FrancophonIA/ELRC3.0 huggingface dataset:
English: Total exposure (subject-years) ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN
Danish: Total eksponering (personår) ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN
English: b. Wash your hands with soap and water.
Danish: b. Vask dine hænder med sæbe og vand.
English: If you do not hear clicking sounds or you do not see green ticks in the injection status window after attempting to inject, the pen may have locked and you may not have received your injection.
Danish: Hvis du ikke hører klikkende lyde, eller du ikke ser grønne flueben i vinduet for injektionsstatus efter at have forsøgt at injicere, kan pennen være låst, og du har muligvis ikke fået injektionen.
English: This small volume of distribution indicates that daclizumab is primarily confined to the vascular and interstitial spaces.
Danish: Dette lille fordelingsvolumen angiver, at daclizumab primært fordeles til vaskulære og interstitielle rum.
English: However, Zinbryta's effect on other vaccines (live vaccines) is not known.
Danish: Zinbrytas virkning på andre vacciner (levende vacciner) kendes dog ikke.
English: Study design Treatment
Danish: Studiedesign Behandling
English: Zinbryta may cause serious liver problems that may be life-threatening or result in death.
Danish: Zinbryta kan forårsage alvorlige leverproblemer, der kan være livstruende eller medføre død.
English: It should include the following elements:
Danish: Den bør indeholde følgende,
English: Contact your doctor immediately if you get any serious side effects.
Danish: Kontakt omgående lægen, hvis du får alvorlige bivirkninger.
English: Possible liver problems
Danish: Mulige leverproblemer
English: People with relapsing MS have repeated attacks (relapses) of symptoms caused by their nerves not working properly.
Danish: Mennesker med attakvis MS har gentagne anfald (attakker) med symptomer forårsaget af, at nerverne ikke fungerer ordentligt.
English: Side effects may occur even after stopping treatment (see serious side effects in section 4).
Danish: Bivirkninger kan også opstå efter endt behandling (se alvorlige bivirkninger i punkt 4)
English: Your pen is now ready to inject.
Danish: Pennen er nu klar til injektion.
English: It is very important that you do not miss this blood test.
Danish: Det er meget vigtigt, at du ikke glemmer at få taget denne blodprøve.
English: This has important safety information that you need to know before and during treatment with Zinbryta.
Danish: Det indeholder vigtige oplysninger om sikkerheden, som du skal være bekendt med inden og under behandlingen med Zinbryta.
English: This is normal and the bubbles do not need to be expelled before your injection.
Danish: Dette er normalt, og boblerne skal ikke fjernes før injektion.
English: Exposures (AUC) in these studies ranged from 55 to 140 times that observed with the clinical dose.
Danish: Eksponeringerne (AUC) i disse studier var fra 55 til 140 gange den observerede eksponering ved den kliniske dosis.
English: • increases in body temperature (fever)
Danish: • stigning i kropstemperatur (feber)
English: Although human IgG is secreted into human milk, published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.
Danish: Selvom humant IgG udskilles i human mælk, antyder offentliggjorte data, at antistoffer i mælk ikke går over i nyfødtes og spædbørns kredsløb i betydelige mængder.
English: Zinbryta should be administered with caution to patients with previous or current depressive disorders.
Danish: Zinbryta skal administreres med forsigtighed til patienter med tidligere eller nuværende depressive lidelser.
English: The 300 mg dose did not provide additional benefit over the 150 mg dose.
Danish: 300 mg dosen gav ikke nogen yderligere fordel i forhold til 150 mg dosen.
English: Only one dose should be administered at a time to make up for a missed dose.
Danish: Der må kun administreres én dosis ad gangen til at opveje en glemt dosis.
English: Pharmacotherapeutic group: immunosuppressants, interleukin inhibitors, ATC code: L04AC01
Danish: Farmakoterapeutisk klassifikation: immunsuppressiva, interleukinhæmmere, ATC-kode: L04AC01
English: † MRI analyses used evaluable dataset for each MRI endpoint.
