FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no meaningful differences between doses.
Danish: Der var ingen betydningsfulde forskelle mellem doserne.
English: Percentage of Patients
Danish: Procentdel af patienter
English: • Check the expiry date (EXP).
Danish: • Tjek udløbsdatoen (EXP).
English: Age, gender, ethnicity and body weight
Danish: Alder, køn, etnicitet og kropsvægt
English: General health status was assessed by the Short Form health survey (SF-36).
Danish: Generel sundhedstilstand blev vurderet med Short Form health survey (SF-36).
English: Look at the window.
Danish: Kig på vinduet.
English: Less than 50
Danish: Under 50
English: • If you do not hear the second click, you should still check to see if the window has turned fully yellow.
Danish: • Hvis du ikke hører endnu et klik, skal du alligevel kontrollere om vinduet er blevet helt gult.
English: Interactions with CYP450 substrates
Danish: Interaktioner med CYP450-substrater
English: Table 6: Efficacy results for MONARCH
Danish: Tabel 6: Effektresultater for MONARCH
English: p-value versus adalimumab
Danish: p-værdi versus adalimumab
English: • There will be a “click” when the injection starts.
Danish: • Der lyder et “klik”, når injektionen begynder.
English: As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
Danish: Da infektioner generelt forekommer oftere i den ældre population, bør der udvises forsigtighed ved behandling af ældre.
English: • statins, used to reduce cholesterol level
Danish: • statiner, anvendes til at sænke kolesterolniveauet
English: Fatigue was assessed by the FACIT-Fatigue scale.
Danish: Træthed blev målt ud fra FACIT-Fatigue-skalaen.
English: Tell your doctor straight away if you think you have an infection (which may affect up to 1 in every 10 people).
Danish: Fortæl det straks til lægen, hvis du tror, at du har en infektion (kan forekomme hos op til 1 ud af 10 personer).
English: • The window will start to turn yellow.
Danish: • Vinduet begynder at blive gult.
English: Step A: Get ready for an injection 1.
Danish: Trin A: Forberedelse af injektion 1.
English: Simvastatin is a CYP3A4 and OATP1B1 substrate.
Danish: Simvastatin er et CYP3A4- og OATP1B1-substrat.
English: Look at the medicine.
Danish: Kig på medicinen.
English: If somebody else gives you the injection, you can also use the outer area of the upper arm.
Danish: Hvis en anden person giver dig indsprøjtningen, kan du også vælge ydersiden af overarmen.
English: If the window does not turn fully yellow, do not give yourself a second dose without speaking to your healthcare provider.
Danish: Hvis vinduet ikke bliver helt gult, må du ikke give dig selv en ekstra dosis uden at tale med lægen eller sundhedspersonalet.
English: Women of childbearing potential should use effective contraception during and up to 3 months after treatment.
Danish: Kvinder i den fødedygtige alder bør anvende effektiv prævention under og op til 3 måneder efter behandling.
English: Levels were reduced to normal as early as 4 days after treatment initiation.
Danish: Niveauet blev normaliseret allerede 4 dage efter initiering af behandlingen.
English: • you have ever had any type of cancer.
Danish: • hvis du har haft kræft.
English: • Your doctor may adjust the dose of your medicine based on results of blood tests.
Danish: • Din læge vil muligvis justere din dosis på baggrund af resultaterne af dine blodprøver.
English: There will be a second click.
Danish: Der lyder endnu et klik.
English: • You may see an air bubble, this is normal.
Danish: • Du kan måske se en luftboble.
English: Look at the label.
Danish: Kig på etiketten.
English: If it has been 3 days or less since the missed dose:
Danish: Hvis det er 3 dage eller mindre siden den glemte dosis:
English: Viral reactivation has been reported with immunosuppressive biologic therapies.
Danish: Viral reaktivering er blevet rapporteret med immunsuppressive biologiske lægemidler.
