FrancophonIA/ELRC3.0 huggingface dataset:
English: Of these 188 patients, 164 patients received treatment for at least 2 years, 2 patients continued treatment but had not yet reached 2 years of treatment, and 22 patients discontinued in the second year, and 9 patients discontinued after 2 years of treatment.
Danish: Af disse 188 patienter fik 164 patienter behandling i mindst 2 år, 2 patienter fortsatte med behandlingen, men havde endnu ikke nået 2 års behandling, 22 patienter stoppede i det andet år, og 9 patienter stoppede efter 2 års behandling.
English: • is able to recognise the signs and symptoms of an acute systemic hypersensitivity reaction,
Danish: • kan genkende tegn og symptomer på en akut systemisk overfølsomhedsreaktion
English: Three of these patients experienced severe serum sickness (3/285; 1%), which resulted in treatment discontinuation (2 patients) or treatment interruption (1 patient).
Danish: 3 af disse patienter oplevede svær serumsygdom (3/285, 1 %), som resulterede i seponering af behandlingen (2 patienter) eller afbrydelse af behandlingen (1 patient).
English: Date removed from refrigeration: _____/_____/______ Peel here
Danish: Dato for fjernelse fra køl: _____/_____/______ Træk her
English: Hypersensitivity reactions that include symptoms such as dizziness or syncope may affect the ability to drive and use machines.
Danish: Overfølsomhedsreaktioner, der omfatter symptomer som svimmelhed eller synkope, kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Patients with lower antibody titres for all antibody analytes including NAb had higher pegvaliase concentrations due to less immune-mediated pegvaliase clearance.
Danish: Patienter med lavere antistoftitre for alle antistofanalytter, herunder NAb, havde højere pegvaliasekoncentration på grund af mindre immunmedieret pegvaliase-clearance.
English: Symptoms of mood (confusion, fatigue, depression, tension-anxiety, vigour, and anger domains) were evaluated using the Profile of Mood States (POMS) tool that has been modified to be specific to PKU (PKU-POMS).
Danish: Humørsymptomer (forvirring, udmattelse, depression, anspændthed-ængstelighed, energi og vrede) blev evalueret ved hjælp af værktøjet POMS (Profile of Mood States), som er blevet tilpasset, så det passer specifikt til PKU (PKU-POMS).
English: Injection site reactions were reported in 266 out of 285 (93%) patients.
Danish: Reaktioner på injektionsstedet blev rapporteret hos 266 ud af 285 (93 %) patienter.
English: Adverse reactions were similar in type and frequency to that of adult patients.
Danish: Bivirkningernes type og hyppighed var de samme som hos voksne patienter.
English: Doses should not be divided over the course of the day
Danish: Doser må ikke fordeles over dagen.
English: In case of hypophenylalaninaemia during pregnancy, there is a risk of intrauterine foetal growth retardation.
Danish: Ved hypofenylalaninæmi under graviditet er der risiko for intrauterin væksthæmning.
English: Pegvaliase plasma exposure was primarily driven by immune response to pegvaliase.
Danish: Pegvaliases plasmaeksponering blev primært forårsaget af immunresponset på pegvaliase.
English: The PKU-POMS confusion subscale (ranging from 0 to 12 points with higher scores indicating greater degree of impairment) was considered most sensitive to changes in blood phenylalanine levels.
Danish: PKU-POMS-delskalaen for forvirring (som går fra 0 til 12 point, hvor høje scorer angiver en større grad af handicap) blev anset for at være mest følsom over for ændringer i fenylalaninniveauet i blodet.
English: 12 weeks to 24 weeks2
Danish: 12 uger til 24 uger2
English: Not all subjects had a baseline ADHD inattention score and POMS confusion score taken at the start of the study.
Danish: Ikke alle forsøgspersoner fik taget en baselinescore for ADHD-uopmærksomhed og for POMS-forvirring ved studiets start.
English: Use a new pre-filled syringe for your injection.
Danish: Brug en ny fyldt injektionssprøjte til din injektion.
English: Palynziq contains sodium
Danish: Palynziq indeholder natrium
English: • Your doctor will continue to check your blood phenylalanine levels during treatment and may adjust your dose of Palynziq or ask you to change your diet.
