FrancophonIA/ELRC3.0 huggingface dataset:
English: If you do not not undergo your scheduled blood tests your doctor may decide to stop treatment with Zinbryta.
Danish: Hvis du ikke møder op til dine planlagte blodprøvekontroller, kan lægen beslutte sig for at stoppe behandlingen med Zinbryta.
English: Zinbryta is injected under the skin (subcutaneously) into your thigh, stomach or back of your upper arm.
Danish: Zinbryta injiceres under huden (subkutant) i låret, i maven eller på bagsiden af overarmene.
English: The active substance is daclizumab.
Danish: Aktivt stof: daclizumab.
English: Your doctor will evaluate if any medicines or supplements you are taking have liver side effects and whether you should continue these medicines while receiving Zinbryta.
Danish: Lægen vil evaluere, om nogle af de lægemidler eller kosttilskud, du tager, har leverbivirkninger, og om du må fortsætte med disse lægemidler, mens du får Zinbryta.
English: Zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable (see section 4.4).
Danish: Zinbryta er indiceret til behandling af voksne patienter med attakvis multipel sklerose (MS), der har haft et utilstrækkeligt respons på mindst to sygdomsmodificerende behandlinger (disease modifying therapies, DMT'er) og hvor behandling med enhver anden DMT'er er kontraindiceret eller på anden vis ikke er egnet (se pkt.
English: • However, if it is more than 2 weeks from your missed dose, skip the missed dose and take your next dose on your usual day.
Danish: • Hvis der er gået mere end 2 uger fra din glemte dosis, skal du springe den glemte dosis over og tage den næste dosis på den sædvanlige dag.
English: • Before you use the Zinbryta pre-filled syringe for the first time, your doctor or nurse should show you or your carer how to prepare and inject the Zinbryta pre-filled syringe.
Danish: • Før du bruger den fyldte injektionssprøjte med Zinbryta første gang, skal lægen eller sygeplejersken vise dig, hvordan du klargør og injicerer den fyldte injektionssprøjte med Zinbryta rigtigt.
English: Lung infections:
Danish: Lungeinfektioner:
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne listet med de mindst alvorlige sidst.
English: In the DECIDE study subgroup analysis, there was a statistically significant reduction observed compared to interferon beta-1a (intramuscular) on ARR and the number of new or newly enlarging T2 hyperintense lesions across subgroups (gender, age, prior MS DMT therapy, and disease activity levels).
Danish: I analysen af undergrupper i DECIDE-studiet blev der observeret en statistisk signifikant reduktion sammenlignet med interferon beta-1a (intramuskulært) i ARR og antal nye eller nyligt forstørrede T2-hyperintense læsioner på tværs af undergrupperne (køn, alder, tidligere sygdomsmodificerende behandling af MS og sygdomsaktivitetsniveau).
English: Caution!
Danish: Forsigtig!
English: Treatment initiation is not recommended in patients with ALT or AST ≥ 2 times the upper limit of normal (ULN) and is contraindicated in patients with pre-existing hepatic impairment (see section 4.3).
Danish: Initiering af behandling anbefales ikke hos patienter med ALAT eller ASAT ≥ 2 gange den øvre normalgrænse (ULN), og behandlingen er kontraindiceret hos patienter med forudeksisterende nedsat leverfunktion (se pkt.
English: Subgroup analyses of the SELECT and DECIDE studies demonstrated a consistent effect of Zinbryta compared to placebo and interferon beta-1a (intramuscular) across subgroups defined by demographic and MS disease characteristics.
Danish: Analyser af undergrupper i SELECT- og DECIDE-studierne viste en konsistent effekt af Zinbryta sammenlignet med placebo og interferon beta-1a (intramuskulært) på tværs af undergrupper defineret ved demografiske karakteristika og MS-karakteristika.
English: In patients with neutralising antibodies, daclizumab clearance was increased on average by 19% (see section 5.2).
Danish: Hos patienter med neutraliserende antistoffer steg daclizumab-clearance med gennemsnitligt 19% (se pkt.
