FrancophonIA/ELRC3.0 huggingface dataset:
English: Before you prepare your injection, take the syringe out of the fridge and let it warm to room temperature.
Danish: Før du gør din injektion klar, skal du tage injektionssprøjten ud af køleskabet og lade den opnå stuetemperatur.
English: The majority of patients with lymphadenopathy continued on treatment with Zinbryta, and the majority of cases resolved within 3 months.
Danish: Størstedelen af patienterne med lymfadenopati fortsatte behandlingen med Zinbryta, og størstedelen af tilfældene bedredes inden for 3 måneder.
English: • The management of patients receiving Zinbryta and presenting with signs and symptoms of potential hepatic injury, including treatment discontinuation, potential consideration of additional therapy, and prompt referral to a hepatologist;
Danish: • Behandlingen af patienter, der får Zinbryta og viser tegn og symptomer på en mulig leverskade, herunder seponering af behandlingen, en potentiel overvejelse af tillægsbehandling, og en omgående henvisning til en hepatolog,
English: • Inform patients about the unpredictable risk of serious and potentially fatal hepatic injury at any time during treatment and up to several month after treatment;
Danish: • Informere patienterne om den uforudsigelige risiko for alvorlig og potentielt dødelig leverskade når som helst under behandlingen, og i op til flere måneder efter behandlingen,
English: • increases in liver enzymes in the blood (these will show up in blood tests)
Danish: • forhøjede leverenzymer i blodet (viser sig i blodprøverne)
English: • skin infection (folliculitis, acne)
Danish: • hudinfektion (folliculitis, akne)
English: Your doctor will help you decide whether you should stop breast-feeding, or stop using Zinbryta.
Danish: Din læge vil hjælpe dig med at beslutte, om du skal stoppe med at amme eller stoppe med at bruge Zinbryta.
English: Step 2: Collect your supplies and wash your hands a. Find a well-lit area and a clean, flat surface, like a table, and collect all the supplies you will need to give yourself, or to receive, an injection.
Danish: • a. Find en ren og plan overflade med god belysning, såsom et bord, og saml de ting, du skal bruge til at give dig selv eller få en injektion.
English: It is recommended that patients should be trained in the proper technique for self-administering subcutaneous injection using the pre-filled syringe/pre-filled pen.
Danish: Det anbefales, at patienterne undervises i korrekt teknik, således at patienten selv kan indgive subkutane injektioner med den fyldte injektionssprøjte/fyldte pen.
English: • Each Zinbryta pre-filled syringe can be used once only.
Danish: • Hver fyldt injektionssprøjte med Zinbryta kan kun anvendes én gang.
English: Step 8: Check to make sure you have received your full dose of Zinbryta (see Figure J).
Danish: Trin 8: Kontrollér, at du har fået hele din dosis Zinbryta (se figur J).
English: Consistent with results from individual studies, a cross-study population pharmacokinetic analysis indicated that daclizumab exposure is more than dose-proportional in the 50 mg to 100 mg subcutaneous dose range and is dose proportional in the 100 mg to 300 mg subcutaneous dose range.
Danish: I overensstemmelse med resultater fra individuelle studier indikerede en tværgående farmakokinetisk analyse af studiepopulationen, at eksponeringen for daclizumab er mere end proportional med dosis i dosisintervallet 50 mg til 100 mg subkutant, og proportional med dosis i dosisintervallet 100 mg til 300 mg subkutant.
English: This may cause the pen to accidentally lock.
Danish: Dette kan medføre, at pennen låser ved et uheld.
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Danish: Hovedeffekterne af denne modulering af IL-2-signaleringen, der potentielt er relateret til daclizumabs terapeutiske virkninger ved MS, inkluderer selektiv antagonisering af aktiverede T-celleresponser og ekspansion af immunregulerende CD56bright naturlige dræberceller (NK-celler), som er vist selektivt at reducere aktiverede T-celler.
