FrancophonIA/ELRC3.0 huggingface dataset:
English: Neopterin concentrations return to baseline after the two week dosing interval.
Danish: Neopterinkoncentrationerne returnerer til baseline efter dosisintervallet på to uger.
English: Treatment initiation
Danish: Initiering af behandling
English: Pre-filled syringes/pre-filled pens are for single use only and should be discarded after use.
Danish: Fyldte sprøjter/fyldte penne er kun til éngangsbrug og skal kasseres efter brug.
English: Let the pen warm to room temperature for at least 30 minutes.
Danish: Lad pennen varme op til stuetemperatur i mindst 30 minutter.
English: *Dosed every 2 weeks (14 days)
Danish: *Tages hver 2. uge (hver 14. dag)
English: In clinical studies, a total of 1468 patients received Plegridy for up to 278 weeks with an overall exposure equivalent of 4217 person-years.
Danish: I kliniske studier fik i alt 1.468 patienter Plegridy i op til 278 uger med en samlet eksponering svarende til 4.217 personår.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially those used to treat epilepsy or depression.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig, især medicin mod epilepsi eller depression.
English: Proportion with 24-week confirmed disability progression*
Danish: Antal med 24 ugers bekræftet udvikling af handicap*
English: They may get worse while using Plegridy:
Danish: De kan forværres, mens du bruger Plegridy:
English: Patients may develop antibodies to Plegridy.
Danish: Patienterne kan udvikle antistoffer mod Plegridy.
English: Plegridy binds to the type I interferon receptor on the surface of cells and elicits a cascade of intracellular events leading to the regulation of interferon-responsive gene expression.
Danish: Plegridy bindes til type I-interferonreceptoren på celleoverfladen og fremkalder en kaskade af intracellulære hændelser, der fører til regulering af interferonreaktiv genekspression.
English: Day 14 (94 micrograms)
Danish: Dag 14 (94 mikrogram)
English: Decreases in white blood cell counts were not associated with an increased risk of infections or serious infections.
Danish: Fald i leukocyttallene var ikke forbundet med forhøjet infektionsrisiko eller alvorlige infektioner.
English: Find a well-lit, clean, flat surface to work on like a table.
Danish: Find en godt oplyst, ren og plan overflade som et bord.
English: The usual sites for subcutaneous injections include abdomen, arm, and thigh.
Danish: De sædvanlige injektionssteder for subkutane injektioner er abdomen, arm og lår.
English: The process of covalently conjugating a PEG moiety to a protein can alter the in vivo properties of the unmodified protein, including decreased renal clearance and decreased proteolysis thus extending the circulating half-life.
Danish: Processen med kovalent at konjugere en PEG-fraktion til et protein kan ændre det umodificerede proteins in vivo-egenskaber, herunder nedsat renal clearance og nedsat proteolyse, hvorved halveringstiden forlænges.
English: • Keep the needle inserted in for 5 seconds (see Figure J).
Danish: • Lad kanylen blive siddende i i 5 sekunder (se figur J).
English: c. Check the medicine window and make sure the Plegridy medicine is clear and colourless.
Danish: c. Kontrollér medicinvinduet for at se, at Plegridy-medicinen er klar og farveløs.
English: No serious cardiovascular events were reported in patients who received Plegridy in the ADVANCE study.
Danish: Der var ingen indberetninger om alvorlige kardiovaskulære hændelser hos patienter, som fik Plegridy i ADVANCE-studiet.
English: Table 3: Clinical and MRI results
Danish: Tabel 3: Kliniske resultater og MR-resultater
English: Thrombotic microangiopathy (TMA) (class effects)
Danish: Trombotisk mikroangiopati (TMA) (klassevirkninger)
English: If you are new to Plegridy, your doctor may advise you to gradually increase your dose so that you can adjust to the effects of Plegridy before taking the full dose.
Danish: Hvis du ikke har fået Plegridy før, kan lægen råde dig til at øge dosen gradvist, så du kan vænne dig til bivirkningerne af Plegridy, før du tager den fulde dosis.
English: Choose the correct pen from a pack.
Danish: Vælg den korrekte pen fra pakken.
English: The observed Cmax (mean±SE) was 280 ± 79 pg/mL following repeat dosing of 125 micrograms every two weeks.
Danish: Den observerede Cmax (gennemsnit±SE) var 280 ± 79 pg/ml efter gentagen dosering af 125 mikrogram hver 2. uge.
English: Less than 1% of Plegridy treated patients experienced a serious hypersensitivity event (e.g. angioedema, urticaria) and they recovered promptly after treatment with anti-histamines and/or corticosteroids.
