FrancophonIA/ELRC3.0 huggingface dataset:
English: A patient may self-inject dupilumab or the patient's caregiver may administer dupilumab if their healthcare professional determines that this is appropriate.
Danish: En patient kan selv injicere dupilumab, eller patientens omsorgsperson kan administrere dupilumab, hvis sundhedspersonalet anser det for passende.
English: B. Choose your injection site B1.
Danish: B. Vælg injektionssted B1.
English: Both play a major role in causing the signs and symptoms of asthma.
Danish: De spiller begge to en stor rolle med hensyn til at forårsage tegn og symptomer på astma.
English: Annualized rate of severe asthma exacerbation events during the 24-week placebo controlled treatment period was also determined.
Danish: Den årlige forekomst af svære astmaeksacerbationer i den placebokontrollerede behandlingsperiode af 24 ugers varighed blev ligeledes vurderet.
English: 60 kg or more
Danish: 60 kg eller derover
English: The primary endpoint was the proportion of patients with EASI-75 at week 16.
Danish: Det primære endepunkt var andelen af patienter med EASI-75 ved uge 16.
English: All Severe Exacerbations DRI12544 study Dupilumab
Danish: Alle svære eksacerbationer DRI12544-studiet Dupilumab
English: Check the medicine
Danish: Kontrollér lægemidlet
English: For the 200 mg every other week dose, patients had a reduction in the rate of severe exacerbations that was consistent with adults.
Danish: For dosis på 200 mg hver anden uge oplevede patienterne en reduktion i hyppigheden af svære eksacerbationer, som var overensstemmende med voksne.
English: Secondary endpoint (week 24)a Proportion of patients achieving a reduction of OCS dose to <5 mg/day
Danish: Sekundært endepunkt (uge 24)a Andel af patienter, der opnåede reduktion af oral kortikosteroiddosis til <5 mg/dag
English: Very limited data are available in patients with severe renal impairment.
Danish: Meget begrænsede data er tilgængelige hos patienter med alvorligt nedsat nyrefunktion.
English: Percent reduction from baseline
Danish: Procentvis reduktion fra baseline
English: DRI12544 was a 24-week dose-ranging study which included 776 patients (18 years of age and older).
Danish: DRI12544 var et 24 ugers dosisbestemmende studie, der inkluderede 776 patienter (18 år og derover).
English: In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
Danish: I tilfælde af en overdosis skal patienten monitoreres for tegn eller symptomer på bivirkninger, og passende symptomatisk behandling skal indledes.
English: Week 16 (FAS)b
Danish: Uge 16 (FAS)b
English: The improvement in pruritus NRS occurred in conjunction with the improvement of objective signs of atopic dermatitis.
Danish: Forbedringen i NRS for kløe forekom i forbindelse med forbedringen af objektive tegn på atopisk dermatitis.
English: Atopic Medical History % Overall (AD %, NP %, AR %)
Danish: Anamnese med atopiske lidelser % i alt (AD %, NP %, AR %)
English: If somebody else administers the injection, the upper arm can also be used.
Danish: Hvis en anden person administrerer injektionen, kan overarmen ligeledes anvendes.
English: A volume of distribution for dupilumab of approximately 4.6 L was estimated by population PK analysis, indicating that dupilumab is distributed primarily in the vascular system.
Danish: Et fordelingsvolumen for dupilumab på cirka 4,6 liter blev estimeret ved farmakokinetisk populationsanalyse, hvilket angav, at dupilumab hovedsaglig fordeles i det vaskulære system.
English: Eosinophil counts declined to near baseline levels during study treatment.
Danish: Eosinofiltal faldt til omkring baseline-niveau i løbet af studiebehandlingen.
English: Time out of refrigeration should not exceed a maximum of 14 days at temperature below 25 °C.
Danish: Tid uden for køleskab må ikke overstige højst 14 dage ved temperaturer under 25 °C.
