FrancophonIA/ELRC3.0 huggingface dataset:
English: If the solution is cloudy, discoloured or contains visible particulate matter, the solution should not be used.
Danish: Hvis opløsningen er uklar, misfarvet eller indeholder synlige partikler, må opløsningen ikke bruges.
English: Do not rub your skin after the injection.
Danish: Lad være med at gnide huden efter injektionen.
English: Treatment effects in subgroups (weight, age, gender, race, and background treatment, including immunosuppressants) in SOLO 1 and SOLO 2 were consistent with the results in the overall study population.
Danish: Behandlingseffekter i undergrupper (vægt, alder, køn, race og baggrundsbehandling, herunder immunsuppressiva) i SOLO 1 og SOLO 2 var overensstemmende med resultaterne for den samlede studiepopulation.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Check with your doctor if you have diarrhea, gas, upset stomach, greasy stools, and dehydration which could be a sign of a parasitic infection.
Danish: Tjek med din læge, hvis du har diarré, luft i maven, mavebesvær, fedtet afføring og dehydrering, som kan være tegn på en parasitisk infektion.
English: Talk to your doctor, pharmacist or nurse before using Dupixent:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Dupixent:
English: Dupilumab has no or negligible influence on the ability to drive or operate machinery.
Danish: Dupilumab påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Do not touch the injection site again or blow on it before the injection.
Danish: Rør ikke ved injektionsstedet igen eller pust ikke på det inden injektion.
English: The safety of dupilumab was evaluated in four randomized, double-blind, placebo-controlled studies and one dose-ranging study in patients with moderate-to-severe atopic dermatitis.
Danish: Sikkerheden af dupilumab blev evalueret i fire randomiserede, dobbeltblindede, placebokontrollerede studier og et dosisbestemmende studie hos patienter med moderat til svær atopisk dermatitis.
English: • Place the orange needle cover on your skin at approximately a 90-degree angle.
Danish: • Placer den orange kanylebeskytter på huden i en vinkel på cirka 90º.
English: c Patients who received rescue treatment or with missing data were considered as non-responders (58.8% and 20.7% in the placebo and dupilumab arms, respectively).
Danish: c Patienter, som fik yderligere behandling eller manglede data, blev betragtet som ikke-respondenter (58,8 % og 20,7 % i henholdsvis placebo- og dupilumabarmen).
English: Organ Class
Danish: Systemorganklasse
English: Quality of Life/Patient-Reported Outcomes in Asthma
Danish: Livskvalitet/patientrapporterede resultater ved astma
English: ICS = inhaled corticosteroid; FEV1 = Forced expiratory volume in 1 second; ACQ-5 = Asthma Control Questionnaire-5; AQLQ = Asthma Quality of Life Questionnaire; AD = atopic dermatitis; NP = nasal polyposis; AR = allergic rhinitis; FeNO = fraction of exhaled nitric oxide; EOS = blood eosinophil aThe population in dupilumab asthma trials included patients on medium and high dose ICS.
Danish: ICS = inhaleret kortikosteroid; FEV1 = Forceret ekspirationsvolumen i 1 sekund; ACQ-5 = Asthma Control Questionnaire-5; AQLQ = Asthma Quality of Life Questionnaire; AD = atopisk dermatitis; NP = nasal polypose; AR = allergisk rinitis; FeNO = udåndet, fraktioneret nitrogenoxid; EOS = eosinofiltal i blodet aPopulationen i astmastudier med dupilumab omfattede patienter, der fik mellem og høj dosis inhalationskortikosteroid.
English: Proper training should be provided to patients and/or caregivers on the preparation and administration of dupilumab prior to use according to the Instructions for Use (IFU) section in the package leaflet.
Danish: Passende undervisning skal tilbydes patienter og/eller omsorgspersoner i forberedelse og administration af dupilumab inden brug i henhold til brugsanvisningen, som er en del af indlægssedlen.