Danish: Under 1 % af de patienter, som fik Plegridy, havde en alvorlig overfølsomhedsreaktion (f.eks. angioødem, urticaria), og de kom sig, så snart de blev behandlet med antihistaminer og/eller kortikosteroider.
English: The total combined time out of refrigeration at a temperature up to 25°C, should not exceed 30 days.
Danish: Den samlede kombinerede tid uden for køleskab ved temperaturer op til 25 °C må ikke overstige 30 dage.
English: Depression occurs with increased frequency in the multiple sclerosis population and in association with interferon use.
Danish: Depression optræder hyppigere hos patienter med multipel sklerose og i forbindelse med anvendelse af interferon.
English: The safety and efficacy of Plegridy in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials.
Danish: Plegridys sikkerhed og virkning hos patienter på over 65 år er på grund af det begrænsede antal af disse patienter i de kliniske studier ikke undersøgt tilstrækkeligt.
English: The available information on the effects of interferon beta-1a in the peri- and postnatal periods is limited.
Danish: De tilgængelige oplysninger om virkningerne af interferon beta-1a i den peri- og postnatale periode er begrænsede.
English: Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons.
Danish: Dosistitrering ved initiering af behandlingen kan være med til at reducere influenzalignende symptomer, som kan forekomme ved initiering af behandling med interferoner.
English: b. Check the medicine window.
Danish: b. Kontrollér medicinvinduet.
English: Plegridy is for subcutaneous use.
Danish: Plegridy er til subkutant brug.
English: • Plegridy can be removed from and returned to the refrigerator if necessary.
Danish: • Plegridy kan tages ud af køleskab og lægges tilbage, hvis det er nødvendigt.
English: In patients experiencing flu-like symptoms, the median time to onset was 10 hours (interquartile range, 7 to 16 hours) after injection, and the median duration was 17 hours (interquartile range, 12 to 22 hours).
Danish: Hos patienter, der oplevede influenzalignende symptomer, var mediantiden til symptomerne indtrådte 10 timer (interkvartilt interval 7 til 16 timer) efter injektionen, og medianvarigheden var 17 timer (interkvartilt interval 12 til 22 timer).
English: Day 0 (63 micrograms)
Danish: Dag 0 (63 mikrogram)
English: - A low number of white blood cells or platelets, which can cause an increased risk of infection, or bleeding
Danish: - Et lavt antal hvide blodlegemer eller blodplader, som kan give øget risiko for infektion eller blødning
English: Patients should be monitored for symptoms or signs of decreased peripheral blood counts (see section
Danish: Patienterne skal overvåges med henblik på symptomer eller tegn på nedsatte perifere blodtællinger (se pkt.
English: Step 4: Choose and clean your injection site a. Choose an injection site in your thigh, abdomen, or the back of your upper arm (see highlighted areas in Figure D).
Danish: Trin 4: Vælg og rengør injektionsstedet a. Vælg et injektionssted på låret, maven eller bagsiden af overarmen (se de fremhævede områder i figur D).
English: - If any of these effects trouble you, contact a doctor.
Danish: Hvis en eller flere af disse bivirkninger generer dig, skal du kontakte en læge.
English: - Contact a doctor for advice.
Danish: Søg råd hos en læge.
English: Nephrotic syndrome (class effects)
Danish: Nefrotisk syndrom (klassevirkninger)
English: • Pull the needle straight out (See Figure K).
Danish: • Træk kanylen lige ud (se figur K).
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Plegridy should be considered.
Danish: Hurtig behandling af nefrotisk syndrom er påkrævet, og seponering af behandlingen med Plegridy bør overvejes.
English: Step 2: Collect your supplies and wash your hands.
Danish: Trin 2: Saml tingene sammen, og vask hænder.
English: Step 2: Collect your supplies and wash your hands
Danish: Trin 2: Saml tingene sammen, og vask hænder
English: Urinary (renal) clearance is postulated to be a major excretory pathway for Plegridy.
Danish: Urinclearance (renal) postuleres at være en vigtig udskilningsvej for Plegridy.
English: Record date and location
Danish: Notér dato og sted
English: The clinical studies indicate that multiple sclerosis patients can receive Plegridy and corticosteroids during relapses.
Danish: Kliniske studier indikerer, at patienter med multipel sklerose kan behandles med Plegridy og kortikosteroider under attakker.
English: The safety and efficacy of Plegridy in children and adolescents aged 0 to 18 years have not been established in multiple sclerosis.
Danish: Plegridys sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt ved multipel sklerose.
English: Nevertheless, patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia should be monitored for worsening of their cardiac condition, particularly during initiation of treatment.