English: Blocking the IL-4/IL-13 pathway with dupilumab in patients decreases many of the mediators of type 2 inflammation.
Danish: Ved at blokere IL-4/IL-13 signalvejen med dupilimab hos patienter mindskes mange af mediatorerne for type 2-inflammation.
English: Due to nonlinear clearance, dupilumab exposure, as measured by area under the concentration-time curve, increases with dose in a greater than proportional manner following single SC doses from 75600 mg.
Danish: På grund af non-linear clearance stiger dupilumab-eksponering, målt ved arealet under koncentrationstidskurven, mere end proportionalt med dosen efter enkeltvise subkutane doser på 75600 mg.
English: This usually, but not always, happens in people who also take a steroid medicine which is being stopped or for which the dose is being lowered.
Danish: Tilstanden forekommer som regel, men ikke altid, hos personer, der enten skal stoppe med at tage deres steroidmedicin eller sænke dosis af deres steroidmedicin.
English: Live and live attenuated vaccines should not be given concurrently with dupilumab as clinical safety and efficacy has not been established.
Danish: Levende og levende svækkede vacciner bør ikke gives samtidigt med dupilumab, eftersom klinisk sikkerhed og virkning ikke er fastlagt.
English: If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your doctor.
Danish: Hvis du har astma og tager astmamedicin, skal du ikke ændre eller stoppe din astmamedicin uden at tale med din læge.
English: Step 4: Wait 45 minutes
Danish: Trin 4: Vent 45 minutter
English: • Dispose of the pre-filled pens, (needle inside), and yellow caps in a puncture resistant container right away after use.
Danish: • Bortskaf den fyldte pen, (kanyle indeni) og den gule hætte i en beholder til skarpe genstande straks efter brug
English: • a puncture-resistant container* (See Step 12)
Danish: • en beholder til skarpe genstande* (se trin 12)
English: SOLO 2 at Week 16
Danish: SOLO 2 ved uge 16
English: Press the pre-filled pen firmly against your skin until you cannot see the orange needle cover, and hold.
Danish: Tryk den fyldte pen fast mod huden, indtil du ikke kan se den orange kanylebeskytter og hold den der.
English: Dupixent may be used with eczema medicines that you apply to the skin or it may be used on its own.
Danish: Dupixent kan bruges samtidig med lægemidler til eksem, som du smører på huden, eller det kan bruges alene.
English: You and your doctor or nurse should decide if you should inject Dupixent yourself.
Danish: Du og din læge eller sygeplejerske skal beslutte, om du selv skal injicere Dupixent.
English: No reduction or any increase in OCS dose, or dropped out of study
Danish: Ingen reduktion eller stigning i oral kortikosteroiddosis, eller udgik af studiet
English: Common (may affect up to 1 in 10 people) atopic dermatitis only:
Danish: Almindelig (kan forekomme op til 1 ud af 10 personer) kun atopisk dermatitis:
English: Patients with known helminth infections were excluded from participation in clinical studies.
Danish: Patienter, som vides at have ormeinfektioner, var udelukket fra deltagelse i de kliniske studier.
English: Dupixent is unlikely to influence your ability to drive and use machines.
Danish: Det er usandsynligt, at Dupixent vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: At Week 12
Danish: Ved uge 12
English: Do not put the yellow cap back on the pre-filled pen after you have removed it.
Danish: Du må ikke sætte den gule hætte tilbage på den fyldte pen, når du først har taget den af.
English: All patients were on oral corticosteroids for at least 6 months prior to the study initiation.
Danish: Alle patienter havde fået behandling med oral kortikosteroid i mindst 6måneder forud for studiets begyndelse.
English: The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient's level of asthma control.
Danish: Der bør mindst én gang årligt træffes beslutning om at fortsætte behandlingen på baggrund af en lægelig vurdering af patientens niveau af astmakontrol.