English: When observed during Zinbryta clinical studies, lymphopenia was mostly mild to moderate (≥ 500/mm3).
Danish: Lymfopeni observeret i kliniske studier med Zinbryta var for det meste let til moderat (≥ 500/mm3).
English: Injection Status Window
Danish: Vindue for injektionsstatus
English: The most commonly reported adverse reactions leading to discontinuation in patients treated with Zinbryta were hepatic reactions, including elevations of serum transaminases (5%), and cutaneous reactions (4%) (see section 4.4).
Danish: De hyppigst rapporterede bivirkninger, der førte til seponering af Zinbryta, var hepatiske reaktioner, herunder forhøjede aminotransferaser i serum (5%) og kutane reaktioner (4%) (se pkt.
English: In the DECIDE study (see section 5.1), patients were tested for anti-drug (daclizumab) antibodies at week 4 and approximately every 3 months thereafter.
Danish: 5.1) blev patienterne testet for antistoffer mod daclizumab ved uge 4 og cirka hver 3. måned derefter.
English: Due to the risk of hepatic injury, the use of Zinbryta is restricted (see section 4.1).
Danish: På grund af risikoen for leverskade, er anvendelsen af Zinbryta begrænset (se pkt.
English: In clinical studies, the pharmacodynamic effects of Zinbryta 150 mg administered subcutaneously every 4 weeks were consistent with modulation of IL-2 signalling as evidenced by the rapid and sustained saturation of the target CD25 receptors on circulating T-cells and a sustained approximately 2-fold increase in serum IL-2 concentration.
Danish: I kliniske studier var de farmakodynamiske virkninger af Zinbryta 150 mg indgivet subkutant hver 4. uge i overensstemmelse med modulering af IL-2-signalering som vist ved den hurtige og vedvarende mætning af CD25-målreceptorerne på cirkulerende T-celler og en vedvarende omtrentlig 2-folds stigning i IL-2-koncentrationen i serum.
English: The majority of patients with infections continued on treatment with Zinbryta.
Danish: Størstedelen af patienterne med infektioner fortsatte Zinbryta-behandlingen.
English: Use caution when removing the needle cover to avoid getting a needle injury.
Danish: Vær forsigtig, når du fjerner kanylehætten, for ikke at komme til skade på kanylen.
English: Step 6: Inject Medicine
Danish: Trin 6: Injicér lægemidlet
English: Step 3: Choose and clean your injection site
Danish: Trin 3: Vælg og rengør injektionsstedet
English: Available toxicology data in lactating cynomolgus monkeys have shown excretion of daclizumab in milk (for details see section 5.3).
Danish: Tilgængelige toksikologiske data fra diegivende cynomolgusaber har vist, at daclizumab udskilles i mælk (se pkt.
English: 1.0 point improvement p=0.0008
Danish: 3,0 points forværring 1,0 points forbedring p=0,0008
English: The Hepatic Risk Management Guide for Physicians should inform HCPs about:
Danish: Vejledningen til læger i håndtering af risikoen for leverskader skal informere læger og sundhedspersonale om:
English: • Check the expiry date on the Zinbryta prefilled syringe (See Figure D).
Danish: • Kontroller udløbsdatoen på den fyldte Zinbryta injektionssprøjte (se figur D).
English: • You should hold the pen over your injection site at a 90o angle.
Danish: • Hold pennen i en vinkel på 90o over injektionsstedet.
English: In clinical studies, Zinbryta increased the incidence of lymphadenopathy, with onset occurring throughout the treatment period.
Danish: I kliniske studier øgede Zinbryta incidensen af lymfadenopati med debut i hele behandlingsperioden.
English: • your skin or the whites of the eyes turn yellow Increased tiredness, dark urine and skin or whites of the eyes turning yellow also may be symptoms of liver problems, see section above on liver problems.
Danish: Øget træthed, mørk urin, og hvis huden eller det hvide i øjenene bliver gullig, kan også være symptomer på leverproblemer, se punktet ovenfor om leverproblemer.
