FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Zinbryta is daclizumab.
Danish: Det aktive stof i Zinbryta er daclizumab.
English: The study designs and baseline characteristics are presented in Table 3.
Danish: Studiedesign og baseline-karakteristika er vist i tabel 3.
English: Time on study (weeks) Average number of patients at risk
Danish: Tidspunkt under studiet (uger) Gennemsnitligt antal patienter i risikogruppe
English: (Common - may affect up to 1 in 10 people) • lung infection (e.g. pneumonia, bronchitis)
Danish: (Almindelige - kan påvirke op til 1 ud af 10 personer) • lungeinfektion (f.eks. lungebetændelse, bronkitis)
English: You will hear the clicking sounds start.
Danish: Du vil høre en klikkende lyd.
English: The safety of immunisation with live viral vaccines during treatment with Zinbryta has not been studied.
Danish: Sikkerheden ved immunisering med vaccine med levende virus under behandling med Zinbryta er ikke blevet undersøgt.
English: Refer to section below, ‘Educational Guidance', for details of the Hepatic Risk Management Guide for Physicians and Patient Card that are recommended for use with this medicine.
Danish: Se afsnittet nedenfor, ‘Undervisningsvejledning', for oplysninger om vejledningen til læger i håndtering af risikoen for leverskader samt patientkortet, som anbefales til brug sammen med dette lægemiddel.
English: • feeling unusually sad, hopeless or bad about yourself
Danish: • en følelse af ualmindelig tristhed, håbløshed eller ringe selvagtelse
English: Total NK cell counts increased approximately 1.5-fold as a result of the change in CD56bright NK cells.
Danish: Det totale NKcelletal steg cirka 1,5-fold som resultat af ændringen i CD56bright NK-celler.
English: After the clicking sound has stopped, lift the pen from your injection site.
Danish: Efter den klikkende lyd er stoppet, løftes pennen væk fra injektionsstedet.
English: Note: After the pen has been removed from the injection site, the needle cover will lock to protect against needle injury.
Danish: Bemærk: Når pennen fjernes fra injektionsstedet, vil kanylehætten låse for at beskytte mod skade forårsaget af kanylen.
English: There was no apparent correlation of anti-drug antibodies or neutralising antibodies development to clinical response, adverse reactions, or pharmacodynamic profile of daclizumab.
Danish: Der var ingen klar sammenhæng mellem udviklingen af antistoffer mod lægemidlet eller neutraliserende antistoffer og den kliniske respons, bivirkninger eller den farmakodynamiske profil for daclizumab.
English: Step 1: Remove the pen from the fridge a. Remove the pen from the carton in the fridge 30 minutes before giving your injection to allow it to warm to room temperature.
Danish: Trin 1: Tag pennen ud af køleskabet a. Tag pennen ud af æsken i køleskabet 30 minutter før injektionen skal foretages, så den kan få mulighed for at opnå stuetemperatur.
English: The magnitude of the immune response to the seasonal influenza vaccine, and proportion of patients with seroconversion and seroprotection were consistent with those observed in healthy volunteer populations.
Danish: Immunresponsen over for den sæsonbestemte influenzavaccine og andelen af patienter med serokonversion og seroprotektion var konsistent med data hos raske, frivillige populationer.
English: • Inform patients about the need for monitoring of liver function during treatment and for up to 6 months after the last dose of Zinbryta;
Danish: • Informere patienterne om behovet for at monitorere leverfunktionen under behandlingen, og i op til 6 måneder efter den sidste Zinbryta-dosis,
English: This can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Danish: Det kan være med til at reducere antallet af attakker, og det kan forsinke udviklingen af handikap på grund af MS.
English: • Patients who had failed to respond to a full and adequate course (at least 1 year) of prior DMT treatment, having had at least 1 relapse in the previous year while on therapy, and at least 9 T2 hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or having an unchanged or increased relapse rate in the prior year as compared to the previous 2 years.