Danish: Ikke desto mindre bør patienter med eksisterende signifikant hjertesygdom som kongestivt hjertesvigt, kransåresygdom eller arytmi observeres for forværring af deres hjertelidelse, især under initiering af behandlingen.
English: Proportion of subjects relapsed HR
Danish: Andel af studiedeltagere med attakker HR
English: • Check that your Plegridy medicine is clear and colourless (See Figure D).
Danish: • Kontrollér, at Plegridy-medicinen er klar og farveløs (se figur D).
English: b. Wipe your skin with an alcohol wipe.
Danish: b. Tør huden af med en spritserviet.
English: Hypersensitivity Anaphylaxis1
Danish: Overfølsomhed Anafylaksi1
English: - Kidney problems including scarring that may reduce your kidney function
Danish: - Nyreproblemer, herunder ardannelse, der kan nedsætte din nyrefunktion
English: Remove your Plegridy pack from the fridge and select the appropriate pen (dosage) from the pack.
Danish: Tag Plegridy-pakningen ud af køleskabet, og vælg den korrekte pen (dosis) fra pakningen.
English: If you do miss your usual day, inject as soon as you can and carry on as usual.
Danish: Hvis du glemmer din sædvanlige dag, skal du injicere en dosis, så snart du kan, og fortsætte som normalt.
English: Plegridy should be used carefully with medicines that are broken down in the body by a group of proteins called “cytochrome P450” (e.g. some medicines used for epilepsy or depression).
Danish: Plegridy skal bruges med forsigtighed sammen med lægemidler, som nedbrydes i kroppen af en gruppe proteiner, der kaldes “cytokrom P450” (f.eks. nogle lægemidler mod epilepsi eller depression).
English: Following repeat dosing of 125 micrograms doses every two weeks by subcutaneous administration, the volume of distribution uncorrected for bioavailability (mean±SE) was 481 ± 105 L.
Danish: Efter gentagen dosering af doser på 125 mikrogram hver 2. uge med subkutan administration var fordelingsvolumen uden korrektion for biotilgængelighed (gennemsnit±SE) 481 ± 105 l.
English: Mean/Median disease duration (years) Mean number of relapses within the past 3 years 2.5 Mean EDSS score at baseline EDSS: Expanded Disability Status Scale Gd+: Gadolinium-enhancing
Danish: Gennemsnitlig/median sygdomsvarighed (år) Gennemsnitligt antal attakker i de sidste 3 år Gennemsnitlig EDSS-score ved baseline EDSS: Expanded Disability Status Scale Gd+: Gadolinium-forstærkende
English: Only open the pack when you need a new syringe.
Danish: Du må kun åbne pakningen, når du skal bruge en ny sprøjte.
English: Less than 1% of patients who received Plegridy during the placebo controlled phase of the ADVANCE study discontinued treatment due to flu-like symptoms.
Danish: Under 1 % af de patienter, som fik Plegridy under den placebokontrollerede fase af ADVANCE-studiet, afbrød behandlingen på grund af influenzalignende symptomer.
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: Du må ikke løfte pennen fra injektionsstedet, før kliklydene er stoppet, og du ser de grønne striber i injektionsstatusvinduet.
English: This should be considered when switching patients between pegylated and non-pegylated interferons (see section 5.1).
Danish: Dette bør tages i betragtning ved skift af patienter mellem pegyleret og nonpegylerede interferoner (se pkt.
English: Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Danish: Patienter, der viser symptomer på depression, bør overvåges nøje under behandlingen og behandles efter sædvanlig praksis.
English: • Find a well-lit, clean, flat surface to work on, like a table.
Danish: • Find en godt oplyst, ren og plan overflade som et bord.
English: After the injection After Use - Parts of your Plegridy pen (see Figure K):
Danish: Efter injektionen Efter brug - dele på din Plegridy-pen (se figur K):
English: - Blood clots in the small blood vessels may occur during your treatment.
Danish: Der kan forekomme blodpropper i de små blodkar under behandlingen.
English: Giving your injection Step 4: Choose and clean your injection site
Danish: Foretag injektionen Trin 4: Vælg og rengør injektionsstedet
English: - Do not use this medicine if you notice any of the following: - If the pen is broken.
Danish: - Brug ikke lægemidlet, hvis du bemærker et eller flere af følgende: Hvis pennen er gået i stykker.
English: Of the patients who experienced injection site reactions 95% reported them as mild or moderate in severity.
Danish: Af de patienter, som rapporterede reaktioner på injektionsstedet, rapporterede 95 % dem som milde eller moderate.
English: Step 6: Give the injection a. Hold the pen over your injection site.