English: Primary and secondary endpoints for the 52 week SOLO CONTINUE study are summarized in table 7.
Danish: Primære og sekundære endepunkter for 52 ugers SOLO CONTINUE studiet er sammenfattet i tabel 7.
English: The primary endpoint was change from baseline to week 12 in FEV1 (L).
Danish: Det primære endepunkt var ændring fra baseline til uge 12 i FEV1 (l).
English: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of conditions for which dupilumab is indicated (see section 4.1).
Danish: Behandling skal indledes af sundhedspersonale med erfaring i diagnose og behandling af de tilstande, som dupilumab er indiceret til (se pkt.
English: A decision must be made whether to discontinue breast-feeding or to discontinue dupilumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med dupilumab seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Dupixent contains the active substance dupilumab.
Danish: Dupixent indeholder det aktive stof dupilumab.
English: Very Common (may affect more than 1 in 10 people) atopic dermatitis and asthma: • injection site reactions (i.e. redness, swelling, and itching)
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) atopisk dermatitis og astma: • reaktioner på injektionsstedet (dvs. rødme, hævelse og kløe)
English: Carcinogenicity studies have not been conducted with dupilumab.
Danish: Karcinogenicitetsstudier er ikke blevet udført med dupilumab.
English: After removal from the refrigerator, Dupixent must be used within 14 days or discarded.
Danish: Efter Dupixent tages ud af køleskabet, skal det bruges inden for 14 dage eller kasseres.
English: Steroid reductions should be accomplished gradually (see section 4.4).
Danish: Reducering af steroiddosis bør ske gradvist (se pkt.
English: Immune responses to vaccination were assessed in a study in which patients with atopic dermatitis were treated once weekly for 16 weeks with 300 mg of dupilumab.
Danish: Immunrespons på vaccination blev vurderet i et studie, hvor patienter med atopisk dermatitis blev behandlet med 300 mg dupilumab en gang om ugen i 16 uger.
English: % patients with FeNO ppb
Danish: Patienter i % med FeNO ppb
English: - if you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using Dupixent.
Danish: - hvis du tror, at du kan være allergisk, eller ikke er sikker, skal du søge råd hos din læge, apotekspersonalet eller sundhedspersonalet, inden du bruger Dupixent.
English: Dupilumab 200 mg (<60 kg) and
Danish: Dupilumab 200 mg (<60 kg) og
English: No dose adjustment is needed in patients with mild or moderate renal impairment.
Danish: Ingen dosisjustering er nødvendig hos patienter med mild til moderat nedsat nyrefunktion.
English: Systemic, topical, or inhaled corticosteroids should not be discontinued abruptly upon initiation of therapy with dupilumab.
Danish: Systemiske, topikale eller inhalerede kortikosteroider bør ikke seponeres pludseligt efter initiering af behandling med dupilumab.
English: The mutagenic potential of dupilumab has not been evaluated; however monoclonal antibodies are not expected to alter DNA or chromosomes.
Danish: Dupilumabs mutagene potentiale er ikke blevet evalueret, men monoklonale antistoffer forventes ikke at ændre DNA eller kromosomer.
English: Dupixent is not a rescue medicine and should not be used to treat a sudden asthma attack.
Danish: Dupixent er ikke en anfaldsmedicin og bør ikke anvendes til behandling af pludselige astmaanfald.
English: An evaluation of the available evidence related to IL-4Rα inhibition and animal toxicology data with surrogate antibodies does not suggest an increased carcinogenic potential for dupilumab.
Danish: En evaluering af det tilgængelige data relateret til IL-4Rα-hæmning og toksikologiske data fra dyremodeller med surrogat-antistoffer angiver ikke et øget karcinogent potentiale for dupilumab.
English: Clinical efficacy and safety in asthma
Danish: Klinisk virkning og sikkerhed ved astma
English: Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Danish: Reduktion af kortikosteroiddosis kan være associeret med systemiske seponeringssymptomer og/eller afsløre tilstande, som hidtil har været holdt nede af systemisk kortikosteroidbehandling.