English: VENTURE was a 24-week oral corticosteroid-reduction study in 210 patients with asthma unrestricted by baseline type 2 biomarker levels who required daily oral corticosteroids in addition to regular use of high dose inhaled corticosteroids plus an additional controller.
Danish: VENTURE var et 24 ugers oral kortikosteroid-reduktionsstudie med 210 astmapatienter, uafhængigt af baseline-niveau af type 2-inflammatoriske biomarkører, med et dagligt behov for orale kortikosteroider foruden regelmæssig anvendelse af høj dosis inhalationskortikosteroid plus et yderligere lægemiddel.
English: LS = least squares; SE = standard error a All patients were on background topical corticosteroids therapy and patients were permitted to use topical calcineurin inhibitors.
Danish: LS = mindste kvadrater; SE= standardfejl a Alle patienter fik lokal baggrundsbehandling med kortikosteroider, og patienter havde lov til at bruge calcineurin-hæmmere som lokalbehandling.
English: Dupilumab is administered by subcutaneous injection into the thigh or abdomen, except for the 5 cm around the navel.
Danish: Dupilumab administreres ved subkutan injektion i låret eller maven, undtagen i de 5 cm omkring navlen.
English: Do not press or touch the orange needle cover with your fingers.
Danish: Du må ikke trykke på eller røre den orange kanylebeskytter med fingrene.
English: • 1 cotton ball or gauze*
Danish: • 1 stykke vat eller gaze*
English: Steady-state concentrations were achieved by week 16 following the administration of 600 mg starting dose and 300 mg dose every other week.
Danish: Steady state-koncentrationer blev opnået ved uge 16 efter administration af en startdosis på 600 mg og en dosis på 300 mg hver anden uge.
English: Additional secondary endpoints included mean change from baseline to week 16 in the POEM and CDLQI scores.
Danish: Yderligere sekundære endepunkter inkluderede gennemsnitlig ændring fra baseline til uge 16 i POEM- og CDLQI-score.
English: The pharmacokinetics of dupilumab in paediatric patients (< 12 years of age) with atopic dermatitis has not been studied.
Danish: Farmakokinetikken af dupilumab hos pædiatriske patienter (< 12 år) med atopisk dermatitis er ikke blevet undersøgt.
English: Step 4: Wait 30 minutes
Danish: Trin 4: Vent 30 minutter
English: Conjunctivitis occurred more frequently in atopic dermatitis patients who received dupilumab.
Danish: Conjunctivitis forekom mere hyppigt hos patienter med atopisk dermatitis, som fik dupilumab.
English: This device is a single-use pre-filled pen.
Danish: Denne anordning er en fyldt pen til engangsbrug.
English: C. Give injection C1.
Danish: C. Sådan foretager du injektionen C1.
English: In addition, there was one patient with serum sickness and one with serum sickness-like reaction (< 0.1 %) associated with high ADA titers (see section 4.4).
Danish: Endvidere var der én patient med serumsygdom og én med en serumsygdomslignende reaktion (< 0,1 %) forbundet med høje titre af antistoffer mod lægemidlet (se pkt.
English: For single use only Read the package leaflet before use.
Danish: Kun til engangsbrug Læs indlægssedlen inden brug.
English: CAFE study evaluated the efficacy of dupilumab compared to placebo during a 16-week treatment period, administered with concomitant TCS, in adult patients with AD who are not adequately controlled with, or are intolerant to, oral ciclosporin, or when this treatment is currently contraindicated or not medically advisable.
Danish: CAFE studiet evaluerede effekten af dupilumab sammenlignet med placebo i løbet af en 16-ugers behandlingsperiode, ved samtidig administration med TKS hos voksne patienter med atopisk dermatitis, som ikke opnåede tilstrækkelig kontrol med, eller var intolerante over for oral ciclosporin, eller når denne behandling aktuelt er kontraindiceret eller ikke er tilrådelig fra et lægeligt synspunkt.
English: • Do not try to put the yellow cap back on the pre-filled pen.