English: Check the injection status window.
Danish: Kontrollér vinduet for injektionsstatus.
English: You may be tested for TB before starting Zinbryta and monitored during treatment.
Danish: Måske vil din læge teste dig for TB, inden du begynder behandling med Zimbryta, og overvåge dig under behandlingen.
English: The most common skin reactions were rash, dermatitis, and eczema.
Danish: De hyppigste hudreaktioner var udslæt, dermatitis og eksem.
English: Sodium succinate Succinic acid Sodium chloride Polysorbate 80
Danish: Natriumchlorid Polysorbat 80
English: Low red blood cell counts (autoimmune haemolytic anaemia): (Uncommon - may affect up to 1 in 100 people)
Danish: Lavt antal røde blodlegemer (autoimmun hæmolytisk anæmi): (Ikke almindelig - kan påvirke op til 1 ud af 100 personer)
English: Step 4: Choose and clean your injection site a.
Danish: Trin 4: Vælg og rengør dit injektionssted a.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK INNER CARTON (without blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNINGENS INDERPAKNING (uden blå boks)
English: Step 3: Check the Zinbryta Pen (Figure C) a.
Danish: Trin 3: Kontroller Zinbryta pennen (figur C) a.
English: Do not touch the needle.
Danish: Rør ikke ved kanylen.
English: • The importance of the liver function monitoring, at least monthly during treatment (or more frequently as clinically indicated), and for up to 6 months after the last dose;
Danish: • Vigtigheden af at overvåge leverfunktionen, mindst månedligt i løbet af behandlingen (eller hyppigere efter klinisk indikation), og i op til 6 måneder efter den sidste dosis,
English: Patient serum transaminase and total bilirubin levels should be monitored at least monthly and as close as possible before each administration, and more frequently as clinically indicated during treatment and up to 6 months after the last dose of Zinbryta.
Danish: Patientens aminotransferaser og totalt bilitrubin i serum skal monitoreres mindst månedligt så tæt på hver administration som muligt, og hyppigere efter klinisk indikation under behandlingen og i op til 6 måneder efter den sidste Zinbryta-dosis.
English: Hepatic Risk Management Guide for Physicians, Patient Card and Acknowledgment Form
Danish: Vejledning til læger i håndtering af risikoen for leverskader, patientkort og samtykkeerklæring
English: Zinbryta can be stored at room temperature (up to 30oC) in the original pack for 30 days.
Danish: Zinbryta kan opbevares ved stuetemperatur (op til 30 oC) i den originale yderpakning i 30 dage.
English: Note: Do not touch or blow on this area before giving your injection.
Danish: Bemærk: Undlad at berøre eller puste på dette sted, før injektionen foretages.
English: If a patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g. unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine), it is recommended to promptly measure serum transaminases, discontinue treatment with Zinbryta, as appropriate, and promptly refer the patient to a hepatologist.
Danish: Hvis en patient udvikler kliniske tegn eller symptomer, der tyder på leverdysfunktion (dvs. uforklarlig kvalme, opkastning, abdominalsmerter, træthed, anoreksi eller icterus og/eller mørk urin), anbefales det at måle aminotransferaseniveauerne i serum omgående, seponere Zinbryta-behandlingen, og omgående henvise patienten til en hepatolog.
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C for up to 30 days.
Danish: • Om nødvendigt kan Zinbryta opbevares uden afkøling i den lukkede originale æske ved op til 30 °C i op til 30 dage.
English: • The pen is for use under the skin only (subcutaneous).
Danish: • Pennen er kun beregnet til injektion under huden (subkutant).
English: Elimination As an IgG1 monoclonal antibody, daclizumab is not expected to undergo renal elimination.
Danish: Elimination Som et IgG1monoklonalt antistof forventes daclizumab ikke at blive elimeret via nyrerne.
English: Re-capping could cause the pen to lock.
Danish: Hvis den sættes på igen, kan det medføre, at pennen låser.
English: - 3 month multipack containing three 150 mg pre-filled pens (3 boxes containing 1 pen each).
