FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of subcutaneous RoActemra has been studied in one Phase III study (WA28119) with 251 GCA patients.
Danish: Sikkerheden af subkutan RoActemraer blevet undersøgt i et fase III-studie (WA28119) med 251 GCA-patienter.
English: The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, number of prior treatments or disease status.
Danish: Behandlingseffekten var den samme, uafhængig af reumafaktorstatus, alder, køn, race, antal tidligere behandlinger eller sygdomsstatus.
English: In study WA28119, the SF-36 results were separated into the physical and mental component summary scores (PCS and MCS, respectively).
Danish: I WA28119 studiet blev SF-36-resultaterne adskilt i henholdsvis den fysiske og mentale opsummerende komponent-score (henholdsvis fysisk komponent score og mental komponent score).
English: PK differences are not accompanied by marked differences in PD parameters and so the clinical relevance is unknown.
Danish: Farmakokinetiske-forskelle ledsages ikke af markante forskelle i farmadynamiske-parametre, og den kliniske relevans er derfor ukendt.
English: All 112 patients were tested for anti-tocilizumab antibodies at baseline.
Danish: Alle 112 patienter blev testet for anti-tocilizumab-antistoffer ved baseline.
English: Serious hepatic injury occurred between 2 weeks to more than 5 years after initiation of RoActemra.
Danish: Alvorlige leverskader opstod fra mellem 2 uger og op til over 5 år efter påbegyndelse af RoActemra behandlingen.
English: The potential for central demyelination with RoActemra is currently unknown.
Danish: Risikoen for central demyelisering efter behandling med RoActemra er på nuværende tidspunkt ukendt.
English: • Be sure not to touch the cleaned area prior to the injection.
Danish: • Vær omhyggelig med ikke at røre det rensede område inden indsprøjtningen.
English: Exploratory Endpoints Annualized relapse rate, Week 52§
Danish: Eksploratoriske endepunkter Årlig relaps hyppighed, uge 52§
English: These instructions do not replace training from your healthcare provider.
Danish: Denne vejledning kan ikke erstatte oplæring fra lægen eller sygeplejersken.
English: At high serum concentrations, when total clearance of RoActemra is dominated by linear clearance, an effective t ½ of approximately 32 days was derived from the population parameter estimates.
Danish: Ved høje serumkoncentrationer, når den samlede clearance af RoActemra domineres af lineær clearance, blev en effektiv t ½ på ca. 32 dage afledt af populationsparameter estimaterne.
English: Cellulitis, Pneumonia, Oral herpes simplex, Herpes zoster
Danish: Cellulitis, pneumoni, oral herpes simplex, herpes zoster
English: Only solutions which are clear to opalescent, colourless to pale yellow and free of visible particles should be diluted.
Danish: Kun opløsninger, som er klare til opaliserende, farveløse til lysegule og fri for synlige partikler, må fortyndes.
English: Viral reactivation
Danish: Viral reaktivering
English: No impact on RoActemra exposure was noted in these patients.
Danish: Ingen påvirkning af RoActemra eksponeringen blev registreret hos disse patienter.
English: • Do not inject into areas that could be bothered by a belt or waistband.
Danish: • Giv ikke indsprøjtningen på steder, der kan blive generet af et bælte eller linningen.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler, skal det administrerede produkts handelsnavn og batchnummer tydeligt registreres patientjournalen.
English: Read and follow the Instructions for Use that come with your RoACTEMRA pre-filled pen before you start using it and each time you get a prescription refill.
Danish: Læs vejledningen grundigt og følg brugsanvisningen, der følger med den fyldte RoActemra-pen, inden du begynder at bruge den og hver gang du får udleveret medicin.
English: Doses above 1.2 g have not been evaluated in clinical studies (see section 5.1).
Danish: Doser over 1,2 g er ikke undersøgt i de kliniske studier (se pkt.
English: These proportions were highly significantly different (p<0.0001).
Danish: Forskellen mellem disse andele var stærkt signifikant (p < 0,0001).
English: Due to the dependence of total clearance on RoActemra serum concentrations, the half-life of RoActemra is also concentration-dependent and varies depending on the serum concentration level.
Danish: På grund af afhængigheden af den samlede clearance for RoActemras serumkoncentrationer er halveringstiden for RoActemra også koncentrationsafhængig og varierer afhængigt af serumkoncentrationsniveauet.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: Efficacy for the treatment of macrophage activation syndrome has not been investigated.
Danish: Effekt ved behandling af makrofag-aktiveringssyndrom er ikke blevet undersøgt.