English: Dupilumab trough concentrations were lower in subjects with higher body weight with no meaningful impact on efficacy.
Danish: De laveste koncentrationer af dupilumab var lavere hos forsøgspersoner med højere kropsvægt uden nogen meningsfuld påvirkning på effekt.
English: Patients continued to receive their existing asthma medicine during the study; however their OCS dose was reduced every 4 weeks during the OCS reduction phase (week 4-20), as long as asthma control was maintained.
Danish: Patienterne fortsatte med at tage deres eksisterende astmamedicin i løbet af studiet, men deres orale kortikosteroid-dosis blev reduceret hver 4. uge i reduktionsfasen (uge 4-20), så længe deres astmakontrol blev opretholdt.
English: Pinch a fold of skin at the injection site, as shown in the picture.
Danish: Klem en hudfold på injektionsstedet som vist på billedet.
English: At Week 52
Danish: Ved uge 52
English: SOLO 1 at Week 16
Danish: SOLO 1 ved uge 16
English: SANOFI WINTHROP INDUSTRIE 1051 Boulevard Industriel, 76580 LE TRAIT, FRANCE
Danish: Sanofi Winthrop Industrie 1051 Boulevard Industriel, 76580 Le Trait, Frankrig
English: Tell your doctor or pharmacist - if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, - hvis du bruger anden medicin eller har gjort det for nylig.
English: At higher concentrations, dupilumab elimination is primarily through a non-saturable proteolytic pathway, while at lower concentrations, the non-linear saturable IL-4R α target-mediated elimination predominates.
Danish: Ved højere koncentrationer sker eliminering hovedsagligt gennem en non-saturabel proteolytisk pathway, mens den ikke-linære, saturable IL-4Rα target-medierede elimination dominerer ved lavere koncentrationer.
English: • You can inject into your thigh or belly (stomach), except for the 5 cm around your navel.
Danish: • Du kan foretage injektionen i låret eller på maven (abdomen), undtagen i de 5 cm omkring navlen.
English: Specific metabolism studies were not conducted because dupilumab is a protein.
Danish: Der blev ikke udført specifikke undersøgelser af stofskifte, da dupilumab er et protein.
English: If needed to control intolerable symptoms, patients were permitted to receive rescue treatment at the discretion of the investigator.
Danish: Hvis det var nødvendigt at kontrollere uudholdelige symptomer, kunne patienter få yderligere behandling efter investigators skøn.
English: Concomitant Use of TCS CHRONOS at Week 16
Danish: Samtidig brug af TKS CHRONOS ved uge 16
English: points compared to placebo at week 2 (p <0.01).
Danish: point sammenlignet med placebo ved uge 2 (p < 0,01).
English: Treatment effects in subgroups (weight, age, gender, race, and background treatment, including immunosuppressants) in CHRONOS were consistent with the results in the overall study population.
Danish: Behandlingseffekter i undergrupper (vægt, alder, køn, race og baggrundsbehandling, herunder immunsuppressiva) i CHRONOS var overensstemmende med resultaterne for den samlede studiepopulation.
English: Efficacy data from this study suggests that clinical benefit provided at week 16 was sustained through week 52.
Danish: Effektdata fra studiet tyder på, at den kliniske fordel set i uge 16 blev opretholdt til og med uge 52.
English: Additional secondary endpoints included mean change from baseline to week 16 in the Patient Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), and Hospital Anxiety and Depression Scale (HADS) scores.
Danish: Yderligere sekundære endepunkter inkluderede gennemsnitlig ændring fra baseline til uge 16 i scorerne på Patient Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), og Hospital Anxiety and Depression Scale (HADS).
English: You and your doctor should decide if you will breast-feed or use Dupixent.
Danish: Du og din læge bør beslutte, om du skal amme eller bruge Dupixent.