Danish: † MRI-analyse anvender evaluerbare dataset for hvert MRI-endepunkt.
English: Treatment should be initiated by a physician experienced in the management of multiple sclerosis.
Danish: Behandlingen skal indledes af en læge med erfaring i behandling af multipel sklerose.
English: Even if you have had no previous liver problems, your doctor will carry out blood tests to test your liver function.
Danish: Også selvom du ikke før har haft leverproblemer, vil din læge tage blodprøver for at teste din leverfunktion.
English: There was no effect on foetal development and no evidence of teratogenicity.
Danish: Der var ingen påvirkning af fosterets udvikling og ingen tegn på teratogenicitet.
English: Check the expiry date.
Danish: Kontroller udløbsdatoen.
English: Most patients had mild elevations that were below or up to 3 x ULN and resolved spontaneously.
Danish: De fleste patienter havde let forhøjede niveauer, som var under eller op til 3 x ULN og forsvandt spontant.
English: • Patient details, signature and date;
Danish: • Patientoplysninger, underskrift og dato,
English: Vaccination with live vaccines is not advised during treatment and up to 4 months after discontinuation.
Danish: Vaccination med levende vacciner tilrådes ikke under behandlingen og i 4 måneder efter seponering.
English: • diarrhoea that does not go away
Danish: • diarré, der ikke holder op
English: Symptoms may disappear completely after the relapse is over but, over time, some problems may remain between relapses and interfere with daily activities.
Danish: Symptomerne kan forsvinde helt, når attakket er overstået, men med tiden kan nogle problemer blive permanente mellem attakkerne og gribe ind i de daglige aktiviteter.
English: These symptoms vary from patient to patient but usually involve problems such as difficulty with walking, vision and balance.
Danish: Disse symptomer varierer fra patient til patient, men involverer ofte problemer såsom gangbesvær, synsforstyrrelser og balanceproblemer.
English: Potential adverse reactions beyond this level are expected to be consistent with the safety profile for daclizumab in MS patients.
Danish: Potentielle bivirkninger over dette niveau forventes at være i overensstemmelse med sikkerhedsprofilen for daclizumab hos MS-patienter.
English: • irritability, getting upset easily
Danish: • irritabilitet, bliver hurtigt vred
English: Do not try to treat any side effects yourself, but contact your doctor or nurse.
Danish: Forsøg ikke selv at behandle bivirkninger, men kontakt din læge eller sygeplejerske.
English: Patients have received double the recommended dose of Zinbryta with no serious extra side effects.
Danish: Patienter har taget det dobbelte af den anbefalede dosis Zinbryta uden at få alvorlige, ekstra bivirkninger.
English: Your doctor will decide whether Zinbryta is the right medicine for you.
Danish: Lægen vil beslutte, om Zinbryta er det rette lægemiddel til dig.
English: Reported experience with overdose is limited.
Danish: Der er begrænset erfaring med overdosering.
English: In addition to this leaflet you will be given a Patient Card by your doctor.
Danish: Udover denne indlægsseddel vil din læge give dig et patientkort.
English: Table 4: SELECT study clinical and MRI results (at 52 weeks) Placebo
Danish: Tabel 4: SELECT-studiets kliniske resultater og MRI-resultater (ved 52 uger) Placebo
English: No meaningful differences in clinical efficacy or safety were observed among the subgroups of MS patients by weight quartile in the DECIDE study.
Danish: Der blev ikke observeret betydningsfulde forskelle i klinisk effekt eller sikkerhed i undergrupperne af MS-patienter efter vægtkvartil i DECIDE-studiet.
English: This is a type of medicine called a monoclonal antibody.
Danish: Det tilhører en type lægemidler, der kaldes monoklonale antistoffer.
English: Be sure that this hand is not pushing on the Finger Flange.