Danish: • Lægen vil fortsat kontrollere dit fenylalaninniveau i blodet under behandlingen og vil muligvis justere din dosis af Palynziq eller bede dig om at ændre din kost.
English: Step 2: Remove Palynziq tray(s) from carton and check expiry date: - Take out the cartons needed for your dose from the refrigerator.
Danish: Trin 2: Tag Palynziq-bakken/bakkerne ud af pakningen, og kontrollér udløbsdatoen: - Tag de pakninger, du skal bruge til din dosis, ud af køleskabet.
English: If a caregiver is giving the injection, the top of the buttocks and the back of the upper arms may also be used (see Figure E).
Danish: Hvis en plejer giver injektionen, kan den øverste del af ballerne og bagsiden af overarmene også anvendes (se figur E).
English: All patients treated with Palynziq developed a sustained total anti-pegvaliase antibody (TAb) response with a majority of patients (91%) becoming positive by Week 4.
Danish: Alle patienter, der blev behandlet med Palynziq, udviklede et vedvarende totalt anti-pegvaliase-antistofrespons (TAb), og størstedelen af patienterne (91 %) blev påvist positive i uge 4.
English: Step 3: Allow Palynziq tray(s) to sit at room temperature for 30 minutes before opening: Let the sealed tray(s) sit at room temperature for at least 30 minutes.
Danish: Trin 3: Lad Palynziq-bakken/bakkerne ligge ved rumtemperatur i 30 minutter før åbning: Lad den/de forseglede bakke(r) ligge ved rumtemperatur i mindst 30 minutter.
English: • Your doctor will tell you how long to continue taking medicines such as paracetamol, fexofenadine, and/or ranitidine before you take Palynziq.
Danish: • Lægen fortæller dig, hvor længe du skal fortsætte med at tage medicin som f.eks. paracetamol, fexofenadin og/eller ranitidin, før du tager Palynziq.
English: Pegvaliase is rAvPAL conjugated with linear 20 kDa NHS-PEG at a degree of substitution of 28 to 44 moles of polymer/mole of protein.
Danish: Pegvaliase er rAvPAL konjugeret med lineært 20 kDa NHS-PEG med en substitutionsgrad på 28 til 44 mol polymer/mol protein.
English: Persistent arthralgia (lasting at least 6 months) occurred in 19 (7%) patients with a total of 24 episodes.
Danish: Vedvarende artralgi (varende mindst 6 måneder) forekom hos 19 (7 %) patienter med i alt 24 episoder.
English: In clinical trials, the majority of patients experienced injection site reactions (93%), arthralgia (85%), and hypersensitivity reactions (75%).
Danish: I kliniske forsøg oplevede størstedelen af patienterne reaktioner på injektionsstedet (93 %), artralgi (85 %) og overfølsomhedsreaktioner (75 %).
English: If your healthcare provider decides that you or your caregiver can give your injections of Palynziq at home, your healthcare provider will show you or your caregiver how to inject Palynziq before you inject it for the first time.
Danish: Hvis sundhedspersonalet beslutter, at du selv eller din plejer kan give dig injektioner med Palynziq hjemme, vil sundhedspersonalet vise dig eller din plejer, hvordan Palynziq skal injiceres, før du injicerer det første gang.
English: Use that hand to hold the bottom of the syringe steady.
Danish: Brug denne hånd til at holde bunden af injektionssprøjten rolig.
English: These reactions were consistent with a Type III immune-complex mediated hypersensitivity mechanism and were most frequent in the early phases of treatment (during the induction and titration periods) when the early immune response was dominated by PEG IgM, PEG IgG and PAL IgM responses and C3/C4 levels were at their lowest.
Danish: Disse reaktioner var i overensstemmelse med en type III-immunkompleksmedieret overfølsomhedsmekanisme og var hyppigst i de tidlige behandlingsfaser (i induktions- og titreringsperioden), hvor det tidlige immunrespons blev domineret af PEG IgM-, PEG IgG- og PAL IgM-respons, og hvor C3/C4-niveauet var lavest.