Danish: - 3-måneders multipakning indeholdende tre 150 mg fyldte penne (3 æsker indeholdende 1 pen hver).
English: Daclizumab is not expected to undergo metabolism by hepatic enzymes such as CYP isoenzymes (see section 4.5).
Danish: Daclizumab forventes ikke at blive metaboliseret vha. leverenzymer såsom CYP-isoenzymer (se pkt.
English: In addition, there was a statistically significant effect on 24 week confirmed disability progression in Zinbryta treated patients with a hazard ratio 0.24 [95% CI: 0.09, 0.63].
Danish: Desuden var der en statistisk signifikant effekt på 24 ugers bekræftet handikapprogression hos patienter behandlet med Zinbryta med en hazard ratio på 0,24 [95 % CI 0,09-0,63].
English: It is not known whether Zinbryta is secreted in human milk.
Danish: Det er ukendt, om Zinbryta udskilles i human mælk.
English: Tuberculosis infections have been reported in patients treated with Zinbryta.
Danish: Tuberkulose er rapporteret hos patienter behandlet med Zinbryta.
English: *Observed with a ≥2% higher incidence than placebo †Observed with a ≥2% higher incidence than interferon beta-1a (intramuscular)
Danish: *Observeret med en ≥ 2% højere frekvens end for placebo †Observeret med en ≥ 2% højere frekvens end for interferon beta-1a (intramuskulært) Beskrivelse af udvalgte bivirkninger
English: What Zinbryta is used for
Danish: Hvad bruges Zinbryta til
English: A pre-filled syringe of Zinbryta is contained within a spring-powered pen injector called Zinbryta Pen.
Danish: En fyldt injektionssprøjte med Zinbryta er indeholdt i en fjederaktiveret peninjektor med navnet Zinbryta-pen.
English: If a dose is missed and it is more than 2 weeks from the missed dose, patients should skip the missed dose, wait until their next scheduled dose, and then remain on their original monthly dosing schedule.
Danish: Hvis en dosis glemmes, og der er gået mere end 2 uger fra den glemte dosis, skal den glemte dosis springes over og patienten vente indtil den næste, planlagte dosis og derefter fortsætte behandlingen i henhold til den oprindelige, månedlige doseringsplan.
English: The usual sites for subcutaneous injection include the thigh, abdomen, and back of the upper arm.
Danish: De sædvanlige injektionssteder for subkutane injektioner er lår, abdomen og bagsiden af overarmene.
English: MRI endpoints † Mean number of new or newly enlarging T2 hyperintense lesions
Danish: MRI-endepunkter† Gennemsnitligt antal nye eller nyligt forstørrede T2-hyperintense læsioner
English: No impact on male or female fertility as assessed by fertility indices was detected in animal studies (see section 5.3).
Danish: Der blev ikke registreret nogen indvirkning på handyrs eller hundyrs fertilitet ifølge fertilitetsdata fra dyrestudier (se pkt.
English: • The importance of monitoring the liver function (AST, ALT and total bilirubin levels) at least monthly (or more frequently as clinically indicated) as close as possible before each treatment administration, and for up to six months after the last dose;
Danish: • Vigtigheden af at monitorere leverfunktionen (ASAT-, ALAT- og totale bilirubinniveauer) mindst månedligt (eller hyppigere efter klinisk indikation) så tæt på hver administration af behandlingen som muligt, og i op til 6 måneder efter den sidste dosis,
English: Autoimmune haemolytic anaemia has been reported in patients treated with Zinbryta which resolved with standard treatment and discontinuation of Zinbryta.
Danish: Der er blevet rapporteret autoimmun hæmolytisk anæmi hos patienter behandlet med Zinbryta, som ophørte med standardbehandling og seponering af Zinbryta.
English: If a patient develops severe depression, and/or suicidal ideation, discontinuation of Zinbryta should be considered (see section 4.8).
Danish: Hvis en patient udvikler alvorlig depression og/eller selvmordstanker, bør seponering af Zinbryta overvejes (se pkt.