English: All physicians who intend to prescribe Zinbryta must ensure they are familiar with the Hepatic Risk Management Guide for Physicians for this medicinal product.
Danish: Enhver læge, som har til hensigt at ordinere Zinbryta, skal være bekendt med vejledningen til læger i håndtering af risikoen for leverskader.
English: Carcinogenicity studies with daclizumab have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med daclizumab.
English: The dose of Zinbryta is 150 mg every month.
Danish: Dosis for Zinbryta er 150 mg hver måned.
English: Zinbryta has no or negligible influence on the ability to drive and use machines.
Danish: Zinbryta påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: LIST OF EXCIPIENTS Sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections
Danish: LISTE OVER HJÆLPESTOFFER Natriumsuccinat, ravsyre, natriumchlorid, polysorbat 80, vand til injektionsvæsker
English: There are limited data from the use of Zinbryta in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af Zinbryta til gravide kvinder.
English: • If you do forget a dose, and it is within 2 weeks of your missed dose, inject as soon as you can. Then carry on as normal, sticking to your usual injection day.
Danish: • Hvis du glemmer en dosis, og det er inden for 2 uger fra din glemte dosis, skal du give dig selv en injektion, så snart du kan. Fortsæt derefter som normalt og hold dig til din sædvanlige injektionsdag.
English: • skin rashes, including inflamed, irritated, itchy, dry or peeling skin (dermatitis, eczema,
Danish: • hududslæt, herunder betændt, irriteret, kløende, tør eller skællende hud (dermatitis, eksem, psoriasis)
English: • Store in a refrigerator (2oC to 8oC).
Danish: • Opbevares i køleskab (2 oC til 8 oC).
English: Sustained severe lymphopenia (< 500/mm3), was not observed in clinical studies with Zinbryta.
Danish: Vedvarende, alvorlig lymfopeni (< 500/mm3) blev ikke observeret i kliniske studier med Zinbryta.
English: Daclizumab did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively).
Danish: Daclizumab påvirkede ikke reproduktionsevnen hos cynomolgus-hunner eller -hanner (AUC hos hunner og hanner op til henholdsvis 85 og 100 gange højere end eksponeringen ved den kliniske dosis).
English: The needle cover will extend to cover the needle and will lock (See Figure I).
Danish: Kanylehætten vil bevæge sig ud, så den dækker kanylen, og låse (se figur I).
English: Patients treated with Zinbryta should be advised to report any symptoms of new or worsening depression, and/or suicidal ideation immediately to the prescribing physician.
Danish: Patienter behandlet med Zinbryta skal informeres om straks at rapportere eventuelle symptomer på ny eller forværret depression og/eller selvmordstanker til den ordinerende læge.
English: The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Order Class by frequency and incidence.
Danish: Bivirkningerne er vist i henhold til de foretrukne MedDRA-termer i MedDRA-systemorganklassen og efter frekvens.
English: • The need to provide the patient with the Patient Card and the Acknowledgment Form, discuss their content before starting Zinbryta treatment, informing patients of the risk of hepatic injury, the need for periodic monitoring and the signs or symptoms suggestive of hepatic dysfunction.
Danish: • Behovet for at forsyne patienten med Patientkortet og Samtykkeerklæringen, diskutere deres samtykke før behandlingen med Zinbryta initieres, informere patienterne om risikoen for leverskade, behovet for periodisk monitorering og tegn og symptomer, der kunne tyde på leverdysfunktion.
English: The Card informs patients of the risk of serious hepatic injury, and its possible symptoms, so that they are aware of situations in which they should contact a healthcare professional in a timely manner.
Danish: Kortet informerer patienterne om risikoen for alvorlig leverskade og de mulige symptomer, så de er klar over, i hvilke situationer de skal kontakte en læge eller sundhedsperson i tide.
