FrancophonIA/ELRC3.0 huggingface dataset:
English: In this study, the mean age was 14.5 years, the median weight was 59.4 kg, 41.0 % were female, 62.5% were White, 15.1% were Asian, and 12.0% were Black.
Danish: I studiet var gennemsnitsalderen 14,5 år, gennemsnitsvægten var 59,4 kg, 41,0 % var kvinder, 62,5 % var hvide, 15,1 % var asiatiske og 12,0 % var sorte.
English: Pruritus NRS (>4-point improvement), % respondersc
Danish: NRS for kløe (> 4-point forbedring), % respondenterc
English: Description of selected adverse reactions in atopic dermatitis and asthma indications
Danish: Beskrivelse af udvalgte bivirkninger ved atopisk dermatitis og astmaindikationer
English: b Full analysis set (FAS) includes all patients randomized.
Danish: b Fuldt analysegrundlag (FAS) inkluderer alle randomiserede patienter.
English: Percent Reduction
Danish: Reduktion i %
English: • Do not use the pre-filled pen if the yellow cap is missing or not securely attached.
Danish: • Brug ikke den fyldte pen, hvis den gule hætte mangler eller ikke sidder ordentligt på.
English: In atopic dermatitis clinical trials, treatment with dupilumab was associated with decreases from baseline in concentrations of type 2 immunity biomarkers, such as thymus and activation-regulated chemokine (TARC/CCL17), total serum IgE and allergen-specific IgE in serum.
Danish: I kliniske studier med atopisk dermatitis var behandling med dupilumab forbundet med reduktioner i koncentrationer af biomarkører for type 2 immunitet, såsom thymus og aktiveringsreguleret kemokin (TARC/CCL17), total serum IgE og allergenspecifik IgE i serum i forhold til baseline.
English: The long-term efficacy of dupilumab in adolescent patients with moderate-to-severe AD who had participated in previous clinical trials of dupilumab was assessed in open-label extension study (AD1434).
Danish: Dupilumabs langtidsvirkning hos unge patienter med moderat til svær atopisk dermatitis, som havde deltaget i tidligere kliniske studier med dubilumab, blev vurderet i et åbent forlængelsesstudie (AD1434).
English: Dupilumab should not be used to treat acute bronchospasm or status asthmaticus.
Danish: Dupilumab må ikke anvendes til behandling af akut bronkospasme eller status asthmaticus.
English: Table 11: Demographics and Baseline Characteristics of Asthma Trials
Danish: Tabel 11: Demografi og baseline-karakteristika i astmastudier
English: A total of 210 patients with oral corticosteroid-dependent asthma receiving high-dose inhaled corticosteroids plus up to two additional controllers were enrolled (VENTURE).
Danish: I alt 210 patienter med oral kortikosteroidafhængig astma, som fik høj dosis inhalerede kortikosteroider plus op til to yderligere lægemidler, blev inkluderet (VENTURE).
English: • Clean the injection site with an alcohol wipe.
Danish: • Rengør injektionsstedet med en alkoholserviet.
English: 1 pre-filled syringe with needle shield 2 pre-filled syringes with needle shield Component of a multipack, can't be sold separately.
Danish: 1 fyldt injektionssprøjte med kanylebeskyttelseshylster 2 fyldte injektionssprøjter med kanylebeskyttelseshylster Komponenter i en multipakning kan ikke sælges separat.
English: Pre-dose FEV1 (L) at baseline ± SD Mean percent predicted FEV1 at baseline (%)(± SD) % Reversibility (± SD)
Danish: Prædosis FEV1 (L) ved baseline ± SD Gennemsnitlig forventet procentvis FEV1 ved baseline (%)(± SD) % Reversibilitet (± SD)
English: The safety of dupilumab was assessed in a study of 250 patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD-1526).
Danish: Dupilumabs sikkerhed blev vurderet i et studie med 250 patienter i alderen 12-17 år med moderat til svær atopisk dermatitis (AD-1526).
English: The pre-filled syringe or the pre-filled pen should not be exposed to heat or direct sunlight and should not be shaken.
Danish: Den fyldte injektionssprøjte eller pen må ikke udsættes for varme eller direkte sollys og må ikke rystes.