Danish: • Forsøg ikke at sætte den gule hætte tilbage på den fyldte pen.
English: Look at the medicine through the window on the pre-filled pen.
Danish: Se på lægemidlet gennem den fyldte pens vindue.
English: Step 2: Prepare
Danish: Trin 2: Forberedelse
English: Placebo + TCS
Danish: Placebo + TKS
English: • Do not press or touch the orange needle cover with your fingers.
Danish: • Du må ikke trykke på eller røre den orange kanylebeskytter med fingrene.
English: Do not use the pre-filled pen if the expiration date has passed.
Danish: Brug ikke den fyldte pen, hvis udløbsdatoen er overskredet.
English: Remove yellow cap
Danish: Fjern den gule hætte
English: If you need to permanently remove the carton from the refrigerator, write down the date of removal in the space provided on the outer carton, and use Dupixent within 14 days.
Danish: Hvis du permanent skal fjerne kartonen fra køleskabet, skal du skrive datoen, hvorpå den tages ud af køleskabet, på det dertil beregnede sted på yderkartonen og bruge Dupixent inden for 14 dage.
English: The adverse event profile in adolescents was generally similar to the adults.
Danish: Bivirkningsprofilen hos unge var overvejende den samme som hos voksne.
English: VENTURE evaluated the effect of dupilumab on reducing the use of maintenance oral corticosteroids.
Danish: VENTURE-studiet undersøgte dupilumabs virkning på reduktion af vedligeholdelsesbehandling med orale kortikosteroider.
English: Do not inject through clothes.
Danish: Der må ikke injiceres gennem tøjet.
English: If you stop using Dupixent
Danish: Hvis du holder op med at bruge Dupixent
English: Clinical efficacy and safety in atopic dermatitis
Danish: Klinisk virkning og sikkerhed ved atopisk dermatitis
English: Baseline Characteristics
Danish: Karakteristika ved baseline
English: N Responder rate %
Danish: N Responsrate %
English: Asthma treatment guidelines define type 2 inflammation as eosinophilia ≥ 150 cells/mcL and/or FeNO ≥ 20 ppb.
Danish: Behandlingsvejledningerne for astma definerer type 2-inflammation som eosinofili ≥ 150 celler/mikrol og/eller FeNO ≥ 20 ppb.
English: • Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.
Danish: • Ubrugte injektionssprøjter skal opbevares i den oprindelige karton i køleskab ved 2-8 ºC.
English: Very rarely, Dupixent can cause serious side effects, including allergic (hypersensitivity) reactions and anaphylactic reaction.
Danish: I meget sjældne tilfælde kan Dupixent forårsage alvorlige bivirkninger, herunder allergiske (overfølsomheds-) reaktioner og anafylaktisk reaktion.
English: Do not use the pre-filled pen if the window is yellow.
Danish: Den fyldte pen må ikke bruges, hvis farven i vinduet er gul.
English: For clinical data in adults with atopic dermatitis please refer to the dupilumab 300 mg Summary of Product Characteristics.
Danish: For kliniske data hos voksne med atopisk dermatitis se venligst produktresumeet for dupilumab 300 mg.
English: Body Weight of Patient
Danish: Patientens kropsvægt
English: The most common adverse reaction was injection site erythema.
Danish: Den mest almindelige bivirkning var erytem på injektionsstedet.
English: Dupixent contains sodium
Danish: Dupixent indeholder natrium
English: Patients on dupilumab for moderate-to-severe atopic dermatitis who also have comorbid asthma should not adjust or stop their asthma treatments without consultation with their physicians.
Danish: Patienter, der behandles med dupilumab mod moderat til svær atopisk dermatits, og som også har komorbid astma, skal ikke justere eller stoppe deres astmabehandling uden at rådføre sig med egen læge.
English: Among asthma patients frequency of conjunctivitis was low and similar between dupilumab and placebo (see section
Danish: Hos astmapatienterne var hyppigheden af conjunctivitis lav og ens for dupilumab og placebo (se pkt.