Danish: • Patienter, som ikke har responderet på en komplet og passende forudgående sygdomsmodificerende behandling (mindst 1 år), som har haft mindst 1 attak i det forudgående år samtidig med behandling og mindst 9 T2-hyperintense læsioner på kraniel MRI eller mindst 1 Gd-forstærket læsion, eller som har haft en uændret eller øget attakfrekvens i det sidste år sammenlignet med de forudgående 2 år.
English: Colourless to slightly yellow, clear to slightly opalescent liquid with pH 6.
Danish: Farveløs til let gullig, klar til let opalescerende væske med pH 6.
English: There are no data on the effects of Zinbryta on human fertility.
Danish: Der foreligger ingen data om Zinbrytas indvirkning på fertiliteten hos mennesker.
English: • Very rare (<1/10,000) • Not known (cannot be estimated from the available data)
Danish: • Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator
English: As data on use of Zinbryta during pregnancy are limited, the risk to the baby and benefit to the mother should be taken into consideration.
Danish: Da der kun er begrænsede data om brug af Zinbryta under graviditet, skal risikoen for barnet og fordelen for moderen tages i betragtning.
English: If you do develop liver problems your MS doctor may stop your treatment with Zinbryta and refer you to a liver specialist (see section 4, Possible side effects).
Danish: Hvis du udvikler leverproblemer, kan din MS-læge stoppe behandlingen med Zinbryta og henvise dig til en leverspecialist (se punkt 4, Bivirkninger).
English: • The need to screen for hepatitis B and C prior to treatment initiation and to recommend patients who test positive for HBV or HCV infection to consult with a physician with expertise in the treatment of those conditions.
Danish: • Behovet for at screene for hepatitis B og C før behandlingen iværksættes, og at anbefale, at patienter, der tester positivt for HBV- eller HCV-infektion kontakter en læge med speciale i behandlingen af disse tilstande.
English: Step 6: Give the injection a.
Danish: Trin 6: Foretag injektionen a.
English: In a clinical study, patients (n=90) on long-term treatment with Zinbryta mounted appropriate immune responses to an inactivated trivalent seasonal influenza vaccine.
Danish: I et klinisk studie udviste patienter (n=90) i langtidsbehandling med Zinbryta passende immunresponser på en inaktiveret, trivalent, sæsonbestemt influenzavaccine.
English: Skin reactions generally resolved with standard care, including treatment with topical or systemic steroids.
Danish: Hudreaktionerne forsvandt generelt ved brug af standardbehandling, herunder behandling med topikale eller systemiske steroider.
English: • adhesive bandage or plaster
Danish: • selvklæbende bandage eller plaster
English: • the pen has been dropped or is visibly damaged.
Danish: • pennen er blevet tabt eller er synligt beskadiget.
English: Microglial aggregates in monkeys did not increase in incidence or severity with increased duration of dosing and were not associated with neuronal damage or neurobehavioral effects.
Danish: Mikrogliale aggregater hos aber blev ikke hyppigere eller sværere med øget behandlingsvarighed og var ikke forbundet med neuronal skade eller neuroadfærdsmæssige effekter.
English: As renal excretion is not a major route of elimination, no dose adjustments are considered necessary (see section 5.2).
Danish: Da renal udskillelse ikke er en primær eliminationsvej, betragtes dosisjustering ikke som nødvendig (se pkt.
English: Keep the leaflet and Card with you during treatment and for 6 months after the last dose of Zinbryta, since side effects may occur even after you have stopped treatment.
Danish: Behold indlægssedlen og patientkortet under behandlingen og i 6 måneder efter den sidste dosis Zinbryta, da der kan opstå bivirkninger, også efter du har afsluttet behandlingen.
English: Choose an injection site and wipe the skin with an alcohol wipe.
Danish: Vælg et injektionssted og aftør huden med en spritserviet.
English: • Before you use the pen for the first time, your doctor or nurse should show you or your carer how to prepare and inject the pen.
