw huggingface dataset:
Efter 2 års behandling skal patienterne igen informeres om risici ved behandling med TYSABRI, især den forøgede risiko for at udvikle progressiv multifokal leukoencefalopati (PML), og patienterne og deres hjælpere skal informeres om tidlige tegn og symptomer på PML.
After 2 years of treatment, patients should be reinformed about the risks of TYSABRI, especially the increased risk of Progressive Multifocal Leukoencephalopathy (PML), and should be instructed together with their caregivers on early signs and symptoms of PML.
I tilfælde af signifikant leverskade bør TYSABRI afbrydes.
In cases of significant liver injury TYSABRI should be discontinued.
I løbet af forsøgenes 2 års varighed rapporterede 43,5 % af de patienter, der blev behandlet med natalizumab, bivirkninger (placebo: 39,6 %).
Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%).
Hazard ratio for progression af handikapudvikling var 0,36 (95 % CI: 0,17; 0,76) p=0,008.
Hazard ratio for disability progression was 0.36 (95% CI: 0.17, 0.76) p = 0.008.
Spontane, alvorlige bivirkninger med leverskade er blevet rapporteret i post-marketingfasen.
Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase.
PML bør betragtes som en differentialdiagnose hos enhver MS-patient i behandling med TYSABRI, som har neurologiske symptomer og/eller nye læsioner set på MR-scanninger.
PML should be considered as a differential diagnosis in any MS patient taking TYSABRI presenting with neurological symptoms and/or new brain lesions in MRI.
Hvis en patient, der behandles med TYSABRI, udvikler en opportunistisk infektion, skal behandlingen med lægemidlet afbrydes permanent.
If a patient receiving TYSABRI develops an opportunistic infection, dosing of the medicinal product must be permanently discontinued.
Opbevares i køleskab (2 °C-8 °C).
Store in a refrigerator (2˚C - 8˚C).
EDSS >=1,0 fortsat i 12 eller 24 uger eller mindst 1,5 point stigning i EDSS fra en baseline EDSS =0 fortsat i 12 eller 24 uger.
1 Progression of disability was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS >=1.0 sustained for 12 or 24 weeks or at least a 1.5 point increase on the EDSS from a baseline EDSS =0 sustained for 12 or 24 weeks.
• Hvis De tager enten beta-interferon eller glatirameracetat.
• If you are taking either beta-interferon or glatiramer acetate.
I overensstemmelse med den farmakologiske aktivitet af natalizumab viste ændringer i transporten af lymfocytter sig som en stigning i antallet af hvide blodlegemer såvel som en forøget miltvægt i de fleste in vivo forsøg.
Consistent with the pharmacological activity of natalizumab, altered trafficking of lymphocytes was seen as white blood cell increases as well as increased spleen weights in most in vivo studies.
Patienter med øget risiko for opportunistiske infektioner, herunder immunkompromitterede patienter (inklusive patienter, der aktuelt får immunsuppressiv behandling, eller patienter, som er immunkompromitterede pga. tidligere behandling med f.eks. mitoxantron eller cyclophosphamid, se også pkt.
Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies, e.g. mitoxantrone or cyclophosphamide, see also sections 4.4 and 4.8).
10. Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Hvis der er tvivl, bør yderligere evaluering overvejes, herunder MR-scanning helst med kontrast (sammenlignes med baseline MR inden behandlingen), analyse af cerebrospinalvæsken for JC DNA samt gentagen neurologisk vurdering, som beskrevet i informationen til lægen og i behandlingsvejledningen (se afsnittet Rådgivende vejledning).
If any doubt exists, further evaluation, including MRI scan preferably with contrast (compared with pre-treatment baseline MRI), CSF testing for JC Viral DNA and repeat neurological assessments, should be considered as described in the Physician Information and Management Guidelines (see educational guidance).
Inden for hver enkelt gruppe med samme hyppighed skal bivirkningerne opstilles efter, hvor alvorlige de er.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Natriumdihydrogenphosphatmonohydrat; dinatriumphosphatheptahydrat; natriumchlorid; polysorbat 80 (E433); og vand til injektionsvæsker.