English: Patients who continued on the same dose regimen received in the SOLO 1 and SOLO 2 studies (300 mg Q2W or 300 mg QW) showed the optimal effect in maintaining clinical response while efficacy for other dose regimens diminished in a dose-dependent manner.
Danish: Patienter der fortsatte med samme doseringsregimen, som de havde modtaget i SOLO 1 og SOLO 2 studierne (300 mg en gang hver anden uge eller 300 mg en gang om ugen), opnåede optimal effekt med vedvarende klinisk respons, mens effekten for andre doseringsregimer blev reduceret dosisafhængigt.
English: Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred (see section 5.1).
Danish: Hos patienter, der får samtidig oral kortikosteroid, kan steroiddosis reduceres så snart klinisk bedring med dupilimab indtræder (se pkt.
English: The recommended dose of dupilumab for adults and adolescents (12 years of age and older) is:
Danish: Den anbefalede dosis af dupilumab til voksne og unge (12 år og derover) er:
English: b FAS week 52 includes all patients randomized at least one year before the cutoff date of the primary analysis.
Danish: b FAS uge 52 inkluderer alle patienter randomiseret mindst et år inden afskæringsdatoen for den primære analyse.
English: Step 8: Pinch
Danish: Trin 8: Klem
English: Based on the population analysis, commonly co-administered medications had no effect on dupilumab pharmacokinetics on patients with moderate to severe asthma.
Danish: På baggrund af populationsanalysen havde samtidigt administrerede lægemidler ingen effekt på dupilumabs farmakokinetik hos patienter med moderat til svær astma.
English: Remove the syringe from the carton by holding the middle of the syringe body.
Danish: Tag injektionssprøjten ud af kartonen ved at holde midt på injektionssprøjtens hoveddel.
English: Dupilumab was administered by subcutaneous (SC) injection.
Danish: Dupilumab blev administreret som subkutan (s.c.) injektion.
English: Both play a major role in causing the signs and symptoms of atopic dermatitis and asthma.
Danish: De spiller begge to en stor rolle med hensyn til at forårsage tegn og symptomer på atopisk eksem og astma.
English: The demographics and baseline characteristics of these 3 studies are provided in Table 5 below.
Danish: Demografi og baseline-karakteristika i disse 3 studier er vist i nedenstående tabel 5.
English: Do not put the yellow cap back on.
Danish: Sæt ikke den gule hætte på igen.
English: Dupilumab may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signaling.
Danish: Dupilumab kan påvirke immunresponset på ormeinfektioner ved at hæmme IL-4/IL-13 signalering.
English: • Store pre-filled pens in the original carton to protect it from light.
Danish: • De fyldte penne skal opbevares i den originale karton for at beskytte mod lys.
English: After removing the 200 mg pre-filled syringe or pre-filled pen from the refrigerator, it should be allowed to reach room temperature by waiting for 30 min before injecting Dupixent.
Danish: Efter den fyldte 200 mg injektionssprøjte eller pen tages ud af køleskabet, skal den have lov til at nå stuetemperatur ved at vente 30 min. inden injektion af Dupixent.
English: The demographics and baseline characteristics of these 3 studies are provided in Table 11 below.
Danish: Demografi og baseline-karakteristika i disse 3 studier er vist i nedenstående tabel 11.
English: Subcutaneous use
Danish: Subkutan brug
English: Table 5: Demographics and Baseline Characteristics of Asthma Trials
Danish: Tabel 5: Demografi og baseline-karakteristika i astmastudier
English: No dose adjustment is recommended for elderly patients (see section 5.2).
Danish: Dosisjustering anbefales ikke for ældre patienter (se pkt.
English: Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling.
Danish: Dupilumab er et rekombinant humant IgG4 monoklonalt antistof, som hæmmer interleukin-4 og interleukin-13 signalering.
English: • When placing the orange needle cover on your skin, hold the pre-filled pen so that you can see the window.
Danish: Når du placerer den orange kanylebeskytter mod huden, skal du sørge for, at du kan se vinduet.