Danish: Sørg for, at hånden ikke trykker på fingerkraven.
English: Collect all the supplies you will need to give yourself or to receive an injection.
Danish: Saml de ting, du skal bruge til at give dig selv eller få en injektion.
English: This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.
Danish: Disse oplysninger kan ikke erstatte samtaler med din læge eller sygeplejerske om din sygdom eller din behandling.
English: Daclizumab pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Danish: Daclizumabs farmakokinetik er velbeskrevet ved en 2-kompartmentsmodel med førsteordens absorption og elimination.
English: o Do not freeze.
Danish: o Må ikke nedfryses.
English: For DECIDE, at least 2 relapses (one of which was a clinical relapse) within the prior 3 years was also required
Danish: For DECIDE-studiet var mindst 2 attakker (et af dem et klinisk attak) inden for de forudgående 3 år også påkrævet
English: Zinbryta contains a small amount of sodium
Danish: Zinbryta indeholder en lille mængde natrium
English: Try to keep to a particular day of the month to help remember your injection.
Danish: Forsøg at sætte en fast dag i måneden af til det for således at hjælpe dig med at huske injektionen.
English: This could lock the pen.
Danish: Dette kan låse pennen.
English: Daclizumab had no effect on peri- and post-natal development from birth to up to 6 months in the offspring.
Danish: Daclizumab havde ingen virkning på den peri- og post-natale udvikling hos afkommet fra fødslen og op til 6 måneder efter fødslen.
English: This medicinal product contains 0.14 mmol sodium per dose.
Danish: Denne medicin indeholder 0,14 mmol natrium pr. dosis.
English: Clicking Clicking Stops
Danish: Kliklyd Kliklyd stopper
English: There was limited exposure in patients over 55 years of age in clinical studies with daclizumab.
Danish: Der var en begrænset erfaring med eksponering hos patienter over 55 år fra kliniske studier med daclizumab.
English: In addition, the Card explains the need for monitoring of liver function and educates the patient on the importance of adherence to their monthly blood tests.
Danish: Derudover forklarer kortet behovet for monitorering af leverfunktionen, og det forklarer patienten vigtigheden af at få foretaget blodprøver hver måned.
English: Stomach pain may also be a symptom of liver problems, see section above on liver problems.
Danish: Ondt i maven kan også være et symptom på leverproblemer, se punktet ovenfor om leverproblemer.
English: Green Stripes Visible
Danish: Grønne striber synlige
English: It is essentially ‘sodium-free' and can be used by patients on a sodium-restricted diet.
Danish: Den er i det væsentlige natriumfri og kan anvendes af patienter på en natriumbegrænset diæt.
English: In patients who have had tuberculosis or who live in endemic areas of the disease, screening for active tuberculosis should be performed before starting treatment, and patients should be monitored during treatment.
Danish: Patienter, som har haft tuberkulose, eller som bor i områder, hvor tuberkulose er endemisk, skal screenes for aktiv tuberkulose inden behandlingsstart og monitoreres under behandlingen.
English: Warning!
Danish: Advarsel!
English: In either case, do not use two injections to make up for a missed dose.
Danish: Tag under ingen omstændigheder to injektioner som erstatning for en glemt dosis.
English: In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab on microglial cells but are likely to be attributable to an increase in local IL-2 bioavailability.
Danish: In vitro studier antyder, at mikrogliale aggregater ikke skyldes en direkte virkning af daclizumab på mikrogliale celler, men sandsynligvis kan tilskrives en stigning i lokal IL-2-biotilgængelighed.
English: Prior to launch of Zinbryta in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden markedsføring af Zinbryta i det enkelte medlemsland skal indehaveren af markedsføringstilladelsen og den relevante nationale myndighed blive enige om indhold og format af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetoder og andre aspekter vedrørende programmet.