English: Hypersensitivity reactions, including acute systemic hypersensitivity reactions, angioedema, and serum sickness, have been reported in patients treated with Palynziq and can occur at any time during treatment.
Danish: Overfølsomhedsreaktioner, herunder akutte systemiske overfølsomhedsreaktioner, angioødem og serumsygdom er rapporteret hos patienter behandlet med Palynziq og kan forekomme når som helst under behandlingen.
English: Treatment with Palynziq should be directed by physicians experienced in the management of PKU.
Danish: Behandling med Palynziq bør forestås af læger, der har erfaring med behandling af PKU.
English: Reduced implantations were observed in normal female rats after administration of Palynziq (see section 5.3).
Danish: Reduceret implantation blev observeret hos normale hunrotter efter administration af Palynziq (se pkt.
English: Eighteen out of 21 patients who experience angioedema were re-challenged and 5 patients had at least one recurrence.
Danish: Atten ud af de 21 patienter, der oplevede angioødem, fik afprøvet behandlingen igen, og 5 patienter havde recidiv mindst én gang.
English: Step 13: Use your thumb to push in the plunger slowly and steadily as far as it will go to inject all the medicine (see Figure M).
Danish: Trin 13: Brug tommelfingeren til at skubbe stemplet langsomt og roligt så langt ind, som det kan komme, for at injicere al medicinen (se figur M).
English: Because antibodies bind to the PEG portion of pegvaliase, there may be potential for binding with other PEGylated therapeutics and increased hypersensitivity to other PEGylated injectables.
Danish: Da antistoffer bindes til PEG-delen af pegvaliase, kan der være potentiale for binding med andre PEGylerede lægemidler og øget overfølsomhed over for andre PEGylerede, injicerbare midler.
English: Allergic reactions occur very commonly (may affect more than 1 in 10 people) and range in severity.
Danish: Allergiske reaktioner er meget almindelige (forekommer hos flere end 1 ud af 10 personer) og varierer i sværhedsgrad.
English: • Physician educational material • Patient information pack
Danish: • Uddannelsesmateriale til læger • Informationspakke til patienter
English: Palynziq may also increase hypersensitivity to other PEGylated injectable medicinal products (see Effect of Palynziq on other PEGylated injectable medicinal products).
Danish: Palynziq kan også øge overfølsomheden over for andre PEGylerede, injicerbare lægemidler (se Palynziqs virkning på andre PEGylerede, injicerbare lægemidler).
English: The contribution of maternal phenylalanine depletion to the incidence of embryo-foetal developmental effects was not evaluated.
Danish: Betydningen af maternel fenylalanindepletering for forekomsten af effekter på fosterudviklingen blev ikke evalueret.
English: Table 4: Efficacy results at Month 12, Month 18, Month 24 and Month 36 in Palynziq-treated patients Baseline Month 12 Month 18 Month 24 Month 36
Danish: Tabel 4: Effektresultater ved måned 12, måned 18, måned 24 og måned 36 hos Palynziq-behandlede patienter
English: Your doctor will tell you if you can continue Palynziq treatment.
Danish: Lægen vil fortælle dig, om du kan fortsætte med Palynziq-behandlingen.
English: Treatment difference in LS mean change (95% CI)
Danish: Behandlings forskel i LS-middelændring (95 % CI) P-værdi2
English: The injection site should be checked for redness, swelling, or tenderness.
Danish: Injektionsstedet bør kontrolleres for rødme, hævelse eller ømhed.
English: Adverse reproductive and developmental effects of pegvaliase in rats and rabbits were dose dependent and included reduced implantation rate, smaller litter size, lower foetal weights, and increased foetal alterations.
Danish: Pegvaliases reproduktions- og udviklingsbivirkninger hos rotter og kaniner var dosisafhængige og omfattede reduceret implantationshyppighed, mindre kuld, lavere fostervægt og flere fosterforandringer.