English: LS Mean Difference vs. placebo (95% CI)
Danish: LS gennemsnitlig forskel versus placebo (95 % KI)
English: A total of 107 adolescents aged 12 to 17 years with asthma were enrolled in QUEST study.
Danish: I alt 107 unge i alderen 12-17 år med astma blev inkluderet i QUEST-studiet.
English: • Do not use the pre-filled pen if it has been damaged.
Danish: • Brug ikke den fyldte pen, hvis den er beskadiget.
English: - The active substance is dupilumab.
Danish: - Aktivt stof: dupilumab.
English: For the full list of excipients, see section 6.1.
Danish: Alle hjælpestoffer er anført under punkt 6.1.
English: Odds ratio (95% CI)
Danish: Odds ratio (95 % KI)
English: If you have forgotten to inject a dose of Dupixent, talk to your doctor, pharmacist or nurse.
Danish: Hvis du har glemt at injicere en dosis af Dupixent, skal du tale med lægen, apotekspersonalet eller sundhedspersonalet.
English: POEM, (≥6-point improvement), % responders a Full Analysis Set (FAS) includes all patients randomised.
Danish: POEM, (≥ 6-point forbedring), % respondenter a Fuldt analysegrundlag (full analysis set, FAS) inkluderer alle randomiserede patienter.
English: Do not touch the needle.
Danish: Rør ikke kanylen.
English: Median % reduction in daily OCS dose from baseline
Danish: Median % reduktion i daglig oral kortikosteroiddosis fra baseline
English: Fertility studies conducted in male and female mice using a surrogate antibody against IL-4Rα showed no impairment of fertility (see section 4.6).
Danish: Fertilitetsundersøgelser udført hos han- og hunmus med anvendelse af et surrogat-antistof mod IL-4Rα viste ingen indvirkning på fertilitet (se pkt.
English: No dose adjustment for body weight is recommended for patients with asthma 12 years of age and older or in adults with atopic dermatitis (see section 5.2).
Danish: Ingen dosisjustering baseret på kropsvægt anbefales hos astmapatienter fra 12 år og derover eller hos voksne med atopisk dermatitis (se pkt.
English: Approximately 5 % of patients in the placebo groups in the 52 week studies were also positive for antibodies to dupilumab; approximately 2 % exhibited persistent ADA response and approximately 1% had neutralizing antibodies.
Danish: Cirka 5 % af patienterne i placebogrupperne i studierne af 52 ugers varighed var også positive for antistoffer mod dupilumab; cirka 2 % udviste vedvarende ADA-respons, og cirka 1 % havde neutraliserende antistoffer.
English: If you forget to use Dupixent
Danish: Hvis du har glemt at tage Dupixent
English: A total of 107 adolescents aged 12 to 17 years with asthma were enrolled in the 52 week QUEST study.
Danish: I alt 107 unge i alderen 12-17 år med astma blev inkluderet i QUEST-studiet af 52 ugers varighed.
English: The safety profile of dupilumab in patients followed through week 52 was similar to the safety profile observed at week 16 in AD-1526 study.
Danish: Dupilumabs sikkerhedsprofil for disse patienter, der blev fulgt til og med uge 52, svarede til den observerede sikkerhedsprofil ved uge 16 i AD-1526-studiet.
English: The pharmacokinetics of dupilumab is similar in patients with atopic dermatitis and asthma.
Danish: Dupilumabs farmakokinetik er ens hos patienter med atopisk dermatitis og med astma.
English: After 12 weeks of dupilumab administration, patients were vaccinated with a Tdap vaccine (T cell-dependent), and a meningococcal polysaccharide vaccine (T cell-independent) and immune responses were assessed 4 weeks later.
Danish: Efter 12 ugers administration af dupilumab blev patienter vaccineret mod stivkrampe, difteri og kighoste (T-celle-afhængig) og en meningokok-polysaccharid-vaccine (T-celle-uafhængig).
English: Do not twist the yellow cap off.
Danish: Vrid ikke den gule hætte af.
English: In the pooled analysis of DRI12544 and QUEST, hospitalizations and/or emergency room visits due to severe exacerbations were reduced by 25.5% and 46.9% with dupilumab 200 mg or 300 mg every other week, respectively.