English: Clinical trial data from the DECIDE study demonstrated consistent treatment effects in the highly active disease subgroup.
Danish: Kliniske forsøgsdata fra DECIDE-studiet viste overensstemmende behandlingsvirkninger i undergruppen med højaktiv sygdom.
English: • The recommendation not to initiate treatment in patients with autoimmune disorders (other than multiple sclerosis);
Danish: • Anbefalingen om ikke at iværksætte behandlingen hos patienter med autoimmunsygdomme (andre end multipel sklerose),
English: MRI endpoints#
Danish: MRI-endepunkter#
English: Daclizumab is produced in a mammalian cell line (NS0) by recombinant DNA technology.
Danish: Daclizumab produceres i en pattedyrscellelinje (NS0) vha. rekombinant dna-teknologi.
English: Total lymphocyte counts returned to baseline levels approximately 8-12 weeks after the last dose of Zinbryta (150mg).
Danish: Det totale lymfocyttal vendte tilbage til baseline-niveauerne cirka 8-12 uger efter den sidste dosis Zinbryta (150 mg).
English: Treatment discontinuation should be considered if an adequate response has not been achieved or the patient fails to follow the requirement for scheduled liver test monitoring.
Danish: Det bør overvejes at seponere behandlingen, hvis der ikke opnås et tilstrækkeligt respons, eller hvis patienten ikke følger kravet til skemalagt monitorering af leverfunktionen.
English: The safety and effectiveness of Zinbryta in this age group are not known.
Danish: Zinbrytas sikkerhed og virkning hos denne aldersgruppe er ikke kendt.
English: Do not touch, clean or manipulate the needle cover.
Danish: Undlad at berøre, aftørre eller på anden måde manipulere kanylehætten.
English: The safety of doses above 300 mg administered subcutaneously and 400 mg intravenously have not been evaluated.
Danish: Sikkerheden ved doser over 300 mg subkutant og 400 mg intravenøst er ikke blevet evalueret.
English: The efficacy of Zinbryta was demonstrated in two studies (SELECT and DECIDE) in patients with RMS.
Danish: Effekten af Zinbryta blev vist i to studier (SELECT og DECIDE) hos patienter med attakvis MS.
English: Zinbryta has had very little testing in people older than 55 years old.
Danish: Zinbryta er kun blevet undersøgt hos meget få personer over 55 år.
English: Store in a refrigerator (2oC-8oC).
Danish: Opbevares i køleskab (2 oC-8 oC).
English: In two 9 month studies in monkeys there were no pre-neoplastic or neoplastic tissue observed.
Danish: I to studier af 9 måneders varighed hos aber blev der ikke observeret præ-neoplastisk eller neoplastisk væv.
English: • your skin or the whites of your eyes turn yellow
Danish: • huden eller det hvide i øjnene bliver gullig
English: Table 3: Study design and baseline characteristics for SELECT study and DECIDE study Study name
Danish: Tabel 3: Studiedesign og baseline-karakteristika for SELECT-studiet og DECIDE-studiet
English: Zinbryta is for subcutaneous use.
Danish: Zinbryta er til subkutan brug.
English: When you have any medical treatment, even if it is not for your MS, show the Patient Card to the doctor, pharmacist or nurse.
Danish: Når du får medicin, også selvom det ikke er for din MS, skal du vise patientkortet til lægen, apotekspersonalet eller sundhedspersonalet.
English: Table 5: DECIDE study clinical and MRI results (96 to 144 weeks) (Values refer to results at 96 weeks, unless otherwise indicated.)
Danish: Tabel 5: DECIDE-studiets kliniske resultater og MRI-resultater (uge 96 til uge 144) (Værdierne henviser til resultater ved uge 96, medmindre andet er angivet.)
English: Keep this Card with you during treatment and for 6 months afterwards.
Danish: Behold dette kort under behandlingen og i 6 måneder efter endt behandling.
English: Mutagenesis Genotoxicity studies have not been conducted.