English: An increased incidence of serious colitis (<1%) was reported in patients treated with Zinbryta in clinical studies.
Danish: En øget incidens af svær colitis (<1%) blev rapporteret hos patienter behandlet med Zinbryta i kliniske studier.
English: After your injection After Use - Parts of your Zinbryta Pen (see Figure K):
Danish: Efter injektionen Efter brug - Zinbryta pennens forskellige dele (se figur K):
English: • Keep the Zinbryta pre-filled syringe/pen in its original package to protect from light.
Danish: • Opbevar Zinbryta fyldt injektionssprøjte/pen i den originale yderpakning for at beskytte mod lys.
English: • Prescriber name, signature and date.
Danish: • Navn, underskrift og dato for den ordinerende læge.
English: How long to use Zinbryta
Danish: Hvor længe skal du bruge Zinbryta
English: In addition, there was a statistically significant effect on 24 week confirmed disability progression in Zinbryta treated patients with a hazard ratio 0.73 [95% CI: 0.55, 0.98].
Danish: Desuden var der en statistisk signifikant effekt på 24 ugers bekræftet handikapprogression hos patienter behandlet med Zinbryta med en hazard ratio på 0,73 [95 % CI 0,55-0,98].
English: Back of Upper Arm
Danish: Bagsiden af overarmene
English: Figure 2: Proportion of patients with 24 week confirmed disability (DECIDE study)
Danish: Figur 2: Andel patienter med 24 ugers bekræftet Handikapprogression (DECIDE-studie)
English: • the syringe/pen is cracked or broken.
Danish: • injektionssprøjten/pennen er revnet eller ødelagt
English: • If needed, apply a gauze pad, adhesive bandage or plaster to the injection site.
Danish: • Sæt en gazeserviet, selvklæbende bandage eller plaster på injektionsstedet, hvis det er nødvendigt.
English: Must not be returned to refrigerator after storage at room temperature.
Danish: Må ikke sættes tilbage i køleskab efter opbevaring ved stuetemperatur.
English: • inflamed or enlarged lymph nodes (lymphadenopathy, lymphadenitis)
Danish: • betændte eller forstørrede lymfeknuder (lymfadenopati, lymfadenitis)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OUTER CARTON (with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNINGENS YDERPAKNING (med blå boks)
English: Efficacy in patients with highly active disease Highly active disease was defined as follows:
Danish: Højaktiv sygdom blev defineret på følgende måde:
English: • the solution is any other colour than colourless to slightly yellow
Danish: • injektionsvæsken har en anden farve end farveløs til let gullig
English: You will need: - a blood test before starting treatment to check your liver function and if you have hepatitis B
Danish: Du skal have taget følgende: - en blodprøve inden du starter behandlingen, for at kontrollere leverfunktionen og om du har hepatitis B og C. Hvis din blodprøve viser, at du har leverproblemer, vil lægen beslutte, om
English: Step 7: Remove the Zinbryta Pen from your injection site a.
Danish: Trin 7: Fjern Zinbryta pennen fra injektionsstedet a.
English: Referring patients who develop symptoms of colitis (e.g. abdominal pain, fever, prolonged diarrhoea) to a specialist is advisable (see section 4.8).
Danish: Det tilrådes at henvise patienter, som udvikler symptomer på colitis (f.eks. abdominalsmerter, feber, langvarig diarré), til en specialist (se pkt.
English: Autoimmune haemolytic anaemia
Danish: Autoimmun hæmolytisk anæmi
English: The incidence of discontinuation due to medicine related hepatic disorders was 5% in Zinbryta-treated patients and 4% in interferon beta-1a (intramuscular).
Danish: Incidensen af seponering grundet medicinrelaterede hepatiske bivirkninger var 5% hos Zinbryta-behandlede patienter og 4% hos patienter behandlet med interferon beta-1a (intramuskulært).
English: Your doctor will evaluate if any medicines or supplements you are taking have liver side effects and whether you should continue these medicines while taking Zinbryta - if you have depression or have had it in the past.