English: Among the evaluable patients, the majority of treatment-emergent neutralising antibody responses were transient (6% [56 of 913]) and 2% of patients (15 of 913) had persistent responses.
Danish: Blandt de evaluerbare patienter var størstedelen af responserne på de neutraliserende antistoffer forbigående (6% [56 af 913]), og 2% af patienterne (15 af 913) havde vedvarende neutraliserende antistoffer.
English: Treatment-emergent anti-drug antibodies and neutralising antibodies responses predominantly occurred during the first year of treatment and their frequency declined with continued Zinbryta treatment.
Danish: Antistoffer mod lægemidlet og neutraliserende antistoffer forekom hovedsageligt i det første behandlingsår, og frekvensen af disse faldt ved fortsat behandling med Zinbryta.
English: The majority of patients had skin reactions that were mild or moderate in severity.
Danish: Størstedelen af patienterne havde lette eller moderate hudreaktioner.
English: In two 9 month studies conducted in cynomolgus monkeys daclizumab was subcutaneously administered at bi-weekly doses of 10-200 mg/kg.
Danish: I to studier af 9 måneders varighed udført hos cynomolgusaber blev daclizumab administreret subkutant to gange om ugen i doser på 10-200 mg/kg.
English: Percentage of relapse-free patients
Danish: Procent patienter, der er fri for attakker
English: You should see green stripes.
Danish: Du skal kunne se grønne striber.
English: Note: Do not rest the pen on the injection site until you are ready to inject.
Danish: Bemærk: Lad ikke pennen hvile på injektionsstedet, før du er klar til at injicere.
English: The clinical relevance of microglial aggregates is unknown, however no deleterious neurologic effects attributed to the microscopic change have been observed in monkeys.
Danish: Den kliniske relevans af mikrogliale aggregater er ukendt, men der er ikke blevet observeret skadelige neurologiske effekter hos aber, der kan tilskrives den mikroskopiske forandring.
English: In addition, an increase in CD56bright NK cells and a decrease in regulatory T-cells (defined as CD4+CD127lowFoxP3+ T-cells) was observed within 2 weeks after the first dose, with a sustained 5-fold increase in CD56bright NK cells above baseline and an approximately 60% decrease in regulatory T-cells in the treatment phase, with a return to baseline levels approximately 20-24 weeks after the last dose.
Danish: Derudover blev der observeret et øget antal CD56bright NKceller og et nedsat antal regulatoriske T-celler (defineret som CD4+CD127lavFoxP3+ T-celler) inden for 2 uger efter den første dosis, svarende til en vedvarende 5-folds stigning i CD56bright NK-celler i forhold til baseline og et fald på cirka 60% i regulatoriske T-celler i behandlingsfasen med tilbagevenden til baseline-niveauerne cirka 20-24 uger efter den sidste dosis.
English: • dark (tea-coloured) urine
Danish: • mørk (tefarvet) urin
English: Daclizumab modulates IL-2 signalling by blocking CD25-dependent, highaffinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Danish: Daclizumab modulerer IL-2-signalering ved at blokere CD25-afhængig, højaffinitets IL-2-receptorsignalering, hvilket resulterer i højere niveauer af IL-2, som er tilgængelig for signalering via IL-2-receptoren med intermediær affinitet.
English: Marketing Authorisation Holder Biogen Idec Ltd.
Danish: Indehaver af markedsføringstilladelsen Biogen Idec Ltd.
English: Based on the cross-study population pharmacokinetic analysis, the steady-state volume of distribution of daclizumab is 6.34 L in a patient with a body weight of 68 kg (approximate median of evaluated patients).
Danish: Baseret på den tværgående farmakokinetiske analyse af studiepopulationen er fordelingsvolumenet af daclizumab ved steady state 6,34 l hos en patient, der vejer 68 kg (omtrenlige median for de evaluerede patienter).
English: Do not use Zinbryta - if you have previously had a serious allergic reaction to daclizumab, or any of the other ingredients of this medicine listed in section 6.