English: • Dose calculation (RA, sJIA and pJIA patients), preparation of infusion and infusion rate
Danish: • Dosisberegning (RA-, sJIA- og pJIA-patienter), fremstilling af infusionen og infusionshastigheden
English: Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with RoActemra.
Danish: Der skal være hensigtsmæssig behandling til rådighed til øjeblikkelig brug i tilfælde af, at der opstår en anafylaktisk reaktion under behandling med RoActemra.
English: Available non-clinical data demonstrated the effect of IL-6 on malignant progression and apoptosis resistance to various cancer types.
Danish: De foreliggende non-kliniske data viste virkningen af IL-6 på malign progression og forskellige cancertypers resistens overfor apoptose.
English: • When the purple indicator has stopped moving, release the green button.
Danish: • Når den lilla indikator er holdt op med at bevæge sig, kan du slippe den grønne knap.
English: Cases of opportunistic infections have been reported.
Danish: Der er indberetninger om opportunistiske infektioner.
English: The extent varies with the patient's body weight (increased in light body weight patients and decreased in heavy body weight patients) but clinical outcome is consistent with that observed in intravenous treated patients.
Danish: Omfanget varierer afhængig af patientens vægt (øget hos lette patienter og formindsket hos tunge patienter) men den kliniske effekt er i overenstemmelse med den som er observeret hos patienter, som i intravenøs behandling.
English: • skin infection (cellulitis) sometimes with fever and chills
Danish: • hudinfektioner (cellulitis) nogle gange med feber og kulderystelser
English: • If you don't keep the needle-shield completely pushed against the skin, the green Activation button will not work.
Danish: • Hvis nåleskjoldet ikke holdes helt inde mod huden, virker den grønne aktiveringsknap ikke.
English: The TNF antagonist therapy was discontinued prior to randomisation.
Danish: Behandlingen med TNF-antagonister blev stoppet inden randomiseringen.
English: Very rare reports of pancytopenia have occurred in the post marketing setting.
Danish: Meget sjældne rapporter om pancytopeni er forekommet efter markedsføring.
English: The bioavailability for the subcutaneous formulation was 79%.
Danish: Biotilgængeligheden for den subkutane- formulering var 79%.
English: Study V RADIATE
Danish: Studie V RADIATE
English: • Do not press the green activation button yet.
Danish: • Tryk endnu ikke på den grønne aktiveringsknap.
English: IL-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia.
Danish: IL-6 har været involveret i patogenesen af sygdomme, såsom inflammatoriske sygdomme, osteoporose og neoplasier.
English: How do I dispose of used pre-filled pens?
Danish: Hvordan kommer jeg af med den brugte pen?
English: In study II, 65% of patients achieved a DAS28 < 2.6 at week 104 compared to 48% at 52 weeks and 33% of patients at week 24.
Danish: I studie II opnåede 65 % af patienterne DAS28 < 2,6 i uge 104, sammenlignet med 48 % i uge 52 og 33 % i uge 24.
English: This leaflet was last revised
Danish: Denne indlægsseddel blev senest ændret
English: Be alert for the first signs of infection such as:
Danish: Vær opmærksom på de første tegn på infektion, som fx:
English: If you notice any of these, tell your doctor as soon as possible.
Danish: Hvis du får nogen af disse symptomer, skal du fortælle det til lægen så snart som muligt.
English: If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3 additional doses of RoActemra may be administered.
Danish: Hvis ikke der ses en klinisk forbedring af tegn og symptomer på cytokinfrigivelsessyndrom efter den første dosis, kan der gives op til 3 yderligere doser med RoActemra.
English: • After you remove the green cap, the pre-filled pen is ready for use.
Danish: • Når du har fjernet den grønne hætte, er den fyldte pen klar til brug.
English: Unadjusted difference in proportions (99.5% CI)
Danish: Ujusteret forskel i proportioner (99.5% konfidensinterval)
English: Patients achieving a JIA ACR70 response were permitted corticosteroid dose reduction.
Danish: For patienter, som opnåede et JIA ACR70-respons, var dosisreduktion af kortikosteroid tilladt.
English: Thirty-nine patients (76.5%; 95% CI: 62.5%-87.2%) achieved a response.
Danish: 39 patienter (76,5 %; 95 % konfidensinterval: 62,5 % - 87,2 %) opnåede et respons.
English: All patients received background non-biologic DMARD(s).
Danish: Alle patienter fik non-biologiske DMARDs.
English: • low fibrinogen levels in the blood (a protein involved in blood clotting).