Danish: Trin 6: Foretag injektionen a. Hold pennen over injektionsstedet.
English: Plegridy contains sodium
Danish: Plegridy indeholder natrium
English: Injection Site open here
Danish: Injektionssted åbnes her
English: If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Plegridy is recommended.
Danish: Hvis diagnosen TMA stilles, er omgående behandling nødvendig (plasmaferese skal overvejes), og omgående seponering af Plegridy anbefales.
English: This includes any medicines obtained without a prescription.
Danish: Det gælder også medicin, som ikke er købt på recept.
English: numbness in the face, arms or legs - Acute or chronic pain, bladder and bowel problems, sexual problems and problems with vision - Difficulty thinking and concentrating, depression.
Danish: muskelstivhed og muskelkramper, træthed og følelsesløshed i ansigtet, armene eller benene - Akut eller kronisk smerte, blære- og tarmproblemer, seksuelle problemer og problemer med at se ting - Vanskelighed ved at tænke og koncentrere sig, depression.
English: Your doctor may find changes in your blood and the function of your kidneys.
Danish: Din læge kan muligvis påvise ændringer i dit blod og din nyrefunktion.
English: Plegridy every 2 weeks significantly reduced the annualized relapse rate (ARR) by 36% compared to placebo (p=0.0007) at one year (Table 3) with consistent reductions of the ARR noted in subgroups defined by demographic and baseline disease characteristics.
Danish: Plegridy hver 2. uge reducerede signifikant attakfrekvensen på årsbasis (ARR) med 36 % sammenlignet med placebo (p=0,0007) ved et år (tabel 3) med konsistente reduktioner i ARR i undergrupper defineret efter demografi og sygdomskarakteristika ved baseline.
English: How Plegridy works Plegridy seems to work by stopping the body's immune system from damaging your brain and spinal cord.
Danish: Sådan virker Plegridy Plegridy synes at virke ved, at det forhindrer kroppens immunsystem i at beskadige hjernen og rygmarven.
English: Of the patients who reported flu-like symptoms 90% reported them as mild or moderate in severity.
Danish: Af de patienter, som rapporterede influenzalignende symptomer, rapporterede 90 % dem som milde eller moderate.
English: Elevations of alanine aminotransferase and aspartate aminotransferase (>5 times ULN), were reported in 1% and <1% of placebo-treated patients and 2% and <1% of patients treated with Plegridy respectively.
Danish: Forhøjelserne af alaninaminotransferase og aspartataminotransferase (>5 gange ULN) blev rapporteret hos henholdsvis 1 % og <1 % af de placebobehandlede patienter og 2 % og <1 % af de patienter, som blev behandlet med Plegridy.
English: Subjects with end stage renal disease requiring 2-3 times haemodialysis weekly showed similar AUC and Cmax as compared to subjects with normal renal function.
Danish: Studiedeltagere med terminal nyresygdom og behov for hæmodialyse 2-3 gange pr. uge viste tilsvarende AUC og Cmax som studiedeltagere med normal nyrefunktion.
English: • Each Plegridy pre-filled syringe can be used once only.
Danish: • Hver fyldt Plegridy-sprøjte må kun bruges én gang.
English: Flu-like symptoms are more common when you first start using Plegridy.
Danish: Influenzalignende symptomer er mere almindelige, når man begynder på Plegridy.
English: Which pack
Danish: Hvilken pakning
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 første gang, skal lægen eller sygeplejersken vise dig eller din plejer, hvordan pennen klargøres og injiceres.
English: Do not share the pen with anyone else to avoid giving an infection to them or getting an infection from them.
Danish: Du må ikke dele pennen med andre for at undgå at smitte dem eller blive smittet af dem med en infektion.
English: • It is expired.
Danish: • Udløbsdatoen er overskredet.
English: In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase (AST), alanine aminotransaminase (ALT)), are recommended prior to initiation and at regular intervals following introduction of Plegridy therapy and then periodically thereafter in the absence of clinical symptoms.
Danish: Foruden de laboratorieundersøgelser, der normalt kræves til monitorering af patienter med multipel sklerose, anbefales derfor komplette blodtællinger og differentialtællinger, trombocyttællinger og blodkemi, herunder leverfunktionstest (f.eks. aspartataminotransferase (ASAT), alaninaminotransaminase (ALAT)), før initiering og med jævne mellemrum efter introduktion af Plegridy-behandling og derefter jævnligt i fravær af kliniske symptomer.
English: The efficacy and safety of Plegridy was assessed from the placebo-controlled first year of a 2 year randomised, double-blind, clinical study in patients with relapsing remitting multiple sclerosis (the ADVANCE study).