English: The most common adverse reactions were injection site reactions, conjunctivitis, blepharitis, and oral herpes.
Danish: De mest almindelige bivirkninger var reaktioner på injektionsstedet, conjunctivitis, øjenlågsbetændelse og oral herpes.
English: • If somebody else gives you the injection, they can also use your upper arm.
Danish: • Hvis en anden person giver dig injektionen, kan de desuden bruge din overarm.
English: • a puncture-resistant container* (See Step D)
Danish: • en beholder til skarpe genstande* (se trin D)
English: Inject Dupixent yourself only after you have been trained by your doctor or nurse.
Danish: Du må først injicere Dupixent selv, efter du har modtaget undervisning af din læge eller sygeplejerske.
English: In these 5 trials, 1,689 subjects were treated with subcutaneous injections of dupilumab, with or without concomitant topical corticosteroids (TCS).
Danish: I disse 5 studier blev 1.689 forsøgspersoner behandlet med subkutane injektioner af dupilumab med eller uden TKS.
English: The ACQ-5 and AQLQ(S) were also assessed in VENTURE and showed improvements similar to those in QUEST.
Danish: ACQ-5 og AQLQ(S) blev ligeledes evalueret i VENTURE og viste resultater, der lignede resultaterne fra QUEST.
English: If patients become infected while receiving treatment with dupilumab and do not respond to antihelminth treatment, treatment with dupilumab should be discontinued until infection resolves.
Danish: Hvis patienter bliver inficerede under behandling med dupilumab og ikke udviser respons på ormebehandling, skal behandling med dupilumab stoppes, indtil infektionen går væk.
English: Of the 1,977 patients with asthma exposed to dupilumab, a total of 240 patients were 65 years or older and 39 patients were 75 years or older.
Danish: Af de 1.977 astmapatienter, som fik dupilumab, var i alt 240 patienter 65 år eller derover, og 39 patienter var 75 år eller derover.
English: Using Dupixent for atopic dermatitis (atopic eczema) can improve the condition of your skin and reduce itching.
Danish: Anvendelse af Dupixent til atopisk eksem (atopisk dermatitis) kan forbedre hudens tilstand og reducere kløe.
English: The baseline mean oral corticosteroid use was 11.75 mg in the placebo group and 10.75 mg in the group receiving dupilumab.
Danish: Gennemsnitlig kortikosteroidanvendelse ved baseline var 11,75 mg i placebogruppen og 10,75 mg i gruppen, der fik dupilumab.
English: The primary endpoint was the percent reduction in oral corticosteroid dose assessed in the overall population, based on a comparison of the oral corticosteroid dose at weeks 20 to 24 that maintained asthma control with the previously optimized (at baseline) oral corticosteroid dose.
Danish: Det primære endepunkt var den procentvise reduktion af oral kortikosteroid-dosis vurderet i den samlede population og baseret på en sammenligning af oral kortikosteroid-dosis ved uge 20-24 (som opretholdt astmakontrol) med den tidligere optimerede (ved baseline) orale kortikosteroid-dosis.
English: Dupilumab inhibits IL-4 signaling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα).
Danish: Dupilumab hæmmer IL-4 signalering via Type I-receptoren (IL-4Rα/γc), og både IL-4 og IL-13 signalering via Type II-receptoren (IL-4Rα/IL-13Rα).
English: If needed to control intolerable symptoms of atopic dermatitis, patients were permitted to receive rescue treatment (which included higher potency topical steroids or systemic immunosuppressants) at the discretion of the investigator.
Danish: Hvis det var nødvendigt at kontrollere uudholdelige symptomer på atopisk dermatitis, kunne patienter få yderligere behandling (som inkluderede lokalbehandling med steroider med en højere styrke eller systemiske immunsuppressiva) efter investigators skøn.