Danish: • lavt niveau af fibrinogen i blodet (et protein der gør at blodet størkner)
English: b Non-responder Imputation used for missing data.
Danish: b Ikke-respondenter: der ekstrapoleres for manglende data.
English: Mean haemoglobin levels increased by week 2 and remained within normal range through to week 24.
Danish: Middelkoncentrationerne af hæmoglobin blev øget efter uge 2 og forblev inden for normalområdet frem til uge 24.
English: The needle shield will then move out and lock into place covering the needle (See Figure L).
Danish: Nåleskjoldet vil herefter bevæge sig ud og låse, således at nålen er dækket (se figur L).
English: The once every week dosing interval should be followed.
Danish: Doseringsintervallet med dosering én gang ugentligt bør følges.
English: The ACR response rates were numerically lower for patients with prior biologic treatment as shown in Table 9 below.
Danish: ACR-responsrater var numerisk lavere for patienter, som tidligere havde været i biologisk behandling, som vist i tabel 9 nedenfor.
English: Patients included in the trial had a total disease duration of at least 6 months and active disease but were not experiencing an acute flare requiring corticosteroid doses of more than 0.5 mg/kg prednisone equivalent.
Danish: Patienter, som var inkluderet i studiet, havde en samlet sygdomvarighed på mindst 6 måneder og aktiv sygdom, men oplevede ikke akut flare, som krævede kortikosteroid-doser på mere end 0,5 mg/kg prednison-ækvivalent.
English: * Includes elevations collected as part of routine laboratory monitoring (see text below) 1 See section 4.3
Danish: * Inkluderer stigninger fundet ved rutinemæssig laboratoriekontrol (se tekst nedenfor) 1 Se pkt.
English: RoActemra is given by injection under the skin (subcutaneously).
Danish: RoActemra tages som indsprøjtning under huden (subkutant).
English: The control period in 4 of the studies was 6 months and in 1 study was up to 2 years.
Danish: Kontrolperioden var 6 måneder i 4 studier og op til 2 år i et studie.
English: After proper training in injection technique, patients may self-inject with RoActemra if their physician determines that it is appropriate.
Danish: Efter omhyggelig oplæring i injektionsteknik, kan patienten selv injicere sig med RoActemra, såfremt lægen finder det hensigtsmæssigt.
English: Skin Reactions Rare reports of Stevens-Johnson Syndrome have occurred in the post marketing setting.
Danish: Hudreaktioner Sjældne indrapporteringer af Stevens-Johnsons syndrom er forekommet efter markedsføring.
English: The primary endpoint was the proportion of patients with at least 30% improvement in the JIA ACR core set (JIA ACR30 response) at week 12 and absence of fever (no temperature recording ≥ 37.5°C in the preceding 7 days).
Danish: Det primære endepunkt var andelen af patienter med mindst 30 % forbedring af JIA ACR-respons (JIA ACR30-respons) ved uge 12 og fravær af feber (ingen temperaturmåling ≥ 37,5 °C i de forudgående 7 dage).
English: Certain types of vaccines should not be given while receiving RoActemra.
Danish: Visse typer af vacciner må ikke gives samtidig med, at du får RoActemra.
English: RoActemra must not be given to children weighing less than 10 kg.
Danish: RoActemra må ikke gives til børn, der vejer mindre end 10 kg.
English: Limited data are available regarding exposures following subcutaneous administration of RoActemra in sJIA patients below 2 years of age with a body weight less than 10 kg.
Danish: Der er begrænsede data tilgængelige vedrørende eksponeringer efterfulgt af subkutan administration af RoActemra til sJIA-patienter under 2 år med en kropsvægt på mindre end 10 kg.
English: After 12 weeks or at the time of switching to RoActemra, due to disease worsening, patients were treated in the open label extension phase.
Danish: Efter 12 uger eller på tidspunktet for skift til RoActemra på grund af sygdomsforværring blev patienterne behandlet i den åbne forlængelsesfase.
English: The bioavailability for the SC formulation was 0.8.
Danish: Biotilgængeligheden for subkutan-formuleringen var 0,8.
English: • The RoACTEMRA pre-filled pen should not be reused.
Danish: • RoActemra-pennen må ikke genbruges.
English: RoActemra is used to treat:
Danish: RoActemra anvendes til at behandle:
English: In an independent cohort of 15 patients (range: 9-75 years old) with axicabtagene ciloleucel-induced CRS, 53% responded.
Danish: I en uafhængig kohorte på 15 patienter (i et spænd på 9-75 år) med axicabtagen ciloleucel-induceret cytokinfrigivelsessyndrom, responderede 53 %.