Danish: Mutagenese Der er ikke udført genotoksicitetsstudier.
English: Cases of hepatic injury have occurred in patients taking Zinbryta with other hepatotoxic drugs, although the role of these medicinal products is uncertain.
Danish: Der er opstået tilfælde af leverskade hos patienter, der tager Zinbryta samtidig med andre hepatotoksiske lægemidler, selvom disse lægemidlers rolle ikke er sikker.
English: • Acknowledgment Form.
Danish: • Samtykkeerklæring.
English: Following subcutaneous administration of daclizumab, the median time to reach maximum serum concentrations (Tmax) ranged from 5 to 7 days.
Danish: Efter subkutan administration af daclizumab var gennemsnitstiden til opnåelse af maksimale serumkoncentrationer (Tmax) mellem 5 og 7 dage.
English: You will be given a Patient Card with further information about the things to watch out for while taking Zinbryta.
Danish: Du vil få et patientkort med yderligere oplysninger om, hvad du skal være opmærksom på, mens du tager Zinbryta.
English: Educational guidance
Danish: Undervisningsvejledning
English: Zinbryta is injected monthly.
Danish: Zinbryta injiceres månedligt.
English: Together, these immunomodulatory effects of daclizumab are believed to reduce CNS pathology in MS and thereby reduce the occurrence of relapses and disability progression.
Danish: Tilsammen menes disse immunmodulerende virkninger af daclizumab at reducere de CNS-patologiske træk ved MS og derved reducere forekomsten af attakker og sygdomsprogression.
English: p<0.0001 * Rates and risk reductions/endpoints are calculated over the treatment period up to 144 weeks.
Danish: *Frekvenser og risikoreduktioner/endepunkter er beregnet i løbet af behandlingsperioden på op til 144 uger.
English: Mean number of new T1 Gdenhancing lesions between 8 and 24 weeks (on monthly MRI scans)
Danish: Gennemsnitligt antal nye T1-Gdforstærkede læsioner mellem uge 8 og 24 (på månedlige MRscanninger)
English: If serious infection develops, it could be necessary to withhold treatment with Zinbryta until the infection resolves.
Danish: Hvis en alvorlig infektion udvikles, kan det blive nødvendigt at afbryde behandlingen med Zinbryta, indtil infektionen er forsvundet.
English: • Patients with 2 or more relapses in 1 year, and with 1 or more Gd-enhancing lesions on brain MRI, or
Danish: • Patienter med 2 eller flere attakker på 1 år og med 1 eller flere Gd-forstærkede læsioner på MRscanning af hjernen, eller
English: • runny nose (rhinitis)
Danish: • løbende næse (rhinitis)
English: Pre-filled syringes/Pre-filled pens contain a single dose only and should be discarded after use.
Danish: Fyldte injektionssprøjter/fyldte penne indeholder kun en enkelt dosis og skal kasseres efter brug.
English: Make sure you can see the green stripes in the injection status window (see Figure F).
Danish: Kontrollér, at du kan se de grønne striber i vinduet for status for injektion (se figur F).
English: The physician should discuss the risk of hepatic injury with patients and provide them with a Patient Card.
Danish: Lægen skal drøfte risikoen for leverskade med patienterne og give dem et patientkort.
English: Zinbryta works by stopping the body's immune system from damaging your brain and spinal cord.
Danish: Zinbryta virker ved at forhindre kroppens immunsystem i at beskadige hjernen og rygmarven.
English: In MS, the body's immune system causes inflammation which damages the protective sheath (called myelin) around the nerves in the central nervous system (including the brain and spinal cord).
Danish: Ved MS forårsager kroppens immunsystem en betændelseslignende reaktion (inflammation), som beskadiger den beskyttende isolering (kaldes myelin) omkring nerverne i centralnervesystemet (herunder hjernen og rygmarven).