Danish: Virkningen og sikkerheden af Plegridy blev vurderet ud fra det placebokontrollerede første år af et 2 årigt, randomiseret, dobbeltblindet klinisk studie hos patienter med attakvis multipel sklerose
English: A patient should not administer two doses of Plegridy within 7 days of each other.
Danish: Patienten må ikke tage to doser Plegridy med under 7 dages interval.
English: - For patients with ≥1 relapse in the previous year and ≥9 T2 lesions or ≥1 Gd+ lesion (n=1401),
Danish: - For patienter med ≥1 attak i det foregående år og ≥9 T2-læsioner eller ≥1 Gd+ læsion
English: - If you are unsure of the number of days you have kept a pen out of the fridge, throw the pen away.
Danish: Hvis du er i tvivl om, hvor mange dage en pen har været opbevaret uden for køleskab, skal du smide pennen væk.
English: It is generally recommended that patients start treatment with 63 micrograms at dose 1 (on day 0), increasing to 94 micrograms at dose 2 (on day 14), reaching the full dose of 125 micrograms by dose 3 (on day 28) and continuing with the full dose (125 micrograms) every 2 weeks (14 days) thereafter (see Table 1).
Danish: Det anbefales generelt, at patienterne påbegynder behandlingen med 63 mikrogram ved dosis 1 (på dag 0), stigende til 94 mikrogram ved dosis 2 (på dag 14) og når den fulde dosis på 125 mikrogram ved dosis 3 (på dag 28), hvorefter de fortsætter med den fulde dosis (125 mikrogram) hver 2. uge (hver 14. dag) (se tabel 1).
English: Plegridy pre-filled pen must not be used unless the green stripes are visible in the pen injection status window.
Danish: En fyldt Plegridy-pen må ikke anvendes, medmindre der ses grønne striber i pennens injektionsstatusvindue.
English: Of a total of 1468 patients, 658 patients continued at least 4 years of treatment with Plegridy.
Danish: Ud af i alt 1.468 patienter fortsatte 658 patienter i mindst 4 år med Plegridy-behandling.
English: • Slowly push the plunger all the way down until syringe is empty (See Figure I).
Danish: • Tryk langsomt stemplet helt ned, indtil sprøjten er tom (se figur I).
English: However, results from a population pharmacokinetic analysis (in patients up to 65 years) suggest that age does not impact peginterferon beta-1a clearance.
Danish: Resultater fra en farmakokinetisk populationsanalyse (hos patienter på op til 65 år) indikerer, at alder ikke hæmmer peginterferon beta-1a's clearance.
English: Prophylactic and concurrent use of anti-inflammatory, analgesic and/or antipyretic treatments may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment (see section 4.8).
Danish: Profylaktisk og samtidig anvendelse af antiinflammatoriske, analgetiske og/eller antipyretiske behandlinger kan forebygge eller reducere influenzalignende symptomer, der undertiden forekommer under behandling med interferoner (se pkt.
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 du ser blod ved injektionsstedet, tørrer du det af med en gazetampon og sætter et plaster på
English: Close the pack and put back in the fridge after removing one pen.
Danish: Luk pakningen, og læg den tilbage i køleskabet, når du har taget en pen.
English: In post marketing experience, serious hypersensitivity events including cases of anaphylaxis (frequency not known) have been reported following Plegridy administration.
Danish: Efter markedsføring er der blevet rapporteret alvorlige hændelser med overfølsomhed, herunder tilfælde af anafylaksi (hyppighed ikke kendt), efter administration af Plegridy.
English: Patients should be advised to discontinue Plegridy and seek immediate medical care if they experience signs and symptoms of anaphylaxis or severe hypersensitivity.
Danish: Patienterne skal rådes til at seponere Plegridy og øjeblikkeligt søge lægehjælp, hvis de får tegn og symptomer på anafylaksi eller svære overfølsomhedsreaktioner.
English: Three percent of patients (18/681) developed persistent antibodies to the PEG moiety of peginterferon beta-1a.
Danish: Tre procent af patienterne (18/681) udviklede persisterende antistoffer mod PEG-fraktionen af peginterferon beta-1a.
English: Step 8: Check to make sure you received your full dose of Plegridy (see Figure J)
Danish: Trin 8: Kontrollér, at du har fået den fulde dosis Plegridy (se figur J)
English: Patients with RRMS, with at least 2 relapses within the prior 3 years, and 1 relapse in the prior year, with an EDSS score of ≤5.0
Danish: Patienter med attakvis MS med mindst 2 attakker inden for de foregående 3 år og 1 attak i det foregående år med en EDSS-score på ≤5,0