English: Continued durable responses were seen for over 3 years in the ongoing open label extension studies I-V.
Danish: Der blev set fortsat varig respons i mere end 3 år i de pågående, åbne ekstensionsstudier I-V.
English: Based on the current characterization of PK, RoActemra trough concentration at steady state are 50% higher in this population relative to average concentrations in a large dataset from the RA population.
Danish: Baseret på den aktuelle karakterisering af farmakokinetik, er RoActemra trough-koncentration, ved steady-state 50 % højere i denne population i forhold til gennemsnitskoncentrationer i et stort datasæt fra reumatoid artrit-populationen.
English: In study SC-II, inhibition of structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde modified mean total Sharp score (mTSS).
Danish: I SC-II-studiet blev hæmning af struktureret ledskade vurderet radiografisk og udtrykt som en ændring fra baseline i van der Heijde-modificeret gennemsnitlig total Sharp-score (mTSS).
English: The study consisted of a 52-week blinded period (Part 1), followed by a 104-week open-label extension (Part 2).
Danish: Studiet bestod af en 52 ugers blindet periode (del 1) efterfulgt af en 104 ugers åbenlabel forlængelse (del 2).
English: DATE OF FIRST AUTHORISATION/DATE OF LATEST RENEWAL Date of first authorisation: 16 January 2009
Danish: Dato for første markedsføringstilladelse: 16. januar 2009 Dato for fornyelese af tilladelsen: 25. september 2013
English: Following subcutaneous dosing in RA patients, the time to peak serum RoActemra concentrations tmax was 2.8 days.
Danish: Efter subkutan dosering til RA-patienter var tiden til peak serumkoncentration af RoActemra, tmax, 2,8 dage.
English: RoActemra can affect the way some medicines work, and the dose of these may require adjustment.
Danish: RoActemra kan påvirke virkningen af nogle typer medicin, og det kan blive nødvendigt at ændre deres dosis.
English: Number and Proportion of Patients with a JIA ACR30 Flare and Proportion of Patients with JIA ACR30/50/70/90 Responses at Week 40, by Previous Biologic Use (ITT Population - Study Part II)
Danish: Antal og andel af patienter med en JIA-ACR30-flare samt andel af patienter med JIAACR30/50/70/90-respons ved uge 40, afhængigt af tidligere brug af biologiske lægemidler (ITT population - del II af studiet)
English: If any of these applies to you, tell the doctor or nurse giving you the infusion.
Danish: Hvis noget af det ovenstående passer på dig, skal du fortælle det til den læge eller den sygeplejerske, som giver dig infusionen.
English: Prescribers are reminded of the risk of false negative tuberculin skin and interferon-gamma TB blood test results, especially in patients who are severely ill or immunocompromised.
Danish: Den ordinerende læge skal bør være opmærksom på risikoen for falsk negative resultater af tuberkulin-hudtest og interferon-gamma tuberkulose-blodtest, især hos patienter, som er alvorligt syge eller immunkompromitterede.
English: mTSS Erosion Score JSN 0.03 Radiographic Non-Progression n (%) (change from baseline in mTSS of ≤0)
Danish: mTSS 0,08*** Erosions-score JSN 0,03 Ingen radiografisk progression n (%) (ændring fra baseline i mTSS ≤0)
English: • Do not leave the pre-filled pen to warm up in direct sunlight.
Danish: • Lad ikke den fyldte pen ligge i direkte sollys under opvarmningen.
English: • shingles (herpes zoster)
Danish: • helvedesild (herpes zoster)
English: In the majority of patients, there was no increase in atherogenic indices, and elevations in total cholesterol responded to treatment with lipid lowering agents.
Danish: Hos de fleste patienter steg det aterogene indeks ikke, og stigningerne i total-kolesterol responderede på behandling med lipidsænkende midler.
English: The incidence of anti-tocilizumab antibody formation might be underestimated because of interference of tocilizumab with the assay and higher drug concentration observed in children compared to adults.
Danish: Forekomsten af anti-tocilizumab-antistofdannelse kan være undervurderet på grund af interferens mellem tocilizumab og analysen samt højere lægemiddelkoncentration observeret hos børn sammenlignet med voksne.
English: IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, monocytes and fibroblasts.
Danish: IL-6 er et pleiotropisk pro-inflammatorisk cytokin, som dannes af forskellige celletyper, herunder T- og B-celler, monocytter og fibroblaster.
English: However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.
Danish: RoActemra kan dog også gives alene, hvis din læge mener, at methotrexat ikke egner sig til dig.