English: • The “Instructions for Use” (section 7 of this leaflet) shows you: o how to prepare and inject Palynziq and o how to throw away Palynziq syringes properly after you use them
Danish: • “Brugsanvisning” (punkt 7 i denne indlægsseddel) viser dig: o hvordan du klargør og injicerer Palynziq, og o hvordan du kasserer Palynziq-injektionssprøjter korrekt efter brug
English: Table 2: Adverse reactions in patients treated with Palynziq System organ class
Danish: Tabel 2: Bivirkninger hos patienter behandlet med Palynziq Systemorganklasse
English: Available toxicological data in animals have shown excretion of pegvaliase in milk.
Danish: De tilgængelige toksikologiske data fra dyreforsøg viser, at pegvaliase udskilles i mælk.
English: Results for PKU-POMS confusion subscale over time are shown in Table 4.
Danish: Resultater for PKU-POMS-delskalaen for forvirring over tid er vist i tabel 4.
English: LS mean change from Study 302 RDT baseline to Week 8 (95% CI)
Danish: LS-middelændring fra studie 302 RDT-baseline til uge 8 (95 % CI)
English: If a caregiver is giving the injection, the top of the buttocks and the back of the upper arms are also appropriate injection sites.
Danish: Hvis en plejer giver injektionen, er den øverste del af ballerne og bagsiden af overarmene også egnede injektionssteder.
English: Three out of 7 (1%) patients had severe serum sickness (see section 4.8).
Danish: Tre ud af 7 (1 %) patienter havde svær serumsygdom (se pkt.
English: Acute systemic hypersensitivity reactions generally occurred within the first hour after injection (88%; 22/25 episodes); however, reactions have occurred up to 24 hours after dosing.
Danish: Generelt forekom akutte systemiske overfølsomhedsreaktioner inden for den første time efter injektionen (88 %, 22/25 episoder), men der er forekommet reaktioner op til 24 timer efter dosering.
English: The mean duration of serum sickness was 5 days and ranged from 1 to 8 days.
Danish: Middelvarigheden af serumsygdom var 5 dage med et interval på 1 til 8 dage.
English: At baseline, 149 (57%) patients were receiving part of their total protein intake from medical food and 41 out of 261 (16%) patients were on a phenylalanine-restricted diet (defined as receiving greater than 75% of total protein intake from medical food).
Danish: Ved baseline fik 149 (57 %) patienter en del af deres samlede proteinindtag fraernæringspræparater, og 41 ud af 261 (16 %) patienter var på fenylalaninbegrænset diæt (defineret som mere end 75 % af det samlede proteinindtag fra ernæringspræparater).
English: 3 Post-baseline ADHD-inattention/PKU-POMS confusion values were mapped to the closest 3-month visit (i.e. within a 3-month window).
Danish: ³ Værdier for ADHD-uopmærksomhed/PKU-POMS-forvirring efter baseline blev fastlagt til det næste 3-måneders besøg (dvs. inden for et vindue på 3 måneder).
English: At the time of the data cut-off, 188 out of the 261 patients received treatment for at least 1 year, 4 patients completed treatment, and 69 discontinued treatment in the first year.
Danish: På tidspunktet for data cut-off modtog 188 ud af de 261 patienter behandling i mindst 1 år, 4 patienter gennemførte behandlingen, og 69 stoppede med behandlingen i det første år.
English: Of the 261 patients in Study 301, 11 patients were aged between 16 and 18 years at enrolment.
Danish: Af de 261 patienter i studie 301 var 11 patienter i alderen mellem 16 og 18 år ved optagelsen i studiet.
English: Results for ADHD inattention subscale over time are shown in Table 4.
Danish: Resultater for ADHD-delskalaen for uopmærksomhed over tid er vist i tabel 4.
English: Pegvaliase is primarily cleared by immune-mediated mechanisms following repeat dosing.
Danish: Pegvaliase udskilles hovedsageligt via immunmedierede mekanismer efter gentagen dosering.
English: Injection of other medicines that contain PEG while using Palynziq Palynziq includes an ingredient called polyethylene glycol (PEG).
Danish: Injektion af andre lægemidler, som indeholder PEG, mens du bruger Palynziq Palynziq indeholder et stof, der kaldes polyethylenglykol (PEG).