Danish: Lægen vil evaluere, om de lægemidler eller kosttilskud du tager har leverbivirkninger, og om du må fortsætte med at tage disse lægemidler, mens du tager Zinbryta - Hvis du lider af depression eller har gjort det. - Hvis du har en alvorlig infektion såsom lungebetændelse.
English: What you need to know before you use Zinbryta
Danish: Det skal du vide, før du begynder at bruge Zinbryta
English: The SELECT study was double-blind, randomised, placebo-controlled, with either Zinbryta 150 mg (n=208), or 300 mg (n=209) versus placebo (n=204) every 4 weeks for 52 weeks.
Danish: SELECT-studiet var et dobbeltblindt, randomiseret, placebokontrolleret studie med enten Zinbryta 150 mg (n=208) eller 300 mg (n=209) versus placebo (n=204) hver 4. uge i 52 uger.
English: Do not inject directly into your belly button.
Danish: Injicer ikke direkte ind i navlen.
English: Low level of a type of white blood cells (called lymphocytes): Zinbryta could reduce your level of these white blood cells so you will have a blood test every 3 months.
Danish: Zinbryta kan nedsætte antallet af hvide blodlegemer, derfor skal du have dit blod tjekket hver 3. måned.
English: Do not re-cap the pen.
Danish: Sæt ikke hætten på pennen igen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1107/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1107/001
English: The colitis improved with discontinuation of Zinbryta and standard treatment.
Danish: Colitis bedredes efter seponering af Zinbryta og standardbehandling.
English: Do not use this medicine after the expiry date which is stated on the carton and the label after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Detailed instructions for injecting Zinbryta are given in section 7, Instructions for injecting Zinbryta.
Danish: Du kan se detaljerede anvisninger i, hvordan du injicerer Zinbryta i punkt 7, Sådan injicerer du Zinbryta.
English: Serious hepatic injury, including fatal cases of autoimmune hepatitis and fulminant liver failure have occurred in patients treated with Zinbryta.
Danish: Alvorlig leverskade, herunder dødelige tilfælde af autoimmun hepatitis og fulminant leversvigt, er forekommet hos patienter behandlet med Zinbryta.
English: In addition, Zinbryta reduced clinically meaningful worsening in the patient reported physical impact of MS (≥7.5 point worsening from baseline to week 96 in the MSIS-29
Danish: Derudover reducerede Zinbryta på en klinisk betydningsfuld måde forværring af patientrapporteret MS-relateret fysiske påvirkning (≥7,5 point forværring i MSIS-29 fysisk score fra baseline til uge 96) sammenlignet med interferon beta-1a (intramuskulært).
English: • Common (≥1/100 to <1/10)
Danish: • Almindelig (≥1/100 til <1/10)
English: The recommended dose of Zinbryta is 150 mg injected subcutaneously once a month.
Danish: Den anbefalede dosis er 150 mg Zinbryta som subkutan injektion én gang om måneden.
English: With your other hand, firmly grasp the needle cover and pull it straight off the needle (See Figure G).
Danish: Tag godt fat i kanylehætten med den anden hånd og træk den lige af kanylen (se figur G).
English: Autoimmune haemolytic anaemia was reported in < 1% of patients treated with Zinbryta in clinical studies.
Danish: Der blev rapporteret autoimmun hæmolytisk anæmi hos < 1 % af patienterne behandlet med Zinbryta i kliniske studier.
English: Daclizumab clearance in patients who developed neutralising antibodies was, on average, 19% higher (see section 4.8 Immunogenicity).
Danish: Daclizumabs clearance hos patienter, der udviklede neutraliserende antistoffer, var i gennemsnit 19% højere (se pkt.
English: • decreases in the amount of white blood cells (these will show up in blood tests)
Danish: • nedsat antal leukocyt (viser sig i blodprøverne)
English: You should then contact your doctor, nurse or pharmacist.
Danish: Hvis dette sker, skal du kontakte din læge, sygeplejerske eller apotekspersonalet.