English: All patients received background glucocorticoid (prednisone) therapy.
Danish: Alle patienter modtog sideløbende glukokortikoid behandling (prednison).
English: Active, severe infections (see section 4.4).
Danish: Aktive, svære infektioner (se pkt.
English: Continued durable responses were seen for over 3 years in the open label extension studies I-V.
Danish: Der blev set fortsat varig respons i mere end 3 år i de åbne ekstensionsstudier I-V.
English: RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6.
Danish: RoActemra indeholder det aktive stof tocilizumab, som er et protein fremstillet ud fra specifikke immune celler (monoklonalt antistof), som blokerer virkningen af et specielt protein (cytokin), som kaldes interleukin-6.
English: 3 This adverse reaction was identified through post marketing surveillance but not observed in controlled clinical trials.
Danish: 3 Denne bivirkning var identificeret i en post marketing overvågning, men var ikke obseveret i kontrollerede kliniske studier.
English: Talk to your doctor if you have any questions about giving yourself an injection.
Danish: Kontakt lægen, hvis du har spørgsmål til hvordan du giver dig selv en indsprøjtning.
English: The safety of RoActemra has been studied in 5 Phase III, double-blind controlled trials and their extension periods.
Danish: RoActemras sikkerhed er blevet undersøgt i 5 fase III, dobbeltblindede kontrollerede studier og i deres forlængelsesperiode.
English: Live and live attenuated vaccines should not be given concurrently with RoActemra as clinical safety has not been established.
Danish: Levende og levende, svækkede vacciner bør ikke gives samtidigt med RoActemra, da den kliniske sikkerhed ikke er dokumenteret.
English: Like all medicines, RoActemra can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Tocilizumab normalises expression of these enzymes.
Danish: Tocilizumab normaliserer ekspressionen af disse enzymer.
English: • Guidance on how to diagnose Macrophage Activation Syndrome in sJIA patients
Danish: • Vejledning til diagnosticering af makrofag-aktiveringssyndrom hos sJIA-patienter
English: Corticosteroid tapering was permitted from week six for patients who achieved a JIA ACR70 response.
Danish: Kortikosteroid-nedtrapning var tilladt fra uge 6 for patienter, som opnåede et JIA ACR70-respons.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous infusion after dilution The diluted product should be used immediately Read the package leaflet before use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs infusion efter fortynding Det fortyndede præparat skal bruges omgående Læs indlægssedlen inden brug
English: • cold sores (oral herpes simplex), blisters
Danish: • forkølelsessår (oral herpes simplex), blistre
English: RoActemra should be used with caution in patients with previous history of intestinal ulceration or diverticulitis.
Danish: RoActemra bør anvendes med forsigtighed til patienter med tidligere intestinal ulceration eller diverticulitis.
English: Macrophage activation syndrome (MAS) is a serious life-threatening disorder that may develop in sJIA patients.
Danish: Makrofagaktiveringssyndrom (MAS) er en alvorlig livstruende komplikation, som kan udvikle sig hos patienter med sJIA.
English: • Reference to the Summary of Product Characteristics (e.g., link to EMA website)
Danish: • Reference til produktresumé (fx link til EMA's hjemmeside)
English: Patients were considered responders if CRS resolved within 14 days of the first dose of tocilizumab, if no more than 2 doses of RoActemra were needed, and no drugs other than RoActemra and corticosteroids were used for treatment.
Danish: Patienterne blev defineret som respondenter, hvis cytokinfrigivelsessyndromet var forsvundet inden for 14 dage fra den første dosis med tocilizumab, hvis ikke der var behov for mere end 2 doser af RoActemra, og ikke andre lægemidler end RoActemra og kortikosteroider, blev anvendt til behandlingen.
English: NOTE: Once the needle-cap is removed, the syringe must be used immediately.
Danish: BEMÆRK: Når kanylehætten er fjernet, skal injektionssprøjten bruges straks.
English: Of the 4009 patients in this population, 3577 received treatment for at least 6 months, 3296 for at least one year, 2806 received treatment for at least 2 years and 1222 for 3 years.
Danish: Ud af 4.009 patienter i denne population fik 3.577 behandling i mindst 6 måneder, 3.296 i mindst et år, 2.806 fik behandling i mindst 2 år og 1.222 i 3 år.
English: IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis.
Danish: IL-6 er involveret i diverse fysiologiske processer som f.eks. Tcelleaktivering, induktion af immunoglobulinsekretion, induktion af hepatisk akutfaseproteinsyntese og stimulation af hæmopoiese.