natgillin/translations-raw huggingface dataset:
Dupixent hjælper desuden med at forbedre dine søvnforstyrrelser og den generelle livskvalitet. 
In addition, Dupixent helps improve your sleep disturbance and overall quality of life.
IL-4 og IL-13 er hovedaktører i human type 2-inflammatorisk sygdom, såsom atopisk dermatitis og astma. 
IL-4 and IL-13 are major drivers of human type 2 inflammatory disease, such as atopic dermatitis and asthma.
Der blev ikke observeret aldersrelaterede farmakokinetiske forskelle hos unge patienter efter korrektion for legemsvægt. 
No age-related pharmacokinetic difference was observed in adolescent patients after correction for body weight.
Co-primære endepunkter 
Co-Primary Endpoints
Efter en enkelt subkutan dosis af 75-600 mg dupilumab var den gennemsnitlige tid til maksimal koncentration i serum (tmax) 3-7 dage. 
After a single subcutaneous (SC) dose of 75-600 mg dupilumab, median times to maximum concentration in serum (tmax) were 3-7 days.
• 1 alkoholserviet* 
• 1 alcohol wipe*
4.4 for information om levende vacciner. 
For information on live vaccines see section 4.4.
Hvis du allerede har en parasitinfektion, skal den behandles, inden du begynder behandling med Dupixent. 
If you already have a parasitic infection it should be treated before you start treatment with Dupixent.
Uge 52 (FAS uge 52)b 
Week 52 (FAS Week 52)b
Tabel 7: Resultater af primære og sekundære endepunkter i SOLO CONTINUE studiet Placebo 
Table 7: Results of the primary and secondary endpoints in SOLO CONTINUE study Placebo
En patient kan selv injicere dupilumab, eller patientens omsorgsperson kan administrere dupilumab, hvis sundhedspersonalet anser det for passende. 
A patient may self-inject dupilumab or the patient's caregiver may administer dupilumab if their healthcare professional determines that this is appropriate.
B. Vælg injektionssted B1. 
B. Choose your injection site B1.
De spiller begge to en stor rolle med hensyn til at forårsage tegn og symptomer på astma. 
Both play a major role in causing the signs and symptoms of asthma.
Den årlige forekomst af svære astmaeksacerbationer i den placebokontrollerede behandlingsperiode af 24 ugers varighed blev ligeledes vurderet. 
Annualized rate of severe asthma exacerbation events during the 24-week placebo controlled treatment period was also determined.
60 kg eller derover 
60 kg or more
Det primære endepunkt var andelen af patienter med EASI-75 ved uge 16. 
The primary endpoint was the proportion of patients with EASI-75 at week 16.
Alle svære eksacerbationer DRI12544-studiet Dupilumab 
All Severe Exacerbations DRI12544 study Dupilumab
Kontrollér lægemidlet 
Check the medicine
For dosis på 200 mg hver anden uge oplevede patienterne en reduktion i hyppigheden af svære eksacerbationer, som var overensstemmende med voksne. 
For the 200 mg every other week dose, patients had a reduction in the rate of severe exacerbations that was consistent with adults.
Sekundært endepunkt (uge 24)a Andel af patienter, der opnåede reduktion af oral kortikosteroiddosis til <5 mg/dag 
Secondary endpoint (week 24)a Proportion of patients achieving a reduction of OCS dose to <5 mg/day
Meget begrænsede data er tilgængelige hos patienter med alvorligt nedsat nyrefunktion. 
Very limited data are available in patients with severe renal impairment.
Procentvis reduktion fra baseline 
Percent reduction from baseline
DRI12544 var et 24 ugers dosisbestemmende studie, der inkluderede 776 patienter (18 år og derover). 
DRI12544 was a 24-week dose-ranging study which included 776 patients (18 years of age and older).
I tilfælde af en overdosis skal patienten monitoreres for tegn eller symptomer på bivirkninger, og passende symptomatisk behandling skal indledes. 
In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
Uge 16 (FAS)b 
Week 16 (FAS)b
Forbedringen i NRS for kløe forekom i forbindelse med forbedringen af objektive tegn på atopisk dermatitis. 
The improvement in pruritus NRS occurred in conjunction with the improvement of objective signs of atopic dermatitis.
Anamnese med atopiske lidelser % i alt (AD %, NP %, AR %) 
Atopic Medical History % Overall (AD %, NP %, AR %)
Hvis en anden person administrerer injektionen, kan overarmen ligeledes anvendes. 
If somebody else administers the injection, the upper arm can also be used.