English: Table 6: Results of the primary and secondary endpoints in CAFE study Placebo + TCS
Danish: Tabel 6: Resultater af de primære og sekundære endepunkter i CAFE studiet Placebo + TKS
English: Overall, 92.0% of patients had at least one co-morbid allergic condition; 65.6% had allergic rhinitis, 53.6% had asthma, and 60.8% had food allergies.
Danish: Samlet set havde 92,0 % af patienterne mindst en komorbid allergisk lidelse; 65,6 % havde allergisk rinitis, 53,6 % havde astma og 60,8 % havde fødevareallergi.
English: Mean FeNO ppb (± SD)
Danish: Gennemsnitlig FeNO ppb (± SD)
English: Primary and secondary endpoints for the 16 week CAFE study are summarized in table 6.
Danish: Primære og sekundære endepunkter for CAFE studiet på 16 uger er sammenfattet i tabel 6.
English: Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia.
Danish: Lægen skal være opmærksom på vaskulitis-relateret udslæt, forværrede pulmonale symptomer, hjertekomplikationer og/eller neuropati hos patienter med eosinofili.
English: Patients with comorbid asthma should be monitored carefully following discontinuation of dupilumab.
Danish: Patienter med komorbid astma skal nøje monitoreres efter ophør med dupilumab.
English: Of the 1,472 patients with atopic dermatitis exposed to dupilumab in a phase 2 dose-ranging study or phase 3 placebo-controlled studies, a total of 67 were 65 years or older.
Danish: Ud af de 1.472 patienter med atopisk dermatitis, som blev eksponeret for dupilumab i et fase 2-, dosisbestemmende studie eller fase 3-, placebokontrollerede studier, var i alt 67 patienter 65 år eller derover.
English: A larger percentage of patients randomised to placebo needed rescue treatment (topical corticosteroids, systemic corticosteroids, or systemic non-steroidal immunosuppressants) as compared to the dupilumab group (58.8% and 20.7%, respectively).
Danish: En større procentdel af de patienter, der blev randomiseret til placebo, havde behov for yderligere behandling (topikal behandling med kortikosteroid, systemiske kortikosteroider eller systemiske nonsteroide immunsuppressiva) sammenlignet med dupilumab-gruppen (henholdsvis 58,8 % og 20,7 %).
English: For single use only Subcutaneous use
Danish: Kun til engangsbrug Subkutan brug
English: Key Secondary Endpoints
Danish: Hovedsekundære endepunkter
English: It is recommended that patients should be brought up to date with live and live attenuated immunisations in agreement with current immunisation guidelines prior to treatment with dupilumab.
Danish: Det anbefales, at patienter vaccineres med levende og levende svækkede vacciner i overenstemmelde med gældende retningslinjer før behandling med dupilumab.
English: Patients received dupilumab or placebo with concomitant use of TCS starting at baseline using a standardized regimen.
Danish: Patienter fik dupilumab eller placebo med samtidig brug af TKS fra baseline ifølge et standardiseret regimen.
English: If dupilumab treatment interruption becomes necessary, patients can still be successfully re-treated.
Danish: Hvis det bliver nødvendigt at afbryde behandlingen med dupilumab, kan patienten efterfølgende genoptage behandlingen på succesfuld vis.
English: Patients requiring a third controller were allowed to participate in this trial.
Danish: Patienter, der havde behov for et tredje lægemiddel kunne også deltage i studiet.
English: Anti-Drug-Antibodies (ADA) responses were not generally associated with impact on dupilumab exposure, safety, or efficacy.
Danish: Respons i form af antistoffer mod lægemidlet (ADA - Anti-Drug-Antibodies) påvirkede generelt ikke eksponering, sikkerhed eller effekt af dupilumab.
English: • Do not inject through clothes.
Danish: • Der må ikke injiceres gennem tøjet.
English: • Do not get rid of any air bubbles in the syringe.
Danish: • Fjern ikke eventuelle luftbobler i injektionssprøjten.