English: Do not inject a double dose to make up for a forgotten injection.
Danish: Du må ikke injicere en dobbeltdosis som erstatning for den glemte injektion.
English: Date of removal from the refrigerator: .../.../...
Danish: Dato for udtagning fra køleskab: .../.../...
English: The subsequent dose should be administered at the regularly scheduled time.
Danish: Den efterfølgende dosis skal administreres på det sædvanligt planlagte tidspunkt.
English: These parallel elimination pathways result in an initial half-life of 8 to 10 days, and at steady-state an effective halflife of 21 days is estimated.
Danish: Disse parallelle eliminationsveje resulterer i en initial halveringstid på 8-10 dage og en estimeret effektiv halveringstid ved steady-state på 21 dage.
English: Sarilumab This medicine is subject to additional monitoring.
Danish: Sarilumab Dette lægemiddel er underlagt supplerende overvågning.
English: Patients had at least 8 tender and 6 swollen joints at baseline.
Danish: Patienterne havde som minimum 8 ømme og 6 hævede led ved baseline.
English: Twist or pull off the orange cap.
Danish: Drej eller træk den orange hætte af.
English: Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with Kevzara.
Danish: Immunogenicitet Som for alle terapeutiske proteiner er der potentiale for immunogenicitet med Kevzara.
English: • theophylline, used to treat asthma
Danish: • theophyllin, anvendes til behandling af astma
English: These injection site reactions (including erythema and pruritus) were mild in severity for the majority of patients.
Danish: Disse reaktioner på injektionsstedet (inklusiv erytem og pruritus) var hos størstedelen af patienterne milde i sværhedsgrad.
English: These responses persisted through 3 years of therapy in an open-label extension study.
Danish: Disse responsrater blev opretholdt i 3 år med behandling i et åbent forlængelsesstudie.
English: In MOBILITY and TARGET, physical function and disability were assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI).
Danish: Fysisk funktionsevne og funktionsnedsættelse blev evalueret i MOBILITY og TARGET ud fra Health Assessment Questionnaire Disability Index (HAQ-DI).
English: • Make sure you can see the window.
Danish: • Sørg for, at du kan se vinduet på pennen.
English: • Check that you have the correct medicine and the correct dose.
Danish: • Tjek at du har den rigtige medicin og den rigtige dosis.
English: There are no or limited amount of data from the use of sarilumab in pregnant women.
Danish: Der foreligger ingen eller kun begrænsede data for anvendelse af sarilumab hos gravide kvinder.
English: The patient alert card shall contain the following key messages:
Danish: Patientkortet skal indeholde følgende vigtige oplysninger:
English: Check to see if the entire window has turned yellow before you remove the pen.
Danish: Kontroller om vinduet er blevet helt gult, før du fjerner pennen.
English: Pharmacotherapeutic group: Immunosupressants, Interleukin inhibitors, ATC code: L04AC14
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, interleukinhæmmere, ATC-kode: L04AC14
English: Distribution In patients with RA, the apparent volume of distribution at steady state was 8.3 L.
Danish: Fordeling Hos patienter med RA var det tilsyneladende fordelingsvolumen ved steady-state 8,3 l.
English: Sarilumab was detected in the serum of neonates up to 1 month.
Danish: Sarilumab blev påvist i serum fra nyfødte i op til 1 måned.
English: Do not stop using Kevzara without talking to your doctor.
Danish: Du må ikke stoppe med at bruge Kevzara uden først at tale med din læge.
English: Lipid levels may be reduced in patients with chronic inflammation.
Danish: Lipidniveauer kan være nedsat hos patienter med kronisk inflammation.
English: Check that you have the correct medicine and the correct dose.
Danish: Kontrollere at du har den rigtige medicin og den rigtige dosis.
English: Patients should be advised to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction.
Danish: Patienter skal tilrådes at søge øjeblikkelig lægehjælp, hvis de får symptomer på en overfølsomhedsreaktion.