Danish: • Før du bruger pennen for første gang, skal lægen eller sygeplejersken vise dig eller din hjælper, hvordan du klargør og injicerer pennen.
English: A multipack of three packs of one syringe/pen is also available.
Danish: En multipakning med tre pakker med én injektionssprøjte/pen i hver er også tilgængelig.
English: Zinbryta is used to treat relapsing forms of multiple sclerosis (MS) in adults who have failed to respond despite therapy with at least two MS treatment and who cannot be given other treatments.
Danish: Zinbryta bruges til at behandle voksne med attakvis multipel sklerose (MS), som ikke har haft respons, trods behandling med mindst 2 MS-behandlinger, og som ikke kan få anden behandling.
English: If you forget to take Zinbryta
Danish: Hvis du har glemt at tage Zinbryta
English: AST or ALT ≥ 3 x ULN AND total bilirubin ≥ x 2 ULN
Danish: ASAT eller ALAT ≥ 3 x ULN OG totalt bilirubin ≥ x 2 ULN
English: Treatment discontinuation is recommended in patients who reach ALT or AST >3 times the ULN regardless of bilirubin levels.
Danish: Det anbefales at seponere behandlingen hos patienter, der opnår niveauer af ALAT eller ASAT > 3 gange ULN, uanset bilirubin-niveauerne.
English: Serious reactions, including autoimmune hepatitis, hepatitis and jaundice, were observed in 1.7% of patients in clinical trials.
Danish: Alvorlige reaktioner, herunder autoimmun hepatitis, hepatitis og icterus, blev observeret hos 1,7 % af patienterne i kliniske studier.
English: Zinbryta 150 mg p-value
Danish: Zinbryta 150 mg p-værdi
English: Patients with RMS, at least 1 relapse (clinical and/or MRI) during the year prior to randomisation, and had an EDSS score between 0 to 5.0.
Danish: Patienter med attakvis MS, mindst 1 attak (klinisk og/eller MRI) i løbet af det sidste år før randomisering og en EDSSscore mellem 0 og 5,0.
English: The risk of Progressive Multifocal Leukoencephalopathy (PML) associated to the treatment with Zinbryta has not been established.
Danish: Risikoen for progressiv multifokal leukoencefalopati (PML) associeret med behandling med Zinbryta er ikke blevet klarlagt.
English: A small subset of microglial aggregates were associated with microhaemorrhage but with no evident functional sequelae in monkeys.
Danish: En mindre undergruppe af mikrogliale aggregater var forbundet med mikrohæmoragi, men uden nogen tydelige funktionelle sequelae hos aberne.
English: Chronic administration of daclizumab at all doses increased the incidence of skin findings (compared to those observed in control animals).
Danish: Kronisk administration af daclizumab i alle doser øgede incidensen af hudreaktioner (sammenlignet med kontroldyrene).
English: For additional information on storage at room temperature, see section 6.3.
Danish: For yderligere oplysninger om opbevaring ved stuetemperatur, se pkt.
English: The Finger Flange will allow you to better grip the syringe and should remain attached.
Danish: Fingerkraven giver dig et bedre greb i injektionssprøjten og skal blive på.
English: Seasonal flu vaccines (inactive vaccine) have been shown to be effective when given to patients taking Zinbryta.
Danish: Det er vist, at vacciner mod sæsoninfluenza (inaktiv vaccine) er effektive, når de gives til patienter, der bruger Zinbryta.