LIST OF EXCIPIENTS sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
Denne indlægsseddel blev senest ændret { måned ÅÅÅÅ }.
This leaflet was last revised in {MM/YYYY}.
Derved kan natalizumab undertrykke inflammatorisk aktivitet på sygdomsstedet og hæmme yderligere rekruttering af immunceller ind i inflammeret væv.
As such, natalizumab may act to suppress inflammatory activity present at the disease site, and inhibit further recruitment of immune cells into inflamed tissues.
Der blev ikke observeret forskel i hyppighed eller art af malignitet mellem natalizumab- og placebo-behandlede patienter i løbet af 2 års behandling.
No differences in incidence rates or the nature of malignancies between natalizumab- and placebo-treated patients were observed over 2 years of treatment.
Yderligere infusionsrelaterede reaktioner der var associeret med persisterende antistoffer omfattede rigor, kvalme, opkastning og rødmen (se pkt.
Additional infusion-related reactions associated with persistent antibodies included rigors, nausea, vomiting and flushing (see section 4.4).
Hvis der er mistanke om opportunistisk infektion, skal TYSABRI seponeres, indtil mistanken er afkræftet ved yderligere evalueringer.
If an opportunistic infection is suspected, dosing with TYSABRI is to be suspended until such infections can be excluded through further evaluations.
I kliniske fase III-studier hos MS-patienter var samtidig behandling af attakker med kortvarig kortikosteroid ikke associeret med en øget hyppighed af infektioner.
In Phase 3 MS clinical trials, concomitant treatment of relapses with a short course of corticosteroids was not associated with an increased rate of infection.
6.6) skal infusionen indgives over cirka 1 time, og patienterne skal observeres under infusionen og i 1 time efter infusionen for tegn og symptomer på overfølsomhedsreaktioner.
After dilution (see section 6.6), the infusion is to be administered over approximately 1 hour and patients are to be observed during the infusion and for 1 hour after the completion of the infusion for signs and symptoms of hypersensitivity reactions.
Rådgivende vejledning
Educational guidance
I placebo-kontrollerede forsøg med 1.617 MS-patienter, der blev behandlet med natalizumab i op til 2 år (placebo: 1.135), forekom der hos 5,8 % af de natalizumab-behandlede patienter (placebo: 4,8 %) bivirkninger, der førte til afbrydelse af behandlingen.
In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo: 1,135), adverse events leading to discontinuation of therapy occurred in 5.8% of patients treated with natalizumab (placebo: 4.8%).
4.8, hvordan bivirkninger indberettes.
See section 4.8 for how to report adverse reactions
Blokaden hæmmer yderligere rekruttering af immunceller til inflammeret væv og reducerer derved nydannelse eller forstørrelse af MS-læsioner.
MS and inhibits further recruitment of immune cells into inflamed tissue, thus reducing the formation or enlargement of MS lesions.
For opbevaringsforhold efter fortynding af lægemidlet, se pkt.
For storage conditions after dilution of the medicinal product see section 6.3.
Hændelser, der blev indberettet hyppigere i forbindelse med natalizumab end med placebo, omfattede svimmelhed, kvalme, urticaria og rigor.
Events reported more commonly with natalizumab than with placebo included dizziness, nausea, urticaria and rigors.
De hyppigst indberettede bivirkninger, identificeret i placebokontrollerede forsøg hos patienter med multipel sklerose, hvor natalizumab blev givet ved den anbefalede dosis, er svimmelhed, kvalme, urticaria og rigor associeret med infusioner.
The highest incidence of adverse reactions identified from placebo-controlled trials in multiple sclerosis patients with natalizumab given at the recommended dose, are reported as dizziness, nausea, urticaria and rigors associated with infusions.
• Åndedrætsbesvær
• Difficulty breathing
Hvis en patient udvikler PML, skal behandlingen med TYSABRI afbrydes permanent.
If a patient develops PML the dosing of TYSABRI must be permanently discontinued.
Spontane tilfælde af alvorlige leverskader, øgede leverenzymer, hyperbilirubæmi er blevet rapporteret i post-marketing fasen (se pkt.
Spontaneous cases of serious liver injuries, increased liver enzymes, hyperbilirubinaemia have been reported during the post marketing phase (see section 4.4).