English: The medium ICS dose was defined as equal to 500 mcg fluticasone or equivalent per day.
Danish: Mellem dosis af inhalationskortikosteroid blev defineret som 500 mikrog fluticason eller tilsvarende pr. dag.
English: Pull the yellow cap straight off.
Danish: Træk den gule hætte lige af.
English: Dupilumab-treated patients had a greater mean initial increase from baseline in eosinophil count compared to patients treated with placebo.
Danish: Patienter, som blev behandlet med dupilumab, oplevede en større gennemsnitlig initial stigning fra baseline i eosinofiltal sammenlignet med patienter, der blev behandlet med placebo.
English: • Stomach except for the 5 cm around your belly button (navel).
Danish: • Mave undtagen i de 5 cm omkring navlen.
English: Dupilumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called IL-4 and IL-13.
Danish: Dupilumab er et monoklonalt antistof (en type specialiseret protein), som blokerer virkningen af proteiner kaldet IL-4 og IL-13.
English: Parasitic (intestinal parasites) infection
Danish: Parasitinfektion (tarmparasitter)
English: The pre-filled syringe should not be exposed to heat or direct sunlight and should not be shaken.
Danish: Den fyldte injektionssprøjte må ikke udsættes for varme eller direkte sollys og må ikke rystes.
English: Eligible patients enrolled into this study had previous inadequate response to topical medication.
Danish: Egnede patienter, som deltog i studiet, havde tidligere udvist utilstrækkeligt respons på topikal behandling med et lægemiddel.
English: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis, conditions which are often treated with systemic corticosteroid therapy.
Danish: Patienter, der behandles for astma, kan få alvorlig systemisk eosinofili, som i nogle tilfælde optræder med kliniske symptomer på eosinofil pneumoni eller vaskulitis i overensstemmelse med eosinofil granulomatose med polyangiitis - tilstande som ofte behandles med systemisk kortikosteroidbehandling.
English: Serum sickness/serum sickness-like reactions
Danish: Serumsygdom/serumsygdomslignende reaktioner
English: The absolute bioavailability of dupilumab following a SC dose is similar between AD and asthma patients, ranging between 61% and 64 %, as determined by a population pharmacokinetics (PK) analysis.
Danish: Den absolutte biotilgængelighed af dupilumab efter en subkutan dosis er ens for AD-og astmapatienter og mellem 61 % og 64 % bestemt ud fra en farmakokinetisk populationsanalyse.
English: Efficacy with respect to severe asthma exacerbations and lung function was observed in both adolescents and adults.
Danish: Der blev observeret virkning på svære astmaeksacerbationer og lungefunktion hos både unge og voksne.
English: Rarely patients taking an asthma medicine may develop inflammation of blood vessels or lungs due to an increase of certain white blood cells (eosinophilia).
Danish: I sjældne tilfælde kan personer, der tager astmamedicin, udvikle en betændelseslignende tilstand (inflammation) i blodkarrene eller i lungerne på grund af et forhøjet antal af bestemte hvide blodlegemer (eosinofili).
English: Store in the original carton in order to protect from light.
Danish: Opbevares i den originale æske for at beskytte mod lys.
English: Contents of the pack and other information What Dupixent contains
Danish: Pakningsstørrelser og yderligere oplysninger Dupixent indeholder
English: A total of 2,888 adult and adolescent patients with moderate-to-severe asthma were evaluated in 3 randomised, placebo-controlled, multicentre trials of 24 to 52 weeks duration (DRI12544, QUEST, and VENTURE).
Danish: I alt 2.888 voksne og unge patienter med moderat til svær astma blev evalueret i 3 randomiserede, placebokontrollerede, multicenterstudier af 24-52 ugers varighed (DRI12544, QUEST og VENTURE).
English: Check if the liquid is clear and colourless to pale yellow.
Danish: Kontrollér om væsken er klar og farveløs til svagt gul.