English: • Prior to treatment (re)start, confirmation of: o A discussion between the physician and the patient about the risk of serious and potentially fatal hepatic injury and the unpredictable nature of such reactions and about the possibility of having to switch treatment in case of levels of ALT or AST > 3 times the ULN; o Patient understanding of the risk information provided; o Receipt of a copy of the acknowledgement form; o Receipt of the Patient Card;
Danish: • Før behandlingen initieres eller genoptages, bekræftelse af: o En diskussion mellem lægen og patienten om risikoen for alvorlig og potentielt dødelig leverskade, og uforudsigeligheden af sådanne reaktioner, og om muligheden for, at skifte til en anden behandling i tilfælde af ALAT- eller ASATniveauer > 3 gange ULN, o Patienten skal forstå de formidlede oplysninger om risiko, o Modtagelsen af en kopi af Samtykkeerklæringen, o Modtagelsen af Patientkortet,
English: Prior to treatment initiation with Zinbryta, serum transaminases (ALT and AST) and total bilirubin levels should be obtained, and patients should be screened for Hepatitis B (HBV) and C (HCV).
Danish: Før behandlingen med Zinbryta indledes, skal aminotransferase- (ALAT og ASAT) og totale bilirubinniveauer i serum måles, og patienterne skal screenes for hepatitis B (HBV) og C (HCV).
English: These may be signs of a serious liver problem.
Danish: Disse bivirkninger kan være tegn på et alvorlig leverproblem.
English: Do not lift your pen off your injection site until the clicking sounds stop and you see green ticks in the injection status window.
Danish: Løft ikke pennen væk fra injektionsstedet, før den klikkende lyd er stoppet, og du ser grønne flueben i vinduet for status for injektion.
English: The Acknowledgment Form aims at providing information on the risk of serious hepatic injury to patients.
Danish: Samtykkeerklæringen har til hensigt at give patienterne oplysninger om risikoen for alvorlige leverskade.
English: If you have trouble handling the syringe/pen, tell your doctor or nurse who may be able to help.
Danish: Hvis du har svært med at håndtere injektionssprøjten/pennen, så spørg din sygeplejerske eller læge til råds, de kan sikkert hjælpe dig.
English: Based on the cross-study population pharmacokinetic analysis, body weight accounted for less than 40% of the inter-patient variability in daclizumab clearance.
Danish: Baseret på den tværgående farmakokinetiske analyse af studiepopulationen kunne kropsvægt redegøre for mindre end 40% af den inter-individuelle variabilitet i daclizumabs clearance.
English: The MAH shall ensure that in each EU MS where Zinbryta is marketed, all prescribers are provided with an educational package, aiming at preventing and/or minimising the risk of serious hepatic injury (potentially life threatening or fatal) and informing the patients about the unpredictability of these events and containing the following elements:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle de ordinerende læger i hvert medlemsland i Europa, hvor Zinbryta markedsføres, får udleveret en uddannelsespakke, med det formål at forhindre og/eller minimere risikoen for alvorlig leverskade (potentielt livstruende eller dødelig), og informere patienterne om disse hændelsers uforudsigelighed.
English: Zinbryta is not expected to affect your ability to drive and use machines.
Danish: Det forventes ikke, at Zinbryta vil påvirke din evne til at køre motorkøretøj og bruge maskiner.
English: The other ingredients are sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections (see section 2 ‘Zinbryta contains a small amount of sodium').
Danish: Øvrige indholdsstoffer: natriumsuccinat, ravsyre, natriumchlorid, polysorbat 80, vand til injektionsvæsker (se punkt 2 ‘Zinbryta indeholder en lille mængde natrium').
English: Patients on Zinbryta may receive non-live vaccines.
Danish: Patienter i behandling med Zinbryta kan vaccineres med ikke-levende vacciner.
English: Serious liver problems can occur both early after starting treatment with Zinbryta, any time during treatment and several months after discontinuing treatment.
Danish: Der kan forekomme alvorlige leverproblemer både hurtigt efter behandlingen med Zinbryta påbegyndes, når som helst under behandlingen og flere måneder efter behandlingsophør.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zinbryta in one or more subsets of the paediatric population in treatment of 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 Zinbryta i en eller flere undergrupper af den pædiatriske population ved behandling af multipel sklerose (se pkt.