Et fordelingsvolumen for dupilumab på cirka 4,6 liter blev estimeret ved farmakokinetisk populationsanalyse, hvilket angav, at dupilumab hovedsaglig fordeles i det vaskulære system. 
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.
Eosinofiltal faldt til omkring baseline-niveau i løbet af studiebehandlingen. 
Eosinophil counts declined to near baseline levels during study treatment.
Tid uden for køleskab må ikke overstige højst 14 dage ved temperaturer under 25 °C. 
Time out of refrigeration should not exceed a maximum of 14 days at temperature below 25 °C.
Ved at blokere IL-4/IL-13 signalvejen med dupilimab hos patienter mindskes mange af mediatorerne for type 2-inflammation. 
Blocking the IL-4/IL-13 pathway with dupilumab in patients decreases many of the mediators of type 2 inflammation.
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. 
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.
Tilstanden forekommer som regel, men ikke altid, hos personer, der enten skal stoppe med at tage deres steroidmedicin eller sænke dosis af deres steroidmedicin. 
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.
Levende og levende svækkede vacciner bør ikke gives samtidigt med dupilumab, eftersom klinisk sikkerhed og virkning ikke er fastlagt. 
Live and live attenuated vaccines should not be given concurrently with dupilumab as clinical safety and efficacy has not been established.
Hvis du har astma og tager astmamedicin, skal du ikke ændre eller stoppe din astmamedicin uden at tale med din læge. 
If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your doctor.
Trin 4: Vent 45 minutter 
Step 4: Wait 45 minutes
• Bortskaf den fyldte pen, (kanyle indeni) og den gule hætte i en beholder til skarpe genstande straks efter brug 
• Dispose of the pre-filled pens, (needle inside), and yellow caps in a puncture resistant container right away after use.
• en beholder til skarpe genstande* (se trin 12) 
• a puncture-resistant container* (See Step 12)
SOLO 2 ved uge 16 
SOLO 2 at Week 16
Tryk den fyldte pen fast mod huden, indtil du ikke kan se den orange kanylebeskytter og hold den der. 
Press the pre-filled pen firmly against your skin until you cannot see the orange needle cover, and hold.
Dupixent kan bruges samtidig med lægemidler til eksem, som du smører på huden, eller det kan bruges alene. 
Dupixent may be used with eczema medicines that you apply to the skin or it may be used on its own.
Du og din læge eller sygeplejerske skal beslutte, om du selv skal injicere Dupixent. 
You and your doctor or nurse should decide if you should inject Dupixent yourself.
Ingen reduktion eller stigning i oral kortikosteroiddosis, eller udgik af studiet 
No reduction or any increase in OCS dose, or dropped out of study
Almindelig (kan forekomme op til 1 ud af 10 personer) kun atopisk dermatitis: 
Common (may affect up to 1 in 10 people) atopic dermatitis only:
Patienter, som vides at have ormeinfektioner, var udelukket fra deltagelse i de kliniske studier. 
Patients with known helminth infections were excluded from participation in clinical studies.
Det er usandsynligt, at Dupixent vil påvirke din evne til at føre motorkøretøj og betjene maskiner. 
Dupixent is unlikely to influence your ability to drive and use machines.
Ved uge 12 
At Week 12
Du må ikke sætte den gule hætte tilbage på den fyldte pen, når du først har taget den af. 
Do not put the yellow cap back on the pre-filled pen after you have removed it.
Alle patienter havde fået behandling med oral kortikosteroid i mindst 6måneder forud for studiets begyndelse. 
All patients were on oral corticosteroids for at least 6 months prior to the study initiation.
Der bør mindst én gang årligt træffes beslutning om at fortsætte behandlingen på baggrund af en lægelig vurdering af patientens niveau af astmakontrol. 
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.
Primære og sekundære endepunkter for 52 ugers SOLO CONTINUE studiet er sammenfattet i tabel 7. 
Primary and secondary endpoints for the 52 week SOLO CONTINUE study are summarized in table 7.
Det primære endepunkt var ændring fra baseline til uge 12 i FEV1 (l). 
The primary endpoint was change from baseline to week 12 in FEV1 (L).
Behandling skal indledes af sundhedspersonale med erfaring i diagnose og behandling af de tilstande, som dupilumab er indiceret til (se pkt. 
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of conditions for which dupilumab is indicated (see section 4.1).
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. 
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.
Dupixent indeholder det aktive stof dupilumab. 
Dupixent contains the active substance dupilumab.
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) atopisk dermatitis og astma: • reaktioner på injektionsstedet (dvs. rødme, hævelse og kløe) 
Very Common (may affect more than 1 in 10 people) atopic dermatitis and asthma: • injection site reactions (i.e. redness, swelling, and itching)
Karcinogenicitetsstudier er ikke blevet udført med dupilumab. 
Carcinogenicity studies have not been conducted with dupilumab.
Efter Dupixent tages ud af køleskabet, skal det bruges inden for 14 dage eller kasseres. 
After removal from the refrigerator, Dupixent must be used within 14 days or discarded.
Reducering af steroiddosis bør ske gradvist (se pkt. 
Steroid reductions should be accomplished gradually (see section 4.4).
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. 
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.
Patienter i % med FeNO ppb 
% patients with FeNO ppb
- 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. 
- if you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using Dupixent.
Dupilumab 200 mg (<60 kg) og 
Dupilumab 200 mg (<60 kg) and
Ingen dosisjustering er nødvendig hos patienter med mild til moderat nedsat nyrefunktion. 
No dose adjustment is needed in patients with mild or moderate renal impairment.
Systemiske, topikale eller inhalerede kortikosteroider bør ikke seponeres pludseligt efter initiering af behandling med dupilumab. 
Systemic, topical, or inhaled corticosteroids should not be discontinued abruptly upon initiation of therapy with dupilumab.
Dupilumabs mutagene potentiale er ikke blevet evalueret, men monoklonale antistoffer forventes ikke at ændre DNA eller kromosomer. 
The mutagenic potential of dupilumab has not been evaluated; however monoclonal antibodies are not expected to alter DNA or chromosomes.
Dupixent er ikke en anfaldsmedicin og bør ikke anvendes til behandling af pludselige astmaanfald. 
Dupixent is not a rescue medicine and should not be used to treat a sudden asthma attack.
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. 
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.
Klinisk virkning og sikkerhed ved astma 
Clinical efficacy and safety in asthma
Reduktion af kortikosteroiddosis kan være associeret med systemiske seponeringssymptomer og/eller afsløre tilstande, som hidtil har været holdt nede af systemisk kortikosteroidbehandling. 
Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
De laveste koncentrationer af dupilumab var lavere hos forsøgspersoner med højere kropsvægt uden nogen meningsfuld påvirkning på effekt. 
Dupilumab trough concentrations were lower in subjects with higher body weight with no meaningful impact on efficacy.
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. 
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.
Klem en hudfold på injektionsstedet som vist på billedet. 
Pinch a fold of skin at the injection site, as shown in the picture.
Ved uge 52 
At Week 52
SOLO 1 ved uge 16 
SOLO 1 at Week 16
Sanofi Winthrop Industrie 1051 Boulevard Industriel, 76580 Le Trait, Frankrig 
SANOFI WINTHROP INDUSTRIE 1051 Boulevard Industriel, 76580 LE TRAIT, FRANCE
Fortæl altid lægen eller apotekspersonalet, - hvis du bruger anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist - if you are using, have recently used or might use any other medicines.
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. 
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.
• Du kan foretage injektionen i låret eller på maven (abdomen), undtagen i de 5 cm omkring navlen. 
• You can inject into your thigh or belly (stomach), except for the 5 cm around your navel.
Der blev ikke udført specifikke undersøgelser af stofskifte, da dupilumab er et protein. 
Specific metabolism studies were not conducted because dupilumab is a protein.
Hvis det var nødvendigt at kontrollere uudholdelige symptomer, kunne patienter få yderligere behandling efter investigators skøn. 
If needed to control intolerable symptoms, patients were permitted to receive rescue treatment at the discretion of the investigator.
Samtidig brug af TKS CHRONOS ved uge 16 
Concomitant Use of TCS CHRONOS at Week 16
point sammenlignet med placebo ved uge 2 (p < 0,01). 
points compared to placebo at week 2 (p <0.01).
Behandlingseffekter i undergrupper (vægt, alder, køn, race og baggrundsbehandling, herunder immunsuppressiva) i CHRONOS var overensstemmende med resultaterne for den samlede studiepopulation. 
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.
Effektdata fra studiet tyder på, at den kliniske fordel set i uge 16 blev opretholdt til og med uge 52. 
Efficacy data from this study suggests that clinical benefit provided at week 16 was sustained through week 52.
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). 
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.
Du og din læge bør beslutte, om du skal amme eller bruge Dupixent. 
You and your doctor should decide if you will breast-feed or use Dupixent.