English: Active Comparator-controlled Study
Danish: Aktiv komparator-kontrolleret studie
English: The detection of an immune response is highly dependent on the sensitivity and specificity of the assays used and testing conditions.
Danish: Måling af immunrespons er i høj grad afhængig af de anvendte analysers følsomhed og specificitet og af testforholdene.
English: • cold sores (oral herpes)
Danish: • Forkølelsessår (oral herpes)
English: If anaphylaxis or other hypersensitivity reaction occurs, administration of Kevzara should be stopped immediately.
Danish: Hvis der opstår anafylaksi eller anden overfølsomhedsreaktion, skal administration af Kevzara øjeblikkeligt stoppes.
English: • if you have an active severe infection.
Danish: - hvis du har en aktiv, alvorlig infektion.
English: EU/1/17/1196/005 EU/1/17/1196/006 EU/1/17/1196/007 EU/1/17/1196/008 EU/1/17/1196/009 EU/1/17/1196/010 EU/1/17/1196/011 EU/1/17/1196/012
Danish: EU/1/17/1196/001 EU/1/17/1196/002 EU/1/17/1196/003 EU/1/17/1196/004 EU/1/17/1196/005 EU/1/17/1196/006 EU/1/17/1196/007 EU/1/17/1196/008 EU/1/17/1196/009 EU/1/17/1196/010 EU/1/17/1196/011 EU/1/17/1196/012
English: To allow for a direct comparison of frequency of laboratory abnormalities between placebo and active treatment, data from weeks 0-12 were used as this was prior to patients being permitted to switch from placebo to Kevzara.
Danish: For at kunne foretage en direkte sammenligning af hyppigheden for abnorme laboratorieværdier ved placebo og aktiv behandling, blev data fra uge 0-12 anvendt, da dette var før patienterne kunne skifte fra placebo til Kevzara.
English: Step B: Perform the injection - Perform Step B only after completing Step A “Get ready for an injection”
Danish: Trin B: Sådan foretager du injektionen - Du må først udføre Trin B, når du har gennemgået Trin A “Forberedelse af injektion”
English: Table 3: Clinical Response at Weeks 12, 24, and 52 in Placebo-Controlled Studies, MOBILITY and TARGET
Danish: Tabel 3: Klinisk respons ved uge 12, 24 og 52 i de placebokontrollerede studier MOBILITY og TARGET
English: Treatment with immunosuppressants may result in an increased risk of malignancies.
Danish: Behandling med immunsuppressive lægemidler kan medføre øget risiko for maligne sygdomme.
English: ALT > 1 to 3 x Upper Limit of Normal (ULN)
Danish: ALAT > 1 til 3 x øvre grænse for normal (ULN)
English: In both MOBILITY and TARGET, higher ACR20 response rates were observed within 2 weeks compared to placebo and were maintained for the duration of the studies (see Figures 1 and 2).
Danish: I både MOBILITY og TARGET blev der observeret højere ACR20-responsrater inden for 2 uger sammenlignet med placebo og disse blev opretholdt i studiernes varighed (se Figur 1 og 2).
English: The safety of Kevzara in combination with DMARDs was evaluated based on data from seven clinical studies, of which two were placebo-controlled, consisting of 2887 patients (long- term safety population).
Danish: Kevzaras sikkerhed i kombination med DMARDs blev vurderet på grundlag af data fra syv kliniske studier, hvoraf to var placebokontrollerede og inkluderede 2.887 patienter (langtidssikkerhedspopulation).
English: A more than dose-proportional increase in pharmacokinetic exposure was observed in patients with RA.
Danish: En mere dosisproportional stigning i farmakokinetisk eksponering blev observeret hos patienter med RA.
English: No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving Kevzara.
Danish: Der foreligger ingen data for sekundær overførsel af infektion fra personer via levende vacciner til patienter, som får Kevzara.