English: Innovation House 70 Norden Road
Danish: 70 Norden Road
English: At week 96, Zinbryta demonstrated a statistically significant reduction in the number of new or newly enlarging T2 hyperintense lesions, the number of new T1 Gd-enhancing lesions and the mean number of new T1 hypointense lesions.
Danish: Ved uge 96 viste Zinbryta en statistisk signifikant reduktion i antallet af nye eller nyligt forstørrede T2-hyperintense læsioner, antallet af nye T1-Gd-forstærkede læsioner og det gennemsnitlige antal nye T1-hypointense læsioner.
English: Daclizumab is a humanised IgG1 monoclonal antibody that binds to CD25 (IL-2Rα), and prevents IL-2 binding to CD25.
Danish: Daclizumab er et humaniseret IgG1 monoklonalt antistof, der binder til CD25 (IL-2Rα) og forhindrer IL-2-binding til CD25.
English: Daclizumab was detected in the milk of 11/14 lactating monkeys at levels that were <0.122% of the maternal serum levels, with no adverse reactions observed in the off-spring.
Danish: Daclizumab kunne detekteres i mælken hos 11 ud af 14 diegivende aber med niveauer, der var <0,122% af moderens serumniveau, uden observation af bivirkninger hos afkommet.
English: Treatment with Zinbryta 150 mg every 4 weeks versus placebo significantly reduced the annualised relapse rate (ARR) and risk of relapse compared to placebo.
Danish: Behandling med Zinbryta 150 mg hver 4. uge kontra placebo reducerede signifikant den årlige attakrate (ARR) såvel som risikoen for attak sammenlignet med placebo.
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
Danish: • Den anbefalede opbevaring er kontrolleret afkøling mellem 2 °C og 8 °C i den lukkede, originale yderpakning for at beskytte mod lys.
English: • Check that the Zinbryta medicine is colourless or slightly yellow (See Figure E).
Danish: • Kontroller, at Zinbryta-lægemidlet er farveløst eller let gulligt (se figur E).
English: The majority of the treatment-emergent anti-drug antibodies responses were transient (12% [110/913]) and the remaining minority (7% [65/913]) were persistent.
Danish: Størstedelen af antistofresponserne overfor lægemidlet var forbigående (12% [110/913]), og den resterende minoritet (7% [65/913]) var persisterende.
English: INFORMATION IN BRAILLE Zinbryta
Danish: INFORMATION I BRAILLESKRIFT Zinbryta
English: Pull the pen cap straight off and set it aside (See Figure E).
Danish: Træk pennens hætte lige af og læg den til side (se figur E).
English: Table 1: Adverse reactions reported for Zinbryta 150mg System Organ Class
Danish: Tabel 1: Bivirkninger rapporteret for Zinbryta 150 mg Systemorganklasse
English: Based on the cross-study population pharmacokinetic analysis, daclizumab pharmacokinetics were not influenced by age (range: 18 to 66 years; n=1670) or gender (n = 567 males and 1103 females).
Danish: Baseret på den tværgående farmakokinetiske analyse af studiepopulationen blev daclizumabs farmakokinetik ikke påvirket af alder (interval 18 til 66 år; n = 1.670) eller køn (n = 567 mænd og 1.103 kvinder).
English: If Zinbryta has been outside of the refrigerator for more than a total of 30 days or if you are not sure how long Zinbryta has been at room temperature, it should be discarded.
Danish: Hvis Zinbryta har været uden for køleskab i mere end 30 dage i alt, eller hvis du ikke er sikker på, hvor længe Zinbryta har stået ved stuetemperatur, skal lægemidlet kasseres.
English: Based on the cross-study population pharmacokinetic analysis, the clearance of daclizumab is 0.212 L/day with a terminal half-life value of approximately 21 days.
Danish: Baseret på den tværgående farmakokinetiske analyse af studiepopulationen er daclizumabs clearance 0,212 l/dag med en terminal halveringstid på cirka 21 dage.
English: Choose an injection site in your thigh, abdomen, or the back of your upper arm (See highlighted areas in Figure D).