Danish: I den samlede analyse af DRI12544 og QUEST var hospitalsindlæggelser og/eller besøg på skadestuen på grund af svære eksacerbationer reduceret med 25,5 % og 46,9 % med henholdsvis 200 mg eller 300 mg hver anden uge.
English: Do not give yourself a second dose without speaking to your healthcare provider.
Danish: Du må ikke give dig selv en ekstra dosis uden først at tale med lægen eller sundhedspersonalet.
English: 400 mg (two 200 mg injections)
Danish: 400 mg (to 200 mg injektioner)
English: The asthma development program included three randomised, double-blind, placebo-controlled, parallel-group, multi-centre studies (DRI12544, QUEST, and VENTURE) of 24 to 52 weeks in treatment duration which enrolled a total of 2,888 patients (12 years of age and older).
Danish: Astmaudviklingsprogrammet omfattede tre randomiserede, dobbelblindede, placebokontrollerede, multicenterstudier med parallelgruppebehandling (DRI12544, QUEST og VENTURE) af 24 til 52 ugers behandlingsvarighed og i alt 2.888 patienter (12 år og derover) blev inkluderet i studierne.
English: The effects of this medicine in pregnant women are not known; therefore it is preferable to avoid the use of Dupixent in pregnancy unless your doctor advises to use it.
Danish: Det tilrådes derfor at undgå at bruge Dupixent under graviditet, medmindre din læge råder dig til at bruge lægemidlet.
English: The results for VENTURE by baseline biomarkers are presented in the Table 17.
Danish: Resultaterne for VENTURE i forhold til biomarkører ved baseline er vist i tabel 17.
English: Do not keep Dupixent at room temperature for more than 14 days.
Danish: Dupixent må ikke opbevares ved stuetemperatur i mere end 14 dage.
English: FAS week 52 includes all patients randomized at least one year before the cutoff date of the primary analysis.
Danish: FAS uge 52 inkluderer alle patienter randomiseret mindst et år inden afskæringsdatoen for den primære analyse.
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Danish: Hvis du ammer eller har planer om at amme, skal du tale med lægen, inden du bruger denne medicin.
English: Do not stop or reduce your asthma medicines, unless instructed by your doctor.
Danish: Du må ikke stoppe behandlingen eller nedsætte dosis af din astmamedicin, medmindre du har aftalt det med lægen.
English: From baseline L (%)
Danish: LS gennemsnitlig Δ fra baseline l (%)
English: During a reproductive toxicology study conducted in monkeys, using a surrogate antibody specific to the monkey IL-4Rα, no fetal abnormalities were observed at dosages that saturate the IL-4Rα.
Danish: Under et studie af reproduktionstoksikologi hos aber med anvendelse af et surrogat-antistof specifikt for abe-IL-4Rα blev der ikke set nogen abnormiteter hos fostre ved saturable doser af IL-4Rα.
English: LS = least squares; SE= standard error a Full analysis set (FAS) includes all patients randomized.
Danish: LS = mindste kvadrater; SE= standardfejl a Fuldt analysegrundlag (full analysis set, FAS) inkluderer alle randomiserede patienter.
English: Pre-specified secondary endpoint of ACQ-5 and AQLQ(S) responder rates were analysed at 24 weeks (DRI12544 and VENTURE) and at 52 weeks (QUEST).
Danish: Præspecificerede sekundære endepunkter for ACQ-5- og AQLQ(S)-responsrater blev analyseret ved uge 24 (DRI12544 og VENTURE) og ved uge 52 (QUEST).
English: Recommended dose in adolescents with atopic dermatitis The recommended dose of Dupixent for adolescents (12 to 17 years of age) with atopic dermatitis is based on body weight:
Danish: Anbefalet dosis til unge med atopisk dermatitis Den anbefalede dosis af Dupixent til unge (12-17 år) med atopisk dermatitis er afhængig af kropsvægten.
English: Number of patients with POEM ≥4 at baseline POEM (≥ 4-point improvement), % responders
Danish: Antal patienter med POEM ≥ 4 ved baseline POEM (≥ 4-point forbedring), % respondenter
English: Effects on lung function, on oral steroid and exacerbation reduction were similar irrespective of baseline levels of type 2 inflammatory biomarkers (e.g. blood eosinophils, FeNO).