Danish: Brug ikke Zinbryta - Hvis du er allergisk over for daclizumab eller et af de øvrige indholdsstoffer i Zinbryta angivet i punkt 6.
English: A dose dependent increase in incidence of microglial aggregates above background was observed in the brain and spinal cord of monkeys treated with ≥35 mg/kg, (AUC 27 times higher than the clinical dose).
Danish: Der blev observeret en dosisafhængig stigning i incidensen af mikrogliale aggregater i hjernen og rygmarven hos aber behandlet med ≥ 35 mg/kg (AUC 27 gange højere end ved den kliniske dosis).
English: This tells you that the injection is happening (see Figure G).
Danish: Dette fortæller dig, at medicinen injiceres (se figur G).
English: • The contraindication in all patients with pre-existing hepatic disease or hepatic impairment;
Danish: • Kontraindikationen for alle patienter med forudeksisterende leversygdom eller nedsat leverfunktion,
English: • Educate the patient on the importance of: o Adhering to the monthly liver function tests (or more frequently, as clinically indicated during treatment); o Recognising the symptoms and signs of possible hepatic injury so that they are aware of situations in which they should contact a physician in a timely manner;
Danish: • Uddanne patienten i vigtigheden af at: o Overholde de månedlige leverfunktionsprøver (eller hyppigere efter klinisk indikation under behandlingen), o Genkende symptomer og tegn på mulig leverskade, så de er opmærksomme på situationer, hvor de bør kontakte lægen snarest,
English: If your MS does not respond to Zinbryta, your doctor may decide to stop your treatment with Zinbryta.
Danish: Hvis din MS ikke responderer på Zinbryta, kan lægen beslutte at stoppe din behandling med Zinbryta.
English: This loss of myelin is called demyelination.
Danish: Dette tab af myelin kaldes demyelinisering, og det forhindrer nerverne i at fungere korrekt.
English: Preclinical safety studies were conducted in cynomolgus monkeys due to species specificity of daclizumab binding only to human or primate CD25.
Danish: De prækliniske sikkerhedsstudier blev udført på cynomolgusaber grundet artsspecificitet for daclizumab, der kun binder til CD25 hos mennesker og primater.
English: • The importance of detecting signs and symptoms which might indicate hepatic injury, and if any of these occur, to promptly contact their physician;
Danish: • Vigtigheden af at opdage tegn og symptomer, der kan indikere leverskade, og hvis de opstår, øjeblikkeligt at kontakte lægen,
English: Do not use more than one pre-filled syringe per month.
Danish: Brug ikke mere end én fyldt injektionssprøjte om måneden.
English: If you remove the cap, do not re-cap the pen.
Danish: Hvis du fjerner hætten, må du ikke sætte den på pennen igen.
English: Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Zinbryta should be allowed to warm to room temperature (20°C-30°C) (about 30 minutes) prior to injection.
Danish: Sikkerhedsforanstaltninger før håndtering og administration af lægemidlet Når Zinbryta tages ud af køleskabet, skal det stå, indtil stuetemperatur er opnået (20-30°C) (cirka 30 minutter), før det indgives.
English: • The unpredictable risk of serious and potentially fatal hepatic injury at any time during treatment and up to several months after the last dose;
Danish: • Den uforudsigelige risiko for alvorlig og potentielt dødelig leverskade når som helst under behandlingen, og i op til flere måneder efter den sidste dosis,
English: Patients should be informed about the risk of hepatic injury, the need for periodic monitoring and warned about signs or symptoms suggestive of hepatic dysfunction.
Danish: Patienterne skal informeres om risikoen for leverskade, behovet for periodisk monitorering, og advares om tegn og symptomer, der kunne tyde på leverdysfunktion.
English: Seborrhoeic dermatitis†
Danish: Seboroisk dermatitis†
English: There is limited data on concomitant use of Zinbryta with MS symptomatic therapies.