Danish: Vælg et injektionssted på låret, maven eller bagsiden af overarmen (se fremhævede områder på figur D).
English: Zinbryta has not been studied in patients with immunodeficiency syndromes.
Danish: Zinbryta er ikke blevet undersøgt hos patienter med immundefektsyndromer.
English: Treatment-emergent anti-drug antibodies and neutralising antibodies were observed in 19% (175/913) and 8% (71/913) of study patients, respectively.
Danish: Dannelse af antistoffer mod lægemidlet og neutraliserende antistoffer under behandlingen blev observeret hos henholdsvis 19% (175/913) og 8% (71/913) af studiepatienterne.
English: Your doctor will tell you how long you need to keep using Zinbryta.
Danish: Din læge vil fortælle dig, hvor længe du skal bruge Zinbryta.
English: You will also have a blood test to check your liver every month, as close as possible before each dose of Zinbryta, and more often if your doctor decides this is necessary.
Danish: Du skal også have taget en blodprøve for at måle dine levertal hver måned, så tæt på hver dosis af Zinbryta som muligt, og hyppigere, hvis lægen beslutter, at det er nødvendigt.
English: As an IgG1 monoclonal antibody, daclizumab is expected to undergo catabolism to peptides and amino acids in the same manner as endogenous IgG.
Danish: Som et IgG1 monoklonalt antistof forventes daclizumab at blive kataboliseret til peptider og aminosyrer på samme måde som endogent IgG.
English: At steady state, daclizumab mean maximum serum concentration (Cmax), minimum serum concentration (Cmin) and area under the serum concentrationtime curve over the dosing interval (AUCtau) values were approximately 30 micrograms/mL, 15 micrograms/mL and 640 day*micrograms/mL, respectively, with inter-patient variability (% CV) of approximately 40%.
Danish: Ved steady state var den gennemsnitlige maksimale serumkoncentration af daclizumab (Cmax), den minimale serumkoncentration (Cmin) og arealet under serumkoncentration-tid-kurven over doseringsintervallet (AUCtau) henholdsvis cirka 30 mikrogram/ml, 15 mikrogram/ml og 640 dag∙mikrogram/ml med en inter-individuel variation (% CV) på cirka 40%.
English: The most common adverse reactions reported for Zinbryta were rash, increased alanine aminotransferase (ALT), depression, nasopharyngitis, upper respiratory tract infection, influenza, oropharyngeal pain, and lymphadenopathy.
Danish: De hyppigste bivirkninger rapporteret for Zinbryta var udslæt, forhøjet alaninaminotransferase (ALAT), depression, nasofaryngitis, infektion i de øvre luftveje, influenza, oro-faryngeale smerter og lymfadenopati.
English: Although the effect on disability progression was mainly seen in patients with baseline EDSS < 3.5, evidence of efficacy was shown in patients with relapsing secondary progressive MS (SPMS) as defined by baseline EDSS ≥ 3.5 and at least one of the three: confirmed 24 week worsening of EDSS, or ≥ 20% decline on Timed 25-foot Walk (T25FW), or, ≥ 20% decline on 9-Hole Peg Test (9HPT).
Danish: Selvom effekten på handikapprogression primært blev observeret hos patienter med EDSS < 3,5 ved baseline, var der evidens for effekt hos patienter med attakvis sekundær progressiv MS (SPMS), defineret ved EDSS ≥ 3,5 ved baseline og mindst én af tre: bekræftet 24 ugers forværring af EDSS, ≥ 20 % reduktion ved Timed 25-foot Walk (T25FW) eller ≥ 20 % reduktion ved 9-Hole Peg Test (9-HPT).
English: # Hazard ratio for the risk of relapse.
Danish: # Hazard ratio for attakrisiko.
English: Check the medicine window.
Danish: Kontrollér medicinvinduet.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu .
English: Medicine Visible
Danish: Medicin synlig