Symptomerne på JCV GCN ligner symptomerne på PML (f.eks. cerebellart syndrom).
Symptoms of JCV GCN are similar to symptoms of PML (i.e. cerebellar syndrome).
Er De i tvivl, så spørg lægen.
- If you have any further questions, ask your doctor.
Sjældne bivirkninger (påvirker op til 1 ud af 1.000 personer):
Rare side effects that may affect up to 1 in 1,000 people:
Leukocytmigration over BBB involverer interaktion mellem adhæsionsmolekyler på de inflammatoriske celler og adhæsionsmolekylerne på karvæggens endotelceller.
Leukocyte migration across the BBB involves interaction between adhesion molecules on inflammatory cells and endothelial cells of the vessel wall.
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 Monitoreringsstrategi efter seponering af behandlingen med TYSABRI o Nødvendigheden af at informere patienterne om fordele og risici ved behandling med TYSABRI og forsyne patienterne med: En kopi af formularen til behandlingsstart Et patientinformationskort, der indeholder en basistekst ifølge aftale med CHMP
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 Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
Blokade af de molekylære interaktioner mellem α4β1 og dets bindingssteder (targets) reducerer den inflammatoriske aktivitet, der er til stede i hjernen hos MS-patienter.
Blockade of the molecular interactions of α4β1 with its targets reduces inflammatory activity present in the brain in
Gennemsnitlig middelværdi for steady-state minimumskoncentrationer af natalizumab over behandlingsperioden lå mellem 23 μg/ml og 29 μg/ml.
Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μg/ml to 29 μg/ml.
• TYSABRI må ikke blandes med andre lægemidler eller opløsningsmidler.
• TYSABRI must not be mixed with other medicinal products or diluents.
Tag altid denne medicin nøjagtigt efter lægens anvisning.
Always use this medicine exactly as your doctor has told you.
Der er ikke gennemført studier af evnen til at føre motorkøretøj og betjene maskiner under behandling med TYSABRI.
No studies on the effects on the ability to drive and use machines have been performed with TYSABRI.
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.
Progressive Multifocal Leukoencephalopathy (PML) 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.
I litteraturen er der rapporteret forbigående let til moderat trombocytopeni og anæmi hos børn af kvinder behandlet med TYSABRI i tredje trimester af graviditeten.
Cases from published literature reported transient mild to moderate thrombocytopenia and anaemia observed in infants born to women exposed to TYSABRI in their third trimester of pregnancy.
Opportunistiske infektioner blev også påvist hos MS-patienter behandlet med TYSABRI som monoterapi (se pkt.
Opportunistic infections were also detected in MS patients treated with TYSABRI as a monotherapy (see section 4.8).
Disse ændringer var associeret med forøget ekstramedullær hæmatopoiese i milten, thymus atrofi og nedsat hepatisk hæmatopoiese.
These changes were associated with increased splenic extramedullary haematopoiesis, thymic atrophy and decreased hepatic haematopoiesis.
Natalizumab blokerer interaktionen af α4β7 integrinet med det mukosale addressin celleadhæsionsmolekyle-1
Natalizumab blocks the interaction of α4β7 integrin with the mucosal addressin cell adhesion molecule-1 (MadCAM-1).
Den fortyndede opløsning skal infunderes intravenøst over 1 time med en hastighed på cirka 2 ml/minut.
The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
Nogle patienter, som tidligere har haft en abnorm leverfunktionstest, har oplevet en forværring af de abnorme leverværdier, mens de fik TYSABRI.
Some patients with a past medical history of an abnormal liver test have experienced an exacerbation of abnormal liver test while on TYSABRI.
JC-virus forårsager også JCVgranularcelle-neuronopati (GCN), som er blevet indberettet hos patienter behandlet med TYSABRI.
JC virus also causes JCV granule cell neuronopathy (GCN) which has been reported in patients treated with TYSABRI.
I ét forsøg med marsvin blev der observeret en lille reduktion i overlevelsesraten hos afkommet.
In one study in guinea pigs, a small reduction in pup survival was noted.
Anti-JCV-antistof-analyser giver information, der kan understøtte risikostratifikation ved TYSABRIbehandling.