Danish: Der foreligger begrænsede data for brugen af Zinbryta sammen med symptomatisk MS-behandling.
English: • increased tiredness
Danish: • øget træthed
English: Wipe your skin with an alcohol wipe.
Danish: Aftør huden med en spritserviet.
English: • The liquid is cloudy or contains floating particles.
Danish: o Væsken er uklar eller indeholder partikler.
English: The safety and efficacy of Zinbryta in children and adolescents below 18 years have not been established.
Danish: Zinbrytas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Infections, some serious (e.g. pneumonia and bronchitis), have been reported with Zinbryta.
Danish: Infektioner, nogle alvorlige (f.eks. pneumoni og bronkitis), er blevet rapporteret med Zinbryta.
English: The absolute bioavailability of daclizumab 150 mg subcutaneously administered was approximately 90% based on a cross-study population pharmacokinetic analysis of subcutaneous and intravenous dosing.
Danish: Den absolutte biotilgængelighed af daclizumab 150 mg administreret subkutant var cirka 90% baseret på en tværgående, farmakokinetisk analyse af subkutan og intravenøs dosering hos studiepopulationen.
English: Pack sizes: Each pack contains one pre-filled glass syringe/pre-filled pen with an attached needle, ready to inject.
Danish: Pakningsstørrelser: Hver pakning indeholder en fyldt glas-injektionssprøjte/fyldt pen med en påsat kanyle, klar til injektion.
English: You could get a needle injury.
Danish: Du kan komme til skade på kanylen.
English: Compared with interferon beta-1a intramuscular (n=440), Zinbryta (n=404) led to reductions on ARR (rate ratio 0.52 [95% CI: 0.42, 0.64], p<0.0001), number of new or newly enlarging T2 hyperintense lesions (lesion mean ratio 0.46 [95% CI: 0.37, 0.57], p<0.0001), and 24 weeks confirmed disability progression (hazard ratio 0.60 [95% CI: 0.40, 0.89], p=0.012).
Danish: Sammenlignet med interferon beta-1a intramuskulært (n=440) medførte Zinbryta (n=404) reduktioner i ARR (risikorate 0,52 [95% CI 0,42; 0,641], p<0,0001), antal nye eller nyligt forstørrede T2-hyperintense læsioner (gennemsnitlig læsionsrate 0,46 [95% CI: 0,37; 0,57], p<0,0001) og 24 uger bekræftet handikapprogression (hazard ratio 0,60 [95% CI: 0,40; 0,89], p=0,012).
English: Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom
Danish: Biogen Idec Ltd. Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY Storbritannien
English: o Make sure Zinbryta is out of the refrigerator for no longer than 30 days.
Danish: o Sørg for, at Zinbryta højst er 30 dage uden for køleskab.
English: These findings (dry, red raised patchy areas of the skin, as compared to controls, that correlated microscopically with acanthosis/hyperkeratosis and sub-acute to chronic inflammation) were characterised predominantly as mild to moderate, with one case assessed as severe.
Danish: Disse fund (tørre, rødplettede, hævede områder i huden, der mikroskopisk svarede til acanthose/hyperkeratose og subakut til kronisk inflammation) blev hovedsageligt karakteriseret som lette til moderate, med et tilfælde vurderet som svært.
English: Within the studied regimens of daclizumab 150 mg and 300 mg administered subcutaneous every 4 weeks in MS patients, there was no clear relationship between daclizumab exposure and clinical efficacy endpoints (ARR, T2 lesions and Gd-enhancing lesions) or safety endpoints of interest (serious infection status, moderate or severe cutaneous adverse reaction, and AST/ALT > 5 times the ULN).