English: Animal studies do not indicate direct or indirect harmful effects with respect to reprotoxicity (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: Cumulative incidences of peak ALT or AST increase (based on laboratory data) observed in clinical trials
Danish: Kumulative forekomster af maksimale ALAT- eller ASAT-stigningerer (baseret på laboratoriedata), observeret i kliniske studier
English: Zinbryta should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Zinbryta bør kun anvendes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko for fosteret.
English: You could get a needle injury or the pen may lock.
Danish: Du kan komme til skade på kanylen, eller pennen kan låse.
English: Hold the pen over your injection site.
Danish: Hold pennen over injektionsstedet.
English: If you have injected more than your usual dose, and you notice any side effects, or are concerned, speak with your doctor or nurse.
Danish: Hvis du har injiceret mere end din sædvanlige dosis, og du får bivirkninger eller er bekymret, skal du tale med din læge eller sygeplejerske.
English: Cases occurred early after treatment initiation, in patients having received repeated treatment courses and several months after discontinuation.
Danish: Tilfældene forekom hurtigt efter behandlingen blev initieret, hos patienter, der fik gentagne behandlingsforløb, og flere måneder efter seponering.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 July 2016
Danish: Dato for første markedsføringstilladelse: 01. juli 2016
English: Read the instructions before you start using Zinbryta and each time you get a refill of your prescription.
Danish: Læs disse anvisninger, før du begynder at bruge Zinbryta, og hver gang du får en ny pakning med lægemidlet.
English: *Hazard ratio for the risk of relapse #MRI analyses used evaluable dataset for each endpoint; T1 Gd-enhancing: MRI intensive population
Danish: *Hazard ratio for attakrisiko #MRI-analyser anvendte evaluerbare dataset for hvert endepunkt: TI-Gd-forstærket: MRI-intensive population
English: Colitis has been reported with Zinbryta.
Danish: Colitis er blevet rapporteret med Zinbryta.
English: If you need a vaccination, ask your doctor first because Zinbryta may affect how well vaccines work.
Danish: Hvis du skal vaccineres, skal du spørge din læge først, da Zinbryta kan påvirke, hvor godt vaccinen virker.
English: Do not use external heat sources, such as hot water, to warm the pen.
Danish: Anvend ikke eksterne varmekilder, såsom varmt vand, til at opvarme pennen.
English: Your doctor or nurse should train you to give yourself the injections.
Danish: Din læge eller sygeplejersken skal undervise dig i, hvordan du giver dig selv injektionerne.
English: Dermatitis allergic
Danish: Allergisk dermatitis
English: Zinbryta is not to be used in children and adolescents younger than 18 years old.
Danish: Zinbryta må ikke bruges til børn og unge under 18 år.
English: Do not use the pen if it has been dropped or is visibly damaged.
Danish: Anvend ikke pennen, hvis den er blevet tabt eller er synligt beskadiget.
English: Time on study (weeks) Number of patients at risk
Danish: Tidspunkt under studiet (uger) Antal patienter i risikogruppe
English: If you are over 55 your doctor may still prescribe Zinbryta.
Danish: Hvis du er over 55, kan din læge stadig ordinere Zinbryta til dig.
English: The most common types of infections were upper respiratory tract infections and viral infections.
Danish: De hyppigste typer var infektioner i de øvre luftveje og virusinfektioner.
English: Figure 1: Percentage of patients relapse-free (DECIDE study)
Danish: Figur 1: Procentdel patienter, der er fri for attakker (DECIDE-studie)
English: Hold the Zinbryta pre-filled syringe at a 45°-90° angle to the injection site (see Figure I).
Danish: Hold den fyldte Zinbryta injektionssprøjte i en vinkel på 45-90° i forhold til injektionsstedet (se figur I).
English: Interferon beta-1a (intramuscular) 30 micrograms
Danish: Interferon beta-1a (intramuskulært) 30 mikrogram