English: Insert the Needle completely into the fold of skin at roughly a 45º angle.
Danish: Indfør kanylen helt i hudfolden i en vinkel på cirka 45º.
English: France sanofi-aventis france
Danish: Frankrig sanofi-aventis france
English: If the carton needs to be removed permanently from refrigerator, the date of removal may be recorded on the outer carton.
Danish: Hvis kartonen fjernes permanent fra køleskabet, skal datoen hvorpå den tages ud af køleskabet skrives på det dertil beregnede sted på yderkartonen.
English: Eligible patients enrolled into the three studies had previous inadequate response to topical medication.
Danish: Egnede patienter, som var tilmeldt disse tre studier, havde tidligere udvist utilstrækkeligt respons på lokalbehandling med medicin.
English: Of these, 2,678 had a history of 1 or more severe exacerbations in the year prior to enrolment despite regular use of medium-to-high dose inhaled corticosteroids plus an additional controller(s) (DRI12544 and QUEST).
Danish: Af disse patienter havde 2.678 haft tilfælde af 1 eller flere svære eksacerbationer i løbet af året før inklusion på trods af regelmæssig anvendelse af mellem til høj dosis inhalationskortikosteroid plus et eller flere yderligere lægemidler (DRI12544 og QUEST).
English: Conjunctivitis related events
Danish: Hændelser relateret til conjunctivitis
English: Other medicines and Dupixent
Danish: Brug af anden medicin sammen med Dupixent
English: • Ask your healthcare professional to show you the right way to use the syringe before you inject for the first time.
Danish: • Bed dit sundhedspersonale om at vise dig den korrekte måde at bruge injektionssprøjten på,
English: The recommended dose of dupilumab for adolescent patients 12 to 17 years of age is specified in Table 1.
Danish: Den anbefalede dosis af dupilumab til unge patienter i alderen 12-17 år er angivet i tabel 1.
English: Table 1: Dose of dupilumab for subcutaneous administration in adolescent patients 12 years to 17 years of age with atopic dermatitis Body Weight of Patient
Danish: Tabel 1: Dosis af dupilumab ved subkutan administration til unge patienter i alderen 12-17 år med atopisk dermatitis Patientens kropsvægt
English: The European Medicines Agency has deferred the obligation to submit the results of studies with dupilumab in one or more subset of the paediatric population in atopic dermatitis and asthma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Dupixent til behandling af atopisk dermatitis og astma i en eller flere undergrupper af den pædiatriske population (se pkt.
English: Inject your medicine immediately after removing the needle cap.
Danish: Injicer lægemidlet umiddelbart efter, du har taget kanylehætten af.
English: What you need to know before you use Dupixent Do not use Dupixent
Danish: Det skal du vide, før du begynder at bruge Dupixent Brug ikke Dupixent
English: Dupilumab can be used with or without topical corticosteroids.
Danish: Dupilumab kan anvendes med eller uden lokalbehandling med kortikosteroid.
English: Eczema herpeticum was reported in < 1 % of the dupilumab groups and in < 1 % of the placebo group in the 16-week atopic dermatitis monotherapy studies.
Danish: Eczema herpeticum blev rapporteret hos < 1 % af patienter i gruppen, som fik dupilumab, og hos < 1 % af patienter i placebogruppen i studierne med monoterapi på 16 uger ved atopisk dermatitis.
English: Safety and efficacy in paediatric patients (< 12 years of age) with severe asthma have not been established.
Danish: Sikkerhed og virkning hos pædiatriske patienter (< 12 år) med svær astma er ikke klarlagt.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: Navnet og batchnummeret af det administrerede produkt skal tydeligt registreres for at forbedre sporbarhed af biologiske lægemidler.
English: After removing the 300 mg pre-filled syringe from the refrigerator, it should be allowed to reach room temperature by waiting for 45 min before injecting Dupixent.