Danish: Inden for de undersøgte behandlingsregimer med daclizumab 150 mg og 300 mg administreret subkutant hver 4. uge hos MS-patienter var der ikke en tydelig sammenhæng mellem daclizumabeksponeringen og de kliniske effektendepunkter (ARR, T2-læsioner og Gd-forstærkede læsioner) eller relevante sikkerhedsendepunkter (alvorlig infektionstilstand, moderat eller svær kutan bivirkning eller ASAT/ALAT > 5 gange ULN).
English: Let the injection site dry on its own before injecting the dose.
Danish: Lad injektionsstedet tørre af sig selv, inden dosis injiceres.
English: Step 9: Disposing of used Zinbryta Pens
Danish: Trin 9: Bortskaffelse af brugte Zinbryta penne
English: • Very common (≥ 1/10)
Danish: • Meget almindelig (≥ 1/10)
English: You should see a yellow plunger.
Danish: Du skal kunne se et gult stempel.
English: If a woman wishes to breast-feed during treatment with Zinbryta, the benefit of breast-feeding to the child and of therapy to the woman should be considered.
Danish: Hvis en kvinde ønsker at amme under behandlingen med Zinbryta, skal fordelen ved amning for barnet overvejes i forhold til de terapeutiske fordele for kvinden.
English: The exact metabolic pathway for daclizumab has not been characterised.
Danish: Daclizumabs nøjagtige metabolisme er ikke blevet karakteriseret.
English: Do not touch or blow on this area again before giving your injection.
Danish: Du må ikke røre ved eller puste på dette sted igen, før du giver injektionen.
English: 150 mg Prefilled Syringe Figure A
Danish: 150 mg fyldt injektionssprøjte Figur A
English: In clinical studies, serum transaminase elevations occurred at any time during treatment and up to 6 months after the last dose of Zinbryta.
Danish: I kliniske studier forekom forhøjede aminotransferaser i serum når som helst under behandlingen og i op til 6 måneder efter sidste Zinbryta-dosis.
English: • infections of the airways, such as coughs and colds (nasopharyngitis, upper respiratory tract infection)
Danish: • luftvejsinfektioner såsom hoste og forkølelser (infektion i de øvre luftveje)
English: Following subcutaneous administration of daclizumab 150 mg every 4 weeks, steady-state serum daclizumab concentrations were achieved by the 4th dose and daclizumab accumulated to a level approximately 2.5-fold compared to a single dose.
Danish: Efter subkutan administration af daclizumab 150 mg hver 4. uge blev der opnået steady state koncentrationer af daclizumab i serum ved den 4. dosis, og daclizumab akkumulerede til et niveau på cirka 2,5-fold sammenlignet med en enkelt dosis.
English: Check the medicine window and make sure the Zinbryta medicine is colourless to slightly yellow.
Danish: Kontroller medicinvinduet og se efter, at Zinbryta-injektionsvæsken er farveløs til let gullig.
English: Can be stored at room temperature (up to 30°C) for a single period of up to 30 days.
Danish: Kan opbevares ved stuetemperatur (op til 30 °C) i en enkelt periode på op til 30 dage.
English: • If you see blood at your injection site, wipe it off with the gauze pad and apply an adhesive bandage or plaster.
Danish: • Hvis der er blod på injektionsstedet, skal du tørre det af med gazeservietten og sætte en selvklæbende bandage eller et plaster på.
English: o 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, throw the syringe/pen away (see section 7, Instructions for injecting Zinbryta).
Danish: o 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 du kassere injektionssprøjten/pennen (se punkt 7, Sådan injicerer du Zinbryta).
English: Do not take the Zinbryta pre-filled syringe out of the injection site until you have pushed the plunger all the way down.
Danish: Træk ikke den fyldte Zinbryta injektionssprøjte ud af injektionsstedet, før du har trykket stemplet helt i bund.
English: No studies were conducted to evaluate daclizumab pharmacokinetics in patients with renal or hepatic impairment.
Danish: Der blev ikke udført studier til evaluering af daclizumabs farmakokinetik hos patienter med nedsat nyre- eller leverfunktion.