Anti-JCV antibody testing provides supportive information for risk stratification of TYSABRI treatment.
Hvert enkelt hætteglas er til engangsbrug.
Each vial is for single-use only.
Deres læge vil overvåge Dem under infusionen og i en time herefter for at kontrollere, om der opstår allergiske reaktioner.
Your doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
TYSABRI må ikke blandes med andre lægemidler eller opløsningsmidler.
TYSABRI must not be mixed with other medicinal products or diluents.
I kliniske forsøg har TYSABRI cirka halveret udviklingen af invaliderende virkninger, som var forårsaget af MS.
In clinical trials, TYSABRI approximately halved the progression of the disabling effects of MS and also decreased the number of MS attacks by about two-thirds.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse.
METHOD AND ROUTE(S) OF ADMINISTRATION
Kortvarig steroidbehandling af attakker blev i kliniske forsøg ikke associeret med en øget forekomst af infektioner.
Short courses of steroids used to treat relapses were not associated with increased infections in clinical trials.
Amning bør afbrydes under behandling med TYSABRI.
Breast-feeding should be discontinued during treatment with TYSABRI.
For yderligere information om anti-JCV-antistof-analyser henvises der til Information til lægen og Retningslinjer for behandling.
For further information on anti-JCV antibody testing please see Physician Information and Management Guidelines.
Patienter, som har alle tre risikofaktorer for PML (dvs. er anti-JCV-antistof-positive og har fået mere end 2 års behandling med TYSABRI og tidligere har fået immunsuppressiv behandling) har en betydeligt højere risiko for at udvikle PML.
Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML.
Symptomerne på JCV GCN ligner symptomerne på PML.
The symptoms of JCV GCN are similar to PML.
IRIS optræder hos næsten alle TYSABRI-behandlede patienter med PML efter seponering eller fjernelse af lægemidlet, f.eks. i forbindelse med plasmaferese (se pkt.
IRIS occurs in almost all TYSABRI PML patients after withdrawal or removal of the medicinal product, e.g. by plasma exchange (see section 5.2).
Hvis det fortyndede lægemiddel opbevares ved 2°C - 8°C (må ikke nedfryses), skal man lade opløsningen få stuetemperatur inden infusionen.
If the diluted medicinal product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Undersøg det fortyndede lægemiddel visuelt for partikler eller misfarvning inden administrationen.
Visually inspect the diluted medicinal product for particles or discolouration prior to administration.
• Patienter, som har alle tre risikofaktorer for PML (dvs. er anti-JCV-antistof-positive og har fået mere end 2 års behandling med TYSABRI og tidligere har fået immunsuppressiv behandling),
• Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy),
Hvis det fortyndede lægemiddel opbevares ved 2 ˚C - 8 ˚C (må ikke nedfryses), skal man lade opløsningen få stuetemperatur inden infusionen.
If the diluted medicinal product is stored at 2˚C - 8˚C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Til gengæld opreguleres VCAM-1 på endotelceller og muligvis på gliale celler tæt ved inflammationsstederne, når der er pro-inflammatoriske cytokiner tilstede.
However, in the presence of pro-inflammatory cytokines, VCAM-1 is upregulated on endothelial cells and possibly on glial cells near the sites of inflammation.
Nedsat fertilitet blev observeret i ét forsøg med marsvinehunner ved doser, der overskred dosis hos mennesker; natalizumab påvirkede ikke fertiliteten hos hanner.
Reductions in female guinea pig fertility were observed in one study at doses in excess of the human dose; natalizumab did not affect male fertility.
Hos anti-JCV-antistof-positive, TYSABRI-behandlede patienter, som ikke tidligere er blevet behandlet med immunsuppressive lægemidler, er niveauet af anti-JCV-antistof-respons (indeks) korreleret til risikoen for udvikling af PML.
In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML.
− Længerevarende svimmelhed
− Prolonged dizziness
Alder, år median (område) MS-anamnese, år, median (område)
Age yrs, median (range) MS-history yrs, median (range) Time since diagnosis, yrs median (range)
• Brug aseptisk teknik, når TYSABRI opløsningen klargøres til intravenøs (i.v.)