Danish: Efter den fyldte 300 mg injektionssprøjte tages ud af køleskabet, skal den have lov til at nå stuetemperatur ved at vente 45 min. inden injektion af Dupixent.
English: Dupixent helps prevent severe asthma attacks (exacerbations) and can improve your breathing.
Danish: Dupixent hjælper med at forebygge svære astmaanfald (eksacerbationer) og kan hjælpe dig til nemmere at trække vejret.
English: 81 Columbia Turnpike
Danish: Regeneron Pharmaceuticals Inc. 81 Columbia Turnpike Rensselaer
English: Population PK analysis did not identify mild or moderate renal impairment as having a clinically meaningful influence on the systemic exposure of dupilumab.
Danish: Farmakokinetisk populationsanalyse identificerede ikke mild eller moderat nedsat nyrefunktion som at have en klinisk meningsfuld indflydelse på den systemiske eksponering af dupilumab.
English: In addition, anxiety and depression symptoms as measured by the HADS total score were significantly reduced in the dupilumab groups compared to placebo at 16 weeks.
Danish: Endvidere var symptomerne på angst og depression, målt ved HADS samlet score, betydeligt reduceret i grupperne, som fik dupilumab, sammenlignet med placebo efter 16 uger.
English: If you use more Dupixent than you should or the dose has been given too early, talk to your doctor, pharmacist or nurse.
Danish: Hvis du har brugt for meget Dupixent, eller dosen er blevet givet for tidligt, skal du tale med lægen, apotekspersonalet eller sundhedspersonalet.
English: • Do not use the syringe if it has been dropped on a hard surface or damaged.
Danish: • Brug ikke injektionssprøjten, hvis den er blevet tabt på en hård overflade eller beskadiget.
English: 1 pre-filled pen 2 pre-filled pens 3 pre-filled pens 6 pre-filled pens
Danish: 1 fyldt pen 2 fyldte penne 3 fyldte penne 6 fyldte penne
English: To evaluate maintenance and durability of response, subjects treated with dupilumab for 16 weeks in SOLO 1 and SOLO 2 studies who achieved IGA 0 or 1 or EASI-75 were re-randomized in SOLO CONTINUE study to an additional 36-week treatment of dupilumab or placebo, for a cumulative 52week study treatment.
Danish: For at evaluere opretholdelse og varighed af respons, blev forsøgspersoner behandlet med dupilumab i 16 uger i SOLO 1 og SOLO 2 studierne, som opnåede IGA 0 eller 1 eller EASI-75, randomiseret i SOLO CONTINUE studiet til yderligere 36-ugers behandling med dupilumab eller placebo, for i alt 52-ugers studiebehandling.
English: Dupilumab compared with placebo was evaluated in 107 adolescent and 1,795 adult patients with persistent asthma on a medium-to-high dose inhaled corticosteroid (ICS) and a second controller medication.
Danish: Dupilumab blev sammenlignet med placebo hos 107 unge og 1.795 voksne patienter med persisterende astma, som blev behandlet med mellem til høj dosis inhalationskortikosteroid (ICS) og et yderligere lægemiddel.
English: Prepare the injection site
Danish: Klargør injektionsstedet
English: The safety profile observed was similar to that seen in adults.
Danish: Den observerede sikkerhedsprofil svarede til den observerede sikkerhedsprofil hos voksne.
English: Dupilumab is a fully human monoclonal antibody against interleukin (IL)-4 receptor alpha that inhibits IL-4/IL-13 signalling, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Danish: Dupilumab er et fuldt ud humant monoklonalt antistof mod interleukin (IL)-4 receptor alfa subunit, der hæmmer IL-4/IL-13 signalering, og som produceres i ovarieceller hos kinesiske hamstre (CHO) ved rekombinant DNA-teknologi.
English: Dupixent has also been shown to improve symptoms of pain, anxiety, and depression associated with atopic dermatitis.
Danish: Dupixent har også vist at forbedre symptomer på smerte, angst og depression i forbindelse med atopisk eksem.