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: For at forbedre sporbarheden af biologiske lægemidler skal handelsnavnet samt batchummer på det administrerede lægemiddel tydeligt registreres.
English: ANC greater than 1
Danish: ANC over 1
English: ANC less than 0.5
Danish: ANC under 0,5
English: In addition to this leaflet, you will be given a patient alert card, which contains important safety information that you need before and during treatment with Kevzara.
Danish: Udover denne indlægsseddel vil du få udleveret et patientkort med vigtige sikkerhedsoplysninger, som du skal bruge før og under behandling med Kevzara.
English: Traceability of Kevzara
Danish: Sporbarhed af Kevzara
English: The most commonly reported infections (5% to 7% of patients) were upper respiratory tract infections, urinary tract infections, and nasopharyngitis.
Danish: De hyppigst rapporterede infektioner (5%-7% af patienterne) var øvre luftvejsinfektioner, urinvejsinfektioner og nasofaryngitis.
English: • Slowly push the plunger down as far as it will go until the syringe is empty.
Danish: • Tryk langsomt stemplet helt i bund, indtil sprøjten er tom.
English: Hypercholesterolemia Hypertriglyceridemia
Danish: Hyperkolesterolæmi Hypertriglyceridæmi
English: At higher concentrations, the elimination is predominantly through the linear, non-saturable proteolytic pathway, while at lower concentrations, non-linear saturable target-mediated elimination predominates.
Danish: Ved højere koncentrationer sker eliminationen hovedsageligt gennem lineær, umættet, proteolytisk elimination, mens non-lineær saturabel, målmedieret elimination er fremherskende ved lavere koncentrationer.
English: However, if you are feeling tired or unwell after you use Kevzara, you should not drive or use machines.
Danish: Hvis du imidlertid føler dig træt eller utilpas efter du er blevet behandlet med Kevzara, bør du ikke køre bil eller motorcykel eller betjene maskiner.
English: When clinically indicated, consider other liver function tests such as bilirubin.
Danish: Når det er klinisk indiceret, bør andre leverfunktionstests, f.eks. bilirubin, overvejes.
English: Major clinical response¶
Danish: Større klinisk respons¶
English: It is a type of protein called a monoclonal antibody.
Danish: Det er en type protein kaldet monoklonalt antistof.
English: As a monoclonal antibody sarilumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Danish: Som monoklonalt antistof forventes sarilumab at blive nedbrudt til små Peptider og aminosyrer via katabolske metaboliseringsveje på samme måde som endogent IgG.
English: Prepare all the equipment you will need on a clean, flat working surface.
Danish: Klargør udstyret på en ren, plan arbejdsflade.
English: Kevzara is not recommended in children and adolescents under 18 years of age.
Danish: Kevzara frarådes til børn og unge under 18 år.
English: Population pharmacokinetic analyses in adult patients with RA (ranging in age from18 to 88 years with 14% over 65 years) showed that age, gender and race did not meaningfully influence the pharmacokinetics of sarilumab.
Danish: Farmakokinetiske populationsanalyser med voksne patienter med RA (i alderen 18 til 88 år hvoraf 14% var over 65 år) viste, at alder, køn og race ikke har nogen relevant indflydelse på sarilumabs farmakokinetik.
English: • Do not take Kevzara if you are pregnant unless your doctor specifically recommends it.
Danish: • Du må ikke bruge Kevzara, hvis du er gravid, medmindre din læge udtrykkeligt har anbefalet det.
English: This is to check if you have a low blood cell count, liver problems, or changes in your cholesterol levels.
Danish: Det er for at kontrollere, om du har for få blodlegemer, leverproblemer eller ændringer i dit kolesteroltal.
English: MOBILITY evaluated 1197 patients with RA who had inadequate clinical response to MTX.
Danish: MOBILITY undersøgte 1.197 patienter med RA, som havde et utilstrækkeligt klinisk respons på MTX.