English: Effect of Palynziq on other PEGylated injectable medicinal products
Danish: Palynziqs virkning på andre PEGylerede, injicerbare lægemidler
English: Table 3: LS Mean change from RDT baseline in blood phenylalanine concentration (micromol/l) at RDT Week 8 in patients with PKU (Study 302)
Danish: Tabel 3: LS-middelændring fra RDTbaseline i fenylalaninkoncentration i blodet (mikromol/l) ved RDT uge 8 hos patienter med PKU (studie 302)
English: • The patient information pack should contain: o The patient information leaflet o The guide for patients and trained observers o The patient alert card
Danish: • Informationspakken til patienter bør indeholde: o Patientinformationsbrochure o Vejledningen til patienter og uddannede observatører o Patientinformationskortet
English: 2 Based on the mixed model repeated measures (MMRM) method, with treatment arm, visit, and treatment arm-by-visit interaction (the time profile of blood phenylalanine changes is assessed separately for each treatment arm) as factors adjusting for baseline blood phenylalanine concentration.
Danish: 2 Baseret på MMRM-metoden (mixed model repeated measures) med behandlingsarm-, besøg- og behandlingsarm-pr.-besøg-interaktion (tidsprofilen for ændringer i fenylalanin i blodet vurderes separat for hver arm) som faktorer til justering af fenylalaninkoncentrationen i blodet ved baseline.
English: Release the pinch of skin.
Danish: Slip den sammentrykkede hud.
English: You may have blood phenylalanine levels that are too low when using Palynziq.
Danish: Du kan få et niveau af fenylalanin i blodet, som er for lavt, når du bruger Palynziq.
English: It will take time to find the dose that works best to lower your blood phenylalanine levels.
Danish: Det tager tid at finde frem til den dosis, der er bedst til at sænke fenylalaninniveauet i blodet.
English: • Your doctor will show you how and when to use the adrenaline injection device.
Danish: • Lægen vil vise dig, hvornår og hvordan du skal bruge anordningen til injektion af adrenalin.
English: Step 6: Choose your injection site.
Danish: Trin 6: Vælg injektionssted.
English: • Do not touch the plunger head while inserting the needle into the skin.
Danish: • Rør ikke ved stempelhovedet, mens du fører kanylen ind i huden.
English: • Do not remove the needle cap until you are ready to inject Palynziq.
Danish: • Fjern ikke kanylehætten, før du er klar til at injicere Palynziq.
English: Palynziq contains the active substance pegvaliase, an enzyme that can break down a substance called phenylalanine in the body.
Danish: Palynziq indeholder det aktive stof pegvaliase, et enzym, som kan nedbryde et stof, der kaldes fenylalanin, i kroppen.
English: Once blood phenylalanine levels less than 600 micromol/l on stable dose was reached, patients were considered to be in the maintenance phase thereafter.
Danish: Når et fenylalaninniveau i blodet på mindre end 600 mikromol/l på stabil dosis var nået, blev patienterne derefter anset for at være i vedligeholdelsesfasen.
English: However, due to the substantial variability in antibody titres between patients, no specific antibody titre was predictive of pegvaliase dose required to reach substantial blood phenylalanine reduction, or the development of hypophenylalaninaemia.
Danish: På grund af den store forskel i antistoftitre blandt patienterne var ingen specifik antistoftiter dog prædiktiv for den dosis pegvaliase, der kræves for at nå en væsentlig reduktion af fenylalanin i blodet, eller for udvikling af hypofenylalaninæmi.
English: Of the 261 enrolled patients, 195 (75%) patients reached their randomised maintenance dose (103 patients in the 20 mg once daily arm, 92 patients in the 40 mg once daily arm).
Danish: Af de 261 inkluderede patienter nåede 195 (75 %) patienter deres randomiserede vedligeholdelsesdosis (103 patienter i armen med 20 mg én gang dagligt, 92 patienter i armen med 40 mg én gang dagligt).
English: 2 Hypersensitivity reactions cover a group of terms, including acute systemic hypersensitivity reactions, and can manifest as a range of symptoms including angioedema, serum sickness, rash, and urticaria.