Danish: Virkning på lungefunktion, orale steroider og reduktion i eksacerbationer var ens uanset baseline-niveau af type 2-inflammatoriske biomarkører (f.eks. eosinofiltal i blodet, FeNO).
English: Let your skin dry before injecting.
Danish: Lad huden tørre inden injektionen.
English: Animal studies showed no impairment of fertility (see section 5.3).
Danish: Dyrestudier indikerer ikke reproduktionstoksicitet (se pkt 5.3).
English: Tell your doctor immediately if you develop a combination of symptoms such as a flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash.
Danish: Fortæl det straks til lægen, hvis du udvikler en kombination af symptomer som f.eks. influenzalignende sygdom, snurrende og prikkende fornemmelse eller følelsesløshed i arme og ben, forværrede problemer med lungerne og/eller udslæt.
English: • Keep unused pre-filled pens in the original carton and store in the refrigerator between 2ºC
Danish: • De ubrugte fyldte penne skal opbevares i den oprindelige karton i køleskab ved 2-8 ºC.
English: • Change the injection site for each injection.
Danish: • Skift injektionssted ved hver injektion.
English: Antibody responses to both tetanus vaccine and meningococcal polysaccharide vaccine were similar in dupilumab-treated and placebo-treated patients.
Danish: Antistof-respons på både stivkrampevaccine og meningokok-polysaccharid-vaccine var tilsvarende for patienter behandlet med dupilumab og patienter behandlet med placebo.
English: Step 11: Release and Remove
Danish: Trin 11: Slip og fjern
English: In the overall population in DRI12544 and QUEST subjects receiving either dupilumab 200 mg or 300 mg every other week had significant reductions in the rate of severe asthma exacerbations compared to placebo.
Danish: I den samlede population i DRI12544- og QUEST-studiet oplevede forsøgspersoner, som fik enten dupilumab 200 mg eller 300 mg hver anden uge, signifikante reduktioner i hyppigheden af svære astmaeksacerbationer sammenlignet med placebo.
English: Dupilumab was administered by subcutaneous (SC) injection in all studies.
Danish: Dupilumab blev administreret ved subkutan injektion i alle studier.
English: Patients with pre-existing helminth infections should be treated before initiating dupilumab.
Danish: Patienter med forudeksisterende ormeinfektioner skal behandles inden start af dupilumab.
English: LS mean change (SE) between baseline and week 36 in percent change in EASI Score from Parent Study baseline Percent of patients with EASI-75 at week 36 for patients with EASI-75 at baseline, n (%)
Danish: LS gennemsnitlig ændring (SE) mellem baseline og uge 36 i procent ændring i EASI score hovedstudiets baseline Procent af patienter med EASI-75 ved uge 36 for patienter med EASI-75 ved baseline, n (%)
English: Dupilumab should not be injected into skin that is tender, damaged or has bruises or scars.
Danish: Dupilumab må ikke injiceres i hud, som er øm, beskadiget eller har blå mærker eller ar.
English: Rate of Severe Exacerbations in QUEST Defined by Baseline FeNO Subgroups
Danish: Hyppighed af svære eksacerbationer i QUEST defineret ud fra FeNO undergrupper ved baseline Behandling
English: A reduction of lactate dehydrogenase (LDH), a biomarker associated with AD disease activity and severity, was observed with dupilumab treatment.
Danish: Der blev set en reduktion i laktatdehydrogenase, en biomarkør forbundet med atopisk dermatitis-sygdomsaktivitet, og i sværhedsgrad ved behandling med dupilumab.
English: LS = least squares a In the primary analyses of the efficacy endpoints, patients who received rescue treatment or with missing data were considered non-responders b Full analysis set (FAS) includes all patients randomized.
Danish: LS = mindste kvadrater a I de primære analyser af endepunkter for effekt, blev patienter, som fik yderligere behandling eller manglede data, betragtet som non-respondenter b Fuldt analysegrundlag (FAS) inkluderer alle randomiserede patienter.