• Use aseptic technique when preparing TYSABRI solution for intravenous (IV) infusion.
TYSABRI indeholder 2,3 mmol (eller 52 mg) natrium per hætteglas med lægemiddel.
TYSABRI contains 2.3 mmol (or 52 mg) sodium per vial of medicinal product.
Derfor er det meget vigtigt, at De taler med Deres læge så hurtigt som muligt, hvis De tror, at Deres MS bliver værre, eller hvis De bemærker nye symptomer, mens De er i behandling med TYSABRI eller i op til 6 måneder efter behandlingen med TYSABRI er stoppet.
Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on TYSABRI treatment or for up to 6 months after stopping TYSABRI treatment, it is very important that you speak to your doctor as soon as possible.
Må ikke rystes efter fortyndingen.
After dilution, do not shake.
• De må ikke amme, mens De får TYSABRI.
• Do not breast-feed whilst using TYSABRI.
Almindelige bivirkninger (påvirker op til1 ud af 10 personer):
Common side effects that may affect up to 1 in 10 people:
Alvorlige, livstruende og til tider dødelige tilfælde af encephalitis og meningitis forårsaget af herpes-simplexeller varicella-zoster virus er efter markedsføring blevet rapporteret hos patienter med multipel sklerose i behandling med TYSABRI.
In post marketing experience,serious, life-threatening, and sometimes fatal cases of encephalitis and meningitis caused by herpes simplex or varicella zoster have been reported in multiple sclerosis patients receiving TYSABRI.
• Information om følgende bivirkninger: o Infusionsreaktioner o Overfølsomhedsreaktioner o Antistofdannelse
o Infusion reactions o Hypersensitivity reactions o Antibody formation
Der kan opstå symptomer, som De måske ikke selv bliver opmærksom på som for eksempel ændringer i humør eller opførsel, hukommelsessvigt, besvær med at tale eller kommunikere.
Symptoms might arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML.
• Brugen af immunsuppressive lægemidler inden behandling med TYSABRI.
• Immunosuppressant use prior to receiving TYSABRI.
• Formular til afbrydelse af behandlingen
• Treatment discontinuation form
• TYSABRI-behandlingen skal initieres og kontinuerligt superviseres af speciallæger med erfaring i diagnosticering og behandling af neurologiske tilstande på hospitaler med let adgang til MR-scanning.
• That 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.
Fordele og ulemper ved behandling med TYSABRI under graviditet skal afvejes i forhold til patientens kliniske tilstand og risikoen for fornyet sygdomsaktivitet ved behandlingsstop med lægemidlet.
A benefit-risk evaluation of the use of TYSABRI during pregnancy should take into account the patient's clinical condition and the possible return of disease activity after stopping the medicinal product.
Vend forsigtigt TYSABRI-opløsningen for at blande den helt.
Gently invert the TYSABRI solution to mix completely.
Patienterne skal instrueres i at informere deres læge om, at de bliver behandlet med TYSABRI, hvis de udvikler infektioner af nogen art.
Patients should be instructed that if they develop any infection then they should inform their physician that they are being treated with TYSABRI.
Endepunkt ved ét år
One year endpoint
Typen af infektioner hos natalizumab-behandlede patienter lignede generelt typen af infektioner hos placebo-behandlede patienter.
The nature of the infections was generally similar in natalizumab- and placebo-treated patients.
Ikke almindelige bivirkninger (påvirker op til 1 ud af 100 personer):
Uncommon side effects that may affect up to 1 in 100 people:
Cirka 6 % af patienterne udviklede persisterende anti-natalizumab antistoffer (én positiv test bekræftet ved gentagelse af testen mindst 6 uger senere).
Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least 6 weeks later) developed in approximately 6% of patients.
Efter fortynding med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske anbefales omgående anvendelse.
After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended.
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.
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.
Hvert 15 ml hætteglas med koncentrat til infusionsvæske indeholder 300 mg natalizumab (20 mg/ml).
Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ml).
TYSABRI er en klar, farveløs til lettere uigennemsigtig væske.
What TYSABRI looks like and contents of the pack TYSABRI is a clear, colourless to slightly cloudy liquid.