Danish: 2 Overfølsomhedsreaktioner dækker over en gruppe af termer, herunder akutte systemiske overfølsomhedsreaktioner, og de kan komme til udtryk som en række forskellige symptomer, herunder angioødem, serumsygdom, udslæt og urticaria.
English: The most common cutaneous reactions (at least 5% of patients) reported were pruritus (37 patients; 13%), rash (33 patients; 12%), erythema (15 patients; 5%), and urticaria (15 patients; 5%).
Danish: De mest almindelige kutane reaktioner (mindst 5 % af patienterne), der blev rapporteret, var pruritus (37 patienter, 13 %), udslæt (33 patienter, 12 %), erytem (15 patienter, 5 %) og urticaria (15 patienter, 5 %).
English: Example of steps to reach your blood phenylalanine goal Palynziq dose and how often to take it
Danish: Eksempel på trin til at nå målniveauet for fenylalanin i blodet Palynziq-dosis og hvor tit den tages
English: If your blood phenylalanine levels are too low, your doctor may ask you to change your diet and/or will lower your dose of Palynziq.
Danish: Hvis dit fenylalaninniveau i blodet er for lavt, vil lægen muligvis bede dig om at ændre din kost og/eller sænke din dosis af Palynziq.
English: Maternal blood phenylalanine levels must be strictly controlled between 120 and 360 micromol/l both before and during pregnancy.
Danish: Det maternelle fenylalaninniveau i blodet skal reguleres nøje, så det ligger mellem 120 og 360 mikromol/l både før og under graviditeten.
English: Figure 1: Mean (SE) phenylalanine levels over time
Danish: Figur 1: Fenylalanin middelniveauer (SE) over tid
English: If you inject Palynziq with another injectable medicine that contains PEG, such as PEGylated medroxyprogesterone acetate, you may have an allergic reaction.
Danish: Hvis du injicerer Palynziq samtidig med et andet injicerbart lægemiddel, som indeholder PEG, som f.eks. PEGyleret medroxyprogesteronacetat, kan du få en allergisk reaktion.
English: This person must stay with you for at least 1 hour after your injection to watch you for signs and symptoms of a severe allergic reaction and, if needed, give you an injection of adrenaline and call for emergency medical help.
Danish: Denne person skal blive hos dig i mindst 1 time efter injektionen for at se, om du får tegn og symptomer på en svær allergisk reaktion, og skal om nødvendigt give dig en adrenalininjektion og ringe efter akut lægehjælp.
English: Twelve patients (11 patients from Study 301) aged 16 up to 18 years received Palynziq treatment.
Danish: 12 patienter (11 patienter fra studie 301) i alderen 16 op til 18 år fik behandling med Palynziq.
English: • Do not use the pre-filled syringe if it looks damaged or used.
Danish: • Brug ikke den fyldte injektionssprøjte, hvis den ser beskadiget eller brugt ud.
English: • Your doctor will prescribe medicines for you to take before your Palynziq injection, such as paracetamol, fexofenadine, and/or ranitidine.
Danish: • Lægen ordinerer medicin til dig, som du skal tage før injektionen med Palynziq, f.eks. paracetamol, fexofenadin og/eller ranitidin.
English: Instructions for the preparation and administration of Palynziq are given in the package leaflet.
Danish: Anvisninger til klargøring og administration af Palynziq findes i indlægssedlen.
English: Uncontrolled blood phenylalanine levels (hyperphenylalaninaemia) before and during pregnancy are associated with increased risk for miscarriage, major birth defects (including microcephaly and major cardiac malformations), intrauterine foetal growth retardation and future intellectual disability with low IQ.
Danish: Ukontrollerede fenylalaninniveauer i blodet (hyperfenylalaninæmi) før og under graviditeten er forbundet med øget risiko for abort, alvorlige misdannelser (herunder mikrocefali og alvorlige hjertemisdannelser), intrauterin væksthæmning og fremtidig mental retardering med lav IQ.
English: Dietary phenylalanine intake should remain consistent until a maintenance dose is established.
Danish: Indtaget af fenylalanin i kosten bør være konsistent, indtil der er fastlagt en vedligeholdelsesdosis.