English: Genzyme Flanders BVBA Cipalstraat 8, B-2440 Geel
Danish: Genzyme Flanders BVBA Cipalstraat 8
English: Look at the medicine through the viewing window on the syringe:
Danish: Se på lægemidlet gennem injektionssprøjtens vindue:
English: In this 24-week trial, asthma exacerbations (defined as a temporary increase in oral corticosteroid dose for at least 3 days) were reduced by 59% in subjects receiving dupilumab compared with those receiving placebo (annualized rate 0.65 and 1.60 for the dupilumab and placebo group, respectively; rate ratio 0.41 [95% CI 0.26, 0.63]) and improvement in pre-bronchodilator FEV1 from baseline to week 24 was greater in subjects receiving dupilumab compared with those receiving placebo (LS mean difference for dupilumab versus placebo of 0.22 L [95% CI: 0.09 to 0.34 L]).
Danish: I dette studie af 24 ugers varighed var hyppigheden af astmaeksacerbationer (defineret som en midlertidig stigning i dosis af oral kortikosteroid i mindst 3 dage) reduceret med 59 % hos forsøgspersoner, der fik dupilumab sammenlignet med de forsøgspersoner, der fik placebo (hyppighed på årsbasis på 0,65 og 1,60 for henholdsvis dupilumab-gruppen og placebogruppen; hyppighedsratio 0,41 [95 % KI 0,26; 0,63]) og forbedret præ-bronkodilator FEV1 fra baseline til uge 24 var større hos forsøgspersoner, der fik dupilumab end hos forsøgspersoner, der fik placebo (LS gennemsnitlig ændring for dupilumab versus placebo på 0,22 l [95 % KI: 0,09 til 0,34 l]).
English: Improvements in ACQ-5 and AQLQ(S) were observed as early as week 2 and maintained for 24 weeks in DRI12544 study and 52 weeks in QUEST study.
Danish: Der blev observeret forbedringer i ACQ-5 og AQLQ(S) allerede ved uge 2, og de blev opretholdt i 24 uger i DRI12544-studiet og 52 uger i QUEST-studiet.
English: A significantly larger proportion of patients administered dupilumab groups had clinically meaningful reductions in POEM and DLQI total score (each defined as ≥ 4 points improvement) from baseline to week 16 compared to placebo group.
Danish: En betydeligt større andel af patienter i grupperne, som fik dupilumab, havde klinisk meningsfulde reduktioner i POEM og DLQI total score (hver defineret som forbedring ≥ 4 point) fra baseline til uge 16 sammenlignet med placebogruppen.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Eosinophilic conditions
Danish: Eosinofile tilstande
English: Very common Injection site reactions
Danish: Meget almindelig Reaktioner på injektionsstedet
English: Dupixent may also help reduce the amount of another group of medicines you need to control your asthma, called oral corticosteroids, while preventing severe asthma attacks and improving your breathing.
Danish: Dupixent kan også hjælpe med at reducere din dosis af en anden medicin, kaldet oral kortikosteroid, som du tager for at kontrollere din astma.
English: For both the 200 mg and 300 mg every other week doses, significant improvements in FEV1 (LS mean change from baseline at eek 12) were observed (0.36 L and 0.27 L, respectively).
Danish: For dosis på både 200 mg og 300 mg hver anden uge blev der observeret signifikante forbedringer af FEV1 (LS gennemsnitlig ændring fra baseline ved uge 12) (henholdsvis 0,36 l og 0,27 l).
English: In the subgroup of patients resembling the CAFE study population within the 52 week CHRONOS study, 69.6 % of dupilumab 300 mg Q2W-treated patients reached EASI-75 vs 18.0 % placebo-treated patients at week 16, and 52.4 % of dupilumab 300 mg Q2W-treated vs 18.6 % placebo-treated at week 52.
Danish: I undergruppen af patienter, som ligner CAFE studiepopulationen i CHRONOS studiet på 52 uger, opnåede 69,6 % af patienter behandlet med dupilumab 300 mg en gang hver anden uge EASI-75 vs 18,0 % patienter behandlet med placebo ved uge 16, og 52,4 % af patienter behandlet med dupilumab 300 mg en gang hver anden uge vs 18,6 % behandlet med placebo ved uge 52.