De mest almindelige bivirkninger var reaktioner på injektionsstedet, conjunctivitis, øjenlågsbetændelse og oral herpes. 
The most common adverse reactions were injection site reactions, conjunctivitis, blepharitis, and oral herpes.
• Hvis en anden person giver dig injektionen, kan de desuden bruge din overarm. 
• If somebody else gives you the injection, they can also use your upper arm.
• en beholder til skarpe genstande* (se trin D) 
• a puncture-resistant container* (See Step D)
Du må først injicere Dupixent selv, efter du har modtaget undervisning af din læge eller sygeplejerske. 
Inject Dupixent yourself only after you have been trained by your doctor or nurse.
I disse 5 studier blev 1.689 forsøgspersoner behandlet med subkutane injektioner af dupilumab med eller uden TKS. 
In these 5 trials, 1,689 subjects were treated with subcutaneous injections of dupilumab, with or without concomitant topical corticosteroids (TCS).
ACQ-5 og AQLQ(S) blev ligeledes evalueret i VENTURE og viste resultater, der lignede resultaterne fra QUEST. 
The ACQ-5 and AQLQ(S) were also assessed in VENTURE and showed improvements similar to those in QUEST.
Hvis patienter bliver inficerede under behandling med dupilumab og ikke udviser respons på ormebehandling, skal behandling med dupilumab stoppes, indtil infektionen går væk. 
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.
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. 
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.
Anvendelse af Dupixent til atopisk eksem (atopisk dermatitis) kan forbedre hudens tilstand og reducere kløe. 
Using Dupixent for atopic dermatitis (atopic eczema) can improve the condition of your skin and reduce itching.
Gennemsnitlig kortikosteroidanvendelse ved baseline var 11,75 mg i placebogruppen og 10,75 mg i gruppen, der fik dupilumab. 
The baseline mean oral corticosteroid use was 11.75 mg in the placebo group and 10.75 mg in the group receiving dupilumab.
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. 
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.
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). 
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).
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. 
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.
Tabel 6: Resultater af de primære og sekundære endepunkter i CAFE studiet Placebo + TKS 
Table 6: Results of the primary and secondary endpoints in CAFE study Placebo + TCS
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. 
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.
Gennemsnitlig FeNO ppb (± SD) 
Mean FeNO ppb (± SD)
Primære og sekundære endepunkter for CAFE studiet på 16 uger er sammenfattet i tabel 6. 
Primary and secondary endpoints for the 16 week CAFE study are summarized in table 6.
Lægen skal være opmærksom på vaskulitis-relateret udslæt, forværrede pulmonale symptomer, hjertekomplikationer og/eller neuropati hos patienter med eosinofili. 
Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia.
Patienter med komorbid astma skal nøje monitoreres efter ophør med dupilumab. 
Patients with comorbid asthma should be monitored carefully following discontinuation of dupilumab.
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. 
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.
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 %). 
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).
Kun til engangsbrug Subkutan brug 
For single use only Subcutaneous use
Hovedsekundære endepunkter 
Key Secondary Endpoints
Det anbefales, at patienter vaccineres med levende og levende svækkede vacciner i overenstemmelde med gældende retningslinjer før behandling med dupilumab. 
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.
Patienter fik dupilumab eller placebo med samtidig brug af TKS fra baseline ifølge et standardiseret regimen. 
Patients received dupilumab or placebo with concomitant use of TCS starting at baseline using a standardized regimen.
Hvis det bliver nødvendigt at afbryde behandlingen med dupilumab, kan patienten efterfølgende genoptage behandlingen på succesfuld vis. 
If dupilumab treatment interruption becomes necessary, patients can still be successfully re-treated.
Patienter, der havde behov for et tredje lægemiddel kunne også deltage i studiet. 
Patients requiring a third controller were allowed to participate in this trial.
Respons i form af antistoffer mod lægemidlet (ADA - Anti-Drug-Antibodies) påvirkede generelt ikke eksponering, sikkerhed eller effekt af dupilumab. 
Anti-Drug-Antibodies (ADA) responses were not generally associated with impact on dupilumab exposure, safety, or efficacy.
• Der må ikke injiceres gennem tøjet. 
• Do not inject through clothes.
• Fjern ikke eventuelle luftbobler i injektionssprøjten. 
• Do not get rid of any air bubbles in the syringe.
Hvis opløsningen er uklar, misfarvet eller indeholder synlige partikler, må opløsningen ikke bruges. 
If the solution is cloudy, discoloured or contains visible particulate matter, the solution should not be used.