English: • you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, listlessness, mild fever), or have been in close contact with someone with TB.
Danish: • hvis du har tuberkulose (TB), symptomer på TB (vedvarende hoste, vægttab, sløvhed, let feber) eller har været i tæt kontakt med en person, som har TB.
English: • Check that the liquid is clear and colourless to pale yellow.
Danish: • Tjek at væsken er klar og farveløs til lys gullig.
English: p-value versus adalimumab *Includes patients who increased the frequency of dosing of adalimumab 40 mg to every week because of an inadequate response
Danish: p-værdi versus adalimumab *Omfatter patienter, hvor doseringshyppigheden med adalimumab 40 mg blev øget til hver 2. uge på grund af utilstrækkelig respons
English: Missed dose
Danish: Glemt dosering
English: It is unknown whether sarilumab is excreted in human milk or absorbed systemically after ingestion.
Danish: Det vides ikke, om sarilumab udskilles i modermælk eller absorberes systemisk efter indtagelse.
English: Decrease in ANC was not associated with higher incidence of infections, including serious infections.
Danish: Fald i ANC var ikke associeret med en større forekomst af infektioner, herunder alvorlige infektioner.
English: Push the plunger down.
Danish: Tryk stemplet ned.
English: DAS28-ESR (primary endpoint)
Danish: DAS28-ESR (primært endepunkt)
English: Kevzara is given as an injection under the skin (called “subcutaneous” injection).
Danish: Kevzara indgives som en indsprøjtning under huden (kaldet subkutan injektion).
English: The results of the components of the ACR response criteria at Week 24 for MOBILITY and TARGET are shown in Table 4.
Danish: Resultaterne for komponenterne i ACR-responskriteriet ved uge 24 for MOBILITY og TARGET er vist i Tabel 4.
English: The total content (1.14 ml) of the pre-filled syringe/pre-filled pen should be administered as a subcutaneous injection.
Danish: Hele indholdet (1,14 ml) af den fyldte injektionssprøjte/fyldte pen administreres som subkutan injektion.
English: No long-term animal studies have been performed to establish the carcinogenicity potential of sarilumab.
Danish: Der er ikke udført langtidsstudier på dyr for at fastslå sarilumabs karcinogene potentiale.
English: Sarilumab is eliminated by parallel linear and non-linear pathways.
Danish: Sarilumab udskilles via parallel lineære og non-lineære metaboliseringsveje.
English: The symptoms may include fever, sweats, or chills.
Danish: Symptomerne kan være feber, svedudbrud eller kulderystelser.
English: • The active substance is sarilumab.
Danish: • Aktivt stof: sarilumab.
English: TARGET evaluated 546 patients with RA who had an inadequate clinical response or were intolerant to one or more TNF-α antagonists.
Danish: TARGET undersøgte 546 patienter med RA, som havde et utilstrækkeligt klinisk respons eller ikke tålte en eller flere TNF-α antagonister.
English: Elderly: No dose adjustment is required in patients over 65 years of age (see section 4.4).
Danish: Ældre: Dosisjustering er ikke nødvendig hos patienter over 65 år (se pkt.
English: • The effects of Kevzara on an unborn baby are not known.
Danish: • Det er ukendt hvordan Kevzara påvirker det ufødte barn.
English: The efficacy of sarilumab with concomitant DMARDs on inhibition of radiographic progression that was assessed as part of the primary endpoints at Week 52 in MOBILITY was sustained up to three years from the start of treatment.
Danish: Effekten af sarilumab og samtidigt administrerede DMARDs til hæmning af radiografisk progression, som blev undersøgt som en del af de primære endepunkter ved uge 52 i MOBILITY blev opretholdt i op til tre år fra behandlingsstart.
English: Table 4: Mean reductions from baseline to Week 24 in components of ACR score
Danish: Tabel 4: Gennemsnitlig reduktion fra baseline til uge 24 i komponenterne i ACR-score
English: • Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action.
Danish: • Kevzara kobler sig til et andet protein kaldet interleukin-6 (IL-6)-receptor og hæmmer dets virkning.
English: Treatment with Kevzara + MTX was associated with significantly less radiographic progression of structural damage as compared with placebo.
Danish: Behandling med Kevzara + MTX var associeret med signifikant mindre radiografisk progression af strukturel skade sammenlignet med placebo.
English: • slowing down damage to joints
Danish: • bremse skaderne på dine led
English: Non-clinical data reveal no special hazard for humans based on repeated-dose toxicity studies, carcinogenic risk assessment and reproductive and developmental toxicity studies.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra toksicitetsstudier efter gentagne doser, risikovurdering af karcinogenicitet samt reproduktions- og udviklingstoksicitetsstudier.
English: • inject your missed dose as soon as you can.
Danish: • injicer den glemte dosis, så snart som muligt.
English: The pre-filled syringe/pre-filled pen should be inspected before use.
Danish: Den fyldte injektionssprøjte/fyldte pen bør undersøges før brug.
English: Kevzara should not be used during pregnancy unless the clinical condition of the woman requires treatment with sarilumab.
Danish: Kevzara bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand nødvendiggør behandling med Kevzara.
English: Table 5: Mean Radiographic Change from Baseline at Week 24 and Week 52 in MOBILITY
Danish: Tabel 5: Gennemsnitlig radiografisk ændring fra baseline ved uge 24 og uge 52 i MOBILITY
English: In the event of an overdose, the patient should be closely monitored, treated symptomatically, and supportive measures instituted as required.
Danish: I tilfælde af overdosering bør patienten overvåges tæt, behandles symptomatisk og passende behandling iværksættes efter behov.
English: Do not use if the window is solid yellow.
Danish: Du må ikke bruge pennen, hvis vinduet er helt gult.
English: Lipid parameters (LDL, HDL, and triglycerides) were first assessed at 4 weeks following initiation of Kevzara+ DMARDs in the placebo-controlled population.
Danish: Lipidparametre (LDL, HDL og triglycerider) blev vurderet første gang ved uge 4 efter initiering af Kevzara + DMARDs i den placebokontrollerede population.
English: The metabolic pathway of sarilumab has not been characterised.
Danish: Sarilumabs metaboliseringsvej er ikke blevet beskrevet.
English: In particular, do not use Kevzara and tell your doctor or pharmacist if you are using:
Danish: Du må især ikke anvende Kevzara og skal fortælle det til lægen eller apotekspersonalet, hvis du bruger:
English: The median tmax after a single subcutaneous dose was observed in 2 to 4 days.
Danish: Efter en subkutan enkeltdosis blev median tmax observeret i 2-4 dage.
English: Prior to launch of Kevzara in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of patient alert card, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Danish: Inden lancering af Kevzara i hvert medlemsland skal indehaveren af markedsføringstilladelsen være enig med den nationale kompetente myndighed om indholdet og formatet af patientkortet, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter.
English: It may help you by:
Danish: Kevzara kan hjælpe dig ved at:
English: In isolated cases, disseminated rather than localised infections were observed in patients often taking concomitant immunosuppressants such as MTX or corticosteroids, which in addition to RA may predispose them to infections.
Danish: I enkeltstående tilfælde blev der observeret disseminerede snarere end lokale infektioner hos patienter, som ofte fik samtidig behandling med immunsuppressiva som f.eks. MTX eller kortikosteroid, som ud over RA kan prædisponere dem for infektioner.
English: Kevzara has not been investigated in combination with Janus kinase (JAK) inhibitors or biological DMARDs such as Tumor Necrosis Factor (TNF) antagonists.
Danish: Kevzara er ikke undersøgt i kombination med Janus kinase (JAK)-hæmmere eller biologiske DMARDs som f.eks. tumornekrosefaktor